 |
 |
 |
|
 |
FDA Home Page | Search
FDA Site
| FDA A-Z Index | Contact
FDA | FDA Centennial
Issues 3 – 9 (Responses to ANPRM Questions)
May 19, 2006
Final
Prepared by
ICF International
Fairfax, VA
3.1 - Yes
3.2 - No
3.3 - FD&C Act and amendments
3.3.1 - FD&C Act requires rulemaking.
3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
3.3.3 - Other arguments related to FD&C Act
3.4 - Administrative Procedures Act (APA) arguments
3.5 - Supplemental New Drug Application (SNDA) and New Drug Application (NDA) regulations
3.5.1 - SNDA/NDA regulatory arguments supporting rulemaking
3.5.2 - SNDA/NDA regulatory arguments opposing rulemaking
3.6 - Court opinion legal arguments
3.6.1 - Court case arguments supporting a rulemaking
3.6.2 - Court case arguments opposing a rulemaking
3.7 - Other legal arguments
3.7.1 - Other legal arguments supporting rulemaking
3.7.2 - Other legal arguments opposing rulemaking
3.8 - Policy arguments
3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
3.8.3 - Other policy arguments for initiating a rulemaking
3.8.4 - Interpretation is clear in present form
3.8.5 - Circumstances for OTC safety are case-specific
3.8.6 - Develop/update guidance as alternative for rulemaking
3.8.7 - Cost-benefit concerns regarding rulemaking
3.8.8 - Other policy arguments opposing a rulemaking
3.9 - Examples of previous FDA actions in allowing simultaneous marketing of Rx and OTC products
3.9.1 - Drug approval examples
3.9.2 - FDA guidance or other documents (e.g., FDA 1999 Manual of Policy and Procedures (MAPP) statements, testimony, letters to industry, Q&As)
3.9.3 - Veterinary drug policy
3.9.4 - Other examples
3.10 - Examples of FDA actions disallowing simultaneous marketing
3.11 - Miscellaneous arguments/discussions
4 - Is there significant confusion regarding interpretation of section 503(b) of the act? [ANPRM Q 1.B.]
4.1 - Yes
4.2 - No
4.3 - Arguments supporting significant confusion regarding FDA's interpretation
4.3.1 - FDA's interpretation of FD&C Act 505(b)(2) conflicts with interpretation of 503(b)
4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
4.4 - Arguments indicating that little or no confusion exists
4.4.1 - Legal arguments that little or no confusion exists
4.4.2 - Policy arguments that little or no confusion exists
4.5 - Miscellaneous arguments/discussions
5 - Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.]
5.1 - Yes
5.2 - No
5.3 - Arguments that support concept that a rulemaking would provide clarification
5.3.1 - Legal arguments supporting rulemaking to dispel confusion
5.3.2 - Policy arguments supporting rulemaking to dispel confusion
5.4 - Arguments that a rulemaking would not provide clarification
5.4.1 - Legal arguments that rulemaking would not clarify
5.4.2 - Policy arguments that rulemaking would not clarify
5.4.2.1 - Guidance instead of rulemaking
5.4.2.2 - Other policy arguments
5.4.3 - There is no confusion, therefore rulemaking unnecessary
5.5 - Miscellaneous arguments/discussions
6 - If FDA limited sale of OTC product to sub-population, would FDA be able to enforce limitation as a matter of law? [ANPRM Q 2.A.]
6.1 - Yes
6.2 - No
6.3 - Legal/policy arguments that support/detail FDA's authority to enforce limitation on availability of OTC products by sub-population
6.3.1 - FD&C Act
6.3.2 - No laws prevent the policy
6.3.3 - Court cases
6.3.4 - Age limitations are in line with other meaningful differences
6.3.5 - Other legal/policy arguments
6.4 - Examples/precedents that support/detail FDA's authority to enforce limitation on availability of OTC products by sub-population
6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
6.4.2 - Other examples
6.5 - Legal/policy arguments that FDA does not have authority to enforce the limitation (or permit dual marketing or implement "behind-the-counter" (pharmacist distribution) system)
6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
6.5.2 - Other FD&C Act arguments
6.5.3 - Court cases
6.5.4 - Other arguments
6.6 - Authority of other entities to enforce the limitation
6.6.1 - State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines)
6.6.2 - Congress
6.6.3 - Alcohol and tobacco enforcement
6.6.4 - Other entities
6.7 - Miscellaneous arguments/discussions
7 - Would FDA be able to enforce limitation to sub-population as a practical matter? [ANPRM Q 2.B.]
7.1 - Yes
7.2 - No
7.3 - Actions FDA could take in order to enforce limitation of an OTC product to a sub-population
7.3.1 - Regulate product sponsor
7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
7.3.1.2 - Require retailer, pharmacist, and consumer education programs
7.3.1.3 - Require risk management program...
7.3.1.4 - Other product approval conditions
7.3.2 - Other FDA enforcement practices that it has the legal authority to put in place
7.4 - Other point-of-sale enforcement suggestions
7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
7.4.2 - Involve other authorities (e.g., states, state boards of pharmacies)
7.4.3 - Monitor compliance and enforcement / conduct random inspections
7.4.4 - Require identification for age
7.4.5 - Pursue criminal actions against violators
7.4.6 - Other actions
7.5 - FDA will be unable or it will be difficult to enforce as a practical matter
7.5.1 - FDA does not have authority to enforce limitation, and it cannot enforce as a practical matter
7.5.2 - Infrastructure for FDA enforcement (e.g., resources, personnel, training, monitoring, third-party regulations) not in place
7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
7.5.4 - Other arguments
7.6 - Miscellaneous arguments/discussions
8 - Assuming legal to market both, may the prescription (Rx) and OTC products be legally sold in the same package? [ANPRM Q 3.A.]
8.1 - Yes
8.2 - No
8.3 - Legal arguments supporting one package label for Rx and OTC sales
8.3.1 - FD&C Act arguments (e.g., single label could be created that satisfies both sets of statutory requirements)
8.3.2 - Do not need separate National Drug Code (NDC) numbers
8.3.3 - Court cases
8.3.4 - Other legal arguments supporting one package label
8.4 - Policy arguments supporting one package label for Rx and OTC sales
8.4.1 - Other policy arguments supporting one package label
8.5 - Legal arguments opposing one package for Rx and OTC sales
8.5.1 - FD&C Act - Legal differences between statutory requirements for Rx and OTC
8.5.2 - Court cases arguments opposing one package
8.5.3 - Need separate National Drug Code (NDC) numbers for billing
8.5.4 - Other legal arguments opposing one package
8.6 - Policy arguments opposing one package for Rx and OTC sales
8.6.1 - Single package contrary to meaningful difference standard
8.6.2 - Risk of medication errors or threats to patient safety
8.6.3 - Same packaging permits/encourages trading/swapping
8.6.4 - Other arguments opposing one package
8.7 - Examples of Rx and OTC labeling that is similar but with one or two differences - e.g., dosage/age distinction
8.8 - Examples of similar labeling of Rx and OTC products that are the same drug and dose, in the market place or previously marketed
8.9 - Miscellaneous arguments/discussions
9 - If they can be legally sold in same package, under what circumstances would it be inappropriate to do so? [ANPRM Q 3.B.]
9.1 - Circumstances in which it is inappropriate to distribute products in a single package
9.1.1 - Specific circumstances
9.1.2 - All circumstances (i.e., it's always inappropriate)
9.2 - Circumstance in which it is appropriate to distribute in single package
9.2.1 - Specific circumstances
9.2.2 - All circumstances (i.e., it's always appropriate, there are no inappropriate circumstances)
9.3 - Miscellaneous arguments/discussions
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 24
Excerpt Status: NEW
Excerpt Text:
III. FDA Must Initiate And Complete Full Rulemaking Proceedings In Order To Institute The Simultaneous Dual Marketing Of The Same Rx/OTC Drug Product
FDA has asked whether it should proceed with notice and comment rulemaking to codify the FDA's interpretation of Section 503(b) as to when a drug can be dually marketed as OTC and by prescription, since FDA historically has not allowed marketing of the same active ingredient in a prescription for one population and OTC for another. The brief answer is yes.
Commenter Organization Name: White, Molly
Comment Number: 2005N-0345-EC107
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Sure. Rules are great. Everyone knows the game plan when regulations exist, provided they are short, clear and to the point.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Black, Jerrold
Comment Number: 2005N-0345-EC111
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Mershon, Claire-Helene
Comment Number: 2005N-0345-EC12379
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Yes. Plan B should be available OTC, and while I disagree that it should be split between OTC and prescription, I understand the concerns of the FDA in taking the action for women under 16. However, this should not keep the FDA from keeping it off of the shelves completely. If an active ingredient is judged to be safe for use OTC by women, it should be sold that way. If it is necessary to make the drug prescription for one population in order for that to happen, then the FDA should review its rules and allow the drug to be available in both forms.
Commenter Organization Name: Dougherty, Anne
Comment Number: 2005N-0345-EC126
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
The rulemaking in question is of utmost importance in regards to health and safety of citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that rulemaking on this issue would dispel the confusion that is along with this section 503(b).
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product because the lack of legislation has created interpretations that have had some success but whose scope is not broad enough to address concerns that arise outside of their margins that focus primarily on the safety to the consumer. In the absence of such codification we find misspent FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and pharmaceutical companies, and specific needs of members of our society have been put on hold while the FDA balks in this decision making process. In codifying the aforementioned interpretation of section 503(b), the FDA could maximize its procedural efficiency and increase its service level output to the nation which would generate broader levels of satisfaction to society's needs.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Addressed in this comment are the reasons why I believe there should be an imitative in rulemaking and following are the comments on certain concerns.
Commenter Organization Name: Connors, Meaghan
Comment Number: 2005N-0345-EC141
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes. Doing so would move this prolonged, highly politicized process.
Commenter Organization Name: Soriano, Lauren
Comment Number: 2005N-0345-EC14388
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
The Food and Drug Administration should initiate rulemaking in order to see if an active ingredient can be simultaneously marketed in both a prescription and over-the-counter drug. However, there has to be stipulations on the over-the-counter drug because if the same active ingredient is in both the prescription product and the over-the-counter product, then what would be the purpose of a prescription drug. People would just flock to the OTC drug, since it is so accessible.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
If 503(b) does not allow for the simultaneous marketing of a drug based on age or other factors, it should be amended. Precedences exist for such substances such as alcohol and tobacco products to be marketed based on age. The purchase of other non-ingestible items are certainly marketed by age, mental competency, criminal convictions, etc.. This is not a difficult and/or complexed procedure.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This too is not a difficult or complexed task. If an amendmentis - based on changing circumstances warrants - obvious and needed, than the change(s) should made based on procedural issues and not politics or ideological leanings.
Commenter Organization Name: Loomis, Shirley
Comment Number: 2005N-0345-EC147
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, provided the drug is safe for distribution.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Codifying an interpretation can only help--make it clear exactly why and when a drug is being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but medical.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, I believe a rulemaking is in order.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.4 - Administrative Procedures Act (APA) arguments
Excerpt Text:
The FDA should not render a decision affecting millions of Americans without allowing full notice and comment by physicians and patients, pursuant to a formal rulemaking proceeding. The Administrative Procedures Act (APA) requires notice and comment prior to promulgation of a new rule, and there is no valid reason to deny public input on the important issue of marketing an active ingredient as both a prescription drug and over-the-counter (OTC) drug. AAPS objects to any attempt by the FDA to bypass notice and comment procedures in connection with Section 503(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Durham-Humphrey Amendments, which governs the classification of drugs.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 3.4 - Administrative Procedures Act (APA) arguments
Excerpt Text:
In sum, AAPS objects to any assertion in authority by the FDA to make age-based classifications for prescription and OTC sales of drugs. If the FDA is seeking such authority, then at a minimum it needs to comply with formal rulemaking and address the objections raised by physicians and patients alike.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 4.2 - No
NEW - 4.4.1 - Legal arguments that little or no confusion exists
Excerpt Text:
B. The FDA's interpretation is an accurate interpretation of the law. It is also scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten interpretation should be codified as law.
Commenter Organization Name: Smart, Stephanie
Comment Number: 2005N-0345-EC16
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
A drug is not only its active ingrediant. It is a combination and has different uses based on the combination or the dosage. So yes, I think that a drug should be available by prescription and OTC containing the same active ingrediant.
Commenter Organization Name: Hutson, Paul
Comment Number: 2005N-0345-EC162
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
The FDA should allow for the dispensing of selected drugs without a prescription by a licensed pharmacist, physician's assistant, or nurse practitioner.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, APhA would support efforts by the FDA to codify the Agency's interpretation of Section 503(b), the Federal standard used to classify drug products as prescription or OTC.
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 12
Excerpt Status: NEW
Excerpt Text:
For the foregoing reasons, we strongly suggest that FDA codify its current interpretation of §503(b)(1) of the Federal, Food, Drug and Cosmetic Act.
Commenter Organization Name: Wilson, Rhianna
Comment Number: 2005N-0345-EC186
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes. There are already other laws and rules involved in the process of purchasing OTC medications. Such as only being allowed to purchase so many packages of sudafed etc. So inflicting another law on societies consumers will not come as a shock. Especcially dealing with a medication that carries so much of an importance to release because of its immeditate window of effectivness.
Commenter Organization Name: Moon, Kristin
Comment Number: 2005N-0345-EC1927
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes--often patients will abuse the OTC product--that is--to take it incorrectly and do themselves harm--even when the package is labeled for safe use. Other times, patients need doctor contact to rule out severe illnesses or needs, but having the medication available OTC keeps them out of the doctor's office
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Tuchinsky, Marla
Comment Number: 2005N-0345-EC201
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
To the extent that your interpretation is preventing women from getting access to a perfectly safe and effective drug, yes.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
Yes- and in a realistic way, not as outlawing disguised as regulation.
Commenter Organization Name: Ellis, Pamela
Comment Number: 2005N-0345-EC216
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
yes
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes, this is an issue that needs to be decided, and has certainly been resolved in areas concerning controlled substances. It's not all that new or novel.
Commenter Organization Name: Levinson, R. Saul
Comment Number: 2005N-0345-EC297
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes, there are instances where a professional may prescribe a product when he has contact with a patient, and instances where a drug product may be needed without prescribing professional interaction. This is certainly the case with "Plan-B"... as it is an emergency contraceptive, the user could be in a situation where there is no time for contact with a prescribing professional (weekends, holidays, afterhours, etc.)... and needs immediate access to the drug.
Commenter Organization Name: Wu, Jackie
Comment Number: 2005N-0345-EC307
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Waychoff, W. Aaron
Comment Number: 2005N-0345-EC311
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Yes - the FDA should understand that, just like many other substances in our society, factors beyond simply the direct effectiveness and safety of the product on the human body must be taken into account. Many medications currently available OTC effect persons of different ages differently and carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation - in the form of a prescription. Remember, a prescription is little more than an official recommendation by a physician to use a particular medication at a particular dose.
Commenter Organization Name: Collum, Mark
Comment Number: 2005N-0345-EC33
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
Yes. This should either be fully OTC or it should be classified into a category where RPh can prescribe and dispense it.
Commenter Organization Name: McLeod, Doug
Comment Number: 2005N-0345-EC364
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes it should and the decision should be made to allow this action. Especially if the scientific evidence supports that decision.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Kulshrestha, Vikram V
Comment Number: 2005N-0345-EC405
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
Excerpt Text:
I believe that there are very sound arguements to initiate a rulemaking to define a transitional class of drugs that would be pharmacy-only drugs. Although there is some precedent for concurrent Rx and OTC marketing of drug products, there is much to gained by defining a pharmacy-only class of drugs. Pharmacists already have the skills, knowledge and most importantly, the mechanisms to properly distribute medications based on specific medical and legal criteria.
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.3 - Maintain Rx only
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
Yes. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes, as a consumer and a woman, there should be guidelines as to under 16 years of age use. But, as an adult that option to buy a drug OTC should be available.
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, times are we a consumer can get a product in illegal ways. Why not make it a safe consumer choice?
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Cunningham, Laura
Comment Number: 2005N-0345-EC5
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Ramirez, Robert
Comment Number: 2005N-0345-EC527
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes, if clarification is needed iniate a rulemaking interpretation. If a active ingredient scientifically shows that is safe and effective for the public and the only reason for the product not being available for the public is red-tape, then policy has to be amended.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Yes, this would seem to be a required point considering the amount of drug therapies available and the numders will only increase. In addition, when ever there are regulatory vagaries groups seems to always take advantage and promote unintended agendas.
Commenter Organization Name: Leonard, Ruth Tehila
Comment Number: 2005N-0345-EC59
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I don't quite understand this question, but if you mean should you set a standard whether or not a product with the same active engredient can be sold on and off the counter simultaneously I think the answer is yes.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
If we assume that Plan B has not been shown to be safe without prescription for children under 17, then the new regulations should be considered. A drug that can be very helpful to women and is only denied based on ideaology instead of science should be made available by any truly scientific health organization.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I think that the FDA should make rules about when a drug can be sold as both prescription and OTC
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I think that actually codifying this would be good.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Yes. It would inform the voting and pharmaceutical consuming public to understand how such decisions are analyzed and made, including the medical purpose for creating at once a controlled and an uncontrolled distribution channel for the same product.
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
The FDA should clearly define its policy. Its previous position, that a substance cannot be both prescription and OTC for the same indication, is rational and defensible and should be codified.
Commenter Organization Name: Ray, Amy
Comment Number: 2005N-0345-EC65
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, if the benefit is clearly defined to those who would benefit from such an interpretation.
Commenter Organization Name: Baird, Debora
Comment Number: 2005N-0345-EC66
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Ricci, Stephen
Comment Number: 2005N-0345-EC73
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Carlson, Brent
Comment Number: 2005N-0345-EC77
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Macdonell, Megan
Comment Number: 2005N-0345-EC779
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
There are many medications that have the same active ingredient available in both a generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines by which these decisions are made, however I do not personally see it as a problem. I believe that there should be a "re-wording" of section 503(b).
Commenter Organization Name: Kuskey, Garvan
Comment Number: 2005N-0345-EC793
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.10 - Examples of FDA actions disallowing simultaneous marketing
Excerpt Text:
If 5% testosterone -- a completely benign substance -- must be written on a triplicate prescription, then why not this more dangerous preparation?Or the reverse: if this drug can be marketed without a prescription to those over sixteen years of age, then why can't 5% testosterone be marketed to elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically because of its abuse by body builders. And yet, body builders don't use 5% preparations. In fact, they can and do easily buy much more concentrated products in Mexico.
Commenter Organization Name: Camron, Kiera
Comment Number: 2005N-0345-EC811
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
Despite all of these risks, proponents are agitating (loudly) for these drugs to be made available over the counter, available without the advice of a medical professional who would provide vital education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of EC.
Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000 abortions each year in the United States, yet studies in the prominent medical journal The Journal of the American Medical Association and others in countries where EC has routinely been used for years show no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of EC? What agenda could possibly justify the exploitation of American women?
I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With any luck, they will conclude that over the counter EC is one ?blessing? America can do without.
Commenter Organization Name: Wagner, Patricia
Comment Number: 2005N-0345-EC813
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 8.6.2 - Risk of medication errors or threats to patient safety
Excerpt Text:
The FDA should issue an interpretation of section 503(b) that requires that when drugs are simultaneously marketed as both prescription and OTC their packaging and advertising must be so dissimular that the ordinary customer will identify them as two different products.
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes it should.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Yes. This would clarify the regulations for any future products that may be sold either as prescription or OTC.
Commenter Organization Name: Holden, Karen
Comment Number: 2005N-0345-EC895
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
If a there is evidence that a prescription drug poses a particular risk to a particular subgroup of the population, then the FDA may impose added restrictions for that group, including marketing the drug simultaneously as OTC and prescription. However, the definition of risk should encompass only safety or efficacy of the particular medication, and should be based on accepted evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond the legitimate interest of the FDA.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
Yes, the FDA should codify its interpretation of this act, so that it can address the numerous cases of drugs ingredients that are present in both prescriptions and OTC sales.
Commenter Organization Name: Wurtz, Richard
Comment Number: 2005N-0345-EC94
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
Yes-you have already done this. You can obtain Ibuprofen as an OTC 200 mg tablet, but it is also available as a prescription in 600 and 800 mg doses.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
yes.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.1 - FD&C Act requires rulemaking
Excerpt Text:
The current definition of a prescription drug is found in the Federal Food, Drug, and Cosmetic Act. Prescription drugs, as explained in the act, are withheld form public consumption and regulated due to the implications that misuse of said drug might have. Failing to expressly define an over the counter drug can be viewed as an inherent flaw of the act, because making assumptions, like the understood definition of an over the counter drug, can be dangerous. Due to the language of section 503(b), the FDA is facing a dilemma of whether or not to initiate a rulemaking to possibly permit the sale of a substance both over the counter and by prescription. The FDA should definitely begin a rulemaking process to clearly define the circumstances under which identical drugs can be sold in different arenas.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
NEW - 3.9.1 - Drug approval examples
NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 6.1 - Yes
NEW - 8.1 - Yes
Excerpt Text:
In regards to the FDA?s request for comments on the advance notice of proposed rulemaking for the simultaneous marketing of drugs with identical active ingredients as both over the counter and prescription, I believe that the FDA should proceed with rulemaking to codify its interpretation of section 503 (b), that there is significant confusion in its current state, and that rulemaking would help dispel the confusion that is caused by the current rule. I also believe that the FDA would be able to legally enforce limitations on certain subpopulations and that those limitations could be practically enforced. Finally I believe that it would be legal to sell the products in the same packaging but that there would be some circumstances where selling identical items would be inappropriate.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should most definitely codify its interpretation of section 503 (b) to resolve confusion, it can and should place limits on certain subgroups, most notably those underage, and the FDA should also allow the identical packaging of over the counter and prescription drugs but also keep in mind that this is not always appropriate. The current state of the rules regarding prescription and over the counter drugs is inadequate and the FDA should proceed in the rulemaking process.
Commenter Organization Name: Babalola, Abimbola
Comment Number: 2005N-0345-EMC383
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
In our ever-changing society, it is extremely important that the executive branch of the U.S. federal government fulfills its duties of faithfully executing laws that will benefit the lives of the people of our nation. By employing the law, U.S. federal agencies such as the Food and Drug Administration (FDA) officially announce vital rules on a daily basis to more thoroughly describe how U.S. statutes will be applied to specific circumstances. But, these rules are often politically controversial, requiring agencies to explain the reasons for their rules through the benefit of written public participation. Such is the present case with the FDA, as this agency is seeking public comments in response to their Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 2005N-0345) in dealing with the issue of what types of drugs may be sold simultaneously both by prescription and over-the-counter products. If the FDA initiates a plain-language rulemaking without using complicated and confusing speech in any proposed rule, and for this issue, then drugs that are marketed in both prescription and over-the-counter (OTC) drug products will provide easy access to consumers, will decrease the number of unintended pregnancies in women in the case of the Plan B pill, and will be more affordable to consumers nation-wide.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
In order to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an over the counter (OTC) drug product, the Food and Drug Administration should initiate a rulemaking. Codifying section 503(b) set specific standards that pharmaceutical companies can conform to so that there is no ambiguity in the ways drug companies can supply an active ingredient in both markets. Also made clear would be the conditions under which a drug is to be administered and sold. Established criterion and explanation protects consumers as well as eliminates carelessness of pharmaceutical companies on their pursuit to drop new drugs into the market.
For instance, if a new drug were put on the market with active ingredient 'n,' the drug companies would have to comply to more explicit standards and regulations enforced by the FDA in order to market the drug as a prescription and/or OTC product. Further, codified interpretations of section 503(b) would ensure standardized distribution under law. Providing concrete interpretation eliminates loopholes in which the drug companies may use to their commercial advantage.
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
In response to questions A and B, GSK CH does not believe that FDA should initiate rulemaking to codify its interpretation of section 503 (b).
Commenter Organization Name: University of California, San Franscisco
Comment Number: 2005N-0345-C320
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
The Food and Drug Administration (FDA) has the authority to switch a prescription drug to over-the-counter (OTC) status if the drug is both safe and effective when self- administered; potential users can self-diagnose the condition for which the drug is needed; and, the drug's label provides clear instructions for use. Though Plan B meets all of the criteria for OTC status, the FDA has failed to remove its prescription requirement and instead has launched down a path of bureaucratic indecision that does not serve U.S. women. The FDA has no scientific basis for discriminating the safety of Plan B among women of reproductive age. We strongly urge the FDA to abandon the proposed rulemaking process and approve the original application to switch Plan B to an OTC product without restrictions.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 3.6.2 - Court case arguments opposing a rulemaking
Excerpt Text:
The legislative history of the Durham-Humphrey Amendments, as recorded in Senate Report No. 946, notes that the "not safe" language in the statute is intended to have its ordinary meaning. See 1951 U.S.C.C.A.N. 2,454 at 2,457 and 2,461. If the Agency has determined that a certain drug product is "not safe" for use except under the supervision of a licensed physician, then carving out a subpopulation (by age, for example) would run counter to this "ordinary meaning" -not safe is not safe, regardless of age. Drugs would not be safe for self-medication if "their unsupervised use may indirectly cause injury," as in the case of drug products that contain potent steroid hormones which affect many organ systems. 1951 U.S.C.C.A.N. 2,454, 2,457. See also 35 Fed. Reg. 9,001 (June 11, 1970). In fact, courts have historically noted the safety risks particular to oral contraceptive prescription drug products. Cf. Turner v. Edwards, 1969-l 974 FDLI Jud. Rec. 471,472 (D.D.C. 1970) (stating that "oral contraceptives are prescription drugs, and therefore subject to different requirements as to their use and dispensation than over-the- counter products").
We further note that the legislative history supports the broad applicability of classifying a drug as an Rx product due to the concerns of safety for such drug products. In addressing the concerns in relation to the Durham-Humphrey Amendments, our legislatures made clear that "the broad language of the definition contained in [these provisions] is intended to comprehend all drugs that in fact should be administered under medical supervision in order to insure [sic] their safe use." 1951 U.S.C.C.A.N. 2,454, 2,462 (emphasis added). This Congressional intent on making the definition of a prescription drug apply as broadly as possible is precisely why the statutory language makes sweeping reference to "toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use." See 21 U.S.C. § 353(b)(l)(A). Allowing the marketing of a drug product as OTC based solely on the age of a subpopulation would run counter to the Congressional intent of drafting the statutory language in this broad way.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
NEW - 5.2 - No
Excerpt Text:
In response to the questions posed in RIN 0910-AF72, FPA believes the first three questions (lA, 1B and lC) should be answered in the negative, making it unnecessary to address the remaining questions. We do not believe there is any confusion over the interpretation of section 503 of the Federal Food, Drug, and Cosmetic Act.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
The mission of the FDA is to protect "the public health by assuring the safety, efficacy, and security of human and veterinary drugs.. . ," not to pander to politically motivated opposition where objections have no grounding in medical or scientific research. Because the questions posed in the Request for Information are not the result of medically supportable facts that necessitate placing age restrictions on the medication's USC, it is simply inappropriate for the questions to be considered in conjunction with the FDA's consideration of the Plan B application. We do not support initiating a rule-making process in relation to Plan B.
Commenter Organization Name: Alterton, Faith
Comment Number: 2005N-0345-C83
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
NO.
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
To use an ingredient in both OTC and by prescription only muddies the water as to who will receive what and in what form and intensity (dosage). It should be OTC only to assure that if someone wants it, it's available.
Commenter Organization Name: Shaffer, Kathleen
Comment Number: 2005N-0345-EC106
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
It is a contradiciton to sell an active ingredient simultaneously as a prescription drug and an OTC drug product. Therefore the FDA has no authority to attempt to codify its interpretation of section 503(b), thereby allowing it.
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
It makes very little sense, if the drug is nessisary to the welfare of thousands of American women, to limit and restrict the access to said drug. The FDA needs to base rules on the health & well being of Americans, not politically motivated "interpretations" of sections and codes.
Commenter Organization Name: Roye, Carol
Comment Number: 2005N-0345-EC110
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 10 - Studies/data provided in comment
Excerpt Text:
There is no reason to do this in the case of Plan B. There have been well-done studies that show that Plan B does not promote irresponsible sexual behavior by teenagers. In fact, several studies found that giving Plan B to sexually active teens at routine visits actually encourages more responsible condom use. I refer you to (among others):1) Raines T et al (2005, Jan. 5). Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized clinical trial. JAMA, 293, 54-62; 2)Gold, M.A. et al. (2004). The effects of advance provision of emergency contraception on adolescent women's sexual and contraceptive behaviors. Journal of Pediatric and Adolescent Gynecology, 17, 87-96; 3)Roye C. & Johnsen, J. (2001). Routine provision of emergency contraception to teens and subsequent condom use: A preliminary study. Journal of Adolescent Health , 28, 165- 166.
Commenter Organization Name: Slee, April
Comment Number: 2005N-0345-EC121
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. There are two reasons to have a drug available by prescription. One is so insurance covers it, like blood glucose test strips. The other is that a reasonable person can't be expected to take it safely and correctly without the direction of a doctor. On this second part, either a drug is safe enough or it isn't. Besides, anyone who is 15 is smart enough to get a 16 year old friend to buy it for them.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. Why are you complicating this? The FDA is supposed to regulate drugs based on clinical evidence, not make social policy.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
Please note that APhA is not responding to these questions in the context of a single drug product; rather, we are providing our comments on the overall "dual status" issue which could apply to any number of drug products. As such, pending issues need not necessarily be resolved by rulemaking before the Agency acts on a specific pending application.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
no...drugs cleared for OTC usage should not have additional restraints of prescription requirements based on age. But instead should have clearly labeled information for dosage and dangers, especially when applied to minors.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
No. I believe that the interpretation is overly restrictive and ignores situations such as this (appropriate for a sub-population)and should not be codified. Case by case determination is more appropriate.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. The interpretation is too restrictive
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
n/a The last thing we need in this country is MORE rules!
Commenter Organization Name: Steward, Linda
Comment Number: 2005N-0345-EC181
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
no. It should be one or the other,not both.
Commenter Organization Name: Steward, Linda
Comment Number: 2005N-0345-EC181
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
no.
Commenter Organization Name: Dowell, Duane
Comment Number: 2005N-0345-EC195
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
there is no compelling reason to initiate the process at this time
Commenter Organization Name: Crousey, Joshua
Comment Number: 2005N-0345-EC1970
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Munro, Margaret
Comment Number: 2005N-0345-EC2022
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No - the FDA should not initiate rulemaking.
Commenter Organization Name: Munro, Margaret
Comment Number: 2005N-0345-EC2022
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No - the FDA should not initiate a rulemaking to codify its interpretation.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
This same situation has worked for Claritin. It is now available OTC and by prescription. No other law making is necessary.
Commenter Organization Name: Richman, Bobbi
Comment Number: 2005N-0345-EC21
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
DEFINATELY NOT.
Commenter Organization Name: Young, Stan
Comment Number: 2005N-0345-EC211
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Goggin, Terresa
Comment Number: 2005N-0345-EC213
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
No, I believe your previous guidelines are adequate. If it is safe without a practitioner's prescription then it should be available OTC.
Commenter Organization Name: Rankis, A
Comment Number: 2005N-0345-EC22
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No, Current situation is fine
Commenter Organization Name: Cepeda, Baudi
Comment Number: 2005N-0345-EC226
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No, a rulemaking on Section 503(b) is unnecessary.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 3.9.1 - Drug approval examples
Excerpt Text:
The supplemental application submitted at the request of the FDA presupposes a meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17 and over can take the medication without that condition.
The dual marketing of Plan B to these respective populations defined by the FDA is permissible under Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the others approved for both OTC and prescription use. The FDA has customarily approved drugs for different conditions of use without requiring any statute, regulation, codification, formal or informal guidance. While these administrative tools are often used by the FDA, they have not been deemed necessary for the simultaneous marketing of an OTC and prescription product with identical active ingredients and dosages.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 14
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 7.6 - Miscellaneous arguments/discussions
Excerpt Text:
We strongly urge the FDA to abandon the proposed rulemaking, and to approve over-the-counter availability of Plan B for women of all reproductive ages based on its impressive safety record.
Greater access to this medication is likely to reduce the incidence of unintended pregnancy and abortion. The pharmaceutical and retail industries are well-equipped to handle the approval of Plan B as an OTC drug for those 17 and over, and as a prescription drug for those under 17.
Commenter Organization Name: Myers, Micah
Comment Number: 2005N-0345-EC319
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
There is no scientific or legal reason to have two packages containing the same drug at the same dosage with one only available by prescription. That being said, there are moral and political reasons to do so. Please do not engage in morality or politics.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 9
Excerpt Status: NEW
Excerpt Text:
The FDA acted irresponsibly in issuing the advance notice of proposed rulemaking. The FDA should have done an emergency rulemaking to address the subject of the proposed rulemaking. This advance notice suggests that the next step will be the issuance of proposed ruling. The use of bureaucratic steps to delay making a safe and effective drug available to the American citizens is unwarranted.
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Dolinski, Elizabeth
Comment Number: 2005N-0345-EC522
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
The FDA should only rule on drug safety issues. I am very upset that the FDA is trying to pass moral judgement on the U.S. population. It has been determined to be medically preferable to make plan b available simultaneously available. Therefore, that is what the FDA should do.
Commenter Organization Name: Della Paolera, Mark
Comment Number: 2005N-0345-EC555
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Porter, Rebecca
Comment Number: 2005N-0345-EC56
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Burgess, Annette
Comment Number: 2005N-0345-EC566
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I feel strongly that the FDA should not initiate a rulemaking to codify their interpretation of section 503(b), about duel-marketing both a prescription drug product and simultaneously an OTC product.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
I believe the rulemaking should stay as it is. And not go change policy, allowing duel-marketing of both a prescription drug product and simultaneously an OTC product. The FDA should remain firm on this issue in this regard.
Commenter Organization Name: Venturella, Vincent
Comment Number: 2005N-0345-EC58
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No. No further rulemaking is required to allow for simultaneous Rx/OTC marketing, and the sudden question about the matter is doing a grave disservice to the FDA.
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
No, if an active ingredient needs the supervision of a physician because of potential side effects, drug interactions, or because there might be physical conditions which would render taking such an ingredient unsafe, it should remain "prescription only"
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
No, the policy in effect now is adequate.
Commenter Organization Name: Gordon, Jennifer
Comment Number: 2005N-0345-EC677
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
If this means that it should change its rules to allow the simultaneous marketing of 'Plan B' as an OTC and prescription drug, than no. See below.
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Hager, Joseph R
Comment Number: 2005N-0345-EC716
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
NO!
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
The FDA has already approved the use of drugs in both simultaneous prescription form and over the counter form, ie. Claritin. I argue that such allergy drugs are still only used by allergy sufferers, not the entire population, and yet they are available for use by all.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
Denying the approval of Plan B as an over the counter drug, especially after being so overwhelming approved for such use in clinical recommendations, appears to be a direct (embarrassing) cow-tow to a particularly vocal political minority. No ruling is necessary if the panel on the FDA would take responsibility for their positions as scientists and attempt (and act) as objective voices for the health of the public (rather than the interests of lobbying groups, be they political or pharmaceutical).
Commenter Organization Name: Phlips, Thomas
Comment Number: 2005N-0345-EC788
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Cahoon, Clifton
Comment Number: 2005N-0345-EC80
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Schmierer, Ann
Comment Number: 2005N-0345-EC81
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
NEW - 3.9.1 - Drug approval examples
Excerpt Text:
I think there are a number of drugs available OTC that are similar and used for exactly the same indications as prescription drugs (i.e. Claritin OTC, Prevacid OTC), and there should be no distinction made between the interpretation for these drugs, so why the confusion on Plan B? I believe there is a very distinct political motivation behind this issue being raised. If the product is proven safe and effective by the FDA for OTC, it should be made available to consumers that want it.
Commenter Organization Name: Smith, Rodney
Comment Number: 2005N-0345-EC83
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
No. How can a drug be both, especially when the Rx form is of a HIGHER concentration?
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
As been the process for a long time, the FDA has a statute that an active ingredient may not be simultaneously marketed in both prescription and OTC drug product. This should stand as is, and not be modified just for this one product. FDA makes these regulations for sound reason and should not be overturned just because a case arises with political interests. I am a pharmacist and what I do is guided by, and I rely on, these statutes. The FDS should stick by its regulations, which have worked so well over time.
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
Again, a single active ingredient should not be marketed both as prescription only and over the counter. FDA should stick by their policy which has been in place for many years, without prior incident. They should not make an exception or worse, initiate rulemaking to change this.
Commenter Organization Name: Vander Bleek, Luke
Comment Number: 2005N-0345-EC870
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: Kopp, Margaret
Comment Number: 2005N-0345-EC903
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. The FDA is so thoroughly biased and under the influence of politics that any rule that it makes at this time will be in the interest of politics, and not in the interest of good medicine, nor in the interest of the public sector.
Commenter Organization Name: Hawkins, Susan
Comment Number: 2005N-0345-EC91
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Dalton, Mike
Comment Number: 2005N-0345-EMC166
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
1. Should the FDA create and define a regulation to allow for a drug to be available both with a prescription and without?
No. I believe in practice it would be ineffective and easily circumvented.
Commenter Organization Name: American Civil Liberties Union
Comment Number: 2005N-0345-EMC446
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
A rulemaking proceeding is neither necessary nor legally required to approve Barr's petition for over-the-counter status for Plan B.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I. FDA Lacks The Statutory Authority To Permit The Simultaneous Dual Marketing Of The Same Drug As An Rx And An OTC Product
FDA lacks legal authority under the FDC Act, as amended by the Durham-Humphrey Amendments (Public Law 82-215, 65 Stat. 648), to allow the dual marketing of an active ingredient simultaneously in an Rx drug product and an OTC drug product. The statutory language, the legislative history, the implementing regulations, and the Agency's past interpretations all preclude such dual marketing of au active ingredient.
A. Dual Marketing Runs Counter to the Statutory, Language and Congressional Intent
The FDC Act defines a prescription drug as a drug which ""because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug." 21 U.S.C. $353(b)(1)(A). The concern is the safety of the drug product, and drug products that are not safe to use except under the supervision of a licensed physician are to be dispensed by prescription only.
Commenter Organization Name: Richman, Bobbi
Comment Number: 2005N-0345-EC21
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 1.2.3 - Maintain Rx only
Excerpt Text:
IF IT WERE SAFE ENOUGH FOR OTC SALES IT WOULDN'T NEED TO BE PRESCRIPTION. THE PUBLIC IS NOT KNOWLEDGEABLE ENOUGH TO KNOW WHEN DR. SUPERVISION IS NECESSARY OR NOT.
3.3.1 - FD&C Act requires rulemaking
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
The current definition of a prescription drug is found in the Federal Food, Drug, and Cosmetic Act. Prescription drugs, as explained in the act, are withheld form public consumption and regulated due to the implications that misuse of said drug might have. Failing to expressly define an over the counter drug can be viewed as an inherent flaw of the act, because making assumptions, like the understood definition of an over the counter drug, can be dangerous. Due to the language of section 503(b), the FDA is facing a dilemma of whether or not to initiate a rulemaking to possibly permit the sale of a substance both over the counter and by prescription. The FDA should definitely begin a rulemaking process to clearly define the circumstances under which identical drugs can be sold in different arenas.
3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.6.2 - Court case arguments opposing a rulemaking
NEW - 6.3.2 - No laws prevent the policy
Excerpt Text:
A. FDA's Legal Authority is Clear and Supports Approval
No statutory provision prevents FDA from imposing an age limitation on the prescription drug status of a new drug. As a fundamental matter, the FDCA presumes that a new drug may be available OTC unless it falls within the definition of a prescription drug in Section 503(b) of the Act. 21 USC 353(b). See, e.g., 21 CFR 330.10(a)(4)(vi); see also Leg. Hist. of Durham-Humphrey Act at S. Rep. No. 946, at 1951 USCCAN 2454, 2461. Section 503(b) provides that FDA shall impose a prescription-only restriction where a new drug
because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.
Thus, the statute allows FDA to determine, based either on the data contained in the sNDA or the lack of necessary data, that Plan B poses a "potential for harmful effect" if used in women under age 16. FDA could also find that "collateral measures" are necessary for its safe use by women under age 16 - namely that distribution be limited to circumstances where a licensed practitioner is available to supervise its use. [Footnote 3: Indeed, the statute is silent with respect to whether age is a relevant factor when interpreting and applying section 503(b). Thus, under settled legal principles, the agency may "fill the gaps" in the statute through reasonable interpretation. See US. v Mead Corp., 533 U.S. 218,234 (2001); Chevron, USA., Inc v Natural Resources Defense Council, Inc , 467 U.S. 837 (1984).]
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
The short answer is no; FDA should not initiate formal rulemaking in this case. The FDC Act clearly identifies when a drug product is for prescription use only. On the other hand, the circumstances under which a product may be considered safe and effective for OTC use vary according to product type and should be reserved for a case-by-case evaluation, e.g., a new drug application or monograph. For example, the amount of safety information that may be needed to allow the OTC sale of statins would be far different from that required for the OTC sale of antihistamines.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
1.A. FDA does not need to initiate a rulemaking to codify its interpretation regarding when an active ingredient can be simultaneously marketed in both a prescription and OTC drug product, since ample precedents already exist to guide the agency and the public. As the agency notes in the background information of this ANPR, the 1951 Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act removed the confusion that had existed prior to that time when different manufacturers made different decisions about whether to market a drug as prescription or OTC. Under the Durham-Humphrey Amendments, the same drug, at the same dosage form and strength, and for the same indication, cannot simultaneously be available on a prescription and nonprescription basis.
But since the Durham-Humphrey Amendments, FDA has needed to draw fine distinctions among dosage forms, methods of administration, or indications or uses to regulate an ingredient differently in different settings. These fine distinctions are not limited to whether and when a drug ingredient is prescription or OTC. They run across a gamut of issues, from a product's primary mode of action to whether something is a food, drug, biologic, device, cosmetic, or some combination of them, from whether something is generally recognized as safe and effective or whether it requires a new drug application to other fine distinctions. The commonality in drawing these distinctions, and the very reason for drawing them, balances on whether or not an ingredient is the same thing in two related settings.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
While FDA has established rules to help guide both interested parties and the agency in walking the line between various distinctions on what is or isn't the same and what triggers different treatment, there is no mandate to do so in every instance. In the case of the instant question of prescription and OTC status, there is no need for a rule, as there are ample precedents to give interested parties paths to follow to distinguish among different labeling requirements, leading to a drug active ingredient in two or more settings not being the "same," even if an outside observer less familiar with the nuances involved would not immediately see the distinctions. There are any number of instances where an active ingredient is seen as an OTC drug in one dosage form and strength for a specified indication(s), and also has uses or additional labeling under consultation with a health professional, whether those different uses or labeling are termed prescription use, professional labeling, professional information, or even off-label use.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.6.2 - Court case arguments opposing a rulemaking
Excerpt Text:
The legislative history of the Durham-Humphrey Amendments, as recorded in Senate Report No. 946, notes that the "not safe" language in the statute is intended to have its ordinary meaning. See 1951 U.S.C.C.A.N. 2,454 at 2,457 and 2,461. If the Agency has determined that a certain drug product is "not safe" for use except under the supervision of a licensed physician, then carving out a subpopulation (by age, for example) would run counter to this "ordinary meaning" -not safe is not safe, regardless of age. Drugs would not be safe for self-medication if "their unsupervised use may indirectly cause injury," as in the case of drug products that contain potent steroid hormones which affect many organ systems. 1951 U.S.C.C.A.N. 2,454, 2,457. See also 35 Fed. Reg. 9,001 (June 11, 1970). In fact, courts have historically noted the safety risks particular to oral contraceptive prescription drug products. Cf. Turner v. Edwards, 1969-l 974 FDLI Jud. Rec. 471,472 (D.D.C. 1970) (stating that "oral contraceptives are prescription drugs, and therefore subject to different requirements as to their use and dispensation than over-the- counter products").
We further note that the legislative history supports the broad applicability of classifying a drug as an Rx product due to the concerns of safety for such drug products. In addressing the concerns in relation to the Durham-Humphrey Amendments, our legislatures made clear that "the broad language of the definition contained in [these provisions] is intended to comprehend all drugs that in fact should be administered under medical supervision in order to insure [sic] their safe use." 1951 U.S.C.C.A.N. 2,454, 2,462 (emphasis added). This Congressional intent on making the definition of a prescription drug apply as broadly as possible is precisely why the statutory language makes sweeping reference to "toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use." See 21 U.S.C. § 353(b)(l)(A). Allowing the marketing of a drug product as OTC based solely on the age of a subpopulation would run counter to the Congressional intent of drafting the statutory language in this broad way.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
B. Dual Marketing Runs Counter to the Dichotomous Classification of Drug Products
A plain-meaning interpretation of the statutory language indicates that the Agency may not allow the dual marketing of a drug as both Rx and OTC. The statute states that FDA may "remove drugs.. .from the requirements of [21 U.S.C. § 353(b)(1)] when such requirements are not necessary for the protection of the public health." 21 U.S.C. § 353(b)(3) (emphasis added). The statutory language allows for the Agency to "remove drugs" from one classification (Rx) and into another (OTC). The statutory language, in essence, provides for requisite conditions to market a drug as an OTC drug product by noting inapplicability as an Rx product. Cf. 70 Fed. Reg. 52,050 at 52,051 (stating that the term "OTC drug" has been adopted to refer to any drug that does not meet the definition of a prescription drug in 2l U.S.C. § 353(b)(l)). Thus, a dichotomy exists between the prescription and OTC drug "classification." See id.; see also 21 C.F.R. § 310.200 (describing FDA's prescription exemption procedure).
If one "removes" a drug from regulation as an Rx drug, then that drug becomes an OTC drug. One cannot "remove" a drug from the prescription classification and still regulate that drug product as an Rx drug. Either the drug is "removed" from the prescription drug regulatory rubric and is therefore an OTC drug, or the drug remains under the Rx rubric and is not an OTC drug. The mutually exclusive nature of the dichotomous classification of a drug product as either Rx or OTC is manifest in the statutory language. Cf. 21 U.S.C. 353(b)(4). The dual marketing of the same drug as Rx and OTC therefore runs contrary to the plain-language meaning of the statute.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 8.5.1 - FD&C Act - Legal differences between statutory requirements for Rx and OTC
Excerpt Text:
C. Dual Marketing Causes Confusion Between Drug Products
The underlying concern both for FDA and Congress in the statutorily-required dichotomous classification is the potential. for confusion that would arise if the statute did not provide for this bifurcation between Rx and OTC drugs. .See e.g., 21 U.S.C. §§ 353(b)(4)(A) and (B) (stating, in essence, that a prescription drug must have the "Rx" symbol on its label, whereas an OTC drug must not have this symbol on its label, to avoid the potential for confusion). In fact, courts have noted historically that if birth control pills were extensively disseminated outside distribution channels for prescription drug products, different standards of labeling might be applicable. See, e.g., Turner v. Edwards, 1969-1974 FDLI Jud. Rec. 493, 494 (D.D.C. 1971).
Likewise, the legislative history of the statutory language at hand underscores the concern for labeling confusion by stating:
. . . the interstate label on [prescriptions drugs must bear the statement "Caution: Federal law prohibits dispensing without prescription." On the other hand, over-the-counter drugs are forbidden to bear a label containing this caution statement. A prescription drug, the label on which does not bear the specified caution statement, is deemed to be misbranded. So, too, is an over- the-counter drug, the label on which bears this or a substantially similar statement.
See 1951 U.S.C.C.A.N. 2,454, 2,463. Cf. 1951 U.S.C.C.A.N. 2,454, 2457 (stating that the statutory definition of a prescription drug "could bring an end to the existing confusion in drug labeling and that uniformity can be achieved"). See also 70 Fed. Reg. at 52,051 (noting the resulting confusion and uncertainty that arose due to a lack of criteria in determining when to limit a drug product's approval to prescription use).
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 11
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
E. Past Agency Position Precludes Dual Marketing Without Meaningful Difference
According to FDA's present regulatory interpretation of the Durham-Humphrey Amendments, the marketing of the same active ingredient in different drug products in both the Rx and OTC markets assumes some meaningful difference exists between the two marketed drug products. See, e.g., 70 Fed. Reg. at 52,051 (emphasis added). Historically; FDA has concluded that the meaningful difference relates to five parameters - the product's active ingredient, indication, strength, route of administration, or dosage form. See id. Even so, however, FDA has been reticent to acknowledge a "meaningful difference" in a drug product, determining instead that physician supervision is still necessary when a drug product's strength or dosage form, for instance, is distinct. Only in a few cases in the past 50 years has FDA determined that a change in one of the five drug product parameters provided enough of a difference to. support the safe use of the product without physician supervision, See 70 Fed. Reg. 52,050 (citing specific product differences in indication, dosage form, and strength). And most of those cases involved two separate indications, for which one of the indications a layperson could clearly self- diagnose and self-treat, but the other indication required a physician diagnosis and supervision (e.g., prescription for ulcers vs. OTC for heartburn). In other words, only rarely can a drug product with one parameter (e.g., lower strength) be used safely without physician supervision, when that physician supervision is required for the safe use of the product with a different parameter (e.g., higher strength).
Commenter Organization Name: Shaffer, Kathleen
Comment Number: 2005N-0345-EC106
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
It is a contradiciton to sell an active ingredient simultaneously as a prescription drug and an OTC drug product. Therefore the FDA has no authority to attempt to codify its interpretation of section 503(b), thereby allowing it.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
No. No drug should be both prescriptive & over the counter at the same time. The idea is a contradiction and dilutes the definition of both terms. Prescription drugs indicate caution is required. Over-the-counter items indicate public consumption. That is the mindset of the public and if you allow an item to be both prescriptive & over the counter, then people will automatically assume the lower degree of over the counter and assume it is for public consumption.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes. The only time this should be allowed is when the active ingredients harmful properties are made unharmful in the drug that is over the counter. If it can not be made unharmful for public consumption, then it should be prescriptive.
Commenter Organization Name: Academy of Managed Care Pharmacy
Comment Number: 2005N-0345-EC15687
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
The FDA has interpreted the language in section 503(b) of the Durham-Humphrey Amendments to allow marketing of the same active ingredient in products that are both prescription and OTC, assuming some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner. The key distinction in all current examples of products sold both OTC and by prescription is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage forms). To date, the FDA has not allowed marketing of the same active ingredient in a prescription product for one population and in an OTC product for a subpopulation. However, the FDA has acknowledged that its interpretation of section 503(b) of the act has not been explicitly set forth in any of the regulations that discuss the process by which FDA classifies drugs as OTC or prescription.
Commenter Organization Name: Academy of Managed Care Pharmacy
Comment Number: 2005N-0345-EC15687
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.2 - No
Excerpt Text:
AMCP does not believe that the FDA has the authority to allow marketing of the same product as both a prescription drug and OTC product.
Commenter Organization Name: Academy of Managed Care Pharmacy
Comment Number: 2005N-0345-EC15687
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
For a medication to be granted OTC status, it must have a wide safety margin, be effective, and bear labeling understandable to ensure proper use. The FDA must determine that the labeling provides enough information for safe use by the general public. If the FDA determines that a drug meets the above conditions to be granted OTC status, then the drug is considered safe enough to be sold without a prescription.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 4.2 - No
NEW - 4.4.1 - Legal arguments that little or no confusion exists
Excerpt Text:
B. The FDA's interpretation is an accurate interpretation of the law. It is also scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten interpretation should be codified as law.
Commenter Organization Name: Goggin, Terresa
Comment Number: 2005N-0345-EC213
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
No, I believe your previous guidelines are adequate. If it is safe without a practitioner's prescription then it should be available OTC.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
The FDA notes in the ANPR that it has in numerous instances approved the dual marketing of an active ingredient for both prescription and OTC use in just this manner. The differences noted by the FDA between these products and Plan B (the age at which the user takes the medication and under what degree of medical supervision) are all simply various conditions of use of the product, and are along the same lines as these other differences in condition of use noted by the FDA.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.9.1 - Drug approval examples
Excerpt Text:
The supplemental application submitted at the request of the FDA presupposes a meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17 and over can take the medication without that condition.
The dual marketing of Plan B to these respective populations defined by the FDA is permissible under Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the others approved for both OTC and prescription use. The FDA has customarily approved drugs for different conditions of use without requiring any statute, regulation, codification, formal or informal guidance. While these administrative tools are often used by the FDA, they have not been deemed necessary for the simultaneous marketing of an OTC and prescription product with identical active ingredients and dosages.
Commenter Organization Name: TomHon, Catherine
Comment Number: 2005N-0345-EC281
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 7.3.1 - Regulate product sponsor
Excerpt Text:
I do not see that Plan B represents a unique case that in future should be used to influence FDA activity and decisions. It may be difficult to argue that the population <16 years of age is subject to greater harmful effect. But section 503b B, states that it (a prescription drug) is limited by approved application under section 505.... One could argue that the "Prescription Drug" status is defined by the limitations that must be spelled out in the approval of a drug application. It does not state that the FDA is limited in its approval and must define an approved drug as only OTC or prescription. Therefore it could allow the FDA via its official approval to designate the same drug as OTC and Prescription dependent on different circumstances, in Plan B's case age.
Commenter Organization Name: Ramirez, Robert
Comment Number: 2005N-0345-EC527
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
If an active ingredient is proven scientifically that it is safe for public use in the same dosage there should not be any difference. Make the product OTC. If needed for clarification codify the ingredients and list them for dual markets.
Commenter Organization Name: Leonard, Ruth Tehila
Comment Number: 2005N-0345-EC59
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
I can see no reason why an identical product will have to be given by perscription for one person and free for purchase to another. I suggest you allow certain people to carry open perscriptions for products they need regularly for a particular medical condition, but otherwise substances with the same active engredients in the same doses that you do not deem safe for the entire population should not be sold to one segment over-the-counter and to another as a perscription.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 10
Excerpt Status: NEW
Excerpt Text:
Only pharmaceutical products with the potential for minimal health hazard should be offered as Over The Counter formulations.
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No, if an active ingredient needs the supervision of a physician because of potential side effects, drug interactions, or because there might be physical conditions which would render taking such an ingredient unsafe, it should remain "prescription only"
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 11
Excerpt Status: NEW
Excerpt Text:
Any product which has been judged sufficiently dangerous to warrant professional supervision via prescription -- should not be presented to the public without such protection.
Commenter Organization Name: Smith, Rodney
Comment Number: 2005N-0345-EC83
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. How can a drug be both, especially when the Rx form is of a HIGHER concentration?
3.3.3 - Other arguments related to FD&C Act
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
Excerpt Text:
The Federal Food, Drug, and Cosmetic Act ("FDCA") establishes a standard for classifying a drug as prescription-only that allows the agency to impose age requirements on prescription use. Moreover, FDA has ample legal authority to enforce such a restriction and has done so with respect to at least one other product, an "adults only" Nicorette (nicotine polacrilex) gum.
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
A drug product is approved for those uses set forth in its labeling, the scope of which is limited to specific statements about the "conditions" of its proper use - those "prescribed, recommended, or suggested" in the labeling. 21 USC 355(d)(1). Thus, labeling that includes specific limitations on the appropriate patient population for which the drug is intended can denote a "meaningful difference" in the prescription drug and the OTC drug product. [Footnote 4: In June 2005, FDA approved a drug for use only in a specific subpopulation -African Americans. The drug, BiDil(R) (hydralazine hydrochloride; isosorbide dinitrate), is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients. ] Quite simply, levonorgestrel labeled for prescription use is a different drug that levonorgestrel labeled for OTC use. Indeed, as FDA. acknowledges, it has approved OTC and prescription versions of a product based on differences in "indication," which constitutes a meaningful difference in the two products' intended or labeled uses.
ASRM believes that FDA has ample authority to make a similar distinction between prescription and OTC levonorgestrel and should do so immediately.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
B. The Authority Granted to FDA Under Humphrey-Durham.
The specific authority Congress granted to FDA in the Humphrey-Durham Amendments in response to these concerns is of critical importance as FDA considers the issues it raises in the ANPRM. The agency must look to the precise authority Congress provided in the statute itself.
New Section 503(b)(1) directly addressed the protection of consumers from the dangers arising from OTC dispensation of drugs which could not safely be used without physician supervision. That section forbade the OTC sale of any drug which FDA determined "because of its toxicity or other potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except for under the supervision of a practitioner licensed by law to administer such drug." [Footnote 8: 21 U.S.C. § 353(b)(1); see also S. REP. NO. 82-946, at 4 (1951), reprinted in 1951 U.S.C.C.A.N. 2454, 2456. Section 503(b)(1) also initially barred OTC sale of habit-forming drugs subject to Section 502(d) and drugs determined to require prescription dispensing in a Section 505 application process. 65 Stat. at 648. However, the provision relating to habit-forming drugs was eliminated when Section 502(d) was repealed in 1997. Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-l 15, § 126, 111 Stat. 2296, 2327-2328 (1997).]
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 8.5.1 - FD&C Act - Legal differences between statutory requirements for Rx and OTC
Excerpt Text:
New Section 503(b)(2), supplemented by Section 503(b)(4), addressed the problem of pharmacists needing guidance on how a drug could be lawfully marketed. Under Section 503(b)(2) and (4), a drug required by FDA to be marketed under prescription was required to have "Rx only" on its label, thus: (a) exempting it from any statutory duty to have adequate directions for consumer use and (b) making it unlawful for a pharmacist to dispense it without a prescription. [Footnote 9: 21 U.S.C. §§ 353(b)(2); (b)(4).] A drug not required by FDA to be dispensed under prescription could not bear the "Rx only" mark and could be sold OTC if the manufacturer supplied adequate instructions for consumer use. [Footnote 10: 21 U.S.C. §§ 353(b)(4); 352(f).] The instruction requirement was expressly made inapplicable to all prescription drug sales, including both those with "Rx only" on the label and those requiring prescription by manufacturer direction. [Footnote 11: Id. at § 353(b)(2), stating: "Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of Section 502 [which includes the requirement for adequate directions for consumer use] . . . ." This definition applies to all drugs dispensed by a prescription, rather than only those required to be labeled "Rx only" under 21 U.S.C. § 353(b)(4)(A).]
Accordingly, the presence of the "Rx only" symbol advised pharmacists that FDA required a drug to be dispensed with a prescription so that the pharmacist could avoid the legal risks of selling it OTC. Although manufacturers choosing voluntarily to dispense by prescription could not use the "Rx only" symbol, they would have to label their drugs with FDA-approved prescription labeling, and could not put pharmacists in terrorem with respect to selling identical drugs sold OTC because the absence of the "Rx only" symbol made it clear that OTC dispensation was FDA sanctioned. [Footnote 12: Pursuant to 2 1 C.F.R. § 201.100(c)(1), prescription drug labeling - in lieu of OTC adequate directions for consumer use - is required to contain adequate information for use of the drug at the dosage and for the indications recommended, prescribed or suggested in such labeling under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended.]
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
New Section 503(b)(3) addressed Congress' concern that consumer access to OTC medication not be unduly impaired. The section required FDA to reverse a Section 503(b)(1) determination that a drug be dispensed by prescription only through a rulemaking process "when such requirements are not necessary for the protection of the public health." [Footnote 13: 21 U.S.C. § 353(b)(3).] Thus, when new scientific evidence establishing that OTC dispensation would be safe came to FDA's attention, FDA, on request or at its own initiative, could remove mandatory prescription requirements. A removal of the requirement foreclosed manufacturers from applying the "Rx only" mark, so that pharmacists and other concerned individuals could be made aware that FDA no longer required prescription sale. Manufacturers were also free to propose OTC labeling since OTC distribution was no longer barred. However, nothing in the section prohibited a manufacturer from continuing to limit distribution to prescription-only at its own discretion, as long as the drug continued to have approved prescription labeling and the "Rx-only" mark was not used.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
A. The ANPRM's inquiry about the circumstances under which an active ingredient may be simultaneously marketed both as a prescription and OTC drug can be answered directly from Section 503(b).
1. Multiple formulations with different safety profiles are to be sold. Simultaneous Rx/OTC marketing may occur where there are multiple formulations, the manufacturer seeks to market one or more such formulations without an Rx restriction and FDA determines in its review of the manufacturer's application that one or more formulations, but less than all, must be restricted to "Rx-only". In addition, if FDA determines either initially or in a subsequent 503(b)(3) rulemaking that no "Rx-only" designation is required and the manufacturer exercises its right to confine distribution of one or more such formulations to prescription status, simultaneous Rx/OTC marketing is authorized.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.8.7 - Cost-benefit concerns regarding rulemaking
Excerpt Text:
B. The ANPRM inquires whether a rulemaking to codify FDA's approach would be appropriate. Pfizer does not believe that an expenditure of agency resources on such an endeavor would be justified. Any attempt to describe how FDA would resolve specific safety issues under Sections 503(b)(1) and 503(b)(3) or adequacy of labeling issues under 503(b)(2) would be a complicated undertaking which could either unduly constrain future scientific judgments or result in statements at a level of generality which would be unlikely to advance public understanding of the review process beyond that already established in the Congressional mandate in Section 503.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 12
Excerpt Status: NEW
Excerpt Text:
The newness of a drug may arise from the newness of the "use " of the drug. 21 C.F.R. § 310.3(h)(4) (2005). Intended uses of a drug in different patient subpopulations constitute different uses of the drug, and thus create different new drugs, within the meaning of FDCA §§ 201(p) and 505(a), 21 U.S.C. §§ 321.(p), 355(a). The reason why a supplement is required for an additional indication for an approved new drug is that the additional indication constitutes a new use of the drug and therefore creates a different new drug. A manufacturer of an approved drug that promotes its product for a use different from or additional to the approved use(s) is subject to a charge of violating FDCA §§301(d), 21 U.S.C. § 331(d), as well as to a misbranding charge under FDCA § 502(f)(1), 21 U.S.C. § 352(f)(1). See Decision in Washington Legal Foundation v. Henney, 65 Fed. Reg. 14,286-01, 14,286-01 (Mar. 16, 2000) ("an approved new drug that is marketed for a 'new use' becomes an unapproved new drug with respect to that use").
FDA recognizes that persons age 15 and younger constitute a patient population ("the pediatric age group") distinct from patient populations consisting of persons age 16 or over. See 21 C.F.R. § 201.57(f)(9)(i) (2005). Generally, separate investigations are necessary to support an indication for that population, as distinct from an indication for an adult population. See generally, FDCA $ 505A, 21 U.S.C. § 355a; 21 C.F.R. § 201.57(f}(ii) (2005).
Commenter Organization Name: Garden, Nicole
Comment Number: 2005N-0345-EC14598
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
Excerpt Text:
Part of the reason the birth control pill is marketed as a prescription and not an over-the-counter product is because of the many dosages, forms, and active ingredients it comes available in, which require dosing by a medical professional such as a physician, and monitoring to ensure effectiveness.
Because the emergency contraceptive is a standardized one-time dose, these factors do not come into play.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
If 503(b) does not allow for the simultaneous marketing of a drug based on age or other factors, it should be amended. Precedences exist for such substances such as alcohol and tobacco products to be marketed based on age. The purchase of other non-ingestible items are certainly marketed by age, mental competency, criminal convictions, etc.. This is not a difficult and/or complexed procedure.
Commenter Organization Name: Smart, Stephanie
Comment Number: 2005N-0345-EC16
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
A drug is not only its active ingrediant. It is a combination and has different uses based on the combination or the dosage. So yes, I think that a drug should be available by prescription and OTC containing the same active ingrediant.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 18
Excerpt Status: NEW
Other Sections: NEW - 6.3.1 - FD&C Act
MODIFIED - 7.3.1.3 - Require risk management program
Excerpt Text:
If the FDA approves a product for inclusion in the Pharmacy Care OTC category or for placement within a statutorily-established expansion of the drug classification system, either option could be supplemented, when necessary, with some form of postmarking risk management program. Subpart H of the Act gives the Agency the authority to approve a product with restrictions to assure safe use "if the FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted." [Footnote 6: 21 CFR 314.520] The restrictions can include distribution restricted to certain facilities or physicians with special training or experience; distribution conditioned on the performance of specified medical procedures; or limitations imposed that are commensurate with the specific safety concerns presented. [Footnote 7: Ibid.] The Agency can place these postmarketing restrictions on both prescription and OTC products. The Agency could use its authority under Subpart H to require a risk management program - such as distribution restricted to a pharmacy or entities with a pharmacy or requiring additional education on product use - for products that have been approved with a dual status because the Agency has concluded that the drug may only be safely used in a particular subpopulation as a prescription product.
Commenter Organization Name: Ellis, Pamela
Comment Number: 2005N-0345-EC216
Excerpt Number: 11
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
Excerpt Text:
Plan B is safe for use by women of ALL ages. It has been available OTC in over 38 other countries for years. The data is available on use in teenagers and adults and should have been consulted at the time of application. Withholding this incredibly effective and safe drug, the 2 requirements for OTC status, the FDA is doing a disservice to women and women's healthcare and destroying its reputation as a sound, scientific entity on which the American public can depend.
Commenter Organization Name: Hagan, Jane
Comment Number: 2005N-0345-EC32
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I believe the importance of making this drug available to the public is substantial emough that the FDA should do whatever is necessary to accomplish that.
Commenter Organization Name: McLeod, Doug
Comment Number: 2005N-0345-EC364
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes it should allow active ingredients to be simultaneously sold as both an OTC and a prescription drug. This is especially so when the FDA experts have reviewed the drug and indicated that it should be available as an OTC product.
Commenter Organization Name: Anspach, Kurt
Comment Number: 2005N-0345-EC447
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
If it were safe to take theses pills without a prescription in one form then how can it not be for another use?Thats a double standard.Most of the population that will be taking these pills won't understand that this shouldn't be done without being advised and supervised by a Doctor.
Commenter Organization Name: Porter, Rebecca
Comment Number: 2005N-0345-EC56
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
There is too great a potential for this drug to be abused. There is more to this issue than carding the patient. Fake ids are easily found. Who will monitor these patients that are taking the prescription? Medications that are taken OTC are expected to be safe and not need a doctor's follow up.
Commenter Organization Name: Billingsley, Daniel
Comment Number: 2005N-0345-EC609
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I just believe if a product is safe enough to OTC then a prescription should not be required.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Making sure that OTCs are safe enough to be used without the supervision of a physician must continue in the interests of public safety.Studies show that the American population routinely doubles, triples, even quadruples the recommended dosage on OTC medications - particularly pain medications. We have seen some medications go behind the shelf (pseudoephedrine) because of the misuse of the product. In this particular case of Plan B, it would be VERY easy for the product to be misused (18 year old buying it for a distraught 15 year old friend). People typically don't read instructions, they don't read warnings, they don't read about side affects. They just want to pop a pill and make it (pain, congestion, whatever) go away. How many people with high blood pressure will take Sudafed when the packaging says not to? At least with a prescription, the have the chance to speak with their physician. Their physician knows what they are taking, and knows their health history. Any medication that can cause severe reactions should be controlled.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 16
Excerpt Status: NEW
Excerpt Text:
In addition, it essentially induces an abortion - of sorts. When you see a physician, they know your health history, they can tell you the benefits and the consequences. They can tell you of any potential problems to look for and when to come back or go to the hospital. The typical American does not even read the dosage information on a bottle of ibuprofen. If they hurt they take some, if they hurt a lot, they take a handful. Americans act like every OTC is safe - no matter how they take it or whom (age, weight, medical history, medicines being taken) they give it to.
Commenter Organization Name: Burns, Ben
Comment Number: 2005N-0345-EC93
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
i dont see a problem with it, they already partially do it with naproxen, by having lower doses in the over the counter drug aleve. it would allow cunsumers who could purchas it, as well as allow organizations like planned parenthood, who could prescribe it to low income falmilies.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.9.1 - Drug approval examples
NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Tadeo, Peter
Comment Number: 2005N-0345-EMC373
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Section 503(b) of the Durham-Humphrey Amendment does not simplify the confusion of what is considered an OTC drug and should be changed for drugs to be sold both in the OTC and in the prescription market.
Commenter Organization Name: Tadeo, Peter
Comment Number: 2005N-0345-EMC373
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Regulations should be set in a practical manner, and many current drugs that are only available as prescription could be sold to the public without the supervision of a practitioner. When it comes down to this heavily debated topic the main question is: whether people can inform themselves on the product that they are consuming.
3.4 - Administrative Procedures Act (APA) arguments
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 25
Excerpt Status: NEW
Excerpt Text:
Agency "rules" are broadly defined in Section 551 of the Administrative Procedures Act (APA) as the whole or a part of an agency statement of general or particular applicability and future effect designed tri implement, interpret, or prescribe law & policy, or describing the organization, procedure, or practice requirements of an agency Agency rules include the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances therefor or of valuations, costs, or accounting, or practices bearing on any of the foregoing. [Footnote 13: See 5 U.S.C. § 551. ] Given the magnitude of the regulatory change that FDA would be enacting, despite the Durham-Humphrey Amendments, any FDA approval of an active ingredient for simultaneous Rx and OTC marketing is a new Agency "rule" that triggers notice and comment rulemaking.
In order to issue a rule, an agency must complete a three step process - issuance of a notice of proposed rulemaking, receipt and consideration of comments on the proposed rule, and issuance of a final rule incorporating a statement of its basis and purpose. Section 553(b)(A) of the APA exempts several types of rules from the rulemaking process. The exemptions cover interpretative rules, general statements of policy, procedural rules, rules the agency has "good cause" to issue without the rulemaking process, and rules that apply to particular subject matters -e.g. military or foreign affairs, However, none of these apply to the Plan B dual marketing.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 29
Excerpt Status: NEW
Excerpt Text:
Nevertheless, even in the alternative, it is clear that FDA cannot approve OTC labeling in the Drug Facts Format for Plan B without complying with APA notice and comment rulemaking to fully examine this regulatory conflict. Thus, FDA must initiate and complete full rulemaking proceedings in order to institute the simultaneous dual marketing of the same drug product as Rx and OTC.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
The FDA should not render a decision affecting millions of Americans without allowing full notice and comment by physicians and patients, pursuant to a formal rulemaking proceeding. The Administrative Procedures Act (APA) requires notice and comment prior to promulgation of a new rule, and there is no valid reason to deny public input on the important issue of marketing an active ingredient as both a prescription drug and over-the-counter (OTC) drug. AAPS objects to any attempt by the FDA to bypass notice and comment procedures in connection with Section 503(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), as modified by the Durham-Humphrey Amendments, which governs the classification of drugs.
Commenter Organization Name: Association of American Physicians & Surgeons
Comment Number: 2005N-0345-EC15690
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
In sum, AAPS objects to any assertion in authority by the FDA to make age-based classifications for prescription and OTC sales of drugs. If the FDA is seeking such authority, then at a minimum it needs to comply with formal rulemaking and address the objections raised by physicians and patients alike.
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Furthermore, FDA is constrained to act in accordance with the APA's mandate to refrain from any agency activity that is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law." [Footnote 1: See APA §706(2)(A).] In determining what constitutes "arbitrary" agency action, administrative case law has consistently held that a court will intervene if it "becomes aware, especially through a combination of danger signals, that the agency has not really taken a 'hard look' at the salient problems, and has not genuinely engaged in reasoned decision making." [Footnote 2: See Greater Boston Television Corp. v. FCC, 444 F.2d 841, 850-852 (D.C.Cir.1970).]
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
It appears clear that FDA has not taken a hard look at the salient problems which surround changing its interpretation of the statute. Plan B, the drug which FDA has decided to use towards considering changing its interpretation, is one of the most controversial drugs on the market. Barr Pharmaceuticals has also experienced a long history of falling far short of FDA's testing and safety standards regarding this drug. [Footnote 3: See, e.g., http://www.fda.gov/cder/drug/infopage/planB/planB_NALetter.pdf (accessed Oct. 27, 2005).] To date, Barr has not rectified this situation; there is still a troubling shortage of clinical data on Plan B as to safety and effectiveness, particularly involving young adolescent women. [Footnote 4: See http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm (accessed Oct. 27, 2005).] This disturbing state of facts surrounding FDA's actions is the very definition of a "combination of danger signals" surrounding agency action. In a more general sense, if FDA allows simultaneous marketing of any active ingredient in a drug both prescription and OTC, thus interpreting its rule in a way directly contradictory to its past interpretation, without any apparent justification whatsoever, that easily constitutes arbitrary and capricious agency action.
Commenter Organization Name: Dowell, Duane
Comment Number: 2005N-0345-EC195
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 9.2.2 - All circumstances (i.e., it's always appropriate, there are no inappropriate circumstances)
Excerpt Text:
None
3.5 - Supplemental New Drug Application (SNDA) and New Drug Application (NDA) regulations
3.5.1 - SNDA/NDA regulatory arguments supporting rulemaking
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 41
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
NEW - 1.2.3 - Maintain Rx only
NEW - 3.11 - Miscellaneous arguments/discussions
Excerpt Text:
C. FDA's Jurisdiction Over the "Safety and Efficacy" of Drugs Provides it With Sufficient Authority to Consider Potentially Negative Societal Ramification Related to the OTC Sale of Plan B
FDA's jurisdiction over the "safety and efficacy" of drugs provides it with legal authority to consider morality, misuse, age-appropriate sexual behavior, and related social issues in the context of the Plan B approval for OTC marketing. [Footnote 23: Those who argue that morality should not, affect FDA's decision-making hypocritically cite moral judgments in support of the OTC approval of Plan B. For example, certain Congressional representatives have asserted that "Public health experts have estimated that over-the-counter sales of the emergency contraception pill Plan B would cut the rate of unintended pregnancies in half and reduce the number of abortions by more than 500,000 per year." U.S. Reps. Henry Waxman, D-CA, and Louise Slaughter, D-NY, circulated a "Dear Colleague" letter and Fact Sheet on October 12, 2005, referencing these factors as a reason that FDA should approve the OTC sale of Plan B. FDA cannot take the Societal concern of unintended pregnancies into account, while refusing to consider the social concerns of an increase in unprotected sex and STDs, off-label over-use/repeat, use of Plan B, and sexual abuse.] There is no question that FDA can and should, as a matter of law, take issues of morality and social conscience into account when those issues relate directly to the drug's risk/benefit analysis or safety/efficacy profile -two concepts with which FDA has decades of experiences and" for which the courts provide deference to the Agency. If there is evidence that the expected patient population is likely to use the drug in a way that decreases the drug's safety, negatively impacts the patient's health, or tips the risk/benefit balance toward greater risk, FDA must consider this evidence when addressing the approval decision. FDA routinely takes potentially harmful patient use scenarios into account in its NDA approval decisions, whether for potent pain drugs (for which abuse and misuse are Agency considerations), for obesity drugs (for which preferences for nutritive and exercise are Agency considerations), or for HIV home test kits (for which the patient's mental well-being and need for a learned intermediary or counselor was an Agency consideration). OTC emergency contraceptives fall squarely within this listing of drugs in which self-destructive patient actions may cause more harm than good. [Footnote 24: FDA should reject the argument posited by some that an FDA decision denying OTC approval to Plan B is too paternalistic. FDA has ample precedent over the years where it has made an "unpopular" decision for reasons that were arguably paternalistic. FDA's mission is to protect the public health by assuring the safety, efficacy, and security of human drugs. FDA has viewed this mission broadly over the years to include the ""blocking" of access to certain drug products that, while safe and effective on a scientific basis, were not appropriate for OTC use for broader public health reasons. For example, the FDA removed phenacetin from the market after use as an ingredient, in OTC drug products for over 80 years. In the FDA's notice of the withdrawal of phenacetin from the market, the basis cited for approval was "phenacetin's high potential for misuse and its unfavorable benefit-to-risk ratio when incorporated in analgesic combinations which are then subject to excessive chronic use." (Emphasis in original) 48 Fed. Reg. 45486 (Oct. 5, 1983). In the proposed rule, the FDA stated that phenacetin was not alone among analgesics in its ability to cause nephropathy, but because of its greater likelihood for abuse, the agency believed other safe and effective analgesics would be sufficient for consumers. 47 Fed. Reg. 34636, 34638 (Aug. 10, 1982). Similarly, in 1972 the FDA severely restricted the allowable OTC uses for the drug hexachlorophene as an antibacterial product. The restrictions on the use of hexachlorophene followed the deaths of a number of infants in France due to the use of a baby powder contaminated with six percent hexachlorophene. 37 Fed. Reg. 20160 (Sept. 27, 1972). Although hexachlorophene was recognized as a safe and effective bacteriostatic skin cleanser, FDA concluded that a "risk to benefit ratio" analysis justified restriction of the availability of the drug even though the at-risk population was extremely small. Id. ]
3.5.2 - SNDA/NDA regulatory arguments opposing rulemaking
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Specifically, the regulatory framework governing drug approvals and prescription-to-OTC "switches" are clear and should lead to swift approval of Barr's sNDA.
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
FDA has published regulations governing OTC drugs. In considering whether to allow a drug to be available OTC through publication of a drug monograph, the agency considers established factors - safety and effectiveness, the benefit-to-risk ratio, and whether clear and understandable labeling can be written for self-medication without the intervention of a health professional. See 21 CFR 330.10(a)(4). Similarly, when considering whether a prescription drug should "switch" to OTC status, the agency considers related factors such as a consumer's ability to self-diagnose and self-treat, the incidence of side effects and adverse events, the potential for misuse, and whether the drug's use might mask more serious conditions that require medical attention. As ASRM has repeatedly asserted, these factors strongly support approval of OTC Plan B.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
EC approval process diverges from FDA mission
We are concerned that the FDA has diverged from its role of determining whether a medication that is the subject of an application seeking exemption from prescription-dispensing requirements, is "safe and effective for use in self-medication . . . ," [Footnote 1: 21 C.F.R. §310.200(b). ] FPA has watched with dismay as politics has interfered with the application to make Plan B available as an over the counter medication, Despite the recommendation of two FDA advisory committees that the application be approved, the application was denied. Similarly, the pending application has now been deferred for reasons that have no grounding in science.
It is not the role of the FDA to limit access to a medication because some factions of society are morally opposed to its use. If limiting access to a medication, which has been shown to be safe and effective, is not necessary to protect public health, then it should be exempted from prescription-dispensing requirements. [Footnote 2: See 21 C.F.R § 310.200(b).] The FDA exists to protect public health by making evidence-based decisions; on drug safety; the agency should not allow political agendas to substitute for science in making health decisions.
Commenter Organization Name: American Civil Liberties Union
Comment Number: 2005N-0345-EMC446
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
A rulemaking proceeding is neither necessary nor legally required for the FDA to approve Barr's petition for over-the-counter status for Plan B. Although the FDA may change a drug's status from prescription to over-the-counter via a rulemaking process, as stated in the Advanced Notice of Proposed Rulemaking here, it may also change a drug's status by means of an agency order, in this case by approving a Supplemental New Drug Application by authority granted under the Food, Drug, and Cosmetic Act. [Footnote 3: See SEC v. Chenery, 332 U.S. 194, 202-203 (1947) (an administrative agency has the authority to use either rulemaking or other authority granted it by Congress to make decisions).] There is no compelling reason to require a rulemaking proceeding to evaluate Barr's petition.
3.6 - Court opinion legal arguments
3.6.1 - Court case arguments supporting a rulemaking
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 26
Excerpt Status: NEW
Excerpt Text:
In particular, if the Agency issues a general statement of policy, it need not go through notice and comment. However, the task of distinguishing between a rule and a general statement of policy is complicated by the reality that many rules are also general statements of policy. To determine what procedures an agency must use, courts distinguish between rules and policy statements based on whether the agency statement has binding effect on members of the public. Thus, if a general statement of policy binds the public, the agency must issue the statement using notice and comment procedures. See Pacific Gas and Electric v. FERC , 506 F.2d 33 (D.C. Cir. 1974). The issue of simultaneous marketing would bind the public in the case of Plan B, as well as establish Agency precedent for future Rx-to-OTC switch decisions. Consequently, the issue is not merely a general statement of policy.
An additional exemption to the notice and comment procedures is issuance of an interpretative rule. A majority of the Circuits, the DC Circuit included, utilize the following factors to determine when an agency action is legislative, requiring notice and comment, or interpretative, which is exempt from notice and comment: (1) whether in the absence of the rule, there would not be a basis for enforcement action, (2) whether the legislative rule claimed to be interpretative is too vague or open ended to support the interpretive rule, (3) whether the agency has explicitly invoked its general legislative authority, or (4) whether the rule effectively amends a prior legislative rule. See Health Insurance Association v. Shalala, 23.F.3d 412 (D.C. Cir. 1994) and ANR Pipeline v. FERC, 205 F.3d 403 (D.C. Cir. 2000) Interpretive rules which do not require notice and comment are those which merely clarify or explain existing law or regulations. Malone v. BIA, 38 F.3d 433 (9th Cir. 1994). As argued above, simultaneous dual marketing presents a new and about-face interpretation of the FDC Act, not a mere clarification.
Any claim of exemption from the rulemaking requirements of the APA will be narrowly construed. Further, when rules to be adopted by an agency will have a broad impact not merely on the regulated industry but also on the general public in a matter which concerns the public and transcends economic issues, the notice requirements of the APA must be interpreted liberally. See NRDC V. SEC, 389 F. Supp. 689 (D.D.C , l974). Also, when an agency statement effects a change in existing law or policy, it will be considered a substantive rule requiring notice and comment even if the agency labels the action as interpretative. D&W Food v. Block, 786 F.2d 751 (6th Cir. 1986): Similarly, if a rule constitutes a change in prior agency position and has a substantial impact on the rights and obligations of members of then public, the rule is invalid if there has not been compliance with notice and comment procedures. NRTA v. USPS, 430 F. Supp 141 (D.D.C. 1977), affirmed 593 F.2d 1360. See also Benten v. Kessler, 799 F. Supp. 281 (E.D.N.Y. 1992). Notice and comment rulemaking is required before FDA can approve an NDA Supplement that would produce the kind of sea-change presented by simultaneous dual marketing of an Rx and OTC drug product.
3.6.2 - Court case arguments opposing a rulemaking
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 6.3.2 - No laws prevent the policy
Excerpt Text:
A. FDA's Legal Authority is Clear and Supports Approval
No statutory provision prevents FDA from imposing an age limitation on the prescription drug status of a new drug. As a fundamental matter, the FDCA presumes that a new drug may be available OTC unless it falls within the definition of a prescription drug in Section 503(b) of the Act. 21 USC 353(b). See, e.g., 21 CFR 330.10(a)(4)(vi); see also Leg. Hist. of Durham-Humphrey Act at S. Rep. No. 946, at 1951 USCCAN 2454, 2461. Section 503(b) provides that FDA shall impose a prescription-only restriction where a new drug
because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug.
Thus, the statute allows FDA to determine, based either on the data contained in the sNDA or the lack of necessary data, that Plan B poses a "potential for harmful effect" if used in women under age 16. FDA could also find that "collateral measures" are necessary for its safe use by women under age 16 - namely that distribution be limited to circumstances where a licensed practitioner is available to supervise its use. [Footnote 3: Indeed, the statute is silent with respect to whether age is a relevant factor when interpreting and applying section 503(b). Thus, under settled legal principles, the agency may "fill the gaps" in the statute through reasonable interpretation. See US. v Mead Corp., 533 U.S. 218,234 (2001); Chevron, USA., Inc v Natural Resources Defense Council, Inc , 467 U.S. 837 (1984).]
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
The legislative history of the Durham-Humphrey Amendments, as recorded in Senate Report No. 946, notes that the "not safe" language in the statute is intended to have its ordinary meaning. See 1951 U.S.C.C.A.N. 2,454 at 2,457 and 2,461. If the Agency has determined that a certain drug product is "not safe" for use except under the supervision of a licensed physician, then carving out a subpopulation (by age, for example) would run counter to this "ordinary meaning" -not safe is not safe, regardless of age. Drugs would not be safe for self-medication if "their unsupervised use may indirectly cause injury," as in the case of drug products that contain potent steroid hormones which affect many organ systems. 1951 U.S.C.C.A.N. 2,454, 2,457. See also 35 Fed. Reg. 9,001 (June 11, 1970). In fact, courts have historically noted the safety risks particular to oral contraceptive prescription drug products. Cf. Turner v. Edwards, 1969-l 974 FDLI Jud. Rec. 471,472 (D.D.C. 1970) (stating that "oral contraceptives are prescription drugs, and therefore subject to different requirements as to their use and dispensation than over-the- counter products").
We further note that the legislative history supports the broad applicability of classifying a drug as an Rx product due to the concerns of safety for such drug products. In addressing the concerns in relation to the Durham-Humphrey Amendments, our legislatures made clear that "the broad language of the definition contained in [these provisions] is intended to comprehend all drugs that in fact should be administered under medical supervision in order to insure [sic] their safe use." 1951 U.S.C.C.A.N. 2,454, 2,462 (emphasis added). This Congressional intent on making the definition of a prescription drug apply as broadly as possible is precisely why the statutory language makes sweeping reference to "toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use." See 21 U.S.C. § 353(b)(l)(A). Allowing the marketing of a drug product as OTC based solely on the age of a subpopulation would run counter to the Congressional intent of drafting the statutory language in this broad way.
3.7.1 - Other legal arguments supporting rulemaking
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 27
Excerpt Status: NEW
Other Sections: NEW - 8.5.4 - Other legal arguments opposing one package
Excerpt Text:
With regard to the matter at hand, we question whether the current Rx labeling for Plan B can be simplified to the extent necessary to present information in the OTC-required Drug Facts Format (21 CFR § 201.66), while also adequately warning patients of risks, side effects, and contraindications. For example, the labeling of human prescription drugs requires not only a summary of the essential scientific information needed for the safe and effective use of the drug, but also specific information required under 21 CFR § 201.57 including clinical pharmacology, and detailed contraindications, drug interactions' and warnings. This information on prescription labeling consists of concise, yet still dense paragraphs of detailed drug information.
In contrast, during the rulemaking process for OTC drug labeling, FDA cited literature studies confirming that OTC drug product labeling requires short statements and clear graphical features and visual cues to ensure readability and comprehension. See 64 Fed. Reg. 13254 (March 17, 1999). These and other studies described the importance of adherence to directions for use, and reported on a number of preventable adverse drug reactions from OTC drug products with confusing labeling. Id., Accordingly, for certain drugs it is not possible to convey the amount of information needed to adequately inform consumers of the required directions for use and safety information using the simplified OTC labeling requirements. [Footnote l4: In the proposed rule making for CDTC labeling, the FDA stated "information. . .presented in a paragraph format . . . is unappealing to the eyes and may cause the-reader to lose interest." 62 Fed. Reg. 9,024, 9,028. (February 27,1997).] Plan B is such a drug.
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 28
Excerpt Status: NEW
Excerpt Text:
Moreover, FDA promulgated a regulation acknowledging safe and effective use of contraceptives requires that patients be fully informed of the benefits and risks involved in their use. See 21 CFR § 310.501. To provide full information a patient package insert must be distributed. Id. That package insert must include a number of warnings including: information on medical conditions that are not contraindications to use but deserve special consideration in connection with oral contraceptive use and about which the patient should inform the prescriber; a warning regarding the most serious side effects of oral contraceptives; a statement of other serious adverse reactions and potential safety hazards that may result from the use of an oral contraceptive; a statement concerning common, but less serious side effects which may help the patient evaluate the benefits and risks from the use of an oral contraceptive; as well as eight additional areas of information. Id.
These two rulemakings are in direct conflict with each other in the case of the Plan B oral contraceptive product. We assert that the conflict may only be resolved by FDA adherence to the most comprehensive set of labeling - the patient package insert which, in turn, requires physician interpretation and prescription-only sale.
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
NEW - 5.3.1 - Legal arguments supporting rulemaking to dispel confusion
Excerpt Text:
Rulemaking, in accordance with ADA section 553, is needed as a matter of public health via increasing accessibility to safe, legal medications and removing the unfair burdens currently upon consumers.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
It is illegal to withhold OTC suitable active ingregients based on discrimination by age, gender or race. All packaging should contain full information.
Commenter Organization Name: Padden, Phillip
Comment Number: 2005N-0345-EC505
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Check your congressional mandate. If it requires that interpretations be justified then yes, codifying your interpretation would be an extension of justification.
3.7.2 - Other legal arguments opposing rulemaking
Commenter Organization Name: Ahmed , Stephanie
Comment Number: 2005N-0345-EC1117
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Under the Durham-Humphrey Amendment of 1951, the default option for all new drugs is OTC unless the drug is addictive or dangerous when self-administered. Plan B meets all the criteria for OTC use: low toxicity; no potential for overdose or addiction; no risk of causing birth defects; no need for medical screening; self-identification of need; uniform dosage; and no important drug interactions. In short, no medical reason exists for prescription status of Plan B.
Commenter Organization Name: Blume, John
Comment Number: 2005N-0345-EC167
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
It depends on the subpopulation. It would probably be difficult to do it based on race for example, but not based on age. Although certain drugs seem to be more effective on certain races I don't see how somebody selling a drug is supposed to determine the buyers race. However, age limitations are common.
Commenter Organization Name: Parks, C
Comment Number: 2005N-0345-EC23
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
If there are health risks to those younger than 16 or 17 years of age, they should be made very clear on the packaging of the drug. There are many OTC drugs sold in dosages that are not supposed to be given to children under a certain age, but the FDA has not initiated any special sales practices in order to regulate who buys those drugs. The same practices that are applied to other OTC drugs should be applied to this one.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
The FDA needlessly creating controversy and confusion by suggesting that one drug in one dosage could be two difference products. This is at best a semantic difference (not substantive). This rulemaking by FDA is generating confusion and not resolving it. No one would suggest that a pint of whiskey is a different product when held by a minor than when held by an adult. Nor would anyone believe that a minor attempting to buy a pack of cigarettes makes the pack of cigarettes different from the pack purchased by an adult. The FDA is asking should rules be issued that would attempt to make such artificial distinctions. The FDA is suggesting that Plan B purchased for an adult is different from Plan B prescribed for a minor. The FDA is attempting to say the age of the consumer of a product changes the nature of the product. This is patently foolish.
3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Commenter Organization Name: Speight, Thomas
Comment Number: 2005N-0345-EC1041
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
The FDA should clarify all regulations so that they can be understood by the layman, and possibilties for abuse may be minimized.
Commenter Organization Name: Speight, Thomas
Comment Number: 2005N-0345-EC1041
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
To the extent that the same ingredient may be present in different combinations and different proportions in prescription and OTC medications, yes the FDA should evaluate existing regulations to ensure that the public good is protected.
Commenter Organization Name: White, Molly
Comment Number: 2005N-0345-EC107
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Sure. Rules are great. Everyone knows the game plan when regulations exist, provided they are short, clear and to the point.
Commenter Organization Name: Reynolds, Charles
Comment Number: 2005N-0345-EC12
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, this is an important decision for the future of health care in the US.
Commenter Organization Name: Reynolds, Charles
Comment Number: 2005N-0345-EC12
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.5 - Miscellaneous arguments/discussions
Excerpt Text:
The issue is not one of confusion. The question becomes one of establishing defined criteria for which a drug may be used and marketed both OTC and Rx.
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
There is sufficient reason for the FDA to initiate a rulemaking to codify its interpretation of Section 503(b) as to when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product because the lack of legislation has created interpretations that have had some success but whose scope is not broad enough to address concerns that arise outside of their margins that focus primarily on the safety to the consumer. In the absence of such codification we find misspent FDA resources, delay on the marketing of certain drugs, a consequent profit loss by pharmacies and pharmaceutical companies, and specific needs of members of our society have been put on hold while the FDA balks in this decision making process. In codifying the aforementioned interpretation of section 503(b), the FDA could maximize its procedural efficiency and increase its service level output to the nation which would generate broader levels of satisfaction to society's needs.
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
In codifying its interpretation of section 503(b), the FDA will need to include direct and coherent policy statements that diminish the incomprehensive rhetoric that it currently ascribes to its decision making in section 503(b). The agency should present a multifaceted application that is capable of addressing the contemporary drug product needs of subpopulations such as young adults, that advises pharmaceutical companies of their responsibilities to the FDA in receiving its approval for the less mainstream drug products, that prescribes to the pharmacies and doctors exact procedures as to how and to whom they will distribute these products, and the FDA should refine and make available to anyone concerned their own internal procedures and time frames under which occur the approval processes for such drugs.
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
If the FDA were to formulate policies based on the general principles mentioned here in the codification of its interpretations and in the principles of regulatory distribution, if it were to align itself to the needs of a more contemporary America, and if it could stand firm and make decisions in the face of its opposition, it would function as a far more effective federal agency.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The FDA should initiate a rulemaking to codify it interpretation of section 503[b] of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. With the dichotomous description of the prescription drug and OTC, there have been problems with the interpretation of section 503[b]. In initiating this rulemaking, the benefits would include a simple interpretation of the prescription drug and the OTC drug?s meaning, and a more absolute guideline for the FDA to use to regulate the drugs.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Codifying an interpretation can only help--make it clear exactly why and when a drug is being marketed OTC and Rx at the same time, and make it clear that the reasons are not political but medical.
Commenter Organization Name: Reusch, Elizabeth
Comment Number: 2005N-0345-EC165
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes, this would help to determine the product packaging and restriction labeling requirements needed between a drug sold as a prescription and one sold over the counter. In many instances, the information received with prescriptions is more complete and informative.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
While the Agency's proposal to codify its interpretation of Section 503(b) would only directly address the situation in which an active ingredient can be marketed as both a prescription and as an OTC because of a meaningful difference between the products, it is important for the FDA to formalize its interpretation of the statute on this point. And activities to formalize the Agency's interpretation may also provide the opportunity to engage in a discussion about expanding the current classification system of medications beyond only prescription and OTC.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
The realities of our current health care environment underscore the need for the FDA to clarify its interpretation of Section 503(b) and participate in an open discussion of the drug classification system. Over the past decade, a number of prescription products have made the switch to OTC status. A non-sedating antihistamine, a full strength H2 receptor antagonist, and a proton-pump inhibitor have all made the transition to OTC. And with the support of consumers, manufacturers, and regulators, all indications point to even more products making the move - including products for asymptomatic conditions such as osteoporosis or dyslipidemia. As the number of "switch" applications increase, so will the potential for active ingredients that may best be simultaneously classified as both a prescription and an OTC, or placed in some type of in-between or transition category. An examination of the current two class system and codification of the FDA's interpretation of Section 503(b) will aid the Agency and product sponsors with future switch requests, and will facilitate the transition of appropriate products to OTC status, ultimately providing consumers with greater access to safe and effective medications.
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
It is crucial that FDA continue and codify its current interpretation of this law. FDA has set a consistent standard, the "meaningful difference" standard, which the American public and pharmaceutical companies have relied upon. If FDA codifies its current interpretation, this provides a further service to the public and to pharmaceutical companies, as this would give FDA's future decisions clarity and meaning.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
The FDA already does this for nicotine replacement drugs, and in the interest of legislative clarity, a clear rule should be established for drugs available in both prescription and OTC. This will finally allow the FDA to make a decision regarding Plan B, a decision consumers have waited on for years.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Such a rule will clarify this rule for future drugs so that consumers will have easier access to drugs. As the pharmaceutical industry becomes more and more involved in the everyday lives of Americans, increasing ease and access will aid both industry and consumers in making the right drug choices free from the need for prescriptions for drugs determined to be safe for OTC by the FDA.
Commenter Organization Name: Pechacek, Deborah
Comment Number: 2005N-0345-EC27
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Yes I think the FDA needs to clarify this rule to eliminate any future issues.
Commenter Organization Name: Pechacek, Deborah
Comment Number: 2005N-0345-EC27
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This definitely needs to be done to help Healthcare Professionals know when a product can be sold as an OTC product and when it can not
Commenter Organization Name: TomHon, Catherine
Comment Number: 2005N-0345-EC281
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
This is purely dependent on whether this case represents an anomoly, which is not covered by section 503b. If this is so, then the restriction of OTC status is arbitrary and not based on a scientific basis. The question is whether one desires to leave future FDA drug approvals open to arbitrary arguments or whether the scientific integrity and strength of those decisions should be preserved.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES!!! We need to make this process much more simple and bring these medications to the American public sooner.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 14
Excerpt Status: NEW
Excerpt Text:
Please consider the changes to the code 503B and permit the use of the same ingredient in OTC and prescribed medications. I believe the availability of both products will well serve the general public.
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.11 - Miscellaneous arguments/discussions
Excerpt Text:
While the current interpretation seems reasonable, a lack of codification leaves open a great deal of subjectivity with respect to what is meant by a "meaningful difference" between a prescription product and an OTC product. This codification should go beyond simple differences (e.g., strength, dosage) and require that clinical trials form the basis for any OTC branding - in order to ensure the safety of the population or any subpopulation for which the OTC version is being made available.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Clarity is necessary.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes, this would seem to be a required point considering the amount of drug therapies available and the numders will only increase. In addition, when ever there are regulatory vagaries groups seems to always take advantage and promote unintended agendas.
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
The FDA should clearly define its policy. Its previous position, that a substance cannot be both prescription and OTC for the same indication, is rational and defensible and should be codified.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes. This would clarify the regulations for any future products that may be sold either as prescription or OTC.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes, the FDA should codify its interpretation of this act, so that it can address the numerous cases of drugs ingredients that are present in both prescriptions and OTC sales.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
NEW - 5.1 - Yes
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should initiate the rulemaking process to determine whether or not a single substance can be marketed simultaneously as both a prescription drug and an over the counter one. Carrying out the rulemaking process for such a decision would not only clarify the provisions of the act, but it will also establish clear guidelines for drug vendors and manufactures to follow when introducing a new product. The rulemaking process, by soliciting comments, would allow the decision to be based on public opinion rather than simply the will of the drug and pharmaceutical companies mentioned above. Initiating a rulemaking for this issue is necessary, because the language of the current rule does not expressly mention the conditions under which a substance can be simultaneously manufactured in two different markets.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 2.2 - Support ANPRM request for comments
Excerpt Text:
Considering all the options presented and explained, one might say that ?the key distinction in these examples is that there is some meaningful difference between the two products (indication, strength, route of administration, dosage form) that makes the prescription product safe only under the supervision of a licensed practitioner?. This just might be the case, but if one simultaneously marketed both prescription and over-the-counter with the same ingredient, he or she brings more options to some consumers. For example people who may not be able to afford prescription drugs and they either do not have insurance, or their insurance may not cover their product. This is why it is important for the FDA to setup an Advance Notice of Propose rulemaking to resolve the issue of circumstances under which an active ingredient maybe simultaneously marketed, in both a prescription and over-the-counter form.
Commenter Organization Name: Babalola, Abimbola
Comment Number: 2005N-0345-EMC383
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
In our ever-changing society, it is extremely important that the executive branch of the U.S. federal government fulfills its duties of faithfully executing laws that will benefit the lives of the people of our nation. By employing the law, U.S. federal agencies such as the Food and Drug Administration (FDA) officially announce vital rules on a daily basis to more thoroughly describe how U.S. statutes will be applied to specific circumstances. But, these rules are often politically controversial, requiring agencies to explain the reasons for their rules through the benefit of written public participation. Such is the present case with the FDA, as this agency is seeking public comments in response to their Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 2005N-0345) in dealing with the issue of what types of drugs may be sold simultaneously both by prescription and over-the-counter products. If the FDA initiates a plain-language rulemaking without using complicated and confusing speech in any proposed rule, and for this issue, then drugs that are marketed in both prescription and over-the-counter (OTC) drug products will provide easy access to consumers, will decrease the number of unintended pregnancies in women in the case of the Plan B pill, and will be more affordable to consumers nation-wide.
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
NEW - 3.8.6 - Develop/update guidance as alternative for rulemaking
Excerpt Text:
In general, the current system appears to work well. FDA has the authority and flexibility to require unique, product-specific information on a case-by-case basis, and may consult with expert advisory committees, where appropriate. We believe it would be useful for FDA to issue more written guidance to explain further its interpretation of section 503(b), but we recommend that the guidance remain that - guidance, and not rulemaking - so that industry can better understand the agency's current thinking, without limiting both FDA and companies to a one-size-fits-all approach. While not specifically addressed in this request from FDA, we also suggest that the agency consider, as it formulates its policy in this context, the intermediate designation approach of "behind-the-counter" ("BTC") sale and distribution.
Commenter Organization Name: National Association of Boards of Pharmacy
Comment Number: 2005N-0345-C443
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
NEW - 7.4.2 - Involve other authorities (e.g., states, state boards of pharmacies)
Excerpt Text:
Specifically, the following comments address NABP's position regarding the most effective method by which FDA, with the assistance of the state boards of pharmacy, may safely allow and easily enforce the limited sale of nonprescription drug products to a particular subpopulation, particularly emergency contraceptives.
We believe the best way to do this is via a third, transitional class of drugs, also known as a "counseling" class of drugs. Since 1995, NABP has advocated a counseling class of drugs dispensed, without a prescription, only by licensed health care professionals authorized to prescribe and/or dispense prescription drugs. That year, during NABP's 91st Annual Meeting, the NABP delegation passed the following Resolution, 91-3-95, "Establishment of a Transitional Class of Drugs;"
Whereas, there are a number of prescription-only drugs that are being converted to over-the-counter status; and
Whereas, there are strong economic forces that are encouraging this change in status; and
Whereas, many of the drugs have serious side effects and need proper patient education for their effective use;
Therefore Be It Resolved that such drugs be placed in a special class requiring sale only by health care professionals authorized by law to prescribe and/or dispense prescription drugs; and
Commenter Organization Name: National Association of Boards of Pharmacy
Comment Number: 2005N-0345-C443
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Be It Further Resolved that NABP support the introduction of legislation into the US Congress to create this new transition class of drugs.
NABP believes that a counseling class of drugs could significantly contribute to the overall safety of the public health as more drugs are transitioned from "prescription drug" status. A counseling class of drugs would serve as a beneficial adjunct to FDA's plan to reclassify prescription drugs by ensuring that patients are properly educated in medication use. In addition, it would serve as a means to implement any subpopulation requirements to risk manage specific drugs.
Commenter Organization Name: National Association of Boards of Pharmacy
Comment Number: 2005N-0345-C443
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Overall, the implementation of a counseling class of drugs would not decrease the accessibility of newly reclassified prescription drugs, but would ensure that appropriate patients are using medications in a safe and effective manner.
In closing, NABP hopes that FDA will consider the counseling class of drugs as an approach to ensure patients' proper and safe use of specific, identified prescription drug products.
Commenter Organization Name: Women's Bar Associaion of the State of New York
Comment Number: 2005N-0345-C489
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
Excerpt Text:
WBASNY has supported legislation proposed in New York State (A. 116 Paulin/ S.3661 Spano, currently tabled) that would allow New York State pharmacists (and registered nurses) to dispense emergency contraception to women of childbearing age without a patient specific prescription. This legislation requires that, in dispensing emergency contraception, a licensed pharmacist who has been trained about emergency contraception follow written procedures and protocols. It also requires that the patient be provided with a fact sheet containing clinical considerations, methods for use, the need for follow up care, and referral information. We suggest the development of comparable or equivalent safeguards to the extent possible on the federal level for over the counter use of Plan B by women. Such safeguards might address many of the FDA's concerns about inappropriate use by teenagers. This would allow the FDA to consider permitting access by teenagers to Plan B over the counter as a means of reducing unwanted pregnancy and abortion rates among teenagers.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, by a creating a third class of drugs, those sold by a pharmacist without requiring a prescription.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
Yes, by creating a third class of drugs for sale by a pharmacist. By restricting the sale of a drug by a pharmacist without a prescription, the pharmacist would br held accountable to enforce the limitation on the sale of the product.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 1.1 - General comments on drug approval process
Excerpt Text:
Multiple other industrialized nations have more than 2 classes of drugs. In this day and age when patients are being empowered to take a proactive role in their health, safeguards need to be in place to make sure patients are not harmed by taking inappropriate drugs. With more drugs being switched from prescription to OTC status, having drugs available without a health care practitioner can lead to adverse outcomes. Some of the labeling on current OTC drugs is very confusing to a lay person.
Commenter Organization Name: Corlette, Chauncey
Comment Number: 2005N-0345-EC14491
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
Excerpt Text:
Ways to enforce the limitation of age would to sell the drug behind the counter. The creation of behind the counter option in the United States would alleviate safety concerns between the availability of over the counter drugs to the public without any kind of professional conciliator. Pharmacists would be able not only limit the amount of drugs and keep track of buyers but also to provide counseling prior to administering the drug. The matter of law is making it mandatory for the drug to be sold behind the counter, having the pharmacist describe the drug and its side effects, having the persons who purchase the drug to agree to sign for it and present identification with their age on it. This would enforce the regulations for being able to sell the drug. There is a growing need for behind the counter drugs. For example; There has already been a push to have drugs that contain pseudoephedrine (ex. Sudafed), as their active ingredient, behind the counter because they are used to make crystal methamphetamine, an illegal drug. Having behind the counter drugs would allow effective medications that are relatively safe to be used in proper ways and available to the public.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
Excerpt Text:
I visited Ontario, Canada and saw that they had a form to fill out and keep regarding EC. Of course, Canada already has that third class of "OTC, but limited and behind the counter", where patients must request the medication. We have a similar system in California, where pharmacists can prescribe and dispense EC. This works very well - if you have enough counseling space in your pharmacy.
Commenter Organization Name: Hutson, Paul
Comment Number: 2005N-0345-EC162
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
The FDA should allow for the dispensing of selected drugs without a prescription by a licensed pharmacist, physician's assistant, or nurse practitioner.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
In simplest terms, if a drug does not meet the definition of prescription drug product from Section 503(b) , it must be an OTC. However, there may be drug products in which the standard two class system is not sufficient. For example, certain drug products may not distinctly fall into the "prescription" or "OTC" class - the active ingredient could be considered both a prescription and an OTC if some meaningful difference exists between the products. In other circumstances, certain drug products may not require the assistance of a learned intermediary (the deciding factor in classifying a drug as a prescription), yet patients would still benefit from access to a health care professional's services when selecting and using the product. Such access may not always be available with "full" OTC status.
Commenter Organization Name: Collum, Mark
Comment Number: 2005N-0345-EC33
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes. This should either be fully OTC or it should be classified into a category where RPh can prescribe and dispense it.
Commenter Organization Name: Scarpace, Sarah
Comment Number: 2005N-0345-EC38
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.3.1.1 - Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies)
Excerpt Text:
Yes, the medication itself is likely safe; however, there is special monitoring/intervention required for the medication which makes professional triage and not OTC availability in the best interest of the patient. The best scenario is to find a mechanism to ensure that these patients are seen by a physician in the ER, but the next best option is to at least utilize pharmacists as the fail-safe. Most pharmacists take this responsibility seriously; the recent media attention regarding pharmacists refusing to fill these prescriptions was in my view, embarrassing to the profession, but also highlighted a small minority of practice by pharmacists, probably equal to the percentage of physicians who hold similar ideologies.
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
I believe that there are very sound arguements to initiate a rulemaking to define a transitional class of drugs that would be pharmacy-only drugs. Although there is some precedent for concurrent Rx and OTC marketing of drug products, there is much to gained by defining a pharmacy-only class of drugs. Pharmacists already have the skills, knowledge and most importantly, the mechanisms to properly distribute medications based on specific medical and legal criteria.
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
Excerpt Text:
It is a good time to give careful consideration to creation of a third Pharmacist Only class of medications in this country. Under our current system, medications make a giant leap from the very restricted and regulated prescription distribution system to the incredibly extensive non- prescription marketplace. Making some of these medications so widely available may not be in the best interest of patients' health. Granting pharmacists control over a specific group of prescription medications might serve to improve care in a cost-effective manner. Pharmacists know that they have tremendous impact on their patients' health when they advise and guide the selection and use of medications. Numerous studies have demonstrated the value in both dollars and outcomes when pharmacists are involved in drug therapy management. A third class of drugs would provide consumers with more choices and give them access to professional guidance toward effective health care. Of course, the added benefit would be that pharmacists would enhance the triage function that they already provide, referring patients for physician-provided medical care when indicated. A pharmacist-only class of drugs would be in the best interests of our patients and would have little negative impact on corporate profit margins or on physicians' ability to provide medical care. Actually, there is great potential to broaden the availability of consumer products and enhance the delivery of medical care. This is an idea whose time has finally come. The idea of a pharmacy-only class of drugs is also being considered and may serve as an important transitional step toward a more intelligent distribution system for the myriad of drug products available in this country. Think about the possibilities!
Remember, the purpose of the third class would be to improve access to beneficial medications, not restrict access to OTC products.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Pharmacists are well-educated, compentent healthcare professionals and there is no reason to believe that having a pharmacist control access to Plan B (allowing sale without a prescription for women 17 years of age and older, while requiring a prescription for younger women) would not work to protect the public's health.
3.8.3 - Other policy arguments for initiating a rulemaking
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 23
Excerpt Status: NEW
Other Sections: NEW - 6.6.2 - Congress
NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
D. Without A Third Class of Drugs, OTC Sale Is Unregulated and Uncontrolled
Whether Congress creates a third class, or FDA by regulation creates a third class, without such a creation the Plan B product will be freely available to all consumers. Presently in the U.S., an OTC drug can be sold anywhere to any consumer unless restricted by state law. Thus, if FDA approves Plan B for OTC sale and a state does not restrict the sale to pharmacies, the drug would be available at any gas station, 7-11, or other business that wanted to sell the drug. In such a setting, does anyone believe the under-17 age limit will be observed, much less enforceable? [Footnote 12: For the remainder of these Comments, we will refer to the proposed age restriction for Plan B OTC sales as 17-and-over and under-l 7, as delineated by FDA, though we acknowledge that the Sponsor's NDA Supplement requested a restriction at age 16. See Not Approvable Letter, Lester M. Crawford, DVM, Ph.D., Commissioner, FDA, to Duramed Research, Inc. (Aug. 26, 2005). ] FDA has been given the statutory tools to protect the public health for the nation, and the switch of Plan B without a regulatory framework to control the drug's use in under-age children is without precedent. It may be that some statutory plan can he created to provide this drug OTC to adults, but the current statutes and regulatory scheme do not provide them. Moreover, FDA should not usurp the role of Congress by creating a marketing exception to the laws and regulations currently on the books.
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
It is logical to update codes to include provisions for the simultaneous marketing and selling prescription and OTC drugs. This is especially clear in a case where age is the deciding factor: adult users should not have road blocks put in their way when they seek to buy safe, legal medication. Consider: we do not need a prescription or other form of authorization to buy alcohol, though its selling is age-based. In the case of medication, the issue of accessibility can be much more critical: patients rarely have a chance to get a prescription over the weekend, for example, and some medications are heavily time-sensitive.
Commenter Organization Name: Kwak, Eugene
Comment Number: 2005N-0345-EC13643
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Accessibility would be such an advantage to almost every person there is. Not everyone can go to a doctor at 12am midnight to get a prescription for some powerful nasal decongestant when that person needs it. If the prescription strength nasal decongestant was moved down to the over-the-counter level, it would be available to the person at all times. Also, the less fortunate low-income families would be allowed greater access to medicines as well. Doctor fees are expensive and many of the country's poor are unable to pay these fees and receive proper treatment or medication for their problems, simply due to being unable to pay the costs. If some medicines moved over-the-counter, even these people would benefit for having access to the drugs without the hefty doctor fee.
Moving medication to the shelves can also heighten the level of business competition. It would increase the market size that these companies can sell to. This would make more companies strive harder to reach this market at even further horizons. An initial effect and end effect would be the lowering of costs for medications for the end-user consumer as well. Also, if companies are doing better here, that shows in the status of the country's economy as a whole, so I cannot see where we are being hurt on this matter by going through with this process.
Commenter Organization Name: Kwak, Eugene
Comment Number: 2005N-0345-EC13643
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
America's governing principle is that of liberty, which is also being able to choose and take accountability and responsibility in your actions and the choices you decide to make. So how would moving medicines over-the-counter promote this ideology? Well, if the people aren't able to choose what they can and cannot do for themselves, then isn't that a lack of liberty? Currently, the liability and accountability, for the use and sales of prescription medicines is placed largely on the doctors who prescribe them. If they were to prescribe a patient the wrong medicine, then that doctor would be facing some form of punitive measure. If people were allowed to choose for themselves what is best for them, they would simply be taking liability and responsibility for their own actions. This is the first fundamental step to liberty. People should be able to choose whether or not to take some medicines if they felt the need to be treated.
Commenter Organization Name: Kwak, Eugene
Comment Number: 2005N-0345-EC13643
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
What should the FDA do? I believe the FDA should follow through with this rule, but make sure there is some form the threshold in place to insure that highly abusive substances, such as hydrocodone, be kept out of the open market and behind the counter as it is today. However, going through with the process would enhance accessibility of the medicines to anyone in need, business competition would be heightened, the idea of personal liberty and accountability would be nothing but promoted to a greater degree. These are but a few of the reasons as to why the FDA should follow through with this rule.
Commenter Organization Name: Soriano, Lauren
Comment Number: 2005N-0345-EC14388
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
The Food and Drug Administration should initiate rulemaking in order to see if an active ingredient can be simultaneously marketed in both a prescription and over-the-counter drug. However, there has to be stipulations on the over-the-counter drug because if the same active ingredient is in both the prescription product and the over-the-counter product, then what would be the purpose of a prescription drug. People would just flock to the OTC drug, since it is so accessible.
Commenter Organization Name: Moon, Kristin
Comment Number: 2005N-0345-EC1927
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes--often patients will abuse the OTC product--that is--to take it incorrectly and do themselves harm--even when the package is labeled for safe use. Other times, patients need doctor contact to rule out severe illnesses or needs, but having the medication available OTC keeps them out of the doctor's office
Commenter Organization Name: Witherwax, Carol
Comment Number: 2005N-0345-EC193
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
When the product would help to benefit the majority of the people (in this case women) and assist in aleviating the unneccessary medical, social, and psycological impact on society if the drug was not dispensed.
Commenter Organization Name: Tuchinsky, Marla
Comment Number: 2005N-0345-EC201
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
To the extent that your interpretation is preventing women from getting access to a perfectly safe and effective drug, yes.
Commenter Organization Name: Levinson, R. Saul
Comment Number: 2005N-0345-EC297
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 3.1 - Yes
Excerpt Text:
Yes, there are instances where a professional may prescribe a product when he has contact with a patient, and instances where a drug product may be needed without prescribing professional interaction. This is certainly the case with "Plan-B"... as it is an emergency contraceptive, the user could be in a situation where there is no time for contact with a prescribing professional (weekends, holidays, afterhours, etc.)... and needs immediate access to the drug.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
Excerpt Text:
The manner in which many OTC drugs are used differs from the manner in which the prescribed drug of the same ingredients is used. For example, rare use of Plan B in the emergency situation has been found to be safe. The daily use of the same drug, with potential use for years, does require monitoring and education by a licensed prescriber. Although the drug used in both the emergent and preventative situations has been found to be safe, there are rare but potential health consequences with chronic use. In general, oral contraceptives have been taken by millions of women around the world and are safe.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 12
Excerpt Status: NEW
Excerpt Text:
As a medical provider, I believe that it is safe to have two products be legally market to the general public.
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes, as a consumer and a woman, there should be guidelines as to under 16 years of age use. But, as an adult that option to buy a drug OTC should be available.
Commenter Organization Name: Katrib, Elise
Comment Number: 2005N-0345-EC516
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
The rulemaking should focus on safety. But also take into account that the same drug is widely available in other countries such as Canada and the Britain.
Commenter Organization Name: Ramirez, Robert
Comment Number: 2005N-0345-EC527
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes, if clarification is needed iniate a rulemaking interpretation. If a active ingredient scientifically shows that is safe and effective for the public and the only reason for the product not being available for the public is red-tape, then policy has to be amended.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
If we assume that Plan B has not been shown to be safe without prescription for children under 17, then the new regulations should be considered. A drug that can be very helpful to women and is only denied based on ideaology instead of science should be made available by any truly scientific health organization.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes. It would inform the voting and pharmaceutical consuming public to understand how such decisions are analyzed and made, including the medical purpose for creating at once a controlled and an uncontrolled distribution channel for the same product.
Commenter Organization Name: Camron, Kiera
Comment Number: 2005N-0345-EC811
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Despite all of these risks, proponents are agitating (loudly) for these drugs to be made available over the counter, available without the advice of a medical professional who would provide vital education and assessment of a woman?s risk. The well-being of Americans is at stake; it is the FDA?s responsibility to ensure the involvement of medical professionals and prevent the over the counter sale of EC.
Planned Parenthood claims that EC will prevent 1.7 million unintended pregnancies and prevent 800,000 abortions each year in the United States, yet studies in the prominent medical journal The Journal of the American Medical Association and others in countries where EC has routinely been used for years show no change in pregnancy rates with over the counter availability of EC. So why the stubborn promotion of EC? What agenda could possibly justify the exploitation of American women?
I, for one, am thankful for the FDA taking the time to look more carefully at this dangerous drug. With any luck, they will conclude that over the counter EC is one ?blessing? America can do without.
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
FDA rules are much more readily available as meaningful information to typical consumers.
Commenter Organization Name: Holden, Karen
Comment Number: 2005N-0345-EC895
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
If a there is evidence that a prescription drug poses a particular risk to a particular subgroup of the population, then the FDA may impose added restrictions for that group, including marketing the drug simultaneously as OTC and prescription. However, the definition of risk should encompass only safety or efficacy of the particular medication, and should be based on accepted evidence. Any other basis or concern used to deny access to medication to a partcular subgroup is beyond the legitimate interest of the FDA.
Commenter Organization Name: Mock, Suzanne
Comment Number: 2005N-0345-EC940
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
This should be spelled out very clearly for practitioners and pharmacists, alike, so they cannot misunderstand the language. Selling this product as both a prescription product and an OTC product should not be much different from what is happening now with physician/pharmacist agreements regarding many medications.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
More emphasis needs to be placed on one's ability to make and be responsible for decisions reguarding their own health. People usually become more mature with age and may not use an OTC wisely when younger. One should be able to make a informed decision with information contained or distributed with the medicine.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
NEW - 5.1 - Yes
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should initiate the rulemaking process to determine whether or not a single substance can be marketed simultaneously as both a prescription drug and an over the counter one. Carrying out the rulemaking process for such a decision would not only clarify the provisions of the act, but it will also establish clear guidelines for drug vendors and manufactures to follow when introducing a new product. The rulemaking process, by soliciting comments, would allow the decision to be based on public opinion rather than simply the will of the drug and pharmaceutical companies mentioned above. Initiating a rulemaking for this issue is necessary, because the language of the current rule does not expressly mention the conditions under which a substance can be simultaneously manufactured in two different markets.
Commenter Organization Name: Tadeo, Peter
Comment Number: 2005N-0345-EMC373
Excerpt Number: 4
Excerpt Status: MODIFIED
Excerpt Text:
One of the risks of making more dugs over-the-counter is the threat of abuse of prescription drugs. Over history humans have always seen the beneficial and negative effects of decisions made by governments, whether it is war, laws, or policy. In some circumstance there are people who will constantly decide to abuse a great event, or in this case medicine, and exploit its contribution to many. Currently drugs containing the same active ingredient but with a smaller dosage are sold as OTC, and the more potent dosage is sold as a prescription product. Though, the smaller OTC dosages are still abused by addicts. For example, Ibuprofen is sold OTC at under 400mg, but one could consciously take more of the dosage prescribed on the label. The person taking this drug is knowledgeable about the side effects that this drug will have and making it only prescription should not be implemented because of that small population that chooses to misuse that medicine. Regulation is the option that one should look at when promulgating new policies for OTC drugs.
Commenter Organization Name: Tadeo, Peter
Comment Number: 2005N-0345-EMC373
Excerpt Number: 9
Excerpt Status: MODIFIED
Excerpt Text:
Promulgating policy for prescription drugs should be viewed as a step forward in the right direction. Increasing the introduction of prescription drugs into the OTC market will boost competition and make pharmaceutical products more of a free market. This will in turn lower prices for those that can not afford to obtain drugs. Those with health insurance can still go to there doctor and receive the drug by prescription for only a co-payment or choose to buy it over-the counter. US citizens have the right to know what they are taking and informing the public about the drugs they are consuming would have to be increased. Accessible and affordable drugs are the answer to repairing the tarnished prescription drug system.
Commenter Organization Name: Tadeo, Peter
Comment Number: 2005N-0345-EMC373
Excerpt Number: 10
Excerpt Status: MODIFIED
Excerpt Text:
The FDA needs to approve rulemaking for the sell of an active ingredient in both in a prescription drug product and an over-the counter product so that all American citizens can receive medical help for any illness or problem they may have. A government's job is to keep order and to do what is best for the good of the people.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should most definitely codify its interpretation of section 503 (b) to resolve confusion, it can and should place limits on certain subgroups, most notably those underage, and the FDA should also allow the identical packaging of over the counter and prescription drugs but also keep in mind that this is not always appropriate. The current state of the rules regarding prescription and over the counter drugs is inadequate and the FDA should proceed in the rulemaking process.
Commenter Organization Name: Babalola, Abimbola
Comment Number: 2005N-0345-EMC383
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Another great reason why the FDA should propose a rule to allow drugs to be sold simultaneously both as prescription and OTC drug products is because the drugs could be more affordable to consumers. This can be the case in low-income families, or single-parent households that probably might not have insurance to cover certain drug costs along with paying for doctor visits. For example, if a single mother who is a diabetic needs to buy weekly supplies of insulin prescribed by her doctor and she has no insurance to pay for the drug costs, while also paying for other living expenses, then she can buy cheaper OTC pharmaceutical supplies versus the more expensive prescription. Taking into account some of the beneficial reasons of why certain drugs should be simultaneously marketed as both prescription and OTC drug products, the FDA should initiate a plain-language rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act which provides the Federal standard used to classify drugs as prescription or OTC, and it describes when and how to switch a drug from prescription to OTC status. An FDA rulemaking would grant feasible accessibility of medications to consumers by educating them about a certain drug and would allow them to care for themselves given special circumstances.
Commenter Organization Name: Babalola, Abimbola
Comment Number: 2005N-0345-EMC383
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
In conclusion, a prescription and OTC drug product marketed together would be cost efficient because a consumer can purchase a pharmaceutical OTC drug even if his or her drug costs are not covered by insurance.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
In order to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an over the counter (OTC) drug product, the Food and Drug Administration should initiate a rulemaking. Codifying section 503(b) set specific standards that pharmaceutical companies can conform to so that there is no ambiguity in the ways drug companies can supply an active ingredient in both markets. Also made clear would be the conditions under which a drug is to be administered and sold. Established criterion and explanation protects consumers as well as eliminates carelessness of pharmaceutical companies on their pursuit to drop new drugs into the market.
For instance, if a new drug were put on the market with active ingredient 'n,' the drug companies would have to comply to more explicit standards and regulations enforced by the FDA in order to market the drug as a prescription and/or OTC product. Further, codified interpretations of section 503(b) would ensure standardized distribution under law. Providing concrete interpretation eliminates loopholes in which the drug companies may use to their commercial advantage.
3.8.4 - Interpretation is clear in present form
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Quite simply, if the FDA determines that the data and labeling submitted fulfill the requirement of exemption from section 503(b), then the product is a non-prescription (i.e. OTC) drug. Conversely, if the FDA determines that the data and labeling do not fulfill exemption from section 503(b), then the product is a prescription drug.
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
In addition to 21 CRF 310.200 (Prescription-exemption procedure), the Agency's position on switch products and the associated switch process is made clear by correspondence with a Sponsor and/or as matter of general public record. This occurs via Citizens Petition, NDA action packages, the Advisory Committee process, presentations by CDER Management and staff at public meetings and Part 15 Public Hearings (e.g. June 28, 2000).
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
GSK CH contends that the requirements for exemption from 503(b) regarding OTC suitability are clear. Sponsors should continuously evaluate the healthcare environment for opportunities that benefit both Rx and OTC users. Further regulations would be neither necessary nor helpful and may hinder innovation.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
1.A. FDA does not need to initiate a rulemaking to codify its interpretation regarding when an active ingredient can be simultaneously marketed in both a prescription and OTC drug product, since ample precedents already exist to guide the agency and the public. As the agency notes in the background information of this ANPR, the 1951 Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act removed the confusion that had existed prior to that time when different manufacturers made different decisions about whether to market a drug as prescription or OTC. Under the Durham-Humphrey Amendments, the same drug, at the same dosage form and strength, and for the same indication, cannot simultaneously be available on a prescription and nonprescription basis.
But since the Durham-Humphrey Amendments, FDA has needed to draw fine distinctions among dosage forms, methods of administration, or indications or uses to regulate an ingredient differently in different settings. These fine distinctions are not limited to whether and when a drug ingredient is prescription or OTC. They run across a gamut of issues, from a product's primary mode of action to whether something is a food, drug, biologic, device, cosmetic, or some combination of them, from whether something is generally recognized as safe and effective or whether it requires a new drug application to other fine distinctions. The commonality in drawing these distinctions, and the very reason for drawing them, balances on whether or not an ingredient is the same thing in two related settings.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 13
Excerpt Status: MODIFIED
Excerpt Text:
While the same drug, at the same dosage form and strength, and for the same indication, cannot simultaneously be available on a prescription and nonprescription basis, FDA has long needed to draw fine distinctions among dosage forms, strengths, methods of administration, indications or uses, or on other bases to distinguish between OTC and prescription versions of the same active ingredient, or between OTC labels and professional information/labeling for the same active ingredient.
In other areas apart from this ANPR, FDA in some instances has established rules to help guide both interested parties and the agency in walking the line between various distinctions on what is or isn't the same and what triggers different treatment, but there is no mandate to do so. In the case of the instant question of prescription and OTC status, there are ample precedents to give interested parties paths to follow to distinguish among different labeling requirements, leading to an active ingredient in more than one setting not being the "same," even if an outside observer less familiar with the nuances involved would not immediately see the distinctions.
Given the existing precedents, we see no need for the agency to initiate a rulemaking to codify its interpretation regarding when an active ingredient can be simultaneously marketed in a prescription and OTC drug product.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 9
Excerpt Status: NEW
Excerpt Text:
I. FDA'S INTERPRETATION OF SECTION 503(b) HAS NOT CREATED CONFUSION, AND THERE IS NO NEED FOR ANY RULEMAKING IN ORDER TO APPROVE NDA 21-04S/S011.
FDA need not, and should not, initiate a rulemaking to codify its interpretation of section 503(b) regarding when an active ingredient can be marketed simultaneously in both an Rx drug product and an OTC drug product.
As FDA acknowledges in the Notice, it has on a number of occasions permitted simultaneous Rx and OTC marketing of a product. Were FDA's interpretation of section 503(b) really in need of clarification, that need would have arisen well before now. The fact that the issue has not previously been raised is strong evidence that there is no need for rulemaking regarding FDA's interpretation of section 503(b).
Moreover, the issue presently before FDA is whether this drug product, Plan B, can simultaneously be marketed as both an Rx and an OTC drug product. Resolution of that issue need not, and ultimately does not, implicate FDA's long-standing interpretation of section 503(b).
Commenter Organization Name: Dorn, Kellie
Comment Number: 2005N-0345-EC117
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I agree that if a medication is unsafe for some, it should remain as prescription only.
Commenter Organization Name: Thomas, Tiffany
Comment Number: 2005N-0345-EC13026
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
According to Lester M. Crawford at one time the Federal Drug and Administration "used to prohibit products from being sold both over the counter and prescription at the same. The idea was if an active ingredient was safe and effective with out practitioner's supervision it had to be over the counter." I think that is a major reason that drugs should only sold either over the counter or by prescription no simultaneously. Prescriptions have physician advisory; your doctor can control the amount of the drug you receive and how often you receive it. Whereas, with the over the counter you are only consulting your pharmacist, who does not know you medical history and can not adequately make sure that it is safe for someone's particular body type. This could be dangerous and harmful to your health. Also, with prescriptions somebody can keep track of how much you receive and you can only get the amount that your doctor has prescribed. When a drug is sold over there is no way for you to keep track of who gets what and how much. With drugs such as the "Plan B" drug there would need to be some sort of data base to keep track of who purchases, so that people could not abuse the system, and go from store to store every other day and be like I need this pill. There should a limit on how much you can receive with in a certain time frame.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.8.7 - Cost-benefit concerns regarding rulemaking
Excerpt Text:
You should not be growing a government bureaucracy in order to achieve someone's idea of social policy. If a drug carries clinically proven risks to the affected population, it should be dispensed only by prescription. Period. End of story. Don't play games with drug regulation. The agency's credibility is already on shakey ground.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
A. The FDA's current interpretation of section 503 (b) is a common sense definition of the law. Although it is unnecessary, the FDA could codify its current policy and reasoning for how it decides whether a product with the same active ingredient is distinguished from OTC and prescription (i.e. A product with the same active ingredient is available OTC in low concentrations because it is safe at weak concentrations, while the same product is made prescription based on the greater concentration or more potent method of dispersal). Since the FDA's policy on the law has served our country well for about 20 years, there should be no doubt to the validity of its interpretation.
Commenter Organization Name: Subcommittee on Criminal Justice, Drug Policy
Comment Number: 2005N-0345-EC16770
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Additionally, to allow FDA to change its interpretation of this statute or to allow an exception to its current interpretation for Plan B is against public policy. It not only opens the door to instability in the way agencies interpret their own statutes, but also leads to significant public doubt as to how FDA interprets its own rules. How does FDA serve the American public by arbitrarily changing its statutory interpretation merely at the behest of a pharmaceutical company, which furthermore provides insufficient data to support its request? As an executive agency that ultimately serves the American people, FDA must pay careful attention towards maintaining consistency in its interpretations of law, especially in situations like this where there is little evidence-medical or legal-which would support a change in FDA's existing interpretation.
Commenter Organization Name: Kisly, Anne
Comment Number: 2005N-0345-EC212
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I think the text and examples provide clear examples of when a drug product may be marketed as both prescription and OTC. Examples should not be interpreted to mean that they cover all situations. They are after all, examples.
Commenter Organization Name: Goggin, Terresa
Comment Number: 2005N-0345-EC213
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
No, I believe your previous guidelines are adequate. If it is safe without a practitioner's prescription then it should be available OTC.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
This question can be answer in one word: NO! The FDA is doing the equivalent discussion of 'how many angels can dance on the head of a pin'? The FDA interpretation of section 503(b) is straightforward and simple. This notice suggests that FDA will needlessly add complexity to what is otherwise clear and simple.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 7.4.4 - Require identification for age
Excerpt Text:
If an active ingredient in a drug has been ruled to be physically harmless enough for over-the-counter distribution, it should be marketed over the counter only. Rule-making codifications have already been set for drugs with active ingredients that have been ruled to be physically harmless enough for over the counter distribution but whose distribution might be deemed socially controversial. Please see the rule-making codification for alcohol and tobacco distribution. ID should be required to purchase it and guardians and police should be responsible for enforcing socially appropriate use. It is not the FDA's role to protect the public from physically harmless drugs or to monitor social use of drugs. The FDA's current "dilemma" is an egregious waste of tax-payer's dollars.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
NEW - 4.4.1 - Legal arguments that little or no confusion exists
Excerpt Text:
From the brief that I have available, I believe I understand the intent of the reasoning behind OTC use and prescribed use. Of importance here is the indication of the drug use. Plan B is to be used only in the emergent situation, after intercourse has occurred, to prevent an unintended pregnancy. The drug is not meant to be use daily to prevent. "The key distinction in these examples is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage form) that makes the prescription product safe only under the supervision of a licensed practitioner." The previous quote is from the docket, I believe the key difference is the indication of the drugs' use.
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.3 - Maintain Rx only
NEW - 3.1 - Yes
Excerpt Text:
Yes. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC
Commenter Organization Name: Venturella, Vincent
Comment Number: 2005N-0345-EC58
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
There is no need to initiate any further rulemaking for codification of the action. It is quite clear in its present form.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The current usage - where the molecule/drug is used for different purposes/doses it is either prescription or OTC - seems intelligent enough.
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No, the policy in effect now is adequate.
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 3.8.8 - Other policy arguments opposing a rulemaking
Excerpt Text:
Under the current circumstances, some drugs are OTC and some are not because it is presumed that proper use of prescription drugs requires specialized knowledge that is not available to the general public. Without this knowledge, the public cannot truly give individual and personal consent to the possible consequences of the use of the prescription drug. It these drugs are made OTC, the only source of information available to consumers will be via inadequate package information or through the recommendation of the pharmacist. Any change in the current policy is going to negatively impact both the safety of the public and the role of pharmacists.Patients will become mere consumers and pharmacists will become amateur physicians.
Commenter Organization Name: Schmierer, Ann
Comment Number: 2005N-0345-EC81
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.9.1 - Drug approval examples
Excerpt Text:
I think there are a number of drugs available OTC that are similar and used for exactly the same indications as prescription drugs (i.e. Claritin OTC, Prevacid OTC), and there should be no distinction made between the interpretation for these drugs, so why the confusion on Plan B? I believe there is a very distinct political motivation behind this issue being raised. If the product is proven safe and effective by the FDA for OTC, it should be made available to consumers that want it.
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
As been the process for a long time, the FDA has a statute that an active ingredient may not be simultaneously marketed in both prescription and OTC drug product. This should stand as is, and not be modified just for this one product. FDA makes these regulations for sound reason and should not be overturned just because a case arises with political interests. I am a pharmacist and what I do is guided by, and I rely on, these statutes. The FDS should stick by its regulations, which have worked so well over time.
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
Again, a single active ingredient should not be marketed both as prescription only and over the counter. FDA should stick by their policy which has been in place for many years, without prior incident. They should not make an exception or worse, initiate rulemaking to change this.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
The FDA?s interpretation of this rule has, up until this decision, been consistent for many years; care needs to be taken that political pressures are not entered into the interpretation, but the rule itself is straightforward.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
Excerpt Text:
As a pharmacist and public health practitioner, I do not see where the confusion lies. According to information available at 21CFR Part 310 for Docket 2005N-0345, the current interpretation of the Act includes a differentiation between OTC and Rx drugs by indication (among other things, including strength, dosage form, and route of adminstration). The meaningful difference in the case of Plan B is that the OTC product is indicated for adults; the Rx product is indicated for patients 16 years of age and under. To me, that is the same as saying that meclizine is safe for use for motion sickness OTC but requires supervision for use for vertigo. Plan B is safe for use by adults but requires supervision when used in minors. The fact that the dose is the same for each population is immaterial. These are clearly different populations, thus justifying an OTC and Rx label.
3.8.5 - Circumstances for OTC safety are case-specific
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
NEW - 3.8.6 - Develop/update guidance as alternative for rulemaking
Excerpt Text:
In general, the current system appears to work well. FDA has the authority and flexibility to require unique, product-specific information on a case-by-case basis, and may consult with expert advisory committees, where appropriate. We believe it would be useful for FDA to issue more written guidance to explain further its interpretation of section 503(b), but we recommend that the guidance remain that - guidance, and not rulemaking - so that industry can better understand the agency's current thinking, without limiting both FDA and companies to a one-size-fits-all approach. While not specifically addressed in this request from FDA, we also suggest that the agency consider, as it formulates its policy in this context, the intermediate designation approach of "behind-the-counter" ("BTC") sale and distribution.
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
The short answer is no; FDA should not initiate formal rulemaking in this case. The FDC Act clearly identifies when a drug product is for prescription use only. On the other hand, the circumstances under which a product may be considered safe and effective for OTC use vary according to product type and should be reserved for a case-by-case evaluation, e.g., a new drug application or monograph. For example, the amount of safety information that may be needed to allow the OTC sale of statins would be far different from that required for the OTC sale of antihistamines.
Commenter Organization Name: Paslawsky, JoAnn
Comment Number: 2005N-0345-EC1129
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
As a chemist, I am all too familiar with the exceptions that occur despite the industry's best pre-marketing testing and post-marketing surveillance. Thus, I believe that it is virtually impossible to codify interpretation of section 503(b). I believe strongly that simultaneous marketing of an active ingredient in both prescription and OTC form must be assessed on a case-by-case basis. Otherwise, I believe both patient safety and industry's liability are placed at major risk.
Commenter Organization Name: Mershon, Claire-Helene
Comment Number: 2005N-0345-EC12379
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.1 - Yes
Excerpt Text:
Yes. Plan B should be available OTC, and while I disagree that it should be split between OTC and prescription, I understand the concerns of the FDA in taking the action for women under 16. However, this should not keep the FDA from keeping it off of the shelves completely. If an active ingredient is judged to be safe for use OTC by women, it should be sold that way. If it is necessary to make the drug prescription for one population in order for that to happen, then the FDA should review its rules and allow the drug to be available in both forms.
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
It is logical to update codes to include provisions for the simultaneous marketing and selling prescription and OTC drugs. This is especially clear in a case where age is the deciding factor: adult users should not have road blocks put in their way when they seek to buy safe, legal medication. Consider: we do not need a prescription or other form of authorization to buy alcohol, though its selling is age-based. In the case of medication, the issue of accessibility can be much more critical: patients rarely have a chance to get a prescription over the weekend, for example, and some medications are heavily time-sensitive.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
Please note that APhA is not responding to these questions in the context of a single drug product; rather, we are providing our comments on the overall "dual status" issue which could apply to any number of drug products. As such, pending issues need not necessarily be resolved by rulemaking before the Agency acts on a specific pending application.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
no...drugs cleared for OTC usage should not have additional restraints of prescription requirements based on age. But instead should have clearly labeled information for dosage and dangers, especially when applied to minors.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. I believe that the interpretation is overly restrictive and ignores situations such as this (appropriate for a sub-population)and should not be codified. Case by case determination is more appropriate.
Commenter Organization Name: Kisly, Anne
Comment Number: 2005N-0345-EC212
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The interpretation of it may be confusing because, as in the case in question, the safety data for levonorgestrel is different from the safety data in the examples and the past regulatory decisions. I would expect decisions regarding prescription(RX) and OTC access to be made on a case-by-case basis. Not all drugs will fit the examples provided. The regulatory interpretation of section 503(b) will never explicitly address all the different possible situations.
Commenter Organization Name: Kisly, Anne
Comment Number: 2005N-0345-EC212
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I think a sentence could be added to clarify that decisions are made on a case-by-case basis. I doubt that any rule is hard and fast and will cover all submissions.
Commenter Organization Name: Roettcher, Phil
Comment Number: 2005N-0345-EC224
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Decisions can be made on a case by case level.
Commenter Organization Name: Waychoff, W. Aaron
Comment Number: 2005N-0345-EC311
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes - the FDA should understand that, just like many other substances in our society, factors beyond simply the direct effectiveness and safety of the product on the human body must be taken into account. Many medications currently available OTC effect persons of different ages differently and carry labeling indicating such. In this labeling, use outside what is indicated by young persons is deferred to a physician's recommendation. Similarly, drugs such a Plan B could be made available OTC and carry labeling indicating that its use for women under 16 (or 17) is restricted to a physician's recommendation - in the form of a prescription. Remember, a prescription is little more than an official recommendation by a physician to use a particular medication at a particular dose.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 9
Excerpt Status: NEW
Excerpt Text:
This again would be a cause for concern for the consumers, and controversy could arise, and laws must be changed, and I feel this is incorrect to do a 'blanket change of policy for reinforcement on duel-marketing drugs' in this manner.
What if other drugs arise in the future and likewise the drug companies suppling the consumers would want the same option, and what if there is cause for concern that this would be detrimental to the consumers by doing this? The FDA would then have to do 'damage control' and back-pedal on their policy on rulemaking if they follow this route.
Commenter Organization Name: Rosati, Lucia
Comment Number: 2005N-0345-EC76
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I believe it is acceptable to consider drugs on a case-by-case basis.
Commenter Organization Name: Rosati, Lucia
Comment Number: 2005N-0345-EC76
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
Maybe so; but again, I think each drug should be considered on a case-by-case basis. In most cases, I don't see why a drug would be safe only for certain people. Either it's safe or it isn't.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Codification of the FDA?s interpretation of section 503 (b) would be greatly beneficial. The current wording of the rule is very broad and allows for very few exceptions. It seems to paint all drugs with the same brush when each drug should be looked at separately. The very fact that there is the question of a need for rulemaking illustrates the confusion on how the current rule should be interpreted and applied. Questions could be raised about what qualifies as a difference. Do they have to apply to the drug itself? Or can the circumstances of the some consumers count as a difference? There could also be widely varying interpretations of what is safe and for whom it applies. The current set of rules seems to group all drugs together and tries to separate over the counter from prescription with the same standards for every drug it looks at. But when it gets down to individual drugs, the method of dividing into prescription and over the counter may be totally inadequate. The FDA needs to address these questions in their rulemaking. They need to provide for a clearer way to separate drugs into prescription and over the counter. They also need to allow for exceptions when it comes to individual drugs. A large sweeping set of rules that use the same standards to separate prescription and over the counter is bound to break down along the way, as well as roll over some cases while letting other fall through the cracks. Codification of the FDA?s interpretation of section 503 (b) would help to ensure that every drug gets looked at with the standards it needs to and would allow exceptions based on the unique circumstances of individual drugs.
3.8.6 - Develop/update guidance as alternative for rulemaking
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.2 - Two-class system (OTC and Rx) not sufficient - need a third class of "behind-the-counter" drugs (pharmacist distributed)
NEW - 3.8.5 - Circumstances for OTC safety are case-specific
Excerpt Text:
In general, the current system appears to work well. FDA has the authority and flexibility to require unique, product-specific information on a case-by-case basis, and may consult with expert advisory committees, where appropriate. We believe it would be useful for FDA to issue more written guidance to explain further its interpretation of section 503(b), but we recommend that the guidance remain that - guidance, and not rulemaking - so that industry can better understand the agency's current thinking, without limiting both FDA and companies to a one-size-fits-all approach. While not specifically addressed in this request from FDA, we also suggest that the agency consider, as it formulates its policy in this context, the intermediate designation approach of "behind-the-counter" ("BTC") sale and distribution.
Commenter Organization Name: Arnall Golden Gregory LLP
Comment Number: 2005N-0345-C403
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
As previously noted, we do not see much benefit from formal rulemaking here. However, it would be useful for FDA to issue a clear guidance document to outline the current interpretation by the agency of the circumstances under which an active ingredient may be simultaneously marketed in both a prescription and an OTC product. This guidance could include some recommendations about the amount of safety information that might be required in a marketing application and the format in which it should be presented to FDA. In addition, the written guidance should contain criteria that FDA will consider when evaluating whether there is a "meaningful difference" between a prescription and an OTC drug product.
Another issue that FDA might address in any guidance that it develops is the control of access to certain medications that could be abused or may require additional input from a learned intermediary who is not a physician, such as a pharmacist.
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Nevertheless, sanofi-aventis believes that there is indeed significant confusion over the Agency's interpretation of section 503(b) - confusion created by the Agency's October 1999 Draft Guidance for Industry regarding "Applications Covered by Section 505(b)(2)." [Footnote 5: FDA, Draft Guidance for Industry: Applications Covered by Section 505(b)(2) (October 1999) (hereinafter "1999 Draft Guidance" or "Draft Guidance"). ] However, sanofi-aventis believes that FDA need not initiate rulemaking to dispel this confusion. Rather, the Agency can simply withdraw or amend its 1999 Draft Guidance. In addition to noted confusion, the Draft Guidance raises issues of the Agency's unauthorized "taking" of confidential data belonging to the pioneer manufacturer and the Agency's authority under section 505(b)(2), which are beyond the scope of these comments,
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
FDA need not initiate rulemaking to clarify its interpretation of section 503(b) of the FLEA as to when the same active ingredient may be simultaneously marketed in both a prescription and OTC product. Rather, the Agency can do so simply by withdrawing or amending its 1999 Draft Guidance. By withdrawing that guidance or striking any reference to OTC switches in that document, FDA will affirm its practice (I) of permitting switches through the original applicant's initiative or the Agency's own rulemaking and (2) of allowing the same active ingredient to be marketed simultaneously as a prescription and OTC counter product only where a meaningful distinction between the two products exists.
3.8.7 - Cost-benefit concerns regarding rulemaking
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
NEW - 5.4.3 - There is no confusion, therefore rulemaking unnecessary
Excerpt Text:
We see no need, or benefit, of further regulation. Our FDA submission experience leads GSK CH to conclude that there is no confusion regarding FDA's interpretation of section 503(b). To the contrary, we have found FDA's interpretation very clear. It is our opinion that part C of this question is therefore moot.
Commenter Organization Name: Pfizer, Inc.
Comment Number: 2005N-0345-C407
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
B. The ANPRM inquires whether a rulemaking to codify FDA's approach would be appropriate. Pfizer does not believe that an expenditure of agency resources on such an endeavor would be justified. Any attempt to describe how FDA would resolve specific safety issues under Sections 503(b)(1) and 503(b)(3) or adequacy of labeling issues under 503(b)(2) would be a complicated undertaking which could either unduly constrain future scientific judgments or result in statements at a level of generality which would be unlikely to advance public understanding of the review process beyond that already established in the Congressional mandate in Section 503.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
You should not be growing a government bureaucracy in order to achieve someone's idea of social policy. If a drug carries clinically proven risks to the affected population, it should be dispensed only by prescription. Period. End of story. Don't play games with drug regulation. The agency's credibility is already on shakey ground.
Commenter Organization Name: Young, Stan
Comment Number: 2005N-0345-EC211
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
As a conservative Republican, I'd note that the commissioners should not waste my money trying to go down this twisty path of logic. You'll trip yourselves up, and cost the government and the consumer money.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.2 - No
Excerpt Text:
NO, This seems to be a problem waiting for a whole lot of money to be waisted on. Either a drug is over the counter or it is not.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
Either trust the majority of the population to do right and keep it all OTC or distrust and try to manage the minority and keep products behind a counter under strict control, both will have good and bad social consequences but one will cost more.
Commenter Organization Name: Burgess, Annette
Comment Number: 2005N-0345-EC566
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial burden on stores which carried such products as they'd have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions. Talk about back-log!
Commenter Organization Name: Cahoon, Clifton
Comment Number: 2005N-0345-EC80
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.5.4 - Other arguments
Excerpt Text:
This is making it too confusing. I think they should not allow this subpopulation seperation legal. It presents too many future regulations, regulatory parties, audits, etc. Yes a drug may make OTC status but the monetary and regulatory burden placed therefore on the public would be enormous. The drug would in essence be able to be free of that burden while then the burden rests on taxpayers and retail workers to pay for this drugs audits and regulations. Very unwise when the drug is for such a limited population that the burden is then placed on the general public. Let the population for whom the product is designed for seek to carry the burden by seeking a physician visit and prescription given. This is a ridiculous request by a drug maker, it is obvious they will make the money, market the product and then pass the burden of regulation and audit to the taxpayer. Abuse.
3.8.8 - Other policy arguments opposing a rulemaking
Commenter Organization Name: University of California, San Franscisco
Comment Number: 2005N-0345-C320
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
NEW - 3.2 - No
Excerpt Text:
The Food and Drug Administration (FDA) has the authority to switch a prescription drug to over-the-counter (OTC) status if the drug is both safe and effective when self- administered; potential users can self-diagnose the condition for which the drug is needed; and, the drug's label provides clear instructions for use. Though Plan B meets all of the criteria for OTC status, the FDA has failed to remove its prescription requirement and instead has launched down a path of bureaucratic indecision that does not serve U.S. women. The FDA has no scientific basis for discriminating the safety of Plan B among women of reproductive age. We strongly urge the FDA to abandon the proposed rulemaking process and approve the original application to switch Plan B to an OTC product without restrictions.
Commenter Organization Name: Ruckdeschel, Diana
Comment Number: 2005N-0345-C71
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
f. With regard to the FDA defining a regulation to allow for drugs to be available with and without a prescription....bad idea because of the precedent it will set. Consumers will want that option available for every drug. They will want it because of criteria other than age. Through lawsuits and judicial action, consumers will slowly start to interfere with the FDA's ability to do its job without "checking inn with the public. It will also undermine the FDA's credibility and authority..."Can't the FDA decide for itself?" "Is this drug safe for 0TC use or not?...It either is or it isn't!" "'Can't they make up their minds?"
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
To use an ingredient in both OTC and by prescription only muddies the water as to who will receive what and in what form and intensity (dosage). It should be OTC only to assure that if someone wants it, it's available.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
No. No drug should be both prescriptive & over the counter at the same time. The idea is a contradiction and dilutes the definition of both terms. Prescription drugs indicate caution is required. Over-the-counter items indicate public consumption. That is the mindset of the public and if you allow an item to be both prescriptive & over the counter, then people will automatically assume the lower degree of over the counter and assume it is for public consumption.
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
It makes very little sense, if the drug is nessisary to the welfare of thousands of American women, to limit and restrict the access to said drug. The FDA needs to base rules on the health & well being of Americans, not politically motivated "interpretations" of sections and codes.
Commenter Organization Name: Slee, April
Comment Number: 2005N-0345-EC121
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. There are two reasons to have a drug available by prescription. One is so insurance covers it, like blood glucose test strips. The other is that a reasonable person can't be expected to take it safely and correctly without the direction of a doctor. On this second part, either a drug is safe enough or it isn't. Besides, anyone who is 15 is smart enough to get a 16 year old friend to buy it for them.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. Why are you complicating this? The FDA is supposed to regulate drugs based on clinical evidence, not make social policy.
Commenter Organization Name: Smith, Jennifer
Comment Number: 2005N-0345-EC157
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.3 - Maintain Rx only
Excerpt Text:
If this product contains one of the same active ingredients used in ordinary prescription birth control pills -- only in the case of Plan B ? each pill contains a much higher dose and is taken in a different way. Then, why is it being considered for OTC when other birth control pills require a perscription? Whouldn't some women use this OTC as birth control rather than visit their physician for a perscription and checkup?
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. The interpretation is too restrictive
Commenter Organization Name: Myers, Micah
Comment Number: 2005N-0345-EC319
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
There is no scientific or legal reason to have two packages containing the same drug at the same dosage with one only available by prescription. That being said, there are moral and political reasons to do so. Please do not engage in morality or politics.
Commenter Organization Name: Bilz, Michael
Comment Number: 2005N-0345-EC4
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Has it done so for Ibuprofen? It is sold both ways today.
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This would open up pandora's box as there would be a review of dozens (maybe hundreds?) of other molecules that might "need" to be reevaluated as to their prescription/OTC status.
Commenter Organization Name: Dolinski, Elizabeth
Comment Number: 2005N-0345-EC522
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 3.2 - No
Excerpt Text:
The FDA should only rule on drug safety issues. I am very upset that the FDA is trying to pass moral judgement on the U.S. population. It has been determined to be medically preferable to make plan b available simultaneously available. Therefore, that is what the FDA should do.
Commenter Organization Name: Porter, Rebecca
Comment Number: 2005N-0345-EC56
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
If the medication is not safe enough for OTC use then it should be sold only by prescription to maintain the safety for all parties. Making it OTC will make it available to the group for whom it is not acceptably safe.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
But I have written my serious concerns above (see A), and see no logical reason for the FDA to change their policy on this issue, it would create serious controversay, difficulty, and perhaps even future lawsuits from consumers at the extreme.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
I believe the rulemaking should stay as it is. And not go change policy, allowing duel-marketing of both a prescription drug product and simultaneously an OTC product. The FDA should remain firm on this issue in this regard.
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
A change in this policy could result in decreased safety for OTC drugs. It would shift policy definition from the scientific to the political arena.
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
Under the current circumstances, some drugs are OTC and some are not because it is presumed that proper use of prescription drugs requires specialized knowledge that is not available to the general public. Without this knowledge, the public cannot truly give individual and personal consent to the possible consequences of the use of the prescription drug. It these drugs are made OTC, the only source of information available to consumers will be via inadequate package information or through the recommendation of the pharmacist. Any change in the current policy is going to negatively impact both the safety of the public and the role of pharmacists.Patients will become mere consumers and pharmacists will become amateur physicians.
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This would open the floodgates for evermore trivial excuses to market products which have been judged dangerous enough to require professional oversight -- through a prescription.
Commenter Organization Name: Devine, Naomi
Comment Number: 2005N-0345-EC710
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
If the products are identical and for identical uses, all should be regulated.
Commenter Organization Name: Cahoon, Clifton
Comment Number: 2005N-0345-EC80
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
This is a matter that the FDA must continue to monitor and not make a drug manufacturer the controlling party. Do not allow drugs with such specificity as being subpopulation separated to become the burden of all public buyers. The people who seek such specific medications must continue to seek to establish a physician/patient relationship or pharmacist/patient relationship where legal to do so in order to meet criteria. Let only those trained in health care specific to the disease decide the appropriateness of therapy, not allow the general public to make that determination. It is a shift of burden that must be kept with the FDA and regulated by legend drug rules, and not allowed to be made a public responsibility to determine appropriateness of therapy. It only opens a large decentralization of appropriateness of regulation, appropriateness, and cost.
Commenter Organization Name: Jago, Laura
Comment Number: 2005N-0345-EC839
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
It would be confusing to have a drug both marketed as prescriptions only and over the counter, especially when there is no difference in the drug or packaging.
Commenter Organization Name: Vander Bleek, Luke
Comment Number: 2005N-0345-EC870
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 8.6.4 - Other arguments opposing one package
Excerpt Text:
A prescription product would assume the patient has had the benefit of a medical examination and consultation of a willing physician and pharmacist.
An OTC product which could be acquired in a self service environment would necessarily carry the responsibility to inform the patient of proper use, mechanism of action, and the dangers of not submitting themselves to routine medical examinations to detect diseases. In the case of emergency contraceptive marketing, and despite the most comprehensive labeling, I believe that many young sexually active women will not recognize the value of routine gynecologic exams. These women will likely never submit themselves to routine gynecologic exams and public health will suffer.
Commenter Organization Name: Vander Bleek, Peter
Comment Number: 2005N-0345-EC882
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
It is a certainty that the general public's understanding of the intricacies of how drugs act on the body varies a great deal-from very little to expert. Not many of us have had advanced training in the study of pharmacology or have a working knowledge of advanced chemistry. For this reason, I believe that the average prospective consumer of this drug is vulnerable to this company's aforementioned sales propaganda. I am certain that OTC approval of Plan B(R) would be tantamount to unleashing Barr Labs and its "misinformation sales machine" on an unaware public.
At this time, the public is safeguarded by the knowledge, training and consultation of its doctors and pharmacists. If Plan B(R) were to reach the OTC shelves, these safeguards will have been sacrificed-in my opinion a risk to public health.
Commenter Organization Name: Kopp, Margaret
Comment Number: 2005N-0345-EC903
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
No. The FDA is so thoroughly biased and under the influence of politics that any rule that it makes at this time will be in the interest of politics, and not in the interest of good medicine, nor in the interest of the public sector.
Commenter Organization Name: Dalton, Mike
Comment Number: 2005N-0345-EMC166
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
1. Should the FDA create and define a regulation to allow for a drug to be available both with a prescription and without?
No. I believe in practice it would be ineffective and easily circumvented.
3.9 - Examples of previous FDA actions in allowing simultaneous marketing of Rx and OTC products
3.9.1 - Drug approval examples
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 5
Excerpt Status: MODIFIED
Excerpt Text:
There are many good examples of why active ingredients should be available both as prescription and OTC drugs. These include, for example, oral ibuprofen, H2 antagonists: (cimetidine, ranitidine, famotidine, nizatadine), omeprazole, and topical miconazole and hydrocortisone. For these products FDA have evaluated the data and determined that for some elements of the drug, section 503(b) exemption does not apply, e.g. for reason of indication or dose. Those elements have remained prescription status.
Other actives have switched totally, leaving no prescription status product (e.g. oral & transdermal nicotine replacement therapies (NRT), loratidine). These products were considered section 503(b) exempt in their totality.
Commenter Organization Name: American Society for Reproductive Medicine
Comment Number: 2005N-0345-C350
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
As the agency recognized in the September 1 ANPR, FDA has allowed marketing of the same active ingredient in products that are both prescription and OTC where "some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner." 70 Fed. Reg. 52050 (Sept. 1, 2005). FDA provided several examples of such drugs, and reiterated that the "key distinction" between the OTC and prescription versions of those products is "some meaningful difference between the two products," for example, "indication, strength, route of administration. dosage form." Id.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
The examples which follow provide a partial, not exhaustive, list of those instances where a particular ingredient is seen as an OTC drug in one or more settings, but is a prescription drug or includes prescription labeling, professional labeling, or professional information in others.
(1) Dosage strength variations. As FDA notes in the ANPR, ibuprofen and H2 blockers are both examples in which an active ingredient is prescription in one strength and OTC in another. While FDA also pointed to more readily distinguished differing strengths and indications for the prescription or OTC ibuprofen and H2 blocker examples in the ANPR, one can also point to dosage strength variations where the distinctions between the prescription and OTC versions are finer. For example, prescription-strength 2.5 percent hydrocortisone cream is indicated for relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. OTC 1.0 or 0.5 percent hydrocortisone cream is indicated for temporary relief of itching associated with minor skin irritations, inflammations, and rashes due to a number of listed inflammatory and pruritic conditions, i.e., indications closely related to the higher-dose prescription indication.
As another example, the directions for OTC ibuprofen start at 200 mg, and go up to 400 mg per dose, for aches, pains (including the pain of menstrual cramps), minor pain of arthritis, and reduction of fever. While higher strengths of prescription ibuprofen are available, prescription strength formulations start at 300 mg, between the two OTC doses. In addition, arthritis, including flare-ups of chronic disease, mild to moderate pain, and primary dysmenorrheal are prescription indications. These indications are closely related to the OTC indications.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
(2) Indication variations. In addition to dosage strength variations (some of which include very similar indications, including the examples mentioned earlier), there are prescription and OTC variations based on the indication using the same dosage strength. Ibuprofen again provides an example, where children's ibuprofen is available OTC for children down to 6 months of age in a suspension --100 mg/5 mL - to temporarily reduce fever or to relieve minor aches and pains due to listed common conditions. The same strength is available as a prescription for children down to 6 months of age for reduction of fever, for relief of mild to moderate pain, and for relief of signs and symptoms of juvenile arthritis. Setting aside the juvenile arthritis indication, which can be readily distinguished, the OTC "'temporarily' reduces fever" indication versus the open-ended prescription "reduction of fever," and the OTC minor aches and pains versus the prescription mild to moderate pain indications illustrate the fine line between two products distinguished as not being the "same."
Clotrimazole is a second example, where 1 percent topicals are available: OTC for athlete's foot, jock itch, or ringworm; OTC for treatment of recurrence of symptoms matching a previously diagnosed vaginal yeast infection; and prescription for treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. (There are differing creams, lotions, solutions, or delivery vehicle variations in this example. There are also additional strengths for different treatment durations for vaginal yeast infections.) Again, OTC labeling for recurring vaginal yeast infections versus the prescription labeling for open-ended occurrence/recurrence and with reference to more specific causes of the condition draws a fine line between related contexts that aren't seen as the same. It is worth noting that the first reference to the fact that the OTC product is for recurring infections does not occur in the "use" section of the OTC outer package label. Rather, the direction to consult a doctor if this if the first vaginal itch situation occurs under "warnings" - a different section of the OTC "Drug Facts" label from the "use" section.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
(3) Professional labeling approaches. Under the OTC Review monograph system, many ingredients or classes of ingredients that are generally recognized as safe and effective (GRAS/GRAE) include professional labeling. While it is true that the OTC products with these ingredients are not technically prescription products at the same time, the limitation that this professional labeling is to be provided to health professionals but not to the general public serves the same practical intent: it distinguishes between OTC information (i.e., those uses that are safe and effective for consumers, or information intended to provide for safe and effective use by consumers on the basis of labeling), and information or uses that are intended to be limited to use under the professional supervision of a health practitioner because of potentiality for harmful effect; method of use; or collateral measures necessary to use (i.e., factors in the definition of a prescription drug under 503(b)(1)). Among the many monographs or tentative final monographs with professional labeling are:
- Antacids: Professional labeling for antacids includes additional details on the neutralizing capacity of the product in terms of dosage per minimum time interval; additional indications (for specific disease states or, for certain ingredients, low phosphate diets); additional warning information on kidney disease for certain ingredients where the OTC label includes a contraindication for kidney disease; and additional warning information on prolonged use for certain ingredients where the OTC label includes a duration of use warning. See 21 CFR sec. 331.80 (April 2004) on professional labeling, and 21 CFR sec 331.30 (April 2004) on OTC labeling of antacid products.
- Antiflatulent: Professional labeling here distinguishes between the basic OTC indication to relive gas symptoms and indications tied to a particular subpopulation's state: gas pain in postoperative or endoscopic exam settings. See 21 CRF sec. 332.31 (April 2004) on professional labeling compared and contrasted to OTC labeling at 21 CFR 332.30.
- Topical antifungals: Professional labeling for a specific antifungal ingredient includes an additional indication for superficial skin infections caused by yeast (candida albicans). See 21 CFR 333.280 (April 2004) on professional labeling compared and contrasted with the OTC indications for athlete's foot, jock itch, and ringworm at 21 CFR 333.250.
- Cough, cold, allergy, brouchodilator, and antiasthmatic OTCs: Here again professional labeling includes additional information that may be provided to health professionals, but not to the general public, in this instance focused on age distinctions, including dosage schedules for children 6 years of age to 12, and children 2 to under 6. See 21 CFR 341.90 (April 2004). Similar to the case of antiflatulents, professional labeling in this category includes a narrow distinction within the indication for an expectorant tying the expectorant to an underlying condition, but without changing the basic indication: "'helps loosen phlegm (mucus) and this bronchial secretions to' (select one or more of the follow: 'rid the bronchial passageways of bothersome mucus,' 'drain bronchial tubes,' and 'make coughs more productive')" for the OTC indication compared or contrasted with professional labeling that the expectorant "'helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.'" (Emphasis added.) Compare and contrast 21 CFR 341.78 (April 2004) for OTC expectorant labeling with 21 CRF 341.90(d) for professional labeling.
- Miscellaneous internal OTC products: Cholecystokinetic drug products are GRAS/E for OTC use, and again a distinction is made between consumer labeling and labeling provided to health professionals but not to the general public. Here, the consumer's OTC indication is for the contraction of the gallbladder during diagnostic gallbladder studies, and consumers are directed to take the product only when instructed by a doctor. Left to professional labeling is a description of the implicit 'how' (visualization) of the OTC indication's explicit 'what' (for diagnostic studies): "For visualization of biliary ducts during cholecystography." See 21 CFR 352.350 on OTC labeling and 352.280 on professional labeling. In this final example, there is not free-standing separate indication, or no separate dosage from or strength, to distinguish between the OTC use and the professional (i.e., prescription-like) use. Indeed, in this example, OTC would be predicated on the ultimate professional use. The example yet again illustrates the fine line that can be drawn.
With OTCs subject to a new drug application, FDA has also worked with companies on professional labeling or professional information within approved labeling. For example, at least one of the H2s include not only strength or indication differences between prescription and OTC versions of the ingredient, but professional information for the OTC version discussing pharmacokinetic interactions. Overdosage information provided as professional information in labeling for a number of OTC internal analgesics or antidiarrheals are further illustrations.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
(4) Age distinctions. As covered in the discussion above on professional labeling, age is frequently used to distinguish either OTC labeling from prescription labeling for the same active ingredient, OTC labeling from professional labeling or professional information, or OTC labeling from an off-label use a physician could choose to prescribe for a patient.
In addition to the GRAS/E OTC ingredients discussed earlier, another example would be nicotine replace therapy, where the directions advise potential users to ask a doctor before use if under 18 years of age. NRT products are further labeled as not for sale to those under 18 years or age, and labeling states that proof of age is required. While a version of these products is not labeled for prescription use for those under 18, a doctor, upon being asked, could chose to prescribe a NRT product within their own practice of medicine.
The same can be said for minoxidil in either 5 percent strength for men, or 2 percent strength for women, where the labels warn against use if you are less than 18 years old.
Clotrimazole for recurring vaginal yeast infections of H2s for heartburn are further examples along the lines of NRT and minoxidil, this time with labeling for use in those 12 and over. (Clotrimazole for athlete's foot, jock itch, and ringworm, meanwhile, warnings against use on children under 2.)
In the case of H2s, similar to NRT, the OTC directions are to ask a doctor for children under 12. How a doctor might respond is not addressed, instead being left to their discretion within the practice of medicine. (Meanwhile, prescription versions of the H2s exist in a variety of other strengths.)
Age distinctions for children who are 6 years of age versus those under 6 are even more common. In addition to the GRAS/E illustrations given earlier, the antidiarrheal lopcramide, with OTC directions to ask a doctor before use in children under 6 years of age, includes a professional dosage schedule for children 2-5 years old.
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
(5) Gender distinctions. Distinctions have also been drawn between ingredients in OTC products versus other, prescription, professional information, or presumably off-label uses based on gender. Clotrimazole, discussed earlier, would be one example. Minoxidil would be another.
Minoxidil 5 percent topical solution to help regrow hair is indicated for use in men, and includes warnings against use by women (at the same time, it is not exempt from a general OTC warning to seek the advice of a healthcare professional if the user is pregnant or nursing a baby). Minoxidil 2 percent, meanwhile, is marketed under a brand including a descriptor within the brand name of "For Women." The labeling, however, includes no uses, warnings, or directions limiting its use to women. Earlier versions of OTC minoxidil 2 percent included separate packages and separate labeling for a brand including "for Men" within its brand name, and a version including "for Women" within its brand name. With earlier versions, warnings were included on the "for Women" brand specific to women that were not included in the "for Men" brand (such as the pregnancy/nursing warning). Compare and contrast the "for Men" and "for Women" versions as published in Physicians' Desk Reference for Nonprescription Drugs (1997 edition, Medical Economics). While there neither were not are simultaneous prescription and OTC versions of an ingredient in the minoxidil example, it nonetheless again points to the ability of manufacturers and FDA to draw fine distinctions between two items to make them not the same.
Commenter Organization Name: Micro ICU Project
Comment Number: 2005N-0345-C5
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
At any rate, the questions raised by the Commissioner in his recent statement are pertinent, and he should be commended for bringing them to our attention. But his approach to the question of whether the same molecule can exist in both prescription and over-the-counter forms for the same indication still deserves a note of criticism. For in accepting the finding of the CDER that Plan B is safe as an over-the-counter product for women who are 17 years of age and older, he appears to have contradicted his own question by overlooking the fact that Barr Laboratories' Plan B is the same molecule as Wyeth's prescription-only brand Ovrette, but in a different dosage. For this reason the question should be broadened to address whether prescription and over-the-counter forms of the same molecule can exist to straddle different dosages and/or ages.
Each of two tablets in the Plan B regimen contains the active progestin equivalent of 20 tablets in the Ovrette regimen-a 40 tablet total. Both regimens are indicated by their labels to reduce unplanned pregnancy. Both regimens suggest suppressing ovulation as a mode of action. The molecular equivalence is confirmed by Dr. Trussell and colleagues at Princeton University, who recommend substituting 40 tablets of Ovrette for the two tablets of Plan B. [Footnote 5: "Twenty-one brands of oral contraceptives that can be used for emergency contraception in the United States." http://ec.princeton.edu/questions/dose.html ] So why would the FDA accept the finding of the CDER that the same molecule is safe in high dosage form as an over-the-counter product for women who are 17 years of (age and older, but not in low dosage form? Since it is particularly odd to conclude that the higher dosage of the same molecule should exist in over-the-counter form and the lower dosage in prescription form, by circumstances alone one must conclude that the determinations of the CDER are highly questionable. For although the FDA might consider whether different dosages can be straddled, it is hard to believe that the higher dosage would be the one relegated to over-the-counter status!
Commenter Organization Name: White, Alan
Comment Number: 2005N-0345-EC1121
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
There is no sufficient reason to distinguish the issue of legalizing OTC Plan B over and above that of OTC Loperamide on the basis of 503(b). Since the same general issues apply in both cases, and OTC Loperamide was approved without raising these issues, it is unclear why these issues should be pertinent to this case except for irrelevant moral/social/theological/political reasons.
Commenter Organization Name: White, Alan
Comment Number: 2005N-0345-EC1121
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
It is significant that the commentary on this case is solicited only in terms of the above general questions that cover the specific issue of whether Plan B contraception should be acceptable as an OTC drug. That implies that this case is the first such case considered by the FDA that brings these questions forward. However, for example, the case of Loperamide, which the agency has approved for treatment of diarrhea and is cited in the FDA?s list of dual prescription/OTC-dispensable drugs, completely undercuts this implication. Though the FDA very finely distinguishes the prescription/OTC indication for diarrhea in these two uses as respectively chronic/acute, each occurrence of that condition is in fact an individual medical event, and the prescribed/OTC medication is in fact dispensed in equivalent dosage to prevent a recurrent episode of that condition, whether diagnostically chronic or acute. Logically and medically the use of prescription/OTC Plan B to prevent pregnancy, interpreted merely as an undesirable episodic biological condition, is not different. Should the FDA care to challenge this claim on the basis that potential pregnancy cannot be a medical condition comparable to diarrhea, it should equally consider more carefully the current medical acceptability of procedures such as breast augmentation and rhinoplasty, which are often pursued wholly on the patient?s subjective assessment of somatic undesirability. Clearly both potential pregnancy and potential diarrhea are equivalently undesirable for some patients, and the relevant medications are indicated chiefly for these reasons. Furthermore, if the prevention of possible pregnancy is interpreted by the FDA as something other than an issue of patient-assessed undesirability of a somatic condition, then the FDA would import moral, social, religious, or political assumptions about possible early pregnancy that are of dubious scientific or logical merit to this argument, and might well constitute an unconstitutional basis for any ruling issued by the FDA.
Commenter Organization Name: Farren, Wanda
Comment Number: 2005N-0345-EC11670
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
FDA has precedent for simultaneous prescription and OTC usage, whether at the same or at different doses. The nicotine patch and ibuprofen are two examples. The patch is restricted to buyers ages 18 and older.
Commenter Organization Name: Clague, Alexander
Comment Number: 2005N-0345-EC13
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 8.3.1 - FD&C Act arguments (e.g., single label could be created that satisfies both sets of statutory requirements)
NEW - 8.7 - Examples of Rx and OTC labeling that is similar but with one or two differences - e.g., dosage/age distinction
Excerpt Text:
This is an odd question, since omeprazole (brand name Prilosec) is currently being sold both as a prescription and as an OTC product. The distinction that the OTC product is a different salt than the prescription product has no biologic significance. Accordingly, the same package may be used so long as the "OTC" product contains whatever required language the "prescription" product would require so that there would not be any problems where a pharmacy were "out of stock" of the prescription product while still having an inventory of the OTC product.
Commenter Organization Name: Kwak, Eugene
Comment Number: 2005N-0345-EC13643
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
One may argue that if pharmaceuticals were placed as an over-the-counter drug, it would allow abusers to gain easier access to a substance. Well, naturally the FDA would be drawing a line as to what is and what isn't going to be sold in both market areas. Drugs such as hydrocodone, a powerful painkiller and opiate, would not move from its prescription-only status, naturally due to its potency and highly abusive properties. There are already drugs being in both areas, even today. Acetaminophen, Tylenol's active ingredient, is sold in its original non-prescription form and in prescription strength. What is the difference between the two and why is Tylenol given such treatment? Acetaminophen, unlike hydrocodone, is not highly addictive and doesn't have a likelihood of being abused. Also, the non-prescription form is roughly one-third the amount of acetaminophen per pill. So, if we were to avoid the problem of abuse, then a line should be drawn as to what can and what cannot be moved to the shelves.
Commenter Organization Name: Rahl, Michael
Comment Number: 2005N-0345-EC13845
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The FDA has deemed it appropriate to market the active ingredient in both formats under four conditions: indication, strength, form of dosage, and the manner of product administration. The impetus for these four criteria and the permission to market dual forms of an active ingredient that has varying formula constitutions have been based on the relative safety of the individual that is using the products. A drug such as Meclizine, which in its prescription form is used to treat vertigo and nausea in its OTC form, was tested and deemed to be safe for public consumption in either of the two forms. If one were to examine several of the other drugs that have been evaluated in a similar fashion by the FDA, they would witness the development of a theme which binds this accepted category together: these drugs are not ethically, morally, or normatively questionable to society.
Commenter Organization Name: Soriano, Lauren
Comment Number: 2005N-0345-EC14388
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
If the FDA did approve of the selling of Plan B as both a prescription and over the counter drug, they would have to make stipulations. Limiting the sale to a particular subpopulation should be one of the stipulations that the over-the-counter product should have. Just as other OTC products like flu medicine are sold, Plan B should be sold to women age eighteen years or older and remain as a prescription for others that are under the age of eighteen years old. Much of the controversy lies on whether or not to market the drug to women sixteen years or older, but seeing how women are not even close to being fully developed at age sixteen, the drug should not be available to them because they are more likely to use the drug improperly.
Commenter Organization Name: Corlette, Chauncey
Comment Number: 2005N-0345-EC14491
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.3.4 - Age limitations are in line with other meaningful differences
Excerpt Text:
Currently the FDA allows the same molecule to be sold as a prescription product and an over-the-counter product, but there is a meaningful difference in the way the two products are used. Understanding that and the previous precedent was if a drug was unsafe for any public it would be classified as a prescription drug. The precedent would have to change, to serve the majority of the population it is purposed for, the majority of women would be able to benefit from this drug and be unsafe for a small sub-population. The drug will have a meaningful difference in being safe and appropriate for women 17 years of age and older. This Plan B drug is relatively safe for the majority of the public which is women 17 years of age and older the sub-population of minors until the age of 16 would be the only ones that the drug use would be inappropriate for without the consent of a doctor.
Commenter Organization Name: Scott, Cindy
Comment Number: 2005N-0345-EC148
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 8.1 - Yes
NEW - 8.8 - Examples of similar labeling of Rx and OTC products that are the same drug and dose, in the market place or previously marketed
Excerpt Text:
I ALREADY RECEIVE CLARITIN (LORATADINE) 10 MG BOTH VIA PRESCRIPTION OR I CAN BUY IT OVER THE COUNTER. I DON'T THINK THERE IS A PROBLEM WITH SELLING THE PRODUCT IN THE SAME PACKAGE.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Ibuprofen, ranitidine and other histamine receptor agonists, many drugs are currently sold OTC and prescription, but the issue there is about dosage, not a moral determination.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
It doesn't seem too different from a medication being OTC in one case and not being OTC when combined with something else - especially when that something else is also OTC. Note Guaifenesin - long acting vs short, with or without a decongestant. Patients ask us why these items are prescription but can be bought separately OTC when combined.
Commenter Organization Name: Academy of Managed Care Pharmacy
Comment Number: 2005N-0345-EC15687
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
The FDA has interpreted the language in section 503(b) of the Durham-Humphrey Amendments to allow marketing of the same active ingredient in products that are both prescription and OTC, assuming some meaningful difference exists between the two that makes the prescription product safe only under the supervision of a licensed practitioner. The key distinction in all current examples of products sold both OTC and by prescription is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage forms). To date, the FDA has not allowed marketing of the same active ingredient in a prescription product for one population and in an OTC product for a subpopulation. However, the FDA has acknowledged that its interpretation of section 503(b) of the act has not been explicitly set forth in any of the regulations that discuss the process by which FDA classifies drugs as OTC or prescription.
Commenter Organization Name: Marcelli, Christian
Comment Number: 2005N-0345-EC16427
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
There are already products sold both OTC and via Rx. Ibuprofen is one of them. This has been relatively safe considering the vast benefit to society.
Commenter Organization Name: Saling, Elle
Comment Number: 2005N-0345-EC16546
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Pepcid AC is sold as both prescription and over the counter as is Motrin.
Commenter Organization Name: Wilson, Rhianna
Comment Number: 2005N-0345-EC186
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes. There are already other laws and rules involved in the process of purchasing OTC medications. Such as only being allowed to purchase so many packages of sudafed etc. So inflicting another law on societies consumers will not come as a shock. Especcially dealing with a medication that carries so much of an importance to release because of its immeditate window of effectivness.
Commenter Organization Name: Morrisroe, Julia
Comment Number: 2005N-0345-EC194
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
There are many otc drugs available that are not suitable for children...but here were talking about girls....under 16. Clairitn for adults vs. clairitin for children. We rely on individuals to make the right decision. The FDA is supposed to check on the safety of the drug, not police individual usage, because if individual usage were the issue the FDA has failed miserably....valium for example.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
The FDA already does this for nicotine replacement drugs, and in the interest of legislative clarity, a clear rule should be established for drugs available in both prescription and OTC. This will finally allow the FDA to make a decision regarding Plan B, a decision consumers have waited on for years.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
This same situation has worked for Claritin. It is now available OTC and by prescription. No other law making is necessary.
Commenter Organization Name: Oyen, Duane
Comment Number: 2005N-0345-EC2107
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Please explain the effective difference between, for example, OTC ibuprofen and Motrin 600 with regard to prescription enforcement. This is neither new nor "molecular biochemistry" (a subject specific "rocket science" metaphor)
Commenter Organization Name: Ellis, Pamela
Comment Number: 2005N-0345-EC216
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
It is legal. For example, I currently have OTC Prilosec in my pharmacy AND a prescription-only omeprazole.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
The supplemental application submitted at the request of the FDA presupposes a meaningful difference in the conditions of use ? in this case, the comprehension levels ?between the two populations. The FDA has concluded that users under 17 require a physician?s assistance, while users 17 and over can take the medication without that condition.
The dual marketing of Plan B to these respective populations defined by the FDA is permissible under Section 503(b). Because the FDA has found that the product is safe for OTC users aged 17 and over, OTC and prescription marketing of the same active ingredient is as appropriate with this drug as with any of the others approved for both OTC and prescription use. The FDA has customarily approved drugs for different conditions of use without requiring any statute, regulation, codification, formal or informal guidance. While these administrative tools are often used by the FDA, they have not been deemed necessary for the simultaneous marketing of an OTC and prescription product with identical active ingredients and dosages.
Commenter Organization Name: Salvo, Aaron
Comment Number: 2005N-0345-EC24
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
Currently there are several products that are available over the counter that are typically categorized as controlled substances, but there are also similar prescription productions. For example certain dosages of Ibuprofin are available by prescription only, but lower dosages can be purchased under brand names such as Advil, and there is nothing stopping a consumer from taking a single dose of the non-prescription strength product that would equal or even exceed the prescription dose. Also cigarettes are known to contain Nicotine, which is a narcotic, but Nicotine is now available as an OTC product in forms such as Nicorette Gum. Neither of these products have caused the FDA any consternation.
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes, this is an issue that needs to be decided, and has certainly been resolved in areas concerning controlled substances. It's not all that new or novel.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
The example of ibuprofen cited by FDA in different dosages is in fact two different products. One, the 200 mg product is safe for the general public to self-medicate; however the 800 mg product requires significantly more knowledge to be used safely. Treating the 200 mg and 800 mg dosages of the same ingredient differently is reasonable and proper because of toxicity questions. This is the type of difference that should be controlled and indeed is at the heart of ?safe and effective? because the two items are not the same. Would the FDA consider regulating an 800 mg tablet dyed pink differently than an 800 mg tablet dyed yellow? I think not. The question is about the safety of the drug not cosmetic differences. The FDA should keep its focus on safety and effectiveness issues not on cosmetic differences (or non-existent differences).
Commenter Organization Name: Schulman, Marvin
Comment Number: 2005N-0345-EC418
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
I can find no problem with allowing the same ingredient for both prescription and OTc. I believe this has already been done with many components, the only difference being dose levels. for example, folic acid tablets are OTC but at the 1mg level or higher, they require a prescription
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
I am not aware of confusion within the act; however, I do know that other drugs are over-the-counter and prescription when used in different ways. In doing that, it seems far less easy to regulate a drug that can be bought over the counter by anyone for the prescription use as long as they know what prescription drug it corresponds to.
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I take a drug sold both ways. I buy by prescription because my insurance pays for it that way.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
Excerpt Text:
The FDA has already approved the use of drugs in both simultaneous prescription form and over the counter form, ie. Claritin. I argue that such allergy drugs are still only used by allergy sufferers, not the entire population, and yet they are available for use by all.
Commenter Organization Name: Macdonell, Megan
Comment Number: 2005N-0345-EC779
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
There are many medications that have the same active ingredient available in both a generic/OTC method as well as through prescription. With that said I am also unaware of the guidelines by which these decisions are made, however I do not personally see it as a problem. I believe that there should be a "re-wording" of section 503(b).
Commenter Organization Name: Schmierer, Ann
Comment Number: 2005N-0345-EC81
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
I think there are a number of drugs available OTC that are similar and used for exactly the same indications as prescription drugs (i.e. Claritin OTC, Prevacid OTC), and there should be no distinction made between the interpretation for these drugs, so why the confusion on Plan B? I believe there is a very distinct political motivation behind this issue being raised. If the product is proven safe and effective by the FDA for OTC, it should be made available to consumers that want it.
Commenter Organization Name: Burns, Ben
Comment Number: 2005N-0345-EC93
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.3.3 - Other arguments related to FD&C Act
Excerpt Text:
i dont see a problem with it, they already partially do it with naproxen, by having lower doses in the over the counter drug aleve. it would allow cunsumers who could purchas it, as well as allow organizations like planned parenthood, who could prescribe it to low income falmilies.
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
Yes-you have already done this. You can obtain Ibuprofen as an OTC 200 mg tablet, but it is also available as a prescription in 600 and 800 mg doses.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
There are numerous examples of discretionary drugs (nicotine, alcohol) that are marketed to/available only to subpopulations; they provide more than enough precedent to move forward with the ruling without codifying it.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 17
Excerpt Status: NEW
Other Sections: NEW - 8.8 - Examples of similar labeling of Rx and OTC products that are the same drug and dose, in the market place or previously marketed
Excerpt Text:
Claritin is currently offered over the counter, but some patients continue to obtain prescriptions in order to purchase it at a reduced price with a co-pay, and these packages do not differ.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
As a pharmacist and public health practitioner, I do not see where the confusion lies. According to information available at 21CFR Part 310 for Docket 2005N-0345, the current interpretation of the Act includes a differentiation between OTC and Rx drugs by indication (among other things, including strength, dosage form, and route of adminstration). The meaningful difference in the case of Plan B is that the OTC product is indicated for adults; the Rx product is indicated for patients 16 years of age and under. To me, that is the same as saying that meclizine is safe for use for motion sickness OTC but requires supervision for use for vertigo. Plan B is safe for use by adults but requires supervision when used in minors. The fact that the dose is the same for each population is immaterial. These are clearly different populations, thus justifying an OTC and Rx label.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.3.3 - Other arguments related to FD&C Act
NEW - 4.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 10
Excerpt Status: NEW
Excerpt Text:
A. UNDER THE FDCA AND FDA'S EXISTING REGULATIONS, PLAN B CAN PROPERLY BE AN OTC DRUG FOR ONE PATIENT SUBPOPULATION
Generally, new drug products that are indicated for different patient populations are different "new drugs." Where new drug products are different, one may be an Rx drug product, and the other an OTC drug product, without creating any problem under the FDCA or FDA's regulations.
The Manual of Policies and Procedures of the Center for Drug Evaluation and Research ("MAPP") expressly contemplates that an Rx version and an OTC version of a drug product may differ only in the population for which they are indicated:
Initial Marketing o-f a Drug Product OTC. This category of product could be one of two types: (1) OTC marketing of a product that was never previously marketed as a prescription drug product or (2) OTC marketing of a product in a strength, dose, route of administration, duration of use, population, indication, or dosage form different from ones previously approved for prescription use.
MAPP 60205 at 2 (Jan. 15, 1997) (boldface in original) (emphases added), available at http://www.fda.gov/cder/mapp/6020-5.pdf. [Footnote 16: The universe of OTC drug products consists of (i) those initially marketed OTC, and (ii) those switched from Rx to OTC status. As a matter of terminology, the term "Rx to OTC switch" "refers only to OTC marketing of a product that was once a prescription drug product for the same indication, strength, dose, duration of use, dosage form, population, and route of administration." MAPP 6020.5 at 2. The proposed Plan B subpopulation switch is an "Rx to OTC switch" with respect to the population of women age 16 and over; for that subpopulation, the drug product previously was available only as an Rx product, but would now be available OTC.] The use of the disjunctive "or" in the quoted passage makes clear that the passage expressly contemplates "OTC marketing in a . . . population . . . different from ones previously approved for prescription use," id.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 11
Excerpt Status: NEW
Excerpt Text:
There is no legally relevant distinction between the proposed subpopulation switch of Plan B and the scenario described in MAPP 6020.5. As applied to Plan B, the exact analogy would be a scenario in which Plan B had previously been approved only as an Rx drug for women age 15 and younger, and were now also to be approved as an OTC drug for women age 16 or over. In that scenario, the proposed OTC population would be "different from [the one] previously approved for prescription use." MAPP 6020.5 at 2.
It should make absolutely no difference, however, that Plan B previously has been approved as an Rx drug for women age 16 or over (as well as for women age 15 and younger), In both the scenario described in MAPP 6020.5 and in the proposed scenario for Plan B, after approval of the drug for the specified OTC subpopulation, the drug would simultaneously be approved as an Rx drug for one subpopulation and as an OTC drug for another. Nothing in the discussion in MAPP 6020.5 suggests that, upon the approval of the OTC status for the new patient subpopulation, the Rx status for the remaining patient subpopulation would be withdrawn. Thus, MAPP 6020.5 demonstrates that there is no FDA policy that precludes the approval of a drug for simultaneous marketing as an Rx drug for one patient subpopulation and as an OTC drug for another.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 14
Excerpt Status: NEW
Excerpt Text:
"Sometimes the dose of a product to be marketed OTC may be lower than the previous prescription dose, or the proposed use may differ from the prescription use." FDA, Questions and Answers[:] Over-the-Counter Drug Products-Public Hearing June 28 and 29, 2000, at 3, available at http://www.fda.gov/cder/meeting/otcqa-600.htm (emphasis added). The FDA Questions and Answers expressly contemplate approval of a drug product for simultaneous marketing as an Rx drug for one use and as an OTC drug for another. As just explained, uses by different patient populations are different uses.
The permissibility under the FDCA of approving the same drug product as Rx for one patient population and as OTC for another is valuable and important for protection of the public health. Such a pair of approvals enables the Agency to titrate the degree of intervention by healthcare professionals in patients' access to the drug product. Where FDA appropriately determines that a particular drug product can be safely, effectively, and appropriately used by one patient population with access QTC, but that another patient population needs the supervision of a physician, it would be inappropriate to make the drug product either entirely OTC (in which case the group for whom a prescription requirement is warranted would be put at risk) or entirely Rx (in which case the group for whom a prescription requirement is unwarranted would be subjected to unnecessary burdens and expense and, in this case, may experience unnecessary delay in obtaining the product, whose effectiveness diminishes with delay before use).
3.9.3 - Veterinary drug policy
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 15
Excerpt Status: NEW
Excerpt Text:
Further support for the permissibility under the FDCA and FDA's regulations of simultaneous dispensing to different patient populations of Rx and OTC versions of a drug is provided by FDA policy with respect to veterinary drugs. With respect to the Rx legend, veterinary drugs are subject to provisions very similar to § 503(b)(4). Compare FDCA § 503(b)(4), 21 U.S.C. § 353(b)(4) with FDCA § 503(f)(4), 21 U.S.C. § 353(f)(4). CVM Program Policy & Procedures Manual Guide 1240.2220 § 3.d (Mar. 9, 2000), available at http://www.fda.gov/cvm/Policy-proced/2220.pdf, states:
In the past, the same products used in varying routes of administration, dosage forms, and in varying species of animals may have been labeled prescription in one instance and non-prescription for other uses. The primary question is whether adequate directions for use can be written to assure safe and effective use. If an average food animal producer can safely and effectively administer a product, but a companion animal owner, regardless of label directions, cannot administer it safely and effectively, then the prescription status of the product must be different relative to these intended uses. If directions can be written for use for a particular route of administration (IV, IP, etc.) for one animal species but not for another, it is not inconsistent to grant OTC status for the one use and require the Rx legend for the other.
Id. This passage plainly contemplates that identical versions of a veterinary drug may be labeled in one instance (for one population) Rx and in another instance (for another population) OTC.
In sum, the proposed subpopulation switch of Plan B is consistent with existing written FDA policy. No further policy development is needed to support approval of the proposed subpopulation switch.
3.10 - Examples of FDA actions disallowing simultaneous marketing
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
FDA has consistently interpreted section 503(b)(l) as permitting the marketing of the same active ingredient in products that are both prescription and OTC only if there is "some meaningful difference" between the two, for example in conditions of use, strength, route of administration, or dosage form. [Footnote 4: Id.] FDA has never permitted the same active ingredient to be marketed simultaneously as both a prescription and OTC product for identical conditions of use.
Commenter Organization Name: Kuskey, Garvan
Comment Number: 2005N-0345-EC793
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
Excerpt Text:
If 5% testosterone -- a completely benign substance -- must be written on a triplicate prescription, then why not this more dangerous preparation?Or the reverse: if this drug can be marketed without a prescription to those over sixteen years of age, then why can't 5% testosterone be marketed to elderly men who need HRT? The FDA designated low-dose testosterone a dangerous drug specifically because of its abuse by body builders. And yet, body builders don't use 5% preparations. In fact, they can and do easily buy much more concentrated products in Mexico.
3.11 - Miscellaneous arguments/discussions
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 41
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
NEW - 1.2.3 - Maintain Rx only
NEW - 3.5.1 - SNDA/NDA regulatory arguments supporting rulemaking
Excerpt Text:
C. FDA's Jurisdiction Over the "Safety and Efficacy" of Drugs Provides it With Sufficient Authority to Consider Potentially Negative Societal Ramification Related to the OTC Sale of Plan B
FDA's jurisdiction over the "safety and efficacy" of drugs provides it with legal authority to consider morality, misuse, age-appropriate sexual behavior, and related social issues in the context of the Plan B approval for OTC marketing. [Footnote 23: Those who argue that morality should not, affect FDA's decision-making hypocritically cite moral judgments in support of the OTC approval of Plan B. For example, certain Congressional representatives have asserted that "Public health experts have estimated that over-the-counter sales of the emergency contraception pill Plan B would cut the rate of unintended pregnancies in half and reduce the number of abortions by more than 500,000 per year." U.S. Reps. Henry Waxman, D-CA, and Louise Slaughter, D-NY, circulated a "Dear Colleague" letter and Fact Sheet on October 12, 2005, referencing these factors as a reason that FDA should approve the OTC sale of Plan B. FDA cannot take the Societal concern of unintended pregnancies into account, while refusing to consider the social concerns of an increase in unprotected sex and STDs, off-label over-use/repeat, use of Plan B, and sexual abuse.] There is no question that FDA can and should, as a matter of law, take issues of morality and social conscience into account when those issues relate directly to the drug's risk/benefit analysis or safety/efficacy profile -two concepts with which FDA has decades of experiences and" for which the courts provide deference to the Agency. If there is evidence that the expected patient population is likely to use the drug in a way that decreases the drug's safety, negatively impacts the patient's health, or tips the risk/benefit balance toward greater risk, FDA must consider this evidence when addressing the approval decision. FDA routinely takes potentially harmful patient use scenarios into account in its NDA approval decisions, whether for potent pain drugs (for which abuse and misuse are Agency considerations), for obesity drugs (for which preferences for nutritive and exercise are Agency considerations), or for HIV home test kits (for which the patient's mental well-being and need for a learned intermediary or counselor was an Agency consideration). OTC emergency contraceptives fall squarely within this listing of drugs in which self-destructive patient actions may cause more harm than good. [Footnote 24: FDA should reject the argument posited by some that an FDA decision denying OTC approval to Plan B is too paternalistic. FDA has ample precedent over the years where it has made an "unpopular" decision for reasons that were arguably paternalistic. FDA's mission is to protect the public health by assuring the safety, efficacy, and security of human drugs. FDA has viewed this mission broadly over the years to include the ""blocking" of access to certain drug products that, while safe and effective on a scientific basis, were not appropriate for OTC use for broader public health reasons. For example, the FDA removed phenacetin from the market after use as an ingredient, in OTC drug products for over 80 years. In the FDA's notice of the withdrawal of phenacetin from the market, the basis cited for approval was "phenacetin's high potential for misuse and its unfavorable benefit-to-risk ratio when incorporated in analgesic combinations which are then subject to excessive chronic use." (Emphasis in original) 48 Fed. Reg. 45486 (Oct. 5, 1983). In the proposed rule, the FDA stated that phenacetin was not alone among analgesics in its ability to cause nephropathy, but because of its greater likelihood for abuse, the agency believed other safe and effective analgesics would be sufficient for consumers. 47 Fed. Reg. 34636, 34638 (Aug. 10, 1982). Similarly, in 1972 the FDA severely restricted the allowable OTC uses for the drug hexachlorophene as an antibacterial product. The restrictions on the use of hexachlorophene followed the deaths of a number of infants in France due to the use of a baby powder contaminated with six percent hexachlorophene. 37 Fed. Reg. 20160 (Sept. 27, 1972). Although hexachlorophene was recognized as a safe and effective bacteriostatic skin cleanser, FDA concluded that a "risk to benefit ratio" analysis justified restriction of the availability of the drug even though the at-risk population was extremely small. Id. ]
Commenter Organization Name: Thomas, Tiffany
Comment Number: 2005N-0345-EC13026
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Another issue I have with having both is will the dosage be the same. If you are going have both, then the amount of the active ingredient should be less in the over the counter drugs.
Commenter Organization Name: Thomas, Tiffany
Comment Number: 2005N-0345-EC13026
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Another big factor in determining whether drugs should be sold in both prescription and over the counter is the amount of the active ingredient that is in the drug. If the drugs are going to be sold simultaneously then the dosage should be different in the over the counter drug than it is the prescription drug. That way people could not abuse the drug. In regards to the "Plan B" drug lowering the dosage and selling it in a single package would be essential in making sure that women do not act irresponsibly and try to take multiple dosages of the drug.
Commenter Organization Name: Thomas, Tiffany
Comment Number: 2005N-0345-EC13026
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
There is no reason for a drug to be sold over the counter and by prescription simultaneously, it is absolutely pointless. It should be sold either by prescription or over the counter not both, there is no way that you could regulate how much a person receives and how often if it is sold both ways. When a drug such as the "Plan B" pill is sold both ways there would be no physician advisory for the people who received the drug over the counter there would be no way to tell what the effects were on their bodies this could possibly be dangerous to our society. Many may argue that this is a good idea especially in special circumstances like rape, because then the drug will be very assessable in a limited amount of time. However, I do not think that it is even a good idea in special circumstances such as rape, because once again this would cause people to not to see their physicians who can adequately tell what is right for a particular body type. When something is sold over the counter it can be misused easier than prescription drugs and there is no way to limit and record who takes it and how much, therefore all drugs should be sold either by prescription or over the counter.
Commenter Organization Name: Hibberd, Rachel
Comment Number: 2005N-0345-EC196
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
This is a non-issue, as you are well aware, Mr. Crawford. First of all, there is no reasonable objection to marketing a product as simultaneously OTC and prescription. The only problem this type of marketing is likely to cause is confusion in the public as to why a woman of 16 and a woman of 17 must go through different processes in order to have access to adequate contraceptive care. The confusion will be justfified, because the Not Approvable letter issued to Barr regarding the drug's not being safe for women under 17 was just one of a series of politically motivated and completely irresponsible moves taken by you, against the wishes of the FDA's scientific advisory panel.
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
While the current interpretation seems reasonable, a lack of codification leaves open a great deal of subjectivity with respect to what is meant by a "meaningful difference" between a prescription product and an OTC product. This codification should go beyond simple differences (e.g., strength, dosage) and require that clinical trials form the basis for any OTC branding - in order to ensure the safety of the population or any subpopulation for which the OTC version is being made available.
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 9
Excerpt Status: NEW
Excerpt Text:
It is not significant enough that different strengths of the same product are marketed as prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC product knowing that there is an equivalent prescription dose available. The safety of all market strengths available of a particular product should be considered when evaluating a product's safety for OTC use. Also, limiting OTC sales of a product to population subgroups still exposes that subpopulation to possible harmful effects or cirucmstances due to misuse of the product. Potentiality of harmful effect of a product can also be realised from the circumstances in which a product is used, and not just toxicities from the product itself.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
And I think that the studies for this should be conducted by someone other than the drug comapny and that the FDA should consider the results of ALL studies on a drug BEFORE it is approved for OTC status. Lighter doses of prescription medications as OTCs is helpful to the public and the pharmacies. But allowing a prescription to become an OTC must be done with careful, careful consideration, and with the EXPECTATION that the dosages available OTC will be at least doubled by the average consumer.
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.6 - Develop/update guidance as alternative for rulemaking
Excerpt Text:
Nevertheless, sanofi-aventis believes that there is indeed significant confusion over the Agency's interpretation of section 503(b) - confusion created by the Agency's October 1999 Draft Guidance for Industry regarding "Applications Covered by Section 505(b)(2)." [Footnote 5: FDA, Draft Guidance for Industry: Applications Covered by Section 505(b)(2) (October 1999) (hereinafter "1999 Draft Guidance" or "Draft Guidance"). ] However, sanofi-aventis believes that FDA need not initiate rulemaking to dispel this confusion. Rather, the Agency can simply withdraw or amend its 1999 Draft Guidance. In addition to noted confusion, the Draft Guidance raises issues of the Agency's unauthorized "taking" of confidential data belonging to the pioneer manufacturer and the Agency's authority under section 505(b)(2), which are beyond the scope of these comments,
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
This is unclear and opens a pandora's box of abuses by the pharmaceutical companies.
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Completely.
Commenter Organization Name: Speight, Thomas
Comment Number: 2005N-0345-EC1041
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Yes, if the FDA has finally gotten around to realizing that it needs to be rulemaking.
Commenter Organization Name: Shaffer, Kathleen
Comment Number: 2005N-0345-EC106
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
yes. there is the confusion in terminology as to the ingredient (which is the raw drug) and the medicine (which is the compound drug). There needs to be clarfication as to when you are discussing the ingredient drug versus the medicine drug
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Definitly, because I am certianly confused.
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Dougherty, Anne
Comment Number: 2005N-0345-EC126
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Most consumers do not understand section 503(b)
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 5.1 - Yes
Excerpt Text:
The rulemaking in question is of utmost importance in regards to health and safety of citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that rulemaking on this issue would dispel the confusion that is along with this section 503(b).
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 8.2 - No
NEW - 8.6.2 - Risk of medication errors or threats to patient safety
Excerpt Text:
Overall I don't believe that drugs should be packaged together or that there should be higher doses that could be taken without a practitioner to determine the level of drug that is needed. Drugs are a serious problem in the United States and if the FDA loosens up the restrictions on higher dosage drugs then this will lead to a more abusive situation in regards to prescription and OTC drugs. Also I do believe that if this was done it will take away some of the professionalism from the health professionals and people will self medicate without the proper knowledge and this could lead to serious side affects. Clearly there needs to be a more clear interpretation of the section 503(b) so that it is more effective clear and most importantly that it will have safe rules for people. If this can be done the FDA has done their job on this matter.
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Significant confusion exists, especially in light on concerns that section 503(b)'s criteria may unfairly and negatively impact accessibility to legal and scientifically-validated medications.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Yes. Unfortunately, it is the FDA which has created the confusion. If there is clinical evidence that a significant portion of the target population may be adversely affected by dispensation under non-prescription protocols, then the drug should only be dispensed as a prescription drug.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
There is significant confusion in regarding the FDA?s interpretation of section 503[b].
Commenter Organization Name: Connors, Meaghan
Comment Number: 2005N-0345-EC141
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Confusion at best, disillusionment at worst.
Commenter Organization Name: Loomis, Shirley
Comment Number: 2005N-0345-EC147
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
There's significant confusion regarding all regulations. It's what keeps your lawyers working.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I would say so; confusion and rumor, not to mention bad PR for the FDA.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
There is some confusion regarding the Agency's interpretation of the statute.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
yes...why are you holding up the release of a scientifically approved drug for prescription requirements that would lend the drug ineffective?
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
Affirmitive, you seem quite confused between your role in approving drugs on scientific merit and benefit (vs social engineering and backdoor legisalated morality).
Commenter Organization Name: Moon, Kristin
Comment Number: 2005N-0345-EC1927
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Dowell, Duane
Comment Number: 2005N-0345-EC195
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
There seems to be confusion at the FDA.
Commenter Organization Name: Hibberd, Rachel
Comment Number: 2005N-0345-EC196
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Yes, it makes no sense from a public health standpoint. Women are not served by this kind of maneuvering; if this agency were really interested in protecting women's health, they would allow women access to this needed drug.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
It would seem so.
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Apparently there is, since this question came up.
Commenter Organization Name: Endris, Kelle
Comment Number: 2005N-0345-EC278
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: TomHon, Catherine
Comment Number: 2005N-0345-EC281
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
In the particular case of emergency contraception - Plan B, yes. It is not clear why the FDA believes this section falls short.
Commenter Organization Name: McLeod, Doug
Comment Number: 2005N-0345-EC364
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
Excerpt Text:
There seems to be when political pressure overules the science and expert opinion regarding the drug. For example the Plan B morning after contraceptive has been overwhelmingly rules as safe yet the FDA seems to be racting in response to political pressure rather than scientific evidence. This is clearly the wrong direction for the FDA.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
Excerpt Text:
YES! I think the public and providers are very confused about the process and the length of time it takes to make a decision.
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, the section is open to various interpretations.
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 2.2 - Support ANPRM request for comments
Excerpt Text:
Yes. I do not understand FDA's interpretation of section 503(b) of the act. I applaud Commissioner Crawford's recognition that regulatory policy issues must consider more issues than simply the scientific safety concerns. Observations of human behavior strongly suggests that alterior motives often lead to misuse and abuse of prescription, OTC, and illegal drugs and other substances, such as Scheduled narcotics, alcohol, and tobacco products, leading to a great degree of pain and suffering. FDA must consider all these issues and issue rules that protect vulnerable populations to the greatest extent possible.
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes - to a degree.
Commenter Organization Name: Cunningham, Laura
Comment Number: 2005N-0345-EC5
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Katrib, Elise
Comment Number: 2005N-0345-EC516
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.5 - Miscellaneous arguments/discussions
Excerpt Text:
Yes, it seems that given enough pressure or money, a drug will be able to overcome FDA interpretation of any act.
Commenter Organization Name: Kowalczyk, Brigid
Comment Number: 2005N-0345-EC518
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
there is significan confusion.
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: McGhee, Tim
Comment Number: 2005N-0345-EC53
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes, the FDA's interpretation would create legal confusion.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Billingsley, Daniel
Comment Number: 2005N-0345-EC609
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I believe there is a lot of confusion.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
I think that there is some confusion built into the act because it does not directly define when a product/drug/molecule is allowed to become an OTC. And when they are allowed to become both OTC and prescription at different usages or doses, there is still sp,e confusion about safety, use, etc. It gives the average consumer a false sense of security that no matter how much they take, a medication will not hurt them. The studies show that misuse and overmedication are rampant with OTCs. I also think that considering having the same exact medication as a prescription and as an OTC is a misinterpretation of the act.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
Excerpt Text:
Yes. For the layman and even for the well-informed layman, there appears to be a non-sensical aspect to this aspect of FDA regulations.
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Yes, when applied to the particular application concerning "Plan B".
Commenter Organization Name: Baird, Debora
Comment Number: 2005N-0345-EC66
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Carter, Thomas
Comment Number: 2005N-0345-EC691
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes - I am not even sure what it is!!
Commenter Organization Name: Devine, Naomi
Comment Number: 2005N-0345-EC710
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Yes, there is confusion. It is hard to understand why a drug should be prescription for some and over the counter for others.
Commenter Organization Name: Gorini, Joseph
Comment Number: 2005N-0345-EC717
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
If the FDA applies section 503(b) it would ceate confusion by seeming to accept Plan B as falling under FDA's concern for 'health and safety.' See General Comment.
Commenter Organization Name: Ricci, Stephen
Comment Number: 2005N-0345-EC73
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Rosati, Lucia
Comment Number: 2005N-0345-EC76
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Phlips, Thomas
Comment Number: 2005N-0345-EC788
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Kuskey, Garvan
Comment Number: 2005N-0345-EC793
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
yes
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Information regarding this interpretation is not well understood by the general public today.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Burns, Ben
Comment Number: 2005N-0345-EC93
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
yes there is a lot of confusion over it.
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
Apparently, there is confusion since the FDA chose not approve Plan B for OTC use for adults.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 7.4.4 - Require identification for age
NEW - 8.1 - Yes
Excerpt Text:
Initiating the rulemaking process to revise and clarify the Federal Food, Drug, and Cosmetic Act would be a beneficial move for the FDA. There is considerable confusion regarding the interpretation of whether a drug has to be only sold in one venue, or whether it is possible for circumstances to exist were marketing the drug as both over the counter and prescription is the most practical approach. Imposing age restrictions on the purchase drugs, such a Plan B, is the easiest way to ensure that the drug is safely administered. Requiring identification verification from women purchasing the drug over the counter limits underage sales, and shifts the burden of enforcement from the FDA and doctors to the pharmacist themselves. The packaging of both versions should be identical, as should the price of the drug. All of these topics should be addressed by the FDA by initiating a rulemaking to specifically clarify interpretation of section 503(b), and to establish specific guidelines when a drug can be simultaneously marketed as prescription and over the counter.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.3.3 - Other arguments related to FD&C Act
NEW - 3.9.1 - Drug approval examples
NEW - 5.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 6.1 - Yes
NEW - 8.1 - Yes
Excerpt Text:
In regards to the FDA?s request for comments on the advance notice of proposed rulemaking for the simultaneous marketing of drugs with identical active ingredients as both over the counter and prescription, I believe that the FDA should proceed with rulemaking to codify its interpretation of section 503 (b), that there is significant confusion in its current state, and that rulemaking would help dispel the confusion that is caused by the current rule. I also believe that the FDA would be able to legally enforce limitations on certain subpopulations and that those limitations could be practically enforced. Finally I believe that it would be legal to sell the products in the same packaging but that there would be some circumstances where selling identical items would be inappropriate.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
Excerpt Text:
The Federal Food, Drug, and Cosmetic Act's current language in section 503(b) is vague. Consequently, confusion regarding the FDA's interpretation is significant.
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.7 - Cost-benefit concerns regarding rulemaking
NEW - 5.4.3 - There is no confusion, therefore rulemaking unnecessary
Excerpt Text:
We see no need, or benefit, of further regulation. Our FDA submission experience leads GSK CH to conclude that there is no confusion regarding FDA's interpretation of section 503(b). To the contrary, we have found FDA's interpretation very clear. It is our opinion that part C of this question is therefore moot.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 5.2 - No
Excerpt Text:
In response to the questions posed in RIN 0910-AF72, FPA believes the first three questions (lA, 1B and lC) should be answered in the negative, making it unnecessary to address the remaining questions. We do not believe there is any confusion over the interpretation of section 503 of the Federal Food, Drug, and Cosmetic Act.
Commenter Organization Name: Black, Jerrold
Comment Number: 2005N-0345-EC111
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Paslawsky, JoAnn
Comment Number: 2005N-0345-EC1129
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
Excerpt Text:
I do not believe there is confusion on this point. The FDA has worked diligently to ensure clarity of its interpretations whenever it makes a decision. I believe the media can and often do create confusion in the manner it reports on scientific matters in general and health topics in particular.
Commenter Organization Name: Slee, April
Comment Number: 2005N-0345-EC121
Excerpt Number: 2
Excerpt Status: MODIFIED
Excerpt Text:
No, I think the interpretation is reasonable and correct.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 4.4.1 - Legal arguments that little or no confusion exists
Excerpt Text:
B. The FDA's interpretation is an accurate interpretation of the law. It is also scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten interpretation should be codified as law.
Commenter Organization Name: Smart, Stephanie
Comment Number: 2005N-0345-EC16
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No, but I do not agree with the interpretation.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
No. The American consumer understands that some medications are reasonably safe for self-medication in lower doses, but require physician monitoring for higher doses and certain uses.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
There is no confusion.
Commenter Organization Name: Murphy, Cynthia
Comment Number: 2005N-0345-EC176
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Steward, Linda
Comment Number: 2005N-0345-EC181
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
no.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
I disagree that there is confusion over this issue.
Commenter Organization Name: Young, Stan
Comment Number: 2005N-0345-EC211
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Goggin, Terresa
Comment Number: 2005N-0345-EC213
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
I think the current guidelines are adequate and straightforward. Personal politics are what is clouding the availability of this drug, and probably others in the future if this precedent is allowed.
Commenter Organization Name: Rankis, A
Comment Number: 2005N-0345-EC22
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No,
Commenter Organization Name: Roettcher, Phil
Comment Number: 2005N-0345-EC224
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
only by the FDA who are more politically bound!
Commenter Organization Name: Cepeda, Baudi
Comment Number: 2005N-0345-EC226
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No, there should be no confusion regarding the FDA?s interpretation of Section 503(b)(1).
Commenter Organization Name: Levinson, R. Saul
Comment Number: 2005N-0345-EC297
Excerpt Number: 2
Excerpt Status: MODIFIED
Excerpt Text:
No confusion.... just old fashioned politics are entering into FDAs interpretation of section 503(b) of the act.
Commenter Organization Name: Waychoff, W. Aaron
Comment Number: 2005N-0345-EC311
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The confusion is imagined on the part of the FDA. I belive that it is a trumped up excuse by Lester Crawford to stall the approval of Plan B because it does not meet with his personal religious beliefs and political aspirations.
Commenter Organization Name: Hagan, Jane
Comment Number: 2005N-0345-EC32
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
Since there is a desire to impose an age restriction on whether this drug is available with or without a prescription, there should not be significant confusion regarding whether the consumer is of a certain age or not.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
This question can be answer in one word: NO! The FDA is doing the equivalent discussion of 'how many angels can dance on the head of a pin'? The FDA interpretation of section 503(b) is straightforward and simple. This notice suggests that FDA will needlessly add complexity to what is otherwise clear and simple.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Schulman, Marvin
Comment Number: 2005N-0345-EC418
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Duchon, Kathleen
Comment Number: 2005N-0345-EC426
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No, but it does need to be update as the world issues broaden and expand
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
NO.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Della Paolera, Mark
Comment Number: 2005N-0345-EC555
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Burgess, Annette
Comment Number: 2005N-0345-EC566
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Tansley, Kathleen
Comment Number: 2005N-0345-EC569
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I myself, am not confused by 503(b) as explained on your web site here.
Commenter Organization Name: Venturella, Vincent
Comment Number: 2005N-0345-EC58
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
There is no confusion as I read Commissioner Crawford's thinking on the manner that the decision and/or interpretation that needs to be encompassed.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.9.1 - Drug approval examples
NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
I am not aware of confusion within the act; however, I do know that other drugs are over-the-counter and prescription when used in different ways. In doing that, it seems far less easy to regulate a drug that can be bought over the counter by anyone for the prescription use as long as they know what prescription drug it corresponds to.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
No. If there were, it would have come up long before now
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
Not in the past. Confusion is building due to special interest pressure.
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No, there is not significant confusion.
Commenter Organization Name: Carlson, Brent
Comment Number: 2005N-0345-EC77
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Smith, Rodney
Comment Number: 2005N-0345-EC83
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I do not feel there is.
Commenter Organization Name: Vander Bleek, Luke
Comment Number: 2005N-0345-EC870
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Kopp, Margaret
Comment Number: 2005N-0345-EC903
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.4.2 - Policy arguments that little or no confusion exists
Excerpt Text:
No. It is very clear that the FDA is making the interpretation that is preferred by White House, without regard to actual safety and efficacy of the drug in question. I am not at all confused. I am, however, deeply offended by the actions of the FDA, in hijacking this drug as part of a political agenda.
Commenter Organization Name: Hawkins, Susan
Comment Number: 2005N-0345-EC91
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I do not believe so.
Commenter Organization Name: Wurtz, Richard
Comment Number: 2005N-0345-EC94
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: Wurtz, Richard
Comment Number: 2005N-0345-EC94
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: Brakman, Anita
Comment Number: 2005N-0345-EC97
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Stockton, Melissa
Comment Number: 2005N-0345-EC99
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No.
4.3 - Arguments supporting significant confusion regarding FDA's interpretation
4.3.1 - FDA's interpretation of FD&C Act 505(b)(2) conflicts with interpretation of 503(b)
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
An application under section 505(b)(2) of the FDCA is one for which the investigations of safety and effectiveness on which the applicant relies for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use . . . ." [Footnote 6: FDCA § 505(b)(2), 21 U.S.C. § 355(b)(2). ]In its 1999 Draft Guidance, FDA advanced for the first time its unsupported interpretation of section 505(b)(2) as permitting reliance on proprietary data contained in another manufacturer's application. FDA also asserted in the Draft Guidance that a section 505(b)(2) application could be used to obtain a switch in product indications from prescription only to OTC. [Footnote 7: 1999 Draft Guidance at 5.]
Insofar as it suggested that a section 505(b)(2) application is a suitable vehicle for obtaining approval of a switch from a prescription indication to an QTC indication for another applicant holder's product, the Agency's Draft Guidance does not account for the potential for Durham-Humphrey misbranding issues. Under the Draft Guidance, the Agency could theoretically approve an OTC product in reliance on a pioneer's data for an approved prescription product. That prescription product would continue to be covered by the pioneer's NDA. The pioneer with an approved NDA for its product is entitled to -indeed must - sell that product in conformity with the terms of its NDA, including selling it only as a prescription product. Through its Draft Guidance, the Agency thus opened the door to the same active ingredient being simultaneously marketed for the same conditions of use as both a prescription and an OTC drug product, thereby creating an unworkable tension with section 503(b) of the FDCA.
Commenter Organization Name: Aventis Pharmaceuticals, Inc and Sanofi- Synthelabo, Inc.
Comment Number: 2005N-0345-C453
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Significantly, any attempt to remedy the inherent confusion of the Agency's Draft Guidance by forcing the innovator company to take its product OTC upon approval of another applicant's section 505(b)(2) application would raise serious legal concerns. Among other things, section 503(b) of the FDCA does not anticipate such broad-based OTC switches absent rulemaking. [Footnote 8: FDCA § 503(b)(3); 21 U.S.C. 8 353(b)(3).] In addition, questions of constitutional rights must be addressed.
4.3.2 - Diverse industry and public opinion/reaction to ANPRM and statements re: FDA's authority
Commenter Organization Name: Paslawsky, JoAnn
Comment Number: 2005N-0345-EC1129
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
I do not believe there is confusion on this point. The FDA has worked diligently to ensure clarity of its interpretations whenever it makes a decision. I believe the media can and often do create confusion in the manner it reports on scientific matters in general and health topics in particular.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.1 - Yes
Excerpt Text:
I believe that health professionals and consumers expect the FDA to make a decision. Also they expect that the FDA can make any decision - and we will of course comply, whatever it is - even if it is novel.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
The confusion has also been evidenced recently in the reaction to the Agency's decision to seek public comment on these regulatory issues. After the Agency's announcement, members of the private sector began making public, and conflicting, pronouncements on whether the FDA currently has the authority to approve a product as both a prescription and as an OTC, how the Agency has handled similar approvals in the past, and what restrictions, if any, the Agency can place on such approvals. The differing opinions on these issues illustrate the need for clarification of Section 503(b).
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 21
Excerpt Status: MODIFIED
Excerpt Text:
In closing, we would like to reiterate our appreciation for the opportunity to contribute to the public dialogue on these important regulatory and policy issues. There is a great deal of confusion regarding the FDA's process for classifying drugs as prescription or OTC, and the level of confusion has increased dramatically in recent months as the Agency has discussed the concept of simultaneously approving drug products as both prescription and OTC.
Commenter Organization Name: Pechacek, Deborah
Comment Number: 2005N-0345-EC27
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Obviously there is since the Drug company is asking you to do something that I thought was not legal.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
YES! I think the public and providers are very confused about the process and the length of time it takes to make a decision.
Commenter Organization Name: Dolinski, Elizabeth
Comment Number: 2005N-0345-EC522
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
the FDA CAN make a drug both prescription and over the counter. That is clear to me and should be made clear to the public.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes. For the layman and even for the well-informed layman, there appears to be a non-sensical aspect to this aspect of FDA regulations.
4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
The act does not define OTC drug. This has caused the confusion over what can be marketed and hence the debate over which drug can be available in both fields.
Commenter Organization Name: Owens, B
Comment Number: 2005N-0345-EC14261
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
This submission is in response to FDA Advanced notice of proposed rulemaking of Docket number 2005N-0345. It is quite apparent that the issue that is in contention now has obviously been one of great controversy for quite some time now. Upon submission of the Federal Food, Drug, and Cosmetic Act, there was already confusion as to which drugs were acceptable for public use without the supervision of a licensed medical practitioner and which drugs were not. Section 503(b), which was enacted in 1951, was the attempt to remedy the aforementioned confusion. The apparent problem with section 503(b) is that it attempts to regulate any product which we now term as an OTC drug, but in doing so fails to give a clear definition of the term. In fact, the term OTC is missing from the section altogether. In solving the problem and answering the questions put forth for submission, the most obvious remedy comes in the form of precedent. The key question is whether or not an active ingredient can be simultaneously marketed as both prescription drug and OTC. Several drugs that have been released over the years have done so, but only when a meaningful difference exists between the two products, (i.e. ibuprofen given at 400+mg for arthritis but given at 400mg and below for aches and pains).
Commenter Organization Name: Collum, Mark
Comment Number: 2005N-0345-EC33
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes. It is written entirely in legal jargon which most people cannot understand. In fact, even highly educated health professional must consult lawyers as to its interpretation. It needs to be worded such that a "regular" person can understand its provisions. Remove all legal jargon and replace it with intelligible phrases and words.
Commenter Organization Name: Schulman, Marvin
Comment Number: 2005N-0345-EC418
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
I really don't understand the FDA's view of this matter. The issue is much simpler. If a product is safe for OTC sales, it should be available. It is irrelevant, If it also available as a prescription, in the same or a differnt package.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Excerpt Text:
I think that there is some confusion built into the act because it does not directly define when a product/drug/molecule is allowed to become an OTC. And when they are allowed to become both OTC and prescription at different usages or doses, there is still sp,e confusion about safety, use, etc. It gives the average consumer a false sense of security that no matter how much they take, a medication will not hurt them. The studies show that misuse and overmedication are rampant with OTCs. I also think that considering having the same exact medication as a prescription and as an OTC is a misinterpretation of the act.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
The Federal Food, Drug, and Cosmetic Act's current language in section 503(b) is vague. Consequently, confusion regarding the FDA's interpretation is significant.
4.3.4 - Other policy arguments/statements supporting confusion re: FDA's interpretation
Commenter Organization Name: Speight, Thomas
Comment Number: 2005N-0345-EC1041
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes, if the FDA has finally gotten around to realizing that it needs to be rulemaking.
Commenter Organization Name: Rucker, Gwendolyn
Comment Number: 2005N-0345-EC1080
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
yes. there is the confusion in terminology as to the ingredient (which is the raw drug) and the medicine (which is the compound drug). There needs to be clarfication as to when you are discussing the ingredient drug versus the medicine drug
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Significant confusion exists, especially in light on concerns that section 503(b)'s criteria may unfairly and negatively impact accessibility to legal and scientifically-validated medications.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes. Unfortunately, it is the FDA which has created the confusion. If there is clinical evidence that a significant portion of the target population may be adversely affected by dispensation under non-prescription protocols, then the drug should only be dispensed as a prescription drug.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
As the FDA has acknowledged, the Agency's interpretation of Section 503(b) has not been explicitly set forth in any regulation that addresses the drug classification process. [Footnote 1: 70 FR at 52,051.] Without an official interpretation in the Act or implementing regulations, manufacturers, health care professionals, state regulatory bodies, and even FDA officials, may not have a concrete understanding of the Agency's process to classify, or in some cases, reclassify, drugs as prescription or OTC.
Commenter Organization Name: Morrisroe, Julia
Comment Number: 2005N-0345-EC194
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The confusion relates to the FDA unwillingness to move forward on this particular drug, had the FDA's action been consistently obstructionist about Viagra and access to Viagra, you'd be in a better position to defend this case.
Commenter Organization Name: Hibberd, Rachel
Comment Number: 2005N-0345-EC196
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes, it makes no sense from a public health standpoint. Women are not served by this kind of maneuvering; if this agency were really interested in protecting women's health, they would allow women access to this needed drug.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Apparently when allergy medication is involved and not a political controversy, the FDA has no problem letting the medication go OTC. However, despite medical and health officials deeming Plan B safe, the FDA has a problem with interepretion for political gains.
Commenter Organization Name: Richman, Bobbi
Comment Number: 2005N-0345-EC21
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
IT IS THE MOST POORLY WRITTEN LETTER I HAVE READ. REDUNDANT, POORLY EXPLAINED WITH NO INFORMATION ABOUT PLAN B FOR THE READER. TOTALLY CONFUSING TO UNDERSTAND THE POINT BEING MADE
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
The interpretation is sound. However, there is confusion due to the lack of a documented "decision tree" around the process of FDA approval for the sale of an OTC product.
Commenter Organization Name: McGhee, Tim
Comment Number: 2005N-0345-EC53
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
It's very unclear to me how OTC status would not render completely irrelevant a drug's prescription status--especially when it's the same drug.
Commenter Organization Name: Leonard, Ruth Tehila
Comment Number: 2005N-0345-EC59
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
Excerpt Text:
I can see no reason why an identical product will have to be given by perscription for one person and free for purchase to another. I suggest you allow certain people to carry open perscriptions for products they need regularly for a particular medical condition, but otherwise substances with the same active engredients in the same doses that you do not deem safe for the entire population should not be sold to one segment over-the-counter and to another as a perscription.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
NEW - 4.3.3 - Other legal arguments/conclusions supporting confusion re: FDA's interpretation
Excerpt Text:
I think that there is some confusion built into the act because it does not directly define when a product/drug/molecule is allowed to become an OTC. And when they are allowed to become both OTC and prescription at different usages or doses, there is still sp,e confusion about safety, use, etc. It gives the average consumer a false sense of security that no matter how much they take, a medication will not hurt them. The studies show that misuse and overmedication are rampant with OTCs. I also think that considering having the same exact medication as a prescription and as an OTC is a misinterpretation of the act.
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes, when applied to the particular application concerning "Plan B".
Commenter Organization Name: Devine, Naomi
Comment Number: 2005N-0345-EC710
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes, there is confusion. It is hard to understand why a drug should be prescription for some and over the counter for others.
Commenter Organization Name: Cahoon, Clifton
Comment Number: 2005N-0345-EC80
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
That is hard to justify or explain. It is my opinion that medications which are prescription should not therefore have a simultaneous non- prescription status.
Commenter Organization Name: Holden, Karen
Comment Number: 2005N-0345-EC895
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The confusion arises from FDA's seeming to ignore the advise of its professional staff and instead to bow to political pressures from the religious right.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Apparently, there is confusion since the FDA chose not approve Plan B for OTC use for adults.
4.4 - Arguments indicating that little or no confusion exists
4.4.1 - Legal arguments that little or no confusion exists
Commenter Organization Name: Kirkpatrick & Lockhart Nicholson Graham on behalf of Concerned Women for America, et al.
Comment Number: 2005N-0345-C414
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
The dual marketing of an active ingredient both as an Rx drug and as an OTC drug would only exacerbate this previously-identified confusion, especially if the product was sold in the same package to both markets, or differed only in age-limited dispensing. In order to avoid this confusion, the statutory provisions of the FDC Act prohibit the marketing of the same drug product in an identical package in both the Rx and OTC markets. Instead the law requires, at the very least, labeling with or without the "Rx " symbol. Thus, the inclusion (or exclusion) of the "Rx" symbol on a label would preclude the marketing of a drug product in that package for both the Rx and the OTC markets. Likewise, the FDA's labeling requirements differ substantially for the Rx and OTC markets, such that the labels on the packages could not be the same. See 21 C.F.R. Part 201, subpart B (Rx labeling) and Subpart C (OTC labeling).
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 16
Excerpt Status: NEW
Excerpt Text:
B. FDA'S INTERPRETATION SECTION 503(b) HAS NOT CAUSED ANY CONFUSION.
There has been no history of confusion regarding FDA's interpretation of section 503(b)(1i) of the FDCA as permitting simultaneous Rx and OTC marketing when some meaningful difference exists that makes the drug safe and effective for one patient population only under the supervision of a licensed practitioner but safe and effective for another patient population without such supervision.
There can be no genuine dispute that FDA has the authority to allow simultaneous marketing of the same active ingredient in Rx products and OTC products. In fact, approval of otherwise Rx drug products for OTC use in an appropriate subpopulation is not a novel concept. Whether a subpopulation is defined by a disease state (e.g., mild, moderate, severe), by prior experience with a drug (e.g.,, failed on first-line therapy), by gender, or by age (e.g., pediatric, geriatric) varies with particular products, but the principle is the same: different subpopulations for whom a drug is indicated create different "new drugs," for which separate approval is needed and which separately may be either Rx or OTC.
Although FDA has repeatedly found conditions under which an active ingredient may be marketed simultaneously in both a prescription drug product and an OTC drug product, and has presumably on occasion refused to find that such conditions exist, Duramed has been unable to locate any challenges to the interpretation of section 503(b)(f) that FDA utilizes to make such determinations. A review of the case law reveals that there is no published opinion addressing purported confusion regarding FDA's interpretation. Similarly, a review of the academic literature, including a review of the journals specific to issues relating to FDA and food and drug law, reveals that there has been no scholarly work identifying, or seeking to resolve, any confusion as to FDA's interpretation. In sum, neither the private nor public sector has been confused by FDA 's interpretation.
Commenter Organization Name: Walsh, Melissa
Comment Number: 2005N-0345-EC15931
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.3.2 - FD&C Act is clear regarding when a drug should be prescription only
NEW - 4.2 - No
Excerpt Text:
B. The FDA's interpretation is an accurate interpretation of the law. It is also scientific, because this policy is in keeping with the known fact of chemistry that to decrease the toxicity of a product its concentration must be in some way decreased. Thus it must follow in medicine, if a drug is to be safe it must be marketed at non-injurious levels. If it is sold at higher concentrations it should be under the supervision of a physician. Consequently there should be no confusion to the FDA's policy as it is both scientific and in keeping with the intent of the law. In order to avoid future challenges by drug companies and pharmacies to the FDA's interpretation of 503(b) of the act, the FDA's unwritten interpretation should be codified as law.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Barr established, as required by the relevant regulations, that Plan B is safe and effective to treat a condition that can be diagnosed by the patient. Furthermore, Barr established to the FDA?s satisfaction that women could follow the directions for the medication that would render its self- administration safe and effective.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
NEW - 3.8.4 - Interpretation is clear in present form
Excerpt Text:
From the brief that I have available, I believe I understand the intent of the reasoning behind OTC use and prescribed use. Of importance here is the indication of the drug use. Plan B is to be used only in the emergent situation, after intercourse has occurred, to prevent an unintended pregnancy. The drug is not meant to be use daily to prevent. "The key distinction in these examples is that there is some meaningful difference between the two products (e.g., indication, strength, route of administration, dosage form) that makes the prescription product safe only under the supervision of a licensed practitioner." The previous quote is from the docket, I believe the key difference is the indication of the drugs' use.
4.4.2 - Policy arguments that little or no confusion exists
Commenter Organization Name: Consumer Healthcare Products Association
Comment Number: 2005N-0345-C412
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
B. and C. Given the precedents that already exist, there should not be significant confusion regarding section 503(b), so the question of dispelling confusion is moot. As discussed above, distinctions - some broad, some narrow - have been used for a range of ingredients to allow the ingredients to be labeled and marketed in more than one way, so there should not be significant confusion regarding section 503(b). A range of paths and precedents exist for both the agency and those wishing to label and market a drug product. The question of dispelling confusion is moot.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
The public has been aware since at least May 2004 that FDA is considering permitting simultaneous Rx and OTC marketing of Plan B to different subpopulations, yet Duramed has been unable to find any basis to conclude that the FDCA does not authorize FDA to approve such marketing. It is beyond dispute that, since Duramed filed its supplement, there has been extensive public discussion -in articles and editorials in newspapers, professional journals, and other publications, on television and radio, and elsewhere -of the issues relating to Plan B, including limitation of OTC to a particular subpopulation. Interested members of the public have already had ample opportunity to express their views to the Agency, and have done so. It is time for FDA to take final action on NDA 21-045/S011.
Commenter Organization Name: Jones, Kim
Comment Number: 2005N-0345-EC16543
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
No. The American consumer understands that some medications are reasonably safe for self-medication in lower doses, but require physician monitoring for higher doses and certain uses.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Affirmitive, you seem quite confused between your role in approving drugs on scientific merit and benefit (vs social engineering and backdoor legisalated morality).
Commenter Organization Name: Goggin, Terresa
Comment Number: 2005N-0345-EC213
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
I think the current guidelines are adequate and straightforward. Personal politics are what is clouding the availability of this drug, and probably others in the future if this precedent is allowed.
Commenter Organization Name: Hagan, Jane
Comment Number: 2005N-0345-EC32
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
Since there is a desire to impose an age restriction on whether this drug is available with or without a prescription, there should not be significant confusion regarding whether the consumer is of a certain age or not.
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Although there may SEEM to be so, such confusion is primarily claimed by those who are not entirely familiar with all the circumstances surrounding specific applications of Sec. 503(b).
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
No. If there were, it would have come up long before now
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
Not in the past. Confusion is building due to special interest pressure.
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I think the problem lies in trying to limit the age to purchase the OTC drug.
Commenter Organization Name: Schmierer, Ann
Comment Number: 2005N-0345-EC81
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I think it may be inappropriate for the public to make comments on "FDA's confusion" on the interpretation. I believe there are adequate historical cases and presidence for a number of OTC formulations and similar drugs only availble via prescription, all proven safe and effective by the FDA for dispensing to patients and consumers. This is a political position taken by the Commissioner and the office of HHS, and I believe he and the office should stand down and let the FDA do their job.
Commenter Organization Name: Kopp, Margaret
Comment Number: 2005N-0345-EC903
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 4.2 - No
Excerpt Text:
No. It is very clear that the FDA is making the interpretation that is preferred by White House, without regard to actual safety and efficacy of the drug in question. I am not at all confused. I am, however, deeply offended by the actions of the FDA, in hijacking this drug as part of a political agenda.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
The only confusion resulting from the FDA?s interpretation of this section of the act stems from the FDA?s deviation from precedent established by our scientific understanding of drug effects on women of reproductive age.
4.5 - Miscellaneous arguments/discussions
Commenter Organization Name: Reynolds, Charles
Comment Number: 2005N-0345-EC12
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
Excerpt Text:
The issue is not one of confusion. The question becomes one of establishing defined criteria for which a drug may be used and marketed both OTC and Rx.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I am not confused by the FDA's interpretation. The FDA administration, however, sounds like it's confused about what to do because it is caught between the scientific findings of the FDA's own scientists and the political wants of the Presidential administration that appointed it.
Commenter Organization Name: Anspach, Kurt
Comment Number: 2005N-0345-EC447
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Parts of the statement is good but how many people know the process of filing a complaint?This issue is a very important issue and it should be brought to the attention of the population throught the media.
Commenter Organization Name: Katrib, Elise
Comment Number: 2005N-0345-EC516
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 4.1 - Yes
Excerpt Text:
Yes, it seems that given enough pressure or money, a drug will be able to overcome FDA interpretation of any act.
Commenter Organization Name: Kowalczyk, Brigid
Comment Number: 2005N-0345-EC518
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No drug should be sold both by prescription and OTC.
Commenter Organization Name: Zahn, Steven
Comment Number: 2005N-0345-EC52
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It is not significant enough that different strengths of the same product are marketed as prescription or OTC. That gives the illusion of safety in taking increased doses of the OTC product knowing that there is an equivalent prescription dose available.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 19
Excerpt Status: NEW
Excerpt Text:
And I also encourage you to clarify section 503(b) of the act so that any OTC MUST be a "non-prescription" dose that can be taken at multiple times the recommended dose without harm or has an alternate presentation and use (ex. Benedryl pills or Benedryl in itch cream). And codify the act so that the same dosage of a medication cannot be BOTH prescription and OTC.
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No confusion regarding present practice; plenty of confusion over what may happen in the future.
Commenter Organization Name: Townsend, Elisha
Comment Number: 2005N-0345-EC90
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
There are other drugs that have age limits such a tobacco and alcohol. However both of those have proven negative side effects, and are not also prescription.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 1.2 - Specific comments on drug approval process for Morning-after Pill/Plan B
Excerpt Text:
In every previous ruling, the FDA has considered women of reproductive age as one group when looking at the safety and efficacy of a product. The arbitrary separation here into ?adolescent? women and ?adult? women is unsupported by the scientific literature, particularly in light of studies which find no differences in the frequency or risk of unprotected sex in young women provided emergency contraception in advance. On the contrary, these teens are more likely to use emergency contraception with unprotected coitus, and to use it earlier after the event, making it more effective. In addition, no decreases have been seen in consistent condom use in the teens that had unrestricted access to emergency contraception. Furthermore, studies in both the US and the UK indicate that teens are not more likely to use emergency contraception as a regular birth control method, nor are they more likely to engage in risky sexual behavior as a result of improved access to the drug.
Commenter Organization Name: Etter, Eleanor
Comment Number: 2005N-0345-EC96
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I would think people are wondering whether the FDA still adheres to its policy of basing decisions on science as opposed to ideology. When the FDAs scientists recommend one course of action and the agency acts against that recommendation, the public's trust of the agency is understandably undermined.
5 - Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.]
Commenter Organization Name: Burometto Jr, Charles
Comment Number: 2005N-0345-EC109
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes, a rule would clarify the confusion by stating what actions are to be taken.
Commenter Organization Name: Chihane, Ziad
Comment Number: 2005N-0345-EC13197
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 4.1 - Yes
Excerpt Text:
The rulemaking in question is of utmost importance in regards to health and safety of citizen of the United States. The FDA should absolutely initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug product. The act in itself is unclear and with the high degree of importance that medicine serves to citizens it is imperative that there be rulemaking in regards to this issue. The confusion that occurs with the FDA's interpretation of section 503(b) is that they have set limits in the amount of dosage that something can have depending if it is OTC or a prescription drug. But this is not very clear this is why I believe that FDA should go into a more effective rulemaking process to better regulate this issue. The way that the rule is currently setup I believe leaves a lot of room for speculation, which is not something that needs to be done with prescription or OTC drugs. If we don't put a more effective rule on the section 503(b) it could eventually get out of control. So yes I do believe that rulemaking on this issue would dispel the confusion that is along with this section 503(b).
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.7.1 - Other legal arguments supporting rulemaking
NEW - 5.3.1 - Legal arguments supporting rulemaking to dispel confusion
Excerpt Text:
Rulemaking, in accordance with ADA section 553, is needed as a matter of public health via increasing accessibility to safe, legal medications and removing the unfair burdens currently upon consumers.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
A rulemaking would be the key to help dissolve the confusing language in section 503[b] of the act. With an adjustment and a revision to the language brought on by the rulemaking, this would allow an easier interpretation of the meaning of what constituents a prescription drug or an OTC drug.
Commenter Organization Name: Connors, Meaghan
Comment Number: 2005N-0345-EC141
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Hopefully.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.5 - Miscellaneous arguments/discussions
Excerpt Text:
Certainly greater clarification and less ambiguity is always a plus. 503(b) does not have to be fit for all issues, amendments - with future consolidation - are appropriate.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
Yes. Make it clear what the determiners are of such decisions; that will make it easier on the FDA and clearly more of an issue of fact than politics.
Commenter Organization Name: Lamotte, Diane
Comment Number: 2005N-0345-EC155
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
Yes, just give us the rulemakeing.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 9
Excerpt Status: NEW
Excerpt Text:
Yes, a well developed regulation that codifies the Agency's interpretation of Section 503(b) should reduce confusion.
Commenter Organization Name: American Pharmacists Association
Comment Number: 2005N-0345-EC16675
Excerpt Number: 22
Excerpt Status: NEW
Excerpt Text:
Codifying the Agency's interpretation of Section 503(b) would be a step towards dispelling that confusion.
Commenter Organization Name: Dowell, Duane
Comment Number: 2005N-0345-EC195
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
That is not likely
Commenter Organization Name: Cunningham, Wayne
Comment Number: 2005N-0345-EC240
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Pechacek, Deborah
Comment Number: 2005N-0345-EC27
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
YES!
Commenter Organization Name: Hudson, Ralph
Comment Number: 2005N-0345-EC34
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It may dispel that confusion, if done correctly, but it will not "dispet" that confusion, as is written on your webpage.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I would think so.
Commenter Organization Name: Labbe, Carl
Comment Number: 2005N-0345-EC408
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Thompson, Donald
Comment Number: 2005N-0345-EC416
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Cunningham, Laura
Comment Number: 2005N-0345-EC5
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
YES
Commenter Organization Name: Kowalczyk, Brigid
Comment Number: 2005N-0345-EC518
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Rommel, Scott
Comment Number: 2005N-0345-EC54
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
If there is confusion on any issue, wouldn't making a rule to dispell the confusion take it away. I don't believe this question is even worth asking.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
I think that a more defined set of rules would help alleviate the confusion.
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
It would help to clear up the issue regarding the controversy over age of the women and why those older than 16 "benefit" from OTC status and those under 16 might be harmed by OTC status.
Commenter Organization Name: Baird, Debora
Comment Number: 2005N-0345-EC66
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes
Commenter Organization Name: Carter, Thomas
Comment Number: 2005N-0345-EC691
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It would seem so, although I do not know what the ramifications of such a rulemaking would be.
Commenter Organization Name: Ricci, Stephen
Comment Number: 2005N-0345-EC73
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It is more likely
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.3.1 - Legal arguments supporting rulemaking to dispel confusion
Excerpt Text:
A rule making on thi sissue helps significantly because of the clear, concise language which typically accomponies such rulemaking on the FDA site. While other information is also available on the site, a rulemaking is a more formal, dated document which is often used as a starting point by other stakeholders in creating their own communications.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
Yes it would but rulemaking needs to be flexible enough so that it can accomodate particular states...certain states are more progressive than others, in terms of letting consumers determine whether they can have access to medicine, that remains controversial in other states.
Commenter Organization Name: Burns, Ben
Comment Number: 2005N-0345-EC93
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
it probably would.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
The FDA should initiate the rulemaking process to determine whether or not a single substance can be marketed simultaneously as both a prescription drug and an over the counter one. Carrying out the rulemaking process for such a decision would not only clarify the provisions of the act, but it will also establish clear guidelines for drug vendors and manufactures to follow when introducing a new product. The rulemaking process, by soliciting comments, would allow the decision to be based on public opinion rather than simply the will of the drug and pharmaceutical companies mentioned above. Initiating a rulemaking for this issue is necessary, because the language of the current rule does not expressly mention the conditions under which a substance can be simultaneously manufactured in two different markets.
Commenter Organization Name: Syed, Misbah
Comment Number: 2005N-0345-EMC368
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.3.3 - Other arguments related to FD&C Act
NEW - 3.9.1 - Drug approval examples
NEW - 4.1 - Yes
Excerpt Text:
My comment to this advance notice of proposed rulemaking is that the FDA should consider that in certain circumstances, a drug should be marketed both as prescription and over-the-counter. I will address this concern by answering the following questions provided by the Food and Drug Administration, to clarify that yes, a drug can be marketed for both prescription and over-the-counter use. I will also provide arguments for what position the FDA use in rulemaking and what the FDA should incorporate in any proposed rule.
The FDA should initiate a rulemaking code to clarify the interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously marketed in both a prescription drug and over-the-counter drug form because this section only uses the Federal standard classifying drugs as either prescription or over-the-counter. It also defines what a prescription drug is, ?a drug intended for use by man which because of its toxicity or other potential harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug?. This section does not define over-the-counter drugs. It explains that whatever drug does not meet the standards to make it a prescription drug, is classified as over-the-counter. This section only classifies a drug to be prescription or over-the-counter, but in certain circumstances, the FDA has interpreted certain drugs with the same active ingredients to be marketed as both prescription and over-the-counter. For example Meclizine, which is a prescription for vertigo, but for over-the-counter purposes? It handles nausia with motion sickness. Also Nicotine products like inhalers and nasal sprays, which are prescription drugs, but gums and patches are considered over-the-counter. It brings significant confusion regarding the FDA?s interpretation of section 503(b) because other products like Plan B which is a mourning-after pill is also over-the-counter, but to women 17 and older, otherwise it would be a prescription to those women younger than 17. The section clearly does not define rules about age limits and the agency has not figured out how to prevent younger teenagers from gaining access to the pill. It would then be necessary for the FDA to propose a rulemaking solution for this issue to help dispel the confusion.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.3.1 - Legal arguments supporting rulemaking to dispel confusion
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
Codifying the FDA's interpretation of section 503(b) makes the language more explicit and makes the federal administration more accountable to laws that were meant to protect consumers-as it is their function to serve the public health and not to submit to the lobbying tactics of profit-seeking pharmaceutical companies. In addition, clarification of the language protects consumers through means of education-providing legitimate and obtainable information. Any ambiguity on federal standards with regards to drugs should be accessible and in common language.
Commenter Organization Name: Family Planning Advocates of New York State
Comment Number: 2005N-0345-C61
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 3.2 - No
NEW - 4.2 - No
Excerpt Text:
In response to the questions posed in RIN 0910-AF72, FPA believes the first three questions (lA, 1B and lC) should be answered in the negative, making it unnecessary to address the remaining questions. We do not believe there is any confusion over the interpretation of section 503 of the Federal Food, Drug, and Cosmetic Act.
Commenter Organization Name: Shaffer, Kathleen
Comment Number: 2005N-0345-EC106
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: White, Alan
Comment Number: 2005N-0345-EC1121
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
If there is confusion about what constitutes a safe and effective OTC drug in some circumstances, a ruling in this particular case (Plan B) is not one that could dispel the confusion in any significant way. Studies show that Plan B is safe and effective for the suggested target OTC population (17+ year-old females), and thus poses no significant risk to that population (except, perhaps, in the estimation of those commentators who import questionable and possibly unconstitutional moral or religious assumptions about danger to embryos, as suggested above, and clearly the FDA may not seriously entertain such concerns in its decision-making).
Commenter Organization Name: Paslawsky, JoAnn
Comment Number: 2005N-0345-EC1129
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No, I believe a rulemaking would simply provide additional opportunities for clouding the issue when it is conveyed to the public.
Commenter Organization Name: Severance, Peter
Comment Number: 2005N-0345-EC135
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Loomis, Shirley
Comment Number: 2005N-0345-EC147
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No. You will not dispel confusion. You may just simply be better able to serve the American public.
Commenter Organization Name: Hein, Rachel
Comment Number: 2005N-0345-EC168
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
no...please follow previous rulemaking precedents and release the drug for use.
Commenter Organization Name: Pinkerton, Mike
Comment Number: 2005N-0345-EC171
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 6.5.1 - FDA's authority limited to drug safety, effectiveness/efficacy, and labeling
Excerpt Text:
No. A reminder to the FDA that its role is to approve or dissapprove drugs for use based on potential harm and validity of claims is needed.
Commenter Organization Name: Steward, Linda
Comment Number: 2005N-0345-EC181
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
no.
Commenter Organization Name: Hibberd, Rachel
Comment Number: 2005N-0345-EC196
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Levy, Gayle
Comment Number: 2005N-0345-EC206
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No. No amount of rulemaking (barring the overturn of Roe v. Wade) will change the politics involved.
Commenter Organization Name: Young, Stan
Comment Number: 2005N-0345-EC211
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Rankis, A
Comment Number: 2005N-0345-EC22
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No
Commenter Organization Name: Cepeda, Baudi
Comment Number: 2005N-0345-EC226
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: TomHon, Catherine
Comment Number: 2005N-0345-EC281
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No, the FDA can simply make transparent and concrete the basis for its decision.
Commenter Organization Name: Collum, Mark
Comment Number: 2005N-0345-EC33
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
NO! More rules only add to the confusion. Medicine & Pharmacy are too highly regulated as it is. More rules = more confusion.
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.4.2.2 - Other policy arguments
Excerpt Text:
Further rulemaking would merely open up additional areas of question and urge lawyers and medical personnel to find new avenues for advancing their personal (or constituent) agendas.
Commenter Organization Name: Anspach, Kurt
Comment Number: 2005N-0345-EC447
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
no!
Commenter Organization Name: McGhee, Tim
Comment Number: 2005N-0345-EC53
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
I find this to be unlikely.
Commenter Organization Name: Burgess, Annette
Comment Number: 2005N-0345-EC566
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Billingsley, Daniel
Comment Number: 2005N-0345-EC609
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I don't believe a new rulemaking on confusing rule would help.
Commenter Organization Name: Friedl, Mary Frances
Comment Number: 2005N-0345-EC671
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
no
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Only to you.
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Gorini, Joseph
Comment Number: 2005N-0345-EC717
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Rule making on this issue with regard to Plan B would confuse the proper understanding of 'health and safety.' Plan B should not be considered to fall under the FDA's concern for 'health and safety.' See General Comment.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.4.2.2 - Other policy arguments
Excerpt Text:
I fear that rulemaking on this issue would only further codify the opinion driven barriers which prevent scientific recommendation from being heeded.
Commenter Organization Name: Phlips, Thomas
Comment Number: 2005N-0345-EC788
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No.
Commenter Organization Name: Vander Bleek, Luke
Comment Number: 2005N-0345-EC870
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
NO
Commenter Organization Name: Trubow, Marshall
Comment Number: 2005N-0345-EC95
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Doubtful. We don't need more rules- we need some basic common sense to prevail, and have the politicians stay out of this.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 5.4.1 - Legal arguments that rulemaking would not clarify
Excerpt Text:
Rulemaking on this issue is unlikely to help dispel the confusion mentioned above, as the confusion stems largely from the FDA?s arbitrarily redefining the population of reproductive-age women, and moving away from precedent, not from an incomprehensible or ill-defined law.
Commenter Organization Name: Etter, Eleanor
Comment Number: 2005N-0345-EC96
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
No. Using "rulemaking" to delay approval would not help
Commenter Organization Name: Brakman, Anita
Comment Number: 2005N-0345-EC97
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
No
5.3 - Arguments that support concept that a rulemaking would provide clarification
5.3.1 - Legal arguments supporting rulemaking to dispel confusion
Commenter Organization Name: Peters, Jeanette
Comment Number: 2005N-0345-EC132
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 3.7.1 - Other legal arguments supporting rulemaking
NEW - 5.1 - Yes
Excerpt Text:
Rulemaking, in accordance with ADA section 553, is needed as a matter of public health via increasing accessibility to safe, legal medications and removing the unfair burdens currently upon consumers.
Commenter Organization Name: McLeod, Doug
Comment Number: 2005N-0345-EC364
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
So long as the rule allowed the practice and supported by the scientific evidence and advice of the FDA professional staff who should be independent of political influence.
Commenter Organization Name: O'Hagan, James
Comment Number: 2005N-0345-EC827
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
A rule making on thi sissue helps significantly because of the clear, concise language which typically accomponies such rulemaking on the FDA site. While other information is also available on the site, a rulemaking is a more formal, dated document which is often used as a starting point by other stakeholders in creating their own communications.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
NEW - 5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Excerpt Text:
Codifying the FDA's interpretation of section 503(b) makes the language more explicit and makes the federal administration more accountable to laws that were meant to protect consumers-as it is their function to serve the public health and not to submit to the lobbying tactics of profit-seeking pharmaceutical companies. In addition, clarification of the language protects consumers through means of education-providing legitimate and obtainable information. Any ambiguity on federal standards with regards to drugs should be accessible and in common language.
5.3.2 - Policy arguments supporting rulemaking to dispel confusion
Commenter Organization Name: Dougherty, Anne
Comment Number: 2005N-0345-EC126
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It might, yes. Consumers look only at the availability and price of health care items. In an era where health care is available to far fewer people at an affordable price it is vital that the patient feel he or she is involved in healthcare decisions.
Commenter Organization Name: Nguyen, Marie
Comment Number: 2005N-0345-EC13851
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
A rulemaking would be the key to help dissolve the confusing language in section 503[b] of the act. With an adjustment and a revision to the language brought on by the rulemaking, this would allow an easier interpretation of the meaning of what constituents a prescription drug or an OTC drug.
Commenter Organization Name: Soriano, Lauren
Comment Number: 2005N-0345-EC14388
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Also, Section 503(b), the active ingredient segment, should be more clear and cohesive so that there is no confusion regarding the interpretation of that section. The only way to ensure that section 503(b) would change is if rulemaking is put into affect. No drastic change in the section would be taken seriously without rulemaking approved by the FDA.
Commenter Organization Name: Marshall, Laura
Comment Number: 2005N-0345-EC15
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
Yes. Make it clear what the determiners are of such decisions; that will make it easier on the FDA and clearly more of an issue of fact than politics.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
I believe that the confusion surrounding Plan B stems from religious and political disagreement with the drug itself. However, if a clarification of the rule will allow the FDA to finally make a decision regarding Plan B, I would approve of a rulemaking in order to facilitate decisionmaking.
Commenter Organization Name: Gibbons, Bridget
Comment Number: 2005N-0345-EC2009
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
As stated above, I think the "confusion" is merely a political smokescreen. However, future drugs may cause legitimate confusion, so perhaps it is in the best interest of the consumer population to have a bright-line rule regarding these drugs.
Commenter Organization Name: Levinson, R. Saul
Comment Number: 2005N-0345-EC297
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes....especially since FDA's own advisory group, and the majority of the medical/scientific community support the availability of Plan B as an OTC product and a prescription product.
Commenter Organization Name: Waychoff, W. Aaron
Comment Number: 2005N-0345-EC311
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
It would help as long as the rulemaking is not used simply to further delay needed medications reaching the hands of those in need. The rulemaking *must not be religiously or politically motivated*
Commenter Organization Name: Stier, Christopher
Comment Number: 2005N-0345-EC495
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Document the "meaningful difference" for drug manufacturers and consumers. This will diffuse the effects of marketing, advertising, and labels that can be highly misleading. Men and women deserve to know the truth about drugs being marketed to them.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
If there is confusion on any issue, wouldn't making a rule to dispell the confusion take it away. I don't believe this question is even worth asking.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Potentially, yes. The rule making language should be developed so as to inform the public and thus strengthen understanding and public support for FDA decisions.
Commenter Organization Name: Kortebein, Peter
Comment Number: 2005N-0345-EC654
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
It would help to clear up the issue regarding the controversy over age of the women and why those older than 16 "benefit" from OTC status and those under 16 might be harmed by OTC status.
Commenter Organization Name: Oyola, Sandra
Comment Number: 2005N-0345-EC85
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Yes, because consumers and manufacturers will have a better understanding of the regulations.
Commenter Organization Name: Aengst, Jennifer
Comment Number: 2005N-0345-EC921
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
Yes it would but rulemaking needs to be flexible enough so that it can accomodate particular states...certain states are more progressive than others, in terms of letting consumers determine whether they can have access to medicine, that remains controversial in other states.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Only if it codifies that intended population is a meaningful clinical difference that can be used to distinguish OTC and Rx status of a drug.
Commenter Organization Name: Temple, Jennie
Comment Number: 2005N-0345-EMC355
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.1 - Rulemaking will improve future FDA decisions (clarity, consistency, efficiency)
NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
NEW - 5.1 - Yes
Excerpt Text:
The FDA should initiate the rulemaking process to determine whether or not a single substance can be marketed simultaneously as both a prescription drug and an over the counter one. Carrying out the rulemaking process for such a decision would not only clarify the provisions of the act, but it will also establish clear guidelines for drug vendors and manufactures to follow when introducing a new product. The rulemaking process, by soliciting comments, would allow the decision to be based on public opinion rather than simply the will of the drug and pharmaceutical companies mentioned above. Initiating a rulemaking for this issue is necessary, because the language of the current rule does not expressly mention the conditions under which a substance can be simultaneously manufactured in two different markets.
Commenter Organization Name: Thames, Samuel
Comment Number: 2005N-0345-EMC374
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 3.1 - Yes
NEW - 3.8.3 - Other policy arguments for initiating a rulemaking
Excerpt Text:
The FDA should most definitely codify its interpretation of section 503 (b) to resolve confusion, it can and should place limits on certain subgroups, most notably those underage, and the FDA should also allow the identical packaging of over the counter and prescription drugs but also keep in mind that this is not always appropriate. The current state of the rules regarding prescription and over the counter drugs is inadequate and the FDA should proceed in the rulemaking process.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
NEW - 5.3.1 - Legal arguments supporting rulemaking to dispel confusion
Excerpt Text:
Codifying the FDA's interpretation of section 503(b) makes the language more explicit and makes the federal administration more accountable to laws that were meant to protect consumers-as it is their function to serve the public health and not to submit to the lobbying tactics of profit-seeking pharmaceutical companies. In addition, clarification of the language protects consumers through means of education-providing legitimate and obtainable information. Any ambiguity on federal standards with regards to drugs should be accessible and in common language.
5.4 - Arguments that a rulemaking would not provide clarification
5.4.1 - Legal arguments that rulemaking would not clarify
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 17
Excerpt Status: NEW
Excerpt Text:
C. BECAUSE THERE IS NO CONFUSION REGARDING FDA'S INTERPRETATION, RULEMAKING IS UNWARRANTED.
Because there is no confusion regarding FDA's interpretation of section 503(b), there is no need for rulemaking to clarify FDA's interpretation.
Even if there were some circumstances in which confusion might somehow result from FDA's interpretation of section 503(b), there is no confusion regarding the application of FDA's interpretation to NDA 2l-04S/S011. Thus, no notice-and-comment rulemaking or guidance document is legally required or factually warranted in the circumstances here. The approval Duramed seeks from FDA is specific to NDA 2l-045/S011 as amended, and does not raise broad issues potentially affecting other products.
If FDA is concerned that it has little prior experience with such use of an age restriction or its reflection in labels and labeling, the appropriate response is not to initiate rulemaking now. Instead, it is reasonable and appropriate for the agency to proceed case by case to accumulate experience before embodying a particular approach in a rule adopted in a notice-and-comment proceeding. See, e.g., SEC V. Chenery Corp., 332 US. 194, 202-03 (1947) (agency has discretion to proceed case by case or by notice and comment).
Since there is currently no court-created deadline, a rulemaking seeking to clarify FDA's interpretation of section 503(b), if initiated before approval of NDA 21-245/S011, could potentially delay such approval by years. FDA should not delay a decision on the pending supplement in order to conduct rulemaking to address concern over the clarity of its interpretation in some hypothetical future scenario. The delay that would necessarily accompany rulemaking in this instance would be particularly unjustified because it would deny women age 17 and over prompt and convenient access to a drug that FDA has already found is safe and effective for them when available OTC. Such delay would be flatly contrary to FDCA § 903(b)(1), 21 U.S.C. § 393(b)(1).
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 5.2 - No
Excerpt Text:
Rulemaking on this issue is unlikely to help dispel the confusion mentioned above, as the confusion stems largely from the FDA?s arbitrarily redefining the population of reproductive-age women, and moving away from precedent, not from an incomprehensible or ill-defined law.
5.4.2 - Policy arguments that rulemaking would not clarify
Commenter Organization Name: Brakman, Anita
Comment Number: 2005N-0345-EC97
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
There is no confusion, only politically motivated delay.
5.4.2.1 - Guidance instead of rulemaking
5.4.2.2 - Other policy arguments
Commenter Organization Name: Hibberd, Rachel
Comment Number: 2005N-0345-EC196
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
The majority of the public is not familiar enough with the facets of the FDA's bureaucracy to understand even the questions on this "public" comment form.
Commenter Organization Name: Richman, Bobbi
Comment Number: 2005N-0345-EC21
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 1.3 - Specific comments about other drug product
Excerpt Text:
IF YOU ARE ASKING THE PUBLICS OPINION, AND WE FEEL THERE IS CONFUSION, WHY DO YOU THINK IT WOULD BE ANY CLEARER IF YOU MAKE A DECISION YOURSELVES. WE ALL KNOW THE CORRUPTI0N IN THE FDA IN FAVOR OF MONEY MAKING DRUG COMPANIES SO WHY ASK OUR OPINION. YOU WILL DO WHAT YOU WANT ANYWAY. LOOK AT VIOX. NO MORE TO BE SAID AFTER THAT.
Commenter Organization Name: Lamermayer, Richard J
Comment Number: 2005N-0345-EC43
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.2 - No
Excerpt Text:
Further rulemaking would merely open up additional areas of question and urge lawyers and medical personnel to find new avenues for advancing their personal (or constituent) agendas.
Commenter Organization Name: Anspach, Kurt
Comment Number: 2005N-0345-EC447
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
If there was a rulemaking how would the people know were to look for it?How many people know to go on the FDA website?
Commenter Organization Name: Schulz, Stan
Comment Number: 2005N-0345-EC680
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
It would only change a simple "esy/no" issue into a complex one requiring measurements (of age, for instance) or status (married or not), and set the groundwork for requiring additional bureaucratic action (for instance, requiring proof of age)and the possibility of fiviolous lawsuits based on the decision of a drugstore clerk.
Commenter Organization Name: Long, Laura Jean
Comment Number: 2005N-0345-EC762
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 5.2 - No
Excerpt Text:
I fear that rulemaking on this issue would only further codify the opinion driven barriers which prevent scientific recommendation from being heeded.
Commenter Organization Name: Cahoon, Clifton
Comment Number: 2005N-0345-EC80
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I think it should continue to stay legend vs non-legend and not allow a ruling which would not only put the particular drug at hand to be confusing but there would be too much leeway to allow multiple drugs be given OTC status.
5.4.3 - There is no confusion, therefore rulemaking unnecessary
Commenter Organization Name: GlaxoSmithKline
Comment Number: 2005N-0345-C307
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 3.8.7 - Cost-benefit concerns regarding rulemaking
NEW - 4.2 - No
Excerpt Text:
We see no need, or benefit, of further regulation. Our FDA submission experience leads GSK CH to conclude that there is no confusion regarding FDA's interpretation of section 503(b). To the contrary, we have found FDA's interpretation very clear. It is our opinion that part C of this question is therefore moot.
Commenter Organization Name: Duramed Research, Inc. and Duramed Pharmaceuticals, Inc.
Comment Number: 2005N-0345-C415
Excerpt Number: 1
Excerpt Status: NEW
Excerpt Text:
1. FDA's existing interpretation of section 503(b), 21 U.S.C. § 353(b)(1), regarding simultaneous marketing of an active ingredient as an Rx and OTC product has not caused any confusion, and therefore FDA does not need to initiate any rulemaking on its interpretation. As FDA states in the Notice, it has repeatedly approved simultaneous Rx and OTC marketing in the past; and Duramed has not been able to locate any evidence to support the contention that FDA 's interpretation of section 503(b) as permitting such use is erroneous or needs clarification.
Commenter Organization Name: White, Alan
Comment Number: 2005N-0345-EC1121
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Since there is no reason to believe that the FDA has heretofore interpreted section 503(b) in a confused way, and the case of Plan B introduces no novel issues of safety and efficacy for the target OTC population, then there is no reason to use this case to further refine interpretation of that section. In fact, any ruling on Plan B that further restricts the interpretation of 503(b) may well lead by parity of law to further unintended consequences, such as rescinding the current practice of allowing equivalent-dosage OTC drugs such as Loperamide.
Commenter Organization Name: National Research Center for Women
Comment Number: 2005N-0345-EC2314
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
No, because there is no confusion.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 1.2.2 - Approve simultaneous marketing approach (market both OTC and Rx)
Excerpt Text:
As stated above, there is no need for additional rulemaking. If the FDA decides that additional rulemaking is necessary, the FDA should issue emergency rules and not delay yet again availability of a safe and effective drug. The FDA has already needlessly delayed availability of safe and effective contraceptive products to American citizens. This delay clearly has been to please a religious constituency and not in conformance with the purposes of the act. The FDA should cease its stalling immediately.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
There is no significant confusion to be dispelled.
Commenter Organization Name: Schmierer, Ann
Comment Number: 2005N-0345-EC81
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I am unaware of the definition for the word "dispet" in the English language that is worded in the question, and may be used intentionally to really incite "confusion". If the appropriate word was intended to be "dispel", I believe there are adequate rules within the Federal Register for the FDA to do it's job, and do not have a problem with their interpretation of what has been entered into the code of law governing FDA.
5.5 - Miscellaneous arguments/discussions
Commenter Organization Name: Ladd, Judy
Comment Number: 2005N-0345-EC1032
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
It depends on whether the ruling was in favor of the population as a whole or was it to knuckle under to the pharmaceutical companies.
Commenter Organization Name: Speight, Thomas
Comment Number: 2005N-0345-EC1041
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
If such a rulemaking would not in any way change the intent or action of the section's language, yes.
Commenter Organization Name: White, Molly
Comment Number: 2005N-0345-EC107
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Rules can alleviate confusion or they can make it worse. The nice thing about rules is they provide grounds for further action.
Commenter Organization Name: McCormick, Michelle
Comment Number: 2005N-0345-EC1086
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Maybe so, but more than likely it will restrict the process of issuing drugs even further.
Commenter Organization Name: Steele, Robert
Comment Number: 2005N-0345-EC146
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.1 - Yes
Excerpt Text:
Certainly greater clarification and less ambiguity is always a plus. 503(b) does not have to be fit for all issues, amendments - with future consolidation - are appropriate.
Commenter Organization Name: Morrisroe, Julia
Comment Number: 2005N-0345-EC194
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
If you rule that access is a right for all women.
Commenter Organization Name: Gay, Sarah
Comment Number: 2005N-0345-EC199
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
Yes and No. If FDA Rules are based on scientific recommendations, rather than political pressure, the current application to make 'Plan B' available OTC to women 17 and over is consistent with the FDA Commissioner's own statement that 'The FDA?s drug center, the Center for Drug Evaluation and Research or CDER, completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an over the counter product, but only for women who are 17 years of age and older,' and the drug application should be approved. A rulemaking on the issue of general interpretation of section 503(b) is irrelevant in this case.
Commenter Organization Name: Roettcher, Phil
Comment Number: 2005N-0345-EC224
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
Advance with the technology and society. Change the rules to allow for multiple applications of the same molecule and let the market sort it out.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 6.6.3 - Alcohol and tobacco enforcement
Excerpt Text:
Since I am not confused, it would not help me. It would not help the FDA's administration either, because then it could no longer delay taking appropriate action on the drug, therefore, putting it right back between the findings of it's own scientists and the wants of Presidential Administration that appointed it. In addition, there is no need for new rulemaking, as the rule-making precedent has already been set by the distribution of alcohol and tobacco.
Commenter Organization Name: Bilz, Michael
Comment Number: 2005N-0345-EC4
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
I'm sure that it would - how long would it take to make a rule? Longer than it did when so many people were denied access to the Alzheimer's medication that sent so many people back into the darkness and so many families living with the torment of seeing a loved one suffer? There was a miss-step for the Agency, as it were.
Commenter Organization Name: Dolinski, Elizabeth
Comment Number: 2005N-0345-EC522
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
the FDA CAN make a drug both prescription and over the counter. That is clear to me and should be made clear to the public.
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
only if the rule made it clear that if a prescription is required, it is universally required.
Commenter Organization Name: Holden, Karen
Comment Number: 2005N-0345-EC895
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
Only if the rulemaking were based on legitimate concerns about the SAFETY and EFFICACY of a particular medication in a particular subgroup. Rulemakings done for the sole purpose of social engineering at the behest of religious concerns is insidious and likely unconstitutional. It would increase confusion over the role of the FDA, and lead to lawsuits.
Commenter Organization Name: Townsend, Elisha
Comment Number: 2005N-0345-EC90
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
I'm not so sure. We are trying to change the rules so that our descrimination against young women seems o.k. They are able to consent to their own reproductive healthcare, and thus should be able to purchase this over the counter medication. If you start bending the rules, it opens up the flood gates as you pointed out in your letter. Of course this contradicts my previous statements, but this whole situation is contradictory.
Commenter Organization Name: Rupp, Charles
Comment Number: 2005N-0345-EC323
Excerpt Number: 5
Excerpt Status: MODIFIED
Other Sections: MODIFIED - 2.1 - Comments on time, manner, and nature of rulemaking process
Excerpt Text:
This question is easily and simply answered by looking at the American marketplace today. It is ordinary practice today to restrict sales of products at the point of sale by the age of purchaser. Even the smallest ?mom and pop? convenience store routinely enforces such restrictions in sales of liquor and cigarettes. Waiters and waitresses routinely check the age of customers before serving drinks. Sporting goods stores have no problem with age restrictions on the sale of firearms. Movie theaters restrict attendance at movies by age routinely. All of these examples demonstrate the capability of the marketplace to enforce age related restrictions on product. They also demonstrate that no extraordinary mechanisms are needed to ?train, inform, etc. retailers on age restrictions on products??age restrictions are everyday events in the marketplace. These examples also demonstrate that burdensome regulations about packaging of the products are not needed.
The effectiveness and workability of restrictions at the point of sale by age has been demonstrated in the American marketplace for years. The FDA should not ignore this demonstration. There is clear, strong and convincing evidence that age restrictions on sales are enforceable. If the FDA believes that some additional regulatory authority is needed to require the market to follow age restrictions at the point of sales, this should be done in emergency rulemaking and not be used as an excuse to further delay OTC sales.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 5.5 - Miscellaneous arguments/discussions
Excerpt Text:
Since I am not confused, it would not help me. It would not help the FDA's administration either, because then it could no longer delay taking appropriate action on the drug, therefore, putting it right back between the findings of it's own scientists and the wants of Presidential Administration that appointed it. In addition, there is no need for new rulemaking, as the rule-making precedent has already been set by the distribution of alcohol and tobacco.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 8.1 - Yes
Excerpt Text:
Of course - but the package should have warnings, just like alcohol and tobacco do.
Commenter Organization Name: Llewellyn, Heather
Comment Number: 2005N-0345-EC325
Excerpt Number: 6
Excerpt Status: NEW
Excerpt Text:
The package should have warnings, just like alcohol and tobacco do, preventing any circumstance that would be inappropriate.
Commenter Organization Name: Deneris, Angela
Comment Number: 2005N-0345-EC365
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
YES! We do now with tobacco and alcohol. I see no reason that a pharmacist couldn't ask for ID. They do so now with Schedule I and II medications.
Commenter Organization Name: Scarpace, Sarah
Comment Number: 2005N-0345-EC38
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
If the drug is approved truly as OTC, where the patient could buy the product out in the aisles (as opposed to approving for "behind the counter" to be sold by a pharmacist only), would the store front cashier be responsible for deciding the appropriateness of "carding" a patient for the product to determine age? We know how effective these young adults are in regards to the sale of tobacco and alcohol! I also see a danger in not having some type of "screening" to ensure the safety of the patient in the respects mentioned above in regard to STD screening and social work support - the pharmacist can mention this during a counseling session but your average high school cashier working at minimum wage is not going to provide this level of attention (nor should they) to these patients. Please do not regulate the medication without considering the circumstances surrounding it.
Commenter Organization Name: Tufts, Gillian
Comment Number: 2005N-0345-EC399
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
Excerpt Text:
Such enforcement would likely require that the drug be stored 'behind the counter', like cigerettes, and many women who would benefit from the intended use of the drug would not ask for it.
Commenter Organization Name: Bilz, Michael
Comment Number: 2005N-0345-EC4
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.4.4 - Require identification for age
Excerpt Text:
If there were an age limitation - it would become the responsibility of the Pharmacy provider to determine age - like we do for tobacco and alcohol. Now how does a fifteen year old girl prove her age without a parent? I sell tobacco to people only with a proper I.D. and I challenge everyone that looks younger than 27. Like Alcohol + Tobacco - why wouldn't underage persons solicit the help of someone of legal age to buy this for them? The controls you ask for here have historically had work-arounds since their inception.
Commenter Organization Name: Schulman, Marvin
Comment Number: 2005N-0345-EC418
Excerpt Number: 8
Excerpt Status: NEW
Excerpt Text:
I also believe that few people will seek a prescription if the same product is available OTC. The enforcement issue is bogus. Currently, most pharmacies also sell cigarettes and are required not to sell them to children. The current means of enforcing this rule as well as the one that prevents sale of prescription drugs with a proper prescription should suffice.
Commenter Organization Name: Clason, Dennis
Comment Number: 2005N-0345-EC47
Excerpt Number: 1
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
It seems rather clear that both State and Federal bodies regulate and enforce product restrictions to particular subpopulations. The legal age for alcohol consumption is 21 years in all 50 states, and this age limit is enforced by both the various States and by Federal agencies (e.g., Department of Defense). Many States have laws and regulations which control the distribution of tobacco products to those over an age limit, and they are able to enforce their laws and regulations. Other substances controlled in similar ways include inhalants (toluene-containing glues and aerosols) and spray paints.
Clearly, if it is permissible for State and Federal agencies to restrict distribution of certain compounds by age, it is both permissible and possible for the FDA to do so.
Commenter Organization Name: Katrib, Elise
Comment Number: 2005N-0345-EC516
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 7.4.4 - Require identification for age
Excerpt Text:
How do we enforce the sale of tobacco and alcohol? Just check ID.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
This is already done, for instance, with tobacco and alcohol.
Commenter Organization Name: Rectenwald, Theodore
Comment Number: 2005N-0345-EC535
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 7.1 - Yes
Excerpt Text:
Yes, in the same manner as sales of tobacco and alcohol are controlled.
Commenter Organization Name: Porter, Rebecca
Comment Number: 2005N-0345-EC56
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Look at the amount of alcohol that is sold to minors. There will always be a way for the underaged to get this medications.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 3
Excerpt Status: NEW
Excerpt Text:
By allowing a drug to have an age restriction, if it is truly based on health issues, the drug can be regulated in much the same way as tobacco and alcohol.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
Regulations based on age have existed in this country since it's onset. Voting was the first restriction, tobacco and alcohol have legal ages for purchase at stores across the country.
Commenter Organization Name: Goodman, Evan
Comment Number: 2005N-0345-EC6
Excerpt Number: 7
Excerpt Status: NEW
Excerpt Text:
Similar methods to alcohol and tobacco could easily be used to regulate the sale of drugs.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
Of course this plan would be enforceable under law, just as age restrictions on the purchase of tobacco and alcohol are enforceable under law. The legal powers of the FDA are more than broad enough to allow for this.
Commenter Organization Name: Card, Alan
Comment Number: 2005N-0345-EC61
Excerpt Number: 7
Excerpt Status: NEW
Other Sections: NEW - 7.1 - Yes
NEW - 7.4.2 - Involve other authorities (e.g., states, state boards of pharmacies)
Excerpt Text:
Absolutely. I would recommend the wholesale borrowing of state statutes regulating tobacco sales as the basis for regulation and enforcement.
Commenter Organization Name: Koch, Frances
Comment Number: 2005N-0345-EC610
Excerpt Number: 8
Excerpt Status: NEW
Other Sections: NEW - 6.2 - No
Excerpt Text:
I do not think that this would be possible. The accessibility of alcohol and cigarettes to minors - despite strict laws on the books - shows that in practice, limitations to subpopulations is not a practical solution.
Commenter Organization Name: DeWitte, Conrad
Comment Number: 2005N-0345-EC623
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
This would seem to be "possible" to make this distinction and a common analogy would be the ability to enforce laws regarding the sale of alcoholic beverages to adults but make those same products illegal for sale to minors.
Commenter Organization Name: Peer, Gerald
Comment Number: 2005N-0345-EC626
Excerpt Number: 4
Excerpt Status: NEW
Excerpt Text:
With difficulty. Such a ruling places pharmacists in the same role as alcohol dealers, cigarette sellers and pornography peddlers: limiting exposure of the young to influences that could "corrupt youth."
Commenter Organization Name: Vrankar, Anna
Comment Number: 2005N-0345-EC668
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Is the ban on tobacco sales to minors enforeceable? Absolutely not.
Commenter Organization Name: Gordon, Jennifer
Comment Number: 2005N-0345-EC677
Excerpt Number: 5
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Just as minors easily purchase tobacco, alcohol and other drugs, 'prescription-only' for under 16/17 year old women would be a joke. Not only could minor women get friends and boyfriends to purchase this drug OTC, parents who wish to avoid the hassle and expense of going to the doctor would also purchase the drug for their daughters.
Commenter Organization Name: Socha, Kathleen
Comment Number: 2005N-0345-EC678
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 6.2 - No
Excerpt Text:
You can't even prevent kids from buying cigarettes or alcohol. What are you thinking?
Commenter Organization Name: Dawson, Jennifer
Comment Number: 2005N-0345-EC7
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 6.4.1 - Nicotine replacement therapy (e.g., Nicorette)
Excerpt Text:
Such limitations already exist for medicines like nicotine-replacement therapy, as well as for other controlled substances such as tobacco and alcohol.
Commenter Organization Name: Dawson, Jennifer
Comment Number: 2005N-0345-EC7
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.4.3 - Monitor compliance and enforcement / conduct random inspections
NEW - 7.4.5 - Pursue criminal actions against violators
Excerpt Text:
If there was concern that pharmacists were not carding customers, undercover operations could be used as they are with tobacco and alcohol, and fines could be levied.
Commenter Organization Name: Macdonell, Megan
Comment Number: 2005N-0345-EC779
Excerpt Number: 2
Excerpt Status: NEW
Other Sections: NEW - 7.4.1 - Implement "behind-the-counter" system (pharmacist distributed)
NEW - 7.4.4 - Require identification for age
Excerpt Text:
I believe that a controversial product like Planned B should be placed behind the counter (at the register) to control the buyers age of this product. I am from Oregon, and here our legal age to buy cigarettes is 16 years of age. I believe that if this product was kept behind the counters (literally) that this will prevent theft and the ID's of the buyer can be checked before the product can be purchased. If the consumer does not have a Drivers License or and ID with their birthdate on it, then I believe they should need a form of proper identification that includes their date of birth.
Commenter Organization Name: Wagner, Patricia
Comment Number: 2005N-0345-EC813
Excerpt Number: 3
Excerpt Status: NEW
Other Sections: NEW - 7.5.3 - Actual compliance will be difficult/impossible/burdensome to achieve
Excerpt Text:
Over the last several decades we have had laws forbidding the purchase of tobacco and alcohol by those under age. It has been very difficult to enforce and is frequently circumvented by simply having an older friend or acquaintance make the purchase. As it has become increasingly common for adult men to seek out minor females as sex partners, how will they be prevented from purchasing OTCs and using coercion to convince their "girlfriends" to use them or even slipping them into their food or drink without their knowledge?
Commenter Organization Name: Oberst, Sara
Comment Number: 2005N-0345-EC860
Excerpt Number: 6
Excerpt Status: NEW
Other Sections: NEW - 1.2.1 - Approve for OTC for all
Excerpt Text:
Although I believe that all subgroups should have access to OTC EC, any improvement over the status quo would be welcomed. Perhaps few prescription drugs are treated in this manner, but there are many other examples of assigning age restrictions on substances. Of course with tobacco, for instance, some adolescents under the age of 18 will end up purchasing a pack of cigarettes, but this is a small minority. And because no woman truly wants to use EC it is unlikely that any age restrictions would be broken.
Commenter Organization Name: Brass, Kathryn
Comment Number: 2005N-0345-EC951
Excerpt Number: 9
Excerpt Status: NEW
Other Sections: NEW - 6.1 - Yes
Excerpt Text:
As mentioned above, such limitations on alcohol and tobacco are widespread and enforceable.
Commenter Organization Name: Etter, Eleanor
Comment Number: 2005N-0345-EC96
Excerpt Number: 5
Excerpt Status: NEW
Excerpt Text:
Assuming making a product available to a subpopulation is legal, the enforcement would be fairly straightforward. And, certainly there are currently drugs available that are for use by adults only. The marketing of those drugs does not seem to cause a problem. Currently, almost all pharmacies sell products which only a subpopulation can purchase (eg, tobacco products) and they do it very effectively. Also, alcohol is currently available to adults only and it is effectively sold to only a subpopulation with far less supervision that there would be in a drug store.
Commenter Organization Name: Keys, Lori
Comment Number: 2005N-0345-EC98
Excerpt Number: 7
Excerpt Status: MODIFIED
Excerpt Text:
If alcohol and cigarettes can be sold in this country based on age restrictions, then there is no valid reason to prohibit the OTC sale of Plan B to adult women.
Commenter Organization Name: Dalton, Mike
Comment Number: 2005N-0345-EMC166
Excerpt Number: 2
Excerpt Status: NEW
Excerpt Text:
2. Does the FDA have the authority or ability to enforce restricting a drug from a subpopulation when it would be available to the larger population?
Two examples of this are alcohol and tobacco. The laws around restricting the sale of these two drugs are largely failing, so I would say the FDA has little ability to enforce this as a regulation.
Commenter Organization Name: Vu, Tram
Comment Number: 2005N-0345-EMC397
Excerpt Number: 4
Excerpt Status: NEW
Other Sections: NEW - 7.4.5 - Pursue criminal actions against violators
Excerpt Text:
Another issue raised in this advance notice of proposed rulemaking is whether or not the FDA would be able to enforce a limitation, as a matter of law, on the sale of OTC products to a particular subpopulation. Just as alcohol and tobacco are sold under the supervision of licensed sellers who confirm identification, the prohibition of sale of any other OTC product to a subpopulation could be similarly enforced. If a seller were to violate restrictions on the sale of certain OTC products which require careful administration under law, it should be subject to penalty.