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1 Comments unrelated to specific questions asked in FR notice - Drug approval (1037)
1.1 General comments on drug approval process (35)
1.2 Specific comments on drug approval process for Morning-after Pill/Plan B (1337)
1.2.1 Approve for OTC for all (16470)
1.2.2 Approve simultaneous marketing approach (market both OTC and Rx) (158)
1.2.3 Maintain Rx only (590)
1.2.4 Oppose drug product in any form (147)
1.3 Specific comments about other drug product (9)
2 Comments unrelated to specific questions asked in FR notice - FDA’s general rulemaking process (2470)
2.1 Comments on time, manner, and nature of rulemaking process (5999)
2.2 Support ANPRM request for comments (12)
2.3 Oppose ANPRM request for comments (473)
3 Should FDA initiate a rulemaking regarding its interpretation of section 503(b)? [ANPRM Q 1.A.] (0)
3.1 Yes (199)
3.2 No (249)
3.3 FD&C Act and Amendments (2)
3.3.1 FD&C Act requires rulemaking (1)
3.3.2 FD&C Act is clear regarding when a drug should be prescription only (18)
3.3.3 Other arguments related to FD&C Act (17)
3.4 Administrative Procedure Act (APA) arguments (4)
3.5 Supplemental New Drug Application (SNDA) and New Drug Application (NDA) regulations (0)
3.5.1 SNDA/NDA regulatory arguments supporting rulemaking (1)
3.5.2 SNDA/NDA regulatory arguments opposing rulemaking (3)
3.6 Court opinion legal arguments (0)
3.6.1 Court case arguments supporting a rulemaking (1)
3.6.2 Court case arguments opposing a rulemaking (2)
3.7 Other legal arguments (0)
3.7.1 Other legal arguments supporting rulemaking (4)
3.7.2 Other legal arguments opposing rulemaking (4)
3.8 Policy arguments (0)
3.8.1 Rulemaking will improve future FDA decisions (clarity, consistency, efficiency) (27)
3.8.2 Two-class system (OTC and Rx) not sufficient/behind-the-counter approach (13)
3.8.3 Other policy arguments for initiating a rulemaking (26)
3.8.4 Interpretation is clear in present form (25)
3.8.5 Circumstances for OTC safety are case-specific (17)
3.8.6 Develop/update guidance as alternative for rulemaking (2)
3.8.7 Cost-benefit concerns regarding rulemaking (8)
3.8.8 Other policy arguments opposing a rulemaking (26)
3.9 Examples of previous FDA actions in allowing simultaneous marketing of Rx and OTC products (0)
3.9.1 Drug approval examples (46)
3.9.2 FDA guidance/other docs (e.g., 1999 Manual of Policy and Procedures) (1)
3.9.3 Veterinary drug policy (1)
3.9.4 Other examples (2)
3.10 Examples of FDA actions disallowing simultaneous marketing (3)
3.11 Miscellaneous arguments/discussions (9)
4 Is there significant confusion regarding interpretation of section 503(b) of the act? [ANPRM Q 1.B.] (0)
4.1 Yes (181)
4.2 No (135)
4.3 Arguments supporting significant confusion regarding FDA’s interpretation (0)
4.3.1 FDA’s interpretation of FD&C Act 505(b)(2) conflicts with interpretation of 503(b) (1)
4.3.2 Diverse industry and public opinion/reaction to ANPRM and statements re: FDA’s authority (9)
4.3.3 Other legal arguments/conclusions supporting confusion re: FDA’s interpretation (6)
4.3.4 Other policy arguments/statements supporting confusion re: FDA’s interpretation (20)
4.4 Arguments indicating that little or no confusion exists (0)
4.4.1 Legal arguments that little or no confusion exists (5)
4.4.2 Policy arguments that little or no confusion exists (15)
4.5 Miscellaneous arguments/discussions (14)
5 Would rulemaking for clarification dispel confusion? [ANPRM Q 1.C.] (6)
5.1 Yes (104)
5.2 No (141)
5.3 Arguments that support concept that a rulemaking would provide clarification (0)
5.3.1 Legal arguments supporting rulemaking to dispel confusion (4)
5.3.2 Policy arguments supporting rulemaking to dispel confusion (17)
5.4 Arguments that a rulemaking would not provide clarification (0)
5.4.1 Legal arguments that rulemaking would not clarify (2)
5.4.2 Policy arguments that rulemaking would not clarify (1)
5.4.2.1 Guidance instead of rulemaking (0)
5.4.2.2 Other policy arguments (8)
5.4.3 There is no confusion, therefore rulemaking unnecessary (10)
5.5 Miscellaneous arguments/discussions (17)
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.] (0)
6.1 Yes (174)
6.2 No (193)
6.3 Legal/policy arguments that support/detail FDA’s authority to enforce limitation on availability of OTC products by sub-population (0)
6.3.1 FD&C Act (6)
6.3.2 No laws prevent the policy (3)
6.3.3 Court cases (0)
6.3.4 Age limitations are in line with other meaningful differences (10)
6.3.5 Other legal/policy arguments (16)
6.4 Examples/precedents that support/detail FDA’s authority to enforce limitation by sub-population (0)
6.4.1 Nicotine replacement therapy (e.g., Nicorette) (78)
6.4.2 Other examples (1)
6.5 Legal/policy arguments FDA does not have authority to enforce the limitation (0)
6.5.1 FDA’s authority limited to drug safety, effectiveness/efficacy, and labeling (94)
6.5.2 Other FD&C Act arguments (3)
6.5.3 Court cases (5)
6.5.4 Other arguments (35)
6.6 Authority of other entities to enforce the limitation (0)
6.6.1 State and local agencies have authority to enforce point-of-sale (e.g., recent limitations on cold medicines) (36)
6.6.2 Congress (5)
6.6.3 Alcohol and tobacco enforcement (204)
6.6.4 Other entities (3)
6.7 Miscellaneous arguments/discussions (14)
7 Would FDA be able to enforce limitation to sub-population as practical matter? [ANPRM Q 2.B.] (0)
7.1 Yes (149)
7.2 No (192)
7.3 Actions FDA could take in order to enforce limitation of an OTC product to a sub-population (0)
7.3.1 Regulate product sponsor (1)
7.3.1.1 Require sales restrictions as condition for approval (e.g., restrict sales to entities that are licensed pharmacies) (17)
7.3.1.2 Require retailer, pharmacist, and consumer education programs (8)
7.3.1.3 Require risk management program (2)
7.3.1.4 Other product approval conditions (3)
7.3.2 Other FDA enforcement practices that it has the legal authority to put in place (6)
7.4 Other point-of-sale enforcement suggestions (1)
7.4.1 Implement “behind-the-counter” system (pharmacist distributed) (92)
7.4.2 Involve other authorities (e.g., states, state boards of pharmacies) (7)
7.4.3 Monitor compliance and enforcement / conduct random inspections (16)
7.4.4 Require identification for age (152)
7.4.5 Pursue criminal actions against violators (22)
7.4.6 Other actions (31)
7.5 FDA will be unable or it will be difficult to enforce as a practical matter (0)
7.5.1 FDA does not have authority to enforce limitation, therefore it cannot enforce as a practical matter (6)
7.5.2 Infrastructure for FDA enforcement (e.g., resources, personnel, training, monitoring, third-party regulations) not in place (18)
7.5.3 Actual compliance will be difficult/impossible/burdensome to achieve (165)
7.5.4 Other arguments (13)
7.6 Miscellaneous arguments/discussions (10)
8 Assuming legal to market both, may the prescription (Rx) and OTC products be legally sold in the same package? [ANPRM Q 3.A.] (0)
8.1 Yes (183)
8.2 No (152)
8.3 Legal arguments supporting one package label for Rx and OTC sales (0)
8.3.1 FD&C Act arguments (e.g., single label could be created that satisfies both sets of statutory requirements) (14)
8.3.2 Do not need separate National Drug Code (NDC) numbers (1)
8.3.3 Court cases (0)
8.3.4 Other legal arguments supporting one package label (6)
8.4 Policy arguments supporting one package label for Rx and OTC sales (0)
8.4.1 Other policy arguments supporting one package label (28)
8.5 Legal arguments opposing one package for Rx and OTC sales (5)
8.5.1 FD&C Act - Legal differences between statutory requirements for Rx and OTC (7)
8.5.2 Court cases arguments opposing one package (0)
8.5.3 Need separate National Drug Code (NDC) numbers for billing (3)
8.5.4 Other legal arguments opposing one package (8)
8.6 Policy arguments opposing one package for Rx and OTC sales (3)
8.6.1 Single package contrary to meaningful difference standard (2)
8.6.2 Risk of medication errors or threats to patient safety (26)
8.6.3 Same packaging permits/encourages trading/swapping (7)
8.6.4 Other arguments opposing one package (24)
8.7 Examples of Rx and OTC labeling that is similar but with one or two differences – e.g., dosage/age distinction (10)
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 (9)
8.9 Miscellaneous arguments/discussions (21)
9 If they can be legally sold in same package, under what circumstances would it be inappropriate to do so? [ANPRM Q 3.B.] (0)
9.1 Circumstances in which it is inappropriate to distribute products in a single package (0)
9.1.1 Specific circumstances (66)
9.1.2 All circumstances (i.e., it’s always inappropriate) (73)
9.2 Circumstance in which it is appropriate to distribute in single package (0)
9.2.1 Specific circumstances (13)
9.2.2 All circumstances (i.e., it’s always appropriate, there are no inappropriate circumstances) (222)
9.3 Miscellaneous arguments/discussions (12)
10 Studies/data provided in comment (22)
11 Other miscellaneous comments unrelated to specific questions asked in FR notice (1)