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Ombudsman’s Annual Report for
2005
FDA, Center for Drug Evaluation and Research
The CDER Ombudsman’s office serves as a portal for consumers,
regulated industry, and small business to access CDER to, among
other things, comment on CDER programs and actions, get drug
development and formal and informal dispute resolution information,
obtain general information on drug regulation, and report adverse
drug experiences. Industry, drug and device consultants contacted
the office more often than consumers, and of those “industry”
contacts, about a third related to jurisdictional and drug
development assistance. As in previous years, several people
contacted the office to report irregularities and possible fraud in
conducting and reporting clinical trials, in manufacture’s
promotional activities, and violations in pharmaceutical
manufacturing. Several hundred people contacted the office to
express their opinions urging the Agency to approve some drug
therapies, and to disapprove or rescind the approval of other drug
therapies. It is interesting that consumers commented less in 2005,
than in 2004 on direct-to-consumer prescription drug advertising,
and less on FDA Advisory Committee members.
Some hot topics of 2005 with consumers were the same as in 2004:
FDA’s enforcement against importing drugs from Canada*, and
CDER’s non-approval of over-the-counter sales of Plan B**.
Consumers have definitely made the Internet their primary method of
communication. We received many times more e-mails than telephone
contacts on various issues. Numerous consumers requested assistance
in reporting drug adverse events, and others commented on the high
cost of medication, inconsistence in color and shape between generic
brands of prescription drugs, the necessity to increase the size of
OTC labeling, the loss of Vioxx, Bextra, and Paladone from the
market, abuse of oxycodone, Dr. Susan Wood’s and Dr. Lester
Crawford’s departure from FDA, and the politicizing of FDA.
The Ombudsman’s office handled the following types of cases and
allegations:
- Unethical clinical research conduct including institutional
review board issues
- Violative conduct by pharmaceutical companies (whistle
blowers)
- Review/drug development delay
- Unfair handling of an issue
- FOI backlog
- Management/employee disagreement
- Citizen Petition delays and advice
- Incorrect advice provided to Industry by FDA staff, and
- Import/Export issues.
The CDER Ombudsman serves as the Center’s jurisdiction officer.
Many times it is not readily apparent where proposed products
(especially combination products such as a drug with a device) will
be reviewed and regulated within the Agency or in the Center. The
intracenter jurisdictional issues are coordinated in the FDA’s
Office of Combination Products (OCP). If a sponsor is not clear how
and where a new product will be regulated, they may contact a Center
jurisdiction officer or the OCP. The CDER Ombudsman’s office
responded to more than 200 informal jurisdiction questions that
helped guide product development. If the regulatory assignment is
not readily apparent, the sponsor may submit to FDA a Request for
Designation as defined in 21 CFR 3.7. The Agency received 41 of
these requests in 2005. A large majority of these were combinations
of drugs-devices.
The Ombudsman’s office also is a contact for informal dispute
resolution. In November 2004, the Center developed a pilot program
“Documenting Differing Professional Opinions and Dispute Resolution”
where CDER reviewers are provided a forum to discuss and resolve
differing professional opinions at the Center Director level.
www.fda.gov/cder/mapp/4151.2.pdf We did not review any disputes
under this pilot program in 2005.
The Ombudsman’s office is also the contact for informal dispute
resolution for sponsors and investigators regarding the procedural
issues relating to the review of INDs and NDAs.
The CDER Ombudsman’s office conducted outreach to explain the
Ombudsman’s functions including product jurisdiction and dispute
resolution at several venues including the Generic Pharmaceutical
Manufacturer’s Association, CDER New Drug review divisions, CDER
International Forum, and the CDER New Reviewer’s Workshops.
The CDER Ombudsman’s office reports to the Director of the Center
Director’s Office of Executive Programs. The Ombudsman is a member
of the Coalition of Federal Ombudsmen, and the American Association
of Ombudsmen.
* For information on the importation of prescription drugs from
other countries please see:
http://www.fda.gov/cder/Offices/DDI/faq.htm#1
** Plan B is emergency contraception, a backup method to birth
control. It is in the form of two levonorgestrel pills (0.75 mg in
each pill) that are taken by mouth after unprotected sex.
Levonorgestrel is a synthetic hormone used in birth control pills
for over 35 years. Plan B can reduce a woman’s risk of pregnancy
when taken as directed if she has had unprotected sex. Plan B
contains only progestin, levonorgestrel, a synthetic hormone used in
birth control pills for over 35 years. It is currently available
only by prescription. For further information see:
http://www.fda.gov/cder/drug/infopage/planB/planBQandA.htm
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Date created: April 27, 2006 |
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