Ombudsman’s Annual Report for
2004
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. 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 on FDA Advisory
Committee members, direct-to-consumer prescription drug advertising,
on whether the Agency should approve or not approve drug specific
therapies, and unwanted e-mail promotion by on-line pharmacies. The
hot topics of 2004 were:
-
FDA’s
enforcement against importing drugs from Canada,
-
CDER’s
non-approval of over-the-counter sales of Plan B, and
-
CDER’s drug
safety monitoring program and related testimony before Congress.
Further,
numerous consumers have commented on the association of SSRI
anti-depressants such as Paxil, Prozac, Zoloft, and Effexor with
suicide and suicidal ideation, and addiction. Of the approximate
1,950 people who contacted the office, more than half were via the
e-mail account
Ombudsman@cder.fda.gov. Approximately 250 of these were forwarded to CDER’s “druginfo”
account maintained by the CDER Office of Training and
Communications, Division of Drug Information. The Ombudsman’s
office received approximately 800 specific issue contacts by
telephone.
The Ombudsman’s
office handled the following types of cases and allegations:
- Review/drug
development delay
- Unfair
handling of an issue
- FOI backlog
- Docket
posting dispute
- User fees
dispute
-
Management/employee disagreement
- NDA Priority
designation dispute
- Perceived
retaliation by FDA staff
-
Repackaging/expiration dating disputeImport/Export
issues
- Improper
relationship between regulated Industry and FDA staff
- Unethical
clinical research conduct
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 now 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 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 67 of these requests in
2004. A 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.
http://www.fda.gov/cder/mapp/4151.2.pdf
The Ombudsman’s
office is the initial contact for this dispute resolution. 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.
And lastly,
when sponsors believe their combination product application may not
be acted on by the lead Center’s action date, they may contact the
Office of Combination Products. That Office contacts the Center
Ombudsman’s offices to resolve these issues at the Center level.
http://www.fda.gov/oc/combination/dispute.html
The Ombudsman’s
office conducted outreach to explain the Ombudsman’s functions
including product jurisdiction and dispute resolution at several
venues including the Drug Information Association, the Food and Drug
Law Institute, CDER New Drug review divisions, and the CDER New
Reviewer’s Workshop.
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.
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Date created: April 25, 2005 |