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Center for
Drug Evaluation and Research Ombudsman’s
Annual Report for 2003
The CDER Ombudsman’s office in
2003 changed management with the retirement of James Morrison in
January and the subsequent hiring of Warren Rumble. The overall
tenor of the office did not change. The office serves as a
portal for consumers, regulated industry, and small business to
access CDER to, among other things, comment on CDER programs,
get drug development and FDA Center jurisdictional advice,
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, promotional activities, as well as
violations in pharmaceutical manufacturing. Several hundred
people contacted the office to express their opinions on FDA
Advisory Committee members, on whether the Agency should approve
or not approve drug specific therapies, unwanted e-mail
promotion by on-line pharmacies, and the topic of the year was
FDA’s enforcement against importing drugs from Canada. The newly
instituted e-mail account
ombudsman@cder.fda.gov
has become the preferred method of contacting the Center with
over 1500 contacts. Approximately 570 of these were forwarded to
CDER’s “druginfo” account maintained by the CDER Office of
Training and Communications. The Ombudsman’s office received
approximately 400 specific issue contacts by telephone.
The
Ombudsman’s office handled the following types of cases:
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Review/drug development delay
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Freedom of Information access
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Docket posting dispute
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User fees dispute
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Intellectual property dispute
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Management/employee disagreement
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NDA Priority designation dispute
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Perceived retaliation complaint
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Repackaging/expiration dating dispute
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Import/Export issues
The
CDER Ombudsman serves as the Center’s jurisdiction officer. Many times
it is not readily apparent where proposed products will be reviewed
and regulated within the Center and between Centers. The intracenter
jurisdictional issues are now coordinated in the FDA’s newly formed
Office of Combination Products. If a sponsor is not clear how and
where a new product will be regulated, it may submit to FDA a Request
for Designation as defined in 21 CFR 3.7. The Agency received 35 of
these requests in 2003. Most of these were combinations of
drugs-devices, drug-biologics, or biologics-devices.
Congress created the FDA’s Office of Combination Products (OCP) on
December 24, 2002, and mandated that the new Office should define or
clarify regulations in the area of combination products such as:
Primary Mode of Action, Single-separate Applications, User Fees, and
cGMP. The Office created a Steering Committee that included
representation from CDER, CDRH, CBER, OCP, and Office of Chief Counsel
to advise the new Office on various regulatory activities. The CDER
jurisdiction officer was instrumental in the activities of several of
the initiatives of the OCP including the Steering Committee, and the
Primary Mode of Action, and Single-separate Applications working
groups.
The
CDER Ombudsman is also a member of the working group for the
Commissioner’s initiative in the area of novel drug delivery systems,
and in the Agency’s dispute resolution processes.
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Date created: January 9, 2004 |
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