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Ombudsman’s Annual Report for
2004 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:
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:
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. Date created: April 25, 2005 |
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