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Center for
Drug Evaluation and Research Ombudsman’s 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:
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. Date created: January 9, 2004 |
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