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Executive Summary

The OTC Drugs Advisory Committee's review of alcohol use in systemic OTCs on Dec. 17 will include scientific presentations from six members of the advisory committee, Michael Weintraub, MD, consultant to FDA's Office of OTC Drug Evaluation, told the Food & Drug Law Institute's annual education conference Dec. 9 in Washington. Weintraub reported that on the second day of the Dec. 16-17 inaugural meeting of the OTC advisory committee that "six of the ten advisory committee members will actually be presenting short scientific presentations on different topics concerning alcohol in OTC medications." In addition, he noted that a member of another advisory committee is preparing a video presentation to the OTC committee on the subject. "This represents a general principle" of the new advisory committee, Weintraub added. "We will be inviting people from other FDA advisory committees to sit in with us and offer us their counsel and viewpoint." In explaining FDA's choice for the first substantive topic to be reviewed by the new committee, Weintraub called the subject of alcohol use in OTCs "a classic advisory committee issue." The alcohol issue "is important, it's relatively controversial [and] we do need scientific advice...and good judgment," Weintraub added. He noted that the alcohol issue has been "hanging around for a number of years" and that the American Academy of Pediatrics published a report on the subject in the early 1980s. Since that time, Weintraub pointed out, "there have been a number of changes in the technology of formulation of OTC medications and in the marketplace, so we felt that this was a good time to air all sides of this issue and solicit advice from our advisory committee as well as to make sure that...people with an interest in this area would have a chance to discuss their viewpoints." The agenda for the OTC advisory committee's first meeting includes an orientation day on Dec. 16 and a committee discussion of the alcohol issue on Dec. 17. During the orientation, the committee will hear presentations from FDA staff and from a number of pharmacy, medical, consumer and industry groups, including the Nonprescription Drug Manufacturers Association. The NDMA presenters will likely include association Senior VP-Science & Technology William Soller, PhD, former FDA Commissioner Arthur Hayes, MD, now vice chairman and president of MediScience Associates, and NDMA outside counsel Peter Hutt, from the law firm Covington & Burling. Also, on Dec. 16, the committee is scheduled to meet for an hour in closed session to hear proprietary information about ongoing Rx-to-OTC switches. [Editor's Note: A videotape recording of the OTC Drug Advisory Committee meeting will be available from F-D-C Reports within a few days of the meeting. Contact Amy Burd at (301) 657-9830, Ext. 263.] FDA currently has "more than 20" Rx-to-OTC switch requests "in various stages within the agency," Weintraub said. He also updated the FDLI meeting on the agency's progress in the OTC monograph process. He pointed out that the antihistamine final monograph appeared Dec. 9 (see following story) and indicated that the OTC diaper rash final rules will be out in a few days. Weintraub will formally assume leadership responsibility for the Office of OTC Drug Evaluation on Dec. 14. He has been working with the OTC office in an informal capacity for about a year and may be named acting director of the office once certain details in his contract with the University of Rochester, where he is on the teaching staff, are worked out. Paula Botstein, who has been the acting director of the OTC office, is moving on to direct the Medical Imaging, Surgical and Dental Drugs Division part time. In addition, Weintraub outlined the organizational structure of the OTC office, which will include three divisions: monograph review staff; OTC drug policy staff and medical review staff. He noted that FDA is looking to hire two physicians for the medical review staff and recently ran ads in the Dec. 2 issue of the Journal of the American Medical Association and the Dec. 3 issue of the The New England Journal of Medicine announcing the openings. The Office of OTC Drug Evaluation has expanded from 20 FTEs (full-time equivalents) in fiscal 1991 to 34 FTEs at present and is authorized to grow to 40 FTEs, Weintraub said.

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