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FDA’s OTC DRUGS ADVISORY COMMITTEE WILL BE CHAIRED BY RANDY JUHL, PITT UNIVERSITY PHARMACY SCHOOL DEAN; TWO OTHER MEMBERS SERVED ON OTC DRUG PANELS

Executive Summary

FDA's OTC Drugs Advisory committee chairman for the next four years is Randy Juhl, PhD, dean of the School of Pharmacy at the University of Pittsburgh and the current president of the American Pharmaceutical Association's Academy of Pharmaceutical Research and Science. Juhl was nominated to serve on FDA's brand new OTC Drugs Advisory Committee by APhA and the American Association of Colleges of Pharmacy. He is an APhA member and has worked with the pharmacy professional association as a member of APhA's Bioequivalency Working Group, which was created to provide guidance to pharmacists on how to select generic drug products in the wake of the generic investigations ("The Pink Sheet" Jan. 29, 1990, T&G-2). FDA timed its unveiling of the agency's newest advisory committee on Nov. 13 to coincide with the Nonprescription Drug Association's annual Research & Scientific Conference (see story, p. 3). The first meeting of the advisory committee will be on Dec. 16-17. Juhl will head a relatively diverse group for an FDA advisory committee. Among the ten voting members on the committee are six MDs with specialties in dermatology, asthma-allergy, pediatrics, OB-GYN, and pharmacology. In addition, the committee includes another pharmacist who is director of a poison control center, an epidemiologist and a consumer representative. Non-voting members on the panel include an industry representative and two consultants from Canada. Discussing the new advisory committee at the NDMA meeting, FDA consultant and expected-OTC office director Michael Weintraub, MD, noted that committee members "all have international reputations." However, he added, "we don't want specific expertise -- we want judgment." Weintraub explained that the OTC drugs advisory committee "will operate somewhat differently from other FDA committees, although the evolution of all the FDA advisory committees will be in this direction." The OTC committee, he said, "will be more like an NIH committee where individuals will have assignments that they get weeks in advance and will be preparing work on different issues to present to the whole committee." Of the ten voting members, at least two had experience with FDA's OTC review panels during the early years of the monograph process. Elizabeth Connell, MD, professor of obstetrics and gynecology at Emory University School of Medicine, chaired the OTC vaginal drug products panel from 1973 to 1979. In addition, Connell has extensive experience with FDA device panels. She first served on the Obstetrics and Gynecology Advisory Committee from 1970 to 1978. She was a member on FDA's review panel on obstetrical and gynecological devices from 1976 to 1979. More recently, Connell chaired the Obstetrics and Gynecology Devices Panel from 1988 to 1992 and the General and Plastic Surgery Devices Panel from 1991 until earlier this year. In addition, Marie Chanco Turner, MD, a medical officer in the National Cancer Institute's dermatology branch, worked with FDA's OTC Miscelleneous External review panel. Turner also served on FDA's Dermatologic Drugs Advisory Committee from 1982 to 1986 where she participated in the review of OTC hydrocortisone 1%. In addition, she has done consulting work for the OTC division. Turner was nominated to the committee by the American Academy of Dermatology. She currently is chairman of the academy's Task Force on Therapeutics. The other pharmacist on the committee, Joseph Veltri, PharmD, is the director of the Intermountain Regional Poison Control Center in Salt Lake City. Veltri's dealings with the agency include participation in a 1991 FDA public meeting on OTC phenylpropanolamine adverse reaction reports where he provided evidence that ADR rates included in a report to Rep. Wyden (D- Ore.) were significantly overstated ("The Pink Sheet" May 13, 1991, p. 7). At the time, Veltri was a member of the NDMA phenylpropanolamine working party. Veltri, like Connell and Clairol VP-Research Edward Marlowe, PhD, were among the 16 nominees to the committee prepared by NDMA. The other MDs on the committee are: Louis Cantilena, director of the division of clinical pharmacology at the Uniformed Services/University of Health Sciences; Thomas Petty, director of academic and research affairs at Presbyterian St. Luke's Medical Center in Denver, who is an expert on respiratory conditions; Marcus Reidenburg, professor of pharmacology and medicine at New York University-Cornell Medical Center; and Alan Sinaiko, professor of pediatrics and clinical pharmacology at the University of Minnesota. Also with voting status on the committee are Elisa Lee, PhD, co-director of the Center for Epidemiologic Research at the University of Oklahoma, and consumer representative Lorie Rice, assistant dean for professional relations and advancement at the University of California-San Francisco School of Pharmacy, where she has worked under former FDA Commissioner Jere Goyan, PhD, dean of the pharmacy school. Bernard Schachtel, MD, adjunct professor of epidemiology and biostatistics at McGill University in Montreal, is one of the two non-voting consultants on the advisory committee from Canada. Schachtel is a noted epidemiologist with experience in designing OTC safety and efficacy trials as well as epidemiology studies to determine adverse reactions. In 1991, Schachtel was appointed director of McGill's Center for the Evaluation of Nonprescription Medical Products. The other nonvoting consultant is Canadian Bureau of Nonprescription Drugs Chief Brian Gillespie, MD. Speaking at the NDMA meeting, FDA OTC Division Director William Gilbertson indicated that FDA is leaning toward greater use of consultants from other nations on the advisory committee. FDA, he said, "is going to involve our colleagues in Canada and the EC on these matters as consultants."
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