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Executive Summary

NDMA NOMINEES FOR FDA's OTC DRUGS ADVISORY COMMITTEE include University of Tennessee Dermatology Chairman E. William Rosenberg, MD, who has previous FDA advisory committee experience. Rosenberg chaired the agency's OTC Antiperspirant Drugs Panel from 1974 to 1978. The Nonprescription Drug Manufacturers Association in Nov. 8 and Oct. 24 letters to FDA nominated 16 educators, including 11 physicians and five professors with PhD or PharmD degrees. NDMA told FDA that each of the nominees "would be interested and pleased to serve" on the committee. In a Sept. 24 Federal Register notice, FDA requested nominations for six voting members and one non-voting industry representative to serve on the new committee ("The Pink Sheet" Sept. 30, In Brief). NDMA nominated former Warner-Lambert Consumer Products R&D President Edward Marlowe, PhD, to serve as the panel's non-voting industry liaison. Marlowe, who retired from the company earlier this year, served on NDMA's Scientific Affairs Committee for 15 years. In a Nov. 8 letter to FDA, NDMA recommended expanding the committee to 11 voting members. The association also urged inclusion of pediatricians on the panel; NDMA nominated three. In addition, it objected to inclusion of a voting consumer representative ("The Pink Sheet" Nov. 18, T&G-1). Besides Rosenberg, physicians nominated by NDMA to serve as voting members of the panel are University of Rochester Medical Professor John Baum, MD; Emory University Medical Professor (Gynecology and Obstetrics Department) Elizabeth Connell, MD; Constantine Falliers, MD, from Children's Asthma Research Institute in Denver; University of Medicine and Dentistry of New Jersey Pediatrics Professor Marvin Gottlieb, MD/PhD; University of Virginia Medical Professor Jack Gwaltney, MD; Wayne State University Pediatrics Professor Ralph Kauffman, MD; Howard University Dermatology Professor John Kinney, MD; University of Utah Pharmacology and Toxicology Professor Douglas Rollins, MD/PhD; Duke University Assistant Professor of Pediatrics James Still, MD/PhD; and Donald Vickery, MD, family medicine professor at Medical College of Virginia and Georgetown University. The remaining NDMA nominees are University of Colorado Pharmacology Professor Glenn Appelt, PhD; University of Wisconsin's Health Sciences Center Pharmacology Professor Paul Bass, PhD; St. John's University Pharmacy Dean Albert Belmonte, PhD; University of Tennessee Pediatric Pharmacokinetics & Therapeutics Center Director William Evans; and University of Utah Pharmacy Practice Associate Professor Joseph Veltri. During a 1982 NDMA symposium on the transfer of drugs from prescription to OTC status, Rosenberg maintained that limitations on consumers' ability to self-diagnose should "not be a boundary" to self-medication. "There are a number of chronic diseases which admittedly need to be diagnosed by a professional, but which, once having been diagnosed, can be managed to a greater or lesser degree by the patient himself," he argued then. Rosenberg noted FDA's preamble to a March 1982 recommendation by an OTC advisory panel for use of antifungals to treat vaginal itching. He took issue with the agency's rejection of the recommendation on the grounds that treating the itch without knowing the underlying cause which may require medical attention. His discussion foreshadowed FDA's 1990 Rx-to-OTC switch of Schering-Plough's Gyne-Lotrimin and Ortho's Monistat-7 by eight years. Vickery, who also spoke at the NDMA symposium, asserted that a majority of physicians consider "at least 25%" of patient visits involved conditions amenable to self-treatment. Vickery contended then that government and industry should help patients make "appropriate decisions about costs, risks and benefits of drugs."

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