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Executive Summary

FDA GENERIC DRUGS ADVISORY COMMITTEE's FIRST MEETING DEC. 14 will focus on broad issues related to the agency's regulation of generic drugs and the current status of the generic drug industry. An FDA memorandum states that the committee will discuss: "an overview of generic drugs at FDA, the generic drug industry and the future of generic drugs, FDA compliance issues, bioequivalence of older drug products, research opportunity, and legal review." The memo notes that the agency is giving less than 15 days public notice of the meeting "because of the need to initiate the work of the newly formed committee in a timely fashion." The meeting will be held at the Holiday Inn, Versailles Room, 8120 Wisconsin Ave., Bethesda, Maryland, and is scheduled to begin that Friday at 8 a.m. FDA said that the next regular meeting of the committee "will be scheduled in the near future." One of the first specific issues that the committee may take up is FDA's requirement that generic conjugated estrogens products show rates of absorption equivalent to the brandname product. The agency announced the creation of the advisory committee in a Feb. 20 Federal Register notice. Last month, Department of Health and Human Services Secretary Sullivan mailed invitations to candidates to serve on the panel. Some individuals have publicly announced that they are on the panel, including committee chair Terrence Blaschke, MD, chief of the Division of Clinical Pharmacology at Stanford University ("The Pink Sheet" Nov. 12, T&G-9). During a fellowship program at the University of California at San Francisco, Blaschke was a classmate of FDA Center for Drug Evaluation and Research Director Carl Peck, MD, and the new director of the Office of Generic Drugs, Roger Williams, MD. Two other committee members have UCSF affiliations: UCSF School of Pharmacy, Department of Pharmacy Chair Leslie Benet, PhD, and Associate Professor of Pharmacy Kathleen Giacomini, PhD. Benet was a member of the Generic Pharmaceutical Association's "blue ribbon" panel on generic drugs and served on a special advisory subcommittee on conjugated estrogens. American Pharmaceutical Association Senior Director of Pharmacy Affairs Arthur Kibbe, PhD, has agreed to sit on the committee. He is also serving on an FDA panel looking into possible agency retaliation against generic firms that were whistleblowers in the generic drug scandal. Former American Association of Retired Persons Health Analyst Judith Brown will also serve on the committee. According to the committee roster released Nov. 30, the seven other members are: Gordon Amidon, PhD, professor of pharmaceutics, University of Michigan College of Pharmacy; Win Chiou, PhD, professor of pharmacokinetics, University of Illinois (Chicago), School of Pharmacy; Barbara Hayes, PhD, associate professor of pharmacology, Texas Southern University College of Pharmacy and Health Sciences; Kathleen Lamborn, PhD, assistant director, Biostatistical Consulting Shared Resource, Northern California Cancer Center (Belmont); Thomas Ludden, PhD, professor of pharmacology, University of Texas (San Antonio) Health Science Center; John Rodman, PharmD, associate member and vice chairman, Pharmaceutical Division, St. Jude Children's Research Hospital, Memphis; and Ralph Shangraw, PhD, professor and chairman, Department of Pharmaceutics, University of Maryland School of Pharmacy. Amidon served on the advisory subcommittee that discussed conjugated estrogen issues. Shangraw has served as chairman of U.S. Pharmacopeia's Excipient Subcommittee and on USP's Committee of Revision. He was also on the search committee that chose Jerome Halperin to become USP's executive director.

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