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Executive Summary

FDA GENERIC DRUGS ADVISORY COMMITTEE: STANFORD's TERENCE BLASCHKE, MD, will be the first chair of the 13-person group of advisors. Blaschke is currently chief of the Division of Clinical Pharmacology at Stanford University. He has been associated with the university since 1974. During his academic training, Blaschke was a classmate of Carl Peck, MD, the director of FDA's Center for Drug Evaluation & Research, and the new head of FDA's office of generic drugs, Roger Williams, MD. The formation of a Generic Drugs Advisory Committee was announced by the agency in a Feb. 20 Federal Register notice. Last month, HHS Secretary Sullivan forwarded invitations to candidates to serve on the committee. FDA is trying to set a date for the committee's first meeting, sometime before February. Blaschke received his medical degree from Columbia University and served his residency at the University of California at Los Angeles. After a stint at the National Cancer Institute from 1970-72, Blaschke entered a fellowship program at the University of California at San Francisco. Blaschke's training overlapped with Peck and Williams at UCSF. Two other members of the advisory committee have UCSF affiliations: UCSF School of Pharmacy Department of Pharmacy Chair Leslie Benet, PhD, and Associate Professor of Pharmacy Kathleen Giacomini, PhD. Benet has frequently served as an a expert on bioequivalence issues. He is a member of the Generic Pharmaceutical Industry Association's panel on ANDA reform and has served on an FDA special advisory subcommittee on conjugated estrogens ("The Pink Sheet" May 7, p. 7). In 1986, as president of the American Association of Pharmaceutical Scientists, Benet made recommendations at FDA's hearings on bioequivalence issues. Also invited to serve on the committee is American Pharmaceutical Association Senior Directory of Pharmacy Affairs Arthur Kibbe, PhD. Kibbe is currently serving on an FDA panel that is investigating possible incidents of agency retaliation against generic companies that were whistleblowers during the generic drug scandal ("The Pink Sheet" Oct. 1, T&G-1). Other names mentioned as likely members of the FDA committee are William Barr, PhD, Medical College of Virginia; Marvin Meyer, PhD, University of Tennessee College of Pharmacy; and Gordon Amidon, PhD, University of Michigan School of Pharmacy. Meyer and Amidon served on FDA's special advisory subcommittee on conjugated estrogens. Barr and Meyer were involved in FDA's 1986 bioequivalence hearing. FDA has indicated that one of the first questions that it will take to the advisory committee will be the issues surrounding generic conjugated estrogens and FDA's requirement that those products show rate of absorption equivalent to the brand. Another issue which FDA has said it will present to the committee for consideration is the agency's scale-up policy ("The Pink Sheet" Sept. 17, T&G-8).

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