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Executive Summary

FDA ANTI-VIRAL DRUGS DIVISION DIRECTOR IS DAVID FEIGAL, MD, who will assume his new position by Jan. 1, 1992. Feigal will fill the vacancy at the head of the Division of Anti-Viral Drug Products left by the departure of Ellen Cooper, MD, last December. Feigal, 42, is currently an associate professor of medicine at the University of California at San Diego Medical Center. Cooper was the first director of the anti-virals division. Cooper cited frustration with the position as her reason for requesting a transfer ("The Pink Sheet" Dec. 24, 1990, In Brief). She moved to the Center for Biologics Evaluation and Research as deputy director of Biological Product Review in February. Feigal worked with Cooper as a member of the Antiviral Drugs Advisory Committee. He joined the committee at its inception in March 1989. It was Feigal who suggested "conditional" approval for Bristol-Myers Squibbs' AIDS drug Videx (ddI) at the July 18-19 meeting of the advisory committee ("The Pink Sheet" July 22, p. 3). Videx is reportedly close to approval. FDA Commissioner Kessler commented during an appearance on Larry King's syndicated radio show Aug. 29 that the agency might act "within the next month or so" on ddI ("The Pink Sheet" Sept. 2, In Brief). The advisory committee recommended ddI for approval in the treatment of adults and children with AIDS who are intolerant or resistant to Burroughs Wellcome's Retrovir (AZT). The discussions on ddI approval now are believed to be centered on whether patients will be required to have tried AZT before being switched to ddI. The approved indication could affect patients' ability to qualify for reimbursement for the drug (see related story, p.8). The controversy surrounding ddI is evidence of the pressure that Feigal will face as director of the division. In addition to using conditional approvals, Feigal has suggested that labeling be used as a corrective tool post-approval to limit the use of those drugs when post-marketing studies show them to be toxic in certain situations. Feigal graduated from the the University of Minnesota in 1972 with a BA in psychology, received his MD from Stanford University in 1976 and was awarded an MPH in epidemiology from the University of California at Berkeley in 1983. Feigal has been at San Diego since 1989. FDA Center for Drug Evaluation and Research Director Carl Peck, MD, announced Feigal's appointment in his testimony before Rep. Dingell's (D-Mich.) House Energy & Commerce/Oversight Subcommittee on Sept. 12. Feigal expressed interest in the job by responding to a search initiated by Peck in January ("The Pink Sheet" Feb. 18, In Brief).

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