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Executive Summary

FDA COMMISSIONER SEARCH AD HOC ADVISORY GROUP has reportedly presented Assistant Secretary for Health James Mason with a short list of four names for further consideration. Acting Commissioner James Benson is one of the recommended finalists from a three-month search and review of prospective candidates by a group of 12 consultants. The ad hoc committee, appointed in mid-April, represented a wide range of FDA constituencies. The group met about three times, most recently on June 14. Benson is the only non-MD among the remaining candidates suggested to Mason. As a group, they are relatively young and have held previous positions with unusual visibility and exposure to some of the tough policy issues associated with the top FDA post. All of the candidates appear to have strong political credentials for the Bush Administration. The others are: David Kessler, 39, medical director of the Albert Einstein College of Medicine and formerly a top health aide to Sen. Hatch (R-Utah). Kessler has his MD from Harvard, a law degree from the University of Chicago and his undergraduate degree from Amherst. He has stayed closely involved with FDA issues as a member of the ongoing Edwards "Blue Ribbon" panel review of the FDA mission and resource requirements. The combination of support from Hatch and his affiliation with the Edwards panel are solid credentials for the FDA job at this point. Kenneth W. Kizer, 39, director of the California Department of Health Services and an associate clinical professor at UC-Davis. As head of Medi-Cal, Kizer has been initiated into the debate on state purchasing of pharmaceuticals. He was the top state official at the acceptance of the Merck "best price" discount offer on June 18 (see related story p. 5). Kizer is a Californian with a BS from Stanford, an MPH degree from UCLA and an MD from UCLA. June Osborn, 53, dean of the School of Public Health, University of Michigan and professor of pediatrics and communicable diseases at the University of Michigan Medical School. Osborn, an MD from Case Western with an undergraduate degree from Oberlin, has been active in Washington in recent years on AIDS issues and is currently the chairperson of the National Commission on AIDS. In that position, she has had contact with the White House, once in a small Oval Office meeting with President Bush on March 28 and through a report prepared for the White House in December of last year. The AIDS Commission report was complimentary of FDA's attempt to modify clinical trial procedures to handle AIDS drug development but was more critical of the delivery of products after approval. Osborn has also been active in National Institutes of Health discussions of vaccines and she appeared as a witness at a hearing before Rep. Waxman's House Health Subcommittee in 1987 on health messages and advertising related to AIDS, especially condoms. Benson has a number of top-level options at FDA if he does not get the nod to accede to the job on a permanent basis. His options were increased on June 18 when John Villforth, the director of the agency's medical devices regulatory effort since 1982 announced his resignation to join the Food & Drug Law Institute as executive director. Benson, who was Villforth's top aide prior to moving to the Deputy Commissioner slot under FDA Com. Young, now would appear to have two attractive choices to stay with the agency if a new commissioner is chosen from the outside. Benson could step back either to the deputy commissioner position or to head the Center for Devices and Radiological Health.

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