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Executive Summary

FDA BLUE RIBBON COMMISSION: DESPERATELY SEEKING CHAIRMAN as at least one choice has recently declined the position. While HHS had expected to announce the members of the panel in January, the department has still not decided on a chairman, which is holding up appointment of the other panel members. HHS Secretary Sullivan on Dec. 12 announced formation of the panel to "examine the mission, responsibilities and structure of the FDA in order to make recommendations on how the FDA can be strengthened to benefit the public health" ("The Pink Sheet" Dec. 18, p. 4). Donald Rumsfeld, the former Nixon/Ford senior government official and chairman/CEO of Searle, was the latest candidate reported to have been under consideration for the chairmanship. However, Rumsfeld says he will not participate in the advisory group. Rumsfeld is a senior advisor to the William Blair & Co. investment firm. Rumsfeld reportedly met with Sullivan at one point to discuss the position. As with any special commission, HHS may be having trouble convincing prospective chairmen of the ultimate effectiveness of the advisory group and more specifically, of the extent of HHS' commitment to the group. Selection of a well-known political figure -- like a former Secretary of Defense -- to head the panel, would also raise the issue of how much latitude the chairman should have in selecting panel members. Names circulating as prospective panel members include one current drug company exec, Roche President Irwin Lerner. As chairman of a five year-old PMA special board committee on FDA, Lerner has been closely involved in looking at ways of improving agency activities with regard to new drug review. Lerner is also reportedly one of the few industry execs who is favorably inclined toward user fees. Some Washington observers believe that a positive attitude toward user fees is a key quality being looked for in prospective commission members. Another name reportedly under consideration for the panel is former FDA Commissioner Charles Edwards. The president of the Scripps Clinic and Research Foundation was recently approached as a possible interim successor to former FDA Commissioner Young. Former FDA Associate Commissioner for Regulatory Affairs John Taylor, who retired from the agency in July, has also been mentioned as a candidate. Other names that have been circulating include: former HHS Senior Health Policy Advisor Jane Delgado, now president of the National Coalition of Hispanic Health and Human Services; Bruce Silverglade, director of the Center for Science in the Public Interest; former Health Industry Manufacturers Association President Frank Samuel; and David Kessler, medical director of the Jack D. Weiler Hospital of the Albert Einstein School of Medicine and former staffer to Sen. Hatch (R-Utah), from 1981 to 1984.

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