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Executive Summary

FDA Commissioner Kessler is being reappointed on a permanent basis by the Clinton Administration, giving FDA an unusual continuity in contrast to the shake-ups throughout the rest of the federal government. Emerging a survivor of administration transition politics, Kessler accepted HHS Secretary Shalala's Feb. 26 request to remain as commissioner. Kessler's reappointment is a precedent. While Frank Young stayed on as commissioner through the change of two Republican administrations, no FDA commissioner in recent memory has survived a change of party rule and been allowed to continue an ongoing agenda. On the same day that Kessler was asked to stay on, National Institutes of Health Director Bernadine Healy announced her plans to leave June 30. Clinton's decision to keep Kessler and put a new face in at NIH may, in part, reflect the relative popularity of Kessler and Healy with staffs of key Capitol Hill Democrats. FDA-regulated industries can expect a continuation of Kessler's stepped-up enforcement of agency regulations governing manufacturing and promotion of drugs, medical devices and food. User fees also can be expected to remain a top priority. Kessler's successful 1992 negotiation of user fees for drugs and biologics was tied to his promise that the funds would be earmarked exclusively to improve the drug review process and speed up approval times. However, President Clinton's budget plan, which proposes putting increased user fee revenues towards deficit reduction, adds a new twist to the issue. Kessler will have to reconcile FDA's original plans for user fees and commitment to the industry with the revenue-raising desires of the administration (see related story, T&G-2). Kessler's public appearances after the general election have dovetailed with Clinton Administration philosophy. For example, during a speech in January, the commissioner criticized the cost of new drugs and spoke of his agenda for "change," a Clinton buzzword ("The Pink Sheet" Jan. 18, T&G-1). Healy told a Feb. 26 press conference that "over the past two weeks, I have had discussions with the Secretary Shalala...and it was made clear that it would be best for the president to choose the NIH director." Healy will to go back to the Cleveland Clinic Foundation where, she said, "I will write and do some speaking on health administration." Prior to becoming the NIH director in March 1991, Healy served as chair of the research institute at the Cleveland Clinic from November 1985. In a statement following the announcement, HHS Secretary Shalala commended Healy's work as NIH director and noted that she will "be conferring with scientific leaders and the White House to establish a process for the selection of Dr. Healy's successor." Regarding the next four months at NIH, Healy said they "are of critical importance to NIH. I am very pleased and delighted that I will be at [the] helm during that time." In particular, Healy noted that in the "next two weeks we will be announcing the 15 vanguard centers for the Women's Health Initiative." In addition, Healy indicated that the strategic plan "is done and at the printer. I hope that within a month to six weeks you will see it." Healy also suggested that she is "prepared fully to work on the budget." She noted that "I think it is pretty rough for the new NIH director or no director to be there defending the budget, particularly, at this difficult time economically.

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