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Executive Summary

FDA Commissioner Young, MD, has the support of at least two diverse politically useful constituencies to retain the top agency job in the incoming Bush Administration. Both the Pharmaceutical Manufacturers Association and the Generic Pharmaceutical Industry Association are openly backing Young for the Republican-to-Republican transition. The two groups are looking for continuity of leadership at FDA as one of their principal interests in the next four years. PMA President Mossinghoff frequently commends Young for his efforts to speed the review of new drugs, and the generic segment of the industry has been generally pleased with FDA implementation of the ANDA provisions of the Waxman/Hatch law under Young. The support of the regulated industries is obviously not the key determinant in whether a top level bureaucrat is a holdover from administration to administration; however, it could play an important role in the Reagan-Bush transition. Because of unusually strong ties between Lilly and the two staffs of President-elect Bush and Vice-President-elect Quayle, a supportive word from PMA could be helpful during the transition. The PMA board chairman for 1988-1989, by coincidence, is Lilly Pharmaceutical Division President Eugene Step. The balancing support of the GPIA group assures that an effort to preserve Young's position at FDA through transition will not be viewed as a potential political liability with the advocates of the generic industry on Capitol Hill. The commissioner's own record of dealing with Bush's staff during the current administration should also weight strongly for his retention. In the last year, for example, Young worked expeditiously with a Bush group to tailor a system for speeding the availability of drugs to treat life-threatening diseases. Prompted by the AIDS epidemic, the initiative quietly and effectively eliminated the subject of AIDS as a possible issue for the presidential campaign. Young worked with Bush's counsel, C. Boyden Gray, on the expedited drug proposal. Gray received one of the first publicly announced appointments in the Bush Transition and Administration as the counselor to the President-elect. In the 1970's, Gray was an attorney with Wilmer, Cutler and Pickering, where one of his specialties was FDA law. Commissioner Young's handling of the Treatment IND regulations in the spring of 1987 also directly helped Bush. The press and Capitol Hill made an effort to tie the quick release of those regs to the Vice President's staff, but Young deftly took the criticism and made changes in the program to make it acceptable to Congress without letting the criticism escalate to a major issue. In Young's four years as commissioner, the agency has completed a full-scale revision of both the investigational new drug and new drug application regulations. PMA has been generally supportive of the emphasis placed in those new regulations on expediting the review and approval of important new drug therapies. Under Young, the average time for the approval of new products now averages about two years, down from an average of about three years in the early part of the decade. Drugs classified 1-A, those considered to be new chemical entities representing important therapeutic gains, frequently are reviewed and approved in even less time. In the OTC area, FDA has recently begun to discuss the first steps for developing a regulatory approach to the post-monograph period of regulation. Continuity there also would seem to be a key interest. The support of the OTC segment also heightened because of personal ties to the new administration. Bristol-Myers Chairman Bruce Gelb was at Andover with Bush for preparatory school and was a major fund-raiser for the vice-president in the current campaign. The commissioner has built his position with the regulated industries through an indefatigable schedule, full of meetings with top managers of drug firms and advocacy groups (such as those representing AIDS patients). In the past year, the commissioner has met privately with contingents from individual drug companies and PMA for general discussions of issues a number of times, including as recently as Nov. 7, election day, at the PMA headquarters. At least once, the commissioner has gone on the road to meet company officials at their headquarters. That trip occurred last October when Young traveled to Indianapolis for a visit to Lilly's home base. Young has also developed a reputation for being scrupulous in his observance of the tight conflict-of-interest rules set on FDA employees. After four years at the head of FDA, Young retains his enthusiasm for the job and is showing no sign of the "burn-out" syndrome that has limited the tenure of his recent predecessors to about two to three years. For example, writing in the Nov. 4 issue of the AAAS Observer published by the American Association for the Advancement of Science, Young characterized his last four years as head of FDA as "the most personally satisfying and professionally productive in my career." In the article, Young called on talented scientists to consider government service, following up on one of his most consistent goals as commissioner, to attract top scientific talent to the agency. Young's Capitol Hill experience could be a particular asset in this transition -- based on the Democratic control of Congress and the new law requiring Congressional approval of the FDA appointment. In his frequent trips to testify before Capitol Hill committees, Young has shown a knack for explaining FDA policies and decisions in an upbeat personal style that minimizes confrontation. One of the most skeptical FDA watchers on Capitol Hill, Daniel Sigelman, a staffer with the House Oversight Committee headed by Rep. Weiss (D-NY), has left for private practice taking away one potential critic. As the current FDA commissioner he would be exempt from the Senate confirmation process required by the new legislation. All other factors being equal, the Bush transition team may want to avoid the chance that a Democratic Senate Labor and Human Resources Committee, chaired by long time agency watchdog Sen. Kennedy (D-Mass.), might reject a new commissioner candidate proposed by the administration. Balancing against the factors of Young's remaining at FDA is the weight of tradition and the unwritten laws of bureaucratic life which dictate that when a new administration takes control, top appointees of the previous government are replaced wholesale. Bush has already stated that he does not intend to be an exception to that rule. In his post-election press conference in Houston, Bush said that although "some people at various levels may be asked to remain," he would "for the most part bring in a brand new team of people from across the country," the better to "reinvigorate the process." Whoever is the FDA commissioner in the Bush Adminstration may begin to get some of the elusive budget increases that the agency is constantly seeking. Sentiment seems to be growing in Congress that the agency is not sufficiently funded to carry out its mission at its current budget level of about $ 450 mil. As part of an addition to an FDA appropriations bill, Congress has already approved one expansion of the agency with possibly major long range implications. Under that legislation, FDA is authorized to set up a biotechnology research demonstration project attached to FDA's existing National Center for Toxicological Research. That could be the first step in establishing a significant biotechnology research center managed by FDA. The question of FDA resources was the subject of preliminary legislation introduced in the last Congress by Sen. Hatch (R-Utah); and Hatch, with Sens. Kennedy, Cochran (R-Miss.) and Burdick (D-ND), have promised that the "FDA Revitalization Act" will be revisited in the next Congress. In October, the four senators requested that the General Accounting Office prepare a comprehensive report on FDA resource needs, noting that "the Congress plans to work during the 101st session to ensure that ]FDA[ can adequately meet the growing demand of this nation's research program." The initiative on FDA resources is also widely supported by the regulated industries. The request to GAO from the Senate, for example, was supported by a newly formed coalition of drug firms and medical specialty groups called the "FDA Council." Merck, Pfizer, Upjohn, Squibb, and Sandoz are among the major drug firms in the coalition, as are such biotechnology and specialty companies as Genentech, Cambridge BioScience, and Alza. AARP, the activist group representing the elderly, has also been active in groups seeking more funding for FDA. The government's overall AIDS policy could also have a bearing on who will be the next FDA commissioner. As FDA's responsibilities in AIDS policy increase, it will become more important that the commissioner mesh smoothly with Bush Administration appointees in the Public Health Service and HHS. Young's scientific background in basic biomedical research, the primary battleground in the fight against AIDS, coupled with the management and political experience gained over the last four years work in favor of his retaining the FDA job. However, those qualifications may be overshadowed by the personal agenda of the next HHS secretary.

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