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Executive Summary

FDA may be in for a welcome respite at the beginning of the Clinton Administration from the executive department second- guessing and congressional oversight that characterized the Reagan/Bush years. The agency appears to be headed into a period of consolidation when it can implement the major new programs of the last several years: user fees, medical device amendments and nutritional labeling. Congress can be expected to give FDA a little more breathing room under a Democratic administration. In addition, FDA should have a relatively low profile during the 103rd Congress, which will be tied up with larger, purse-strings issues if Clinton's "first 100 days" legislative agenda is of the magnitude promised during the campaign. Clinton aides are promising quick and bold actions in the first days of the new administration that will include executive orders overriding a number of Bush policies, including the import ban on RU-486 and the research ban on fetal tissue. Those two issues have been viewed as the political work of the right wing of the Republican administration. The November 1991 proposals from Vice President Quayle's Competitiveness Council likewise may come under attack as the new administration moves to purge the most flagrantly doctrinaire Reagan/Bush initiatives. Support at FDA for a number of the recommendations, including outside reviews and IRB approval of INDs, is less than wholehearted. The cornerstone of the recommendations, the accelerated approval proposal, is a candidate for serious revision. Several top FDAers are opposed to the Quayle Council's broad extension of accelerated approval beyond drugs for serious and life-threatening diseases. Also, the industry is opposed to the proposal as it appeared in the Federal Register in April ("The Pink Sheet" July 27, p. 8). The Edwards Committee report in 1991 noted that FDA activities were the subject of 84 congressional oversight hearings from 1985 to 1990 and 44 GAO reports. During the 102nd Congress, FDAers were asked to participate in about 70 congressional hearings, including 25 related to pharmaceutical issues. FDA estimates that agency preparation time for a complex oversight hearing takes about 80- to-120 person hours in the Office of Legislative Affairs alone. Congressional second-guessing in the pharmaceutical area has covered a broad array of issues stretching from specific OTC ingredients to the IND approval for the tamoxifen breast cancer trial; from promotion of unapproved uses to extended NDA reviews for Upjohn's Ansaid and photopheresis treatment for scleroderma. Ironically, FDA, under Clinton, may get the freedom from external political pressures that received such a high priority in the Edwards Committee recommendations. Although given short-shrift by the Bush Administration, one of the Edwards Committee's primary concerns was FDA's lack of independence -- a view also shared by Vice President-elect Gore, who was highly critical of OMB interference when he served in Congress. Rep. Dingell's medical device hearing, scheduled for early 1993, should provide an early indication of Congress' approach to FDA oversight under the new administration. The hearing should establish whether Dingell intends to continue close monitoring of FDA operations and reform efforts, or whether he is inclined to relax his oversight in deference to the Democratic administration. FDA's retooled image as a tough enforcement agency, which Commissioner Kessler has made a top priority since taking office, also could work to the agency's advantage. The stepped-up and highly publicized enforcement activities of the Kessler FDA may satisfy agency watchers on the Hill that increased enforcement powers are no longer necessary. Whether those activities have gone far enough to obviate the reintroduction of enforcement legislation and attendant hearings in the next session of Congress is not clear. Energy & Commerce/health subcommittee Chairman Waxman (D-Calif.) reportedly remains interested in the bill that cleared the full Energy & Commerce Committee earlier this year but failed to make it to the House floor. Dingell is reportedly less sanguine about the bill -- apparently because he is less optimistic about the ability of FDA's field staff to implement the bill. Whether the bill is reintroduced depends in large part whether Clinton's new people are in agreement with Waxman that legislation is needed. If so, the bill can expect clear sailing with hearings likely focusing on the inadequacy of Bush Administration, and Kessler's, reform efforts. Although the political pressure on the agency to change its old "paper tiger" image may subside, a Democratic administration is unlikely to be as comfortable with the anti-regulatory stance of the Reagan and Bush Administrations. Within FDA, staffers involved in enforcement issues clearly do not expect an abatement in the agency's tough-guy image. Speaking at the Regulatory Affairs Professional Society meeting in Washington on Nov. 2, one mid-level FDAer characterized the Clinton campaign as "literally running against the drug industry" and suggested that the reasons for the industry's vulnerability are two-fold: drug prices and "false, misleading and unethical drug promotion." A quiet period free from Congressional scrutiny may be most important to the agency's drug and biologicals review divisions, which must prepare for a wave of biotech products that is expected to hit the agency in the next two-to-three years. Given Clinton's expressed interest in supporting high technology industries and Gore's involvement in biotechnology issues as a congressman, the new administration should be sensitive to industry concerns if FDA becomes a damaging bottleneck. In what likely will be considered his crowning achievement as FDA commissioner, Kessler negotiated the user fee bill with industry and Congress to ensure the resources needed by the agency to meet the expected surge in biotech products. The bill, which was signed into law by President Bush on Oct. 29, is expected to provide the agency with $350 mil. for drug and biologic reviews over the next five years, which will go toward computer upgrades and a staff increase of approximately 600 in the reviewing divisions at CDER and CBER. However, the reviewing divisions will be faced with the monumental task of bringing on and training hundreds of new staff while meeting the review deadlines promised by Kessler. In addition, the political realities of a change in administrations make it likely that the substantial task of implementing the law and making good on Kessler's promises will be his legacy for the next commissioner. There is support on the Hill for Kessler to be kept on into the next administration. However, Kessler would be too large a liability given the visibility of the FDA commissioner post and his willingness to toe the Bush Administration line on the enforcement legislation and the Competitiveness Council recommendations. Unlike FDA's management structure during previous administration changes, the Kessler management team is virtually devoid of career FDAers. Kessler's departure from the helm also is expected to include the next layer of FDA management -- his five deputy commissioners. With the exception of Deputy Commissioner for Operations Jane Henney, MD, who is career PHS, all are political appointees. Senior Advisor Mary Jo Veverka, who expected to receive a deputy commissioner slot, is a term appointee. FDA is finishing its tenure under Commissioner Kessler and the Bush Administration on a definite up note. The user fee legislation for prescription drugs is being hailed by Kessler supporters as the culmination of his two-year effort to restore FDA credibility. Deputy Commissioner for External Affairs Carol Scheman, in a speech on Nov. 2 to RAPS, called the passage and enactment of the user fee legislation "the most persuasive comment on [FDA's] performance" over the past two years. "I believe its fair to say," Scheman declared, "that the act would not have passed, that Congress and the PMA and the IBA would not have thrown their weight behind [the legislation], if FDA had not, in the last two years, regained its credibility as a can-do and caring agency." Scheman also suggested that the "passage of the act...testifies to the vision of Dr. Kessler's policies."

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