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Executive Summary

A Senate confirmation hearing on the expected nomination of David Kessler, MD, as FDA commissioner could be scheduled as early as the week of Oct. 15. Kessler's former boss, Sen. Hatch (R-Utah), is pushing for an early confirmation hearing. Hatch is the ranking Republican on the Senate Labor & Human Resources Committee, which will hold the first confirmation hearing for an FDA commissioner. He employed Kessler on a consulting basis from 1981 to 1984 while the senator chaired the committee. The White House's Oct. 11 announcement of its intent to nominate Kessler to the position ends an unusual six-month off-the-job training period for the candidate. Medical director at the Hospital of the Albert Einstein College of Medicine, Kessler had been among the frontrunners for the FDA position from the start of the serious review of candidates last spring ("The Pink Sheet" May 7, T&G-1). Two months earlier in March, Kessler had been officially named to the Edwards Committee established to review FDA's mission ("The Pink Sheet" March 26, p. 9). In his participation on the committee and as chairman of its Drugs and Biologics Subcommittee, Kessler has benefited from an extensive briefing on the issues and topics that most commissioners must absorb during the weeks between their nomination and assumption of the post. Although Congress had initially set Oct. 5 as a target date for adjournment, it is now expected to stay in session until Oct. 26 or 27 due to the ongoing budget wars. As a result, the Senate Labor & Human Resources Committee may have sufficient time to schedule a confirmation hearing for the FDA commissioner-designate. Kessler's relationship to Hatch could help on a variety of issues, particularly in the area of FDA resources, where Hatch has been a strong advocate for increasing FDA funding despite the current climate of budget constraints. The nominee is no stranger to budgetary issues; he worked on budget reconciliation legislation for Hatch in 1981. Kessler also worked on food safety issues for the committee, so his experience extends beyond therapeutics. In addition, he is an attorney who has written extensively on food and drug law, which he teaches at Columbia University. One of the attractions of nominating a Capitol Hill veteran to a position requiring Senate confirmation is that the process can be expected to proceed smoothly. Hatch and committee Chairman Kennedy (D-Mass.) have had a highly cooperative relationship throughout the 1980s. And the nominee's credentials are considered impeccable. Nevertheless, the confirmation hearing may be a formidable one to the extent it reflects the challenges that will face the next commissioner. Among the questions Kessler will likely be asked is how he plans to lead an agency that is in dire need of greater resources during a period of serious budget constraints. Kessler also is sure to be asked about how he plans to steer the agency out of the turmoil that led to the change in leadership: the generic drug crisis. Several questions on the issue are likely to be asked on behalf of Rep. Dingell (D-Mich.), whose House oversight hearings have publicized the scandal. In addition to learning about the new personalities involved with FDA while serving on the Edwards Committee, Kessler has had access to two of the primary figures from a key period in the agency's history. He has had the opportunity to work with former Commissioner Charles Edwards, who in retrospect is considered to have been an excellent manager while heading the agency in the 1970s. Another fellow committee member is Lawrence Horowitz, MD, one of the agency's most effective and vociferous critics from the 1970s, when he served as Sen. Kennedy's top aide in the investigation of FDA and the drug industry. In his role as member of the Edwards Committee, Kessler has met with Acting Commissioner Benson at FDA at least three times -- on May 7, Aug. 30 and Sept. 14. Finding the right spot for Benson in the new organization will be an interesting early challenge for Kessler. Benson has been given high marks during his tenure as acting commissioner and would be an asset as deputy commissioner. However, Benson is also emminently qualified for the top position at the Center for Devices and Radiological Health, which is vacant following the retirement of John Villforth. The device center director will have the important challenge of beginning to implement what appears to be an imminent revision of the 1976 Medical Device Amendments. However, the presence of current acting director Walter Gundaker at the post may free Benson for the larger role of deputy commissioner -- he could serve as Kessler's "Mr. Inside." Other major issues facing the new commissioner include user fees and a breakup of the agency. The Reagan and Bush Administrations have suggested user fees as a means of significantly increasing FDA resources without increasing government spending on the agency. Key members of congressional committees with legislative jurisdiction over FDA -- Sens. Kennedy and Hatch and Reps. Dingell and Waxman (D-Calif.) -- have argued that the government should fund FDA solely through the appropriations process. The Pharmaceutical Manufacturers Association and other major industry groups also have opposed the concept. However, all four lawmakers have expressed resignation to the idea of user fees for enhancing agency funding while the political reality of budgetary constraints precludes substantially increased appropriations. Rep. Dingell reportedly is considering introducing legislation in the 102nd Congress to authorize FDA to retain revenues received for new drug review and other agency activities. However, FDA and the congressional leadership have apparently dodged the user fee bullet for another year: neither budget reconciliation bill moving through Congress includes a user fee provision for FDA. It has been suggested that FDA should focus on its mission pertaining to drugs, biologics and medical devices and cede regulatory authority over foods and cosmetics to another agency. Such issues undoubtedly will be addressed by the Edwards Committee.

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