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Executive Summary

About 40 leadership and policy-making posts at FDA could be subject to review as a result of the upcoming change in presidential administrations, based on a listing of 9,000 top federal jobs compiled by the Senate Committee on Government Affairs and issued Nov. 10. Prepared after each presidential election, the book is officially the U.S. Government Policy and Supporting Positions but is more widely known as the "Plum Book." It is a road map to the change in administrations when a new President is elected. The Plum Book lists federal government positions "that may be subject to noncompetitive appointment; e.g., positions such as agency heads and their immediate subordinates, policy executives and advisors, and their aides who report to these officials." Many of the positions "may involve advocacy of Administration policies and programs and the incumbents usually have a close and confidential working relationship with the agency head or other key officials." All but nine of the FDA posts subject to review are currently filled by career federal employees. The nine include Commissioner Kessler, MD, whose position requires presidential appointment plus Senate confirmation, and several "non-career appointees," including Deputy Commissioner for External Affairs Carol Scheman, Deputy Commissioner for Policy Michael Taylor, Assistant to the Commissioner Carmen Agoglia, Associate Commissioner for Public Affairs Gary Fendler and Associate Commissioner for Legislative Affairs Marc Scheineson. Other posts currently filled by noncareer employees are Senior Advisor for Strategic Planning and Management Systems Mary Jo Verveka, who was appointed for a three-year tenure which ends in May 1994, Special Assistant for Legislative Affairs Anne Marie Finley and Special Assistant to the Associate Commissioner for Public Affairs Elizabeth Wright. One deputy commissioner, deputy for operations Jane Henney, MD, is a career employee. Henney is acting as FDA's contact person for the Clinton Administration's transition team. Most of the positions listed in the Plum Book are in either the Executive Schedule (e.g., Kessler) or Senior Executive Service. The jobs register notes that only 10% of SES positions can be filled by noncareer appointees at any one time. The Plum Book also lists the director and one or two other key posts at each of FDA's centers, but, in practice, these posts are not subject to across-the-board review and replacement by an incoming administration. Nonetheless, every administration shift tends to create a ripple effect affecting positions which are not generally regarded as "political." Center for Devices and Radiological Health Director James Benson, for example, announced his intention to resign from federal service on Nov. 10. He is apparently headed to the Health Industry Manufacturers Association to fill the post of VP- technology and regulatory affairs. Benson, a 21-year agency veteran with 19 years experience in device and radiological products regulation, said he is leaving the agency "to take advantage of other career opportunities" effective Dec. 2. An interim CDRH leader is expected to be named within 10 days of Benson's Nov. 10 announcement. An announcement regarding Benson's future employment is expected during the week of Nov. 16. The HIMA VP-technology and regulatory affairs post has been vacant for several months. Benson was named acting deputy commissioner of FDA in June 1988 under then-Commissioner Frank Young, moving up from the device center deputy director's post. Following Young's resignation in late 1989, Benson took over as acting commissioner prior to the selection of Kessler. Among Benson's tasks as acting commissioner was to steer the agency through the generic drug scandal. After three years in the top agency posts, he returned to take over the device center helm in June 1991. As part of an overhaul of the device center undertaken by Commissioner Kessler, FDA has been working to increase the presence of officials with medical/clinical backgrounds. It is likely that the search for a CDRH director will focus on physicians. One possible candidate is the Center for Drug Evaluation and Research's Bruce Burlington, MD, who is both CDER deputy director for scientific and medical affairs and deputy director of the Office of Drug Evaluation II. FDA has not indicated whether the CDRH permanent appointment might be delayed until the Clinton Administration comes on board. After transition team officials turn their attention to HHS, appointments to top posts are likely to take some time. Even for candidates whose selection goes smoothly, the standard background checks and clearances can be time-consuming. With the Clinton posture on a reinvigorated ethics code, the delays could be even longer. The Clinton ethics pronouncements could exacerbate the usual administration turnover. Current government officials (below the obvious political appointees) whose long-term plans include private sector employment may be examining the restrictions on post-government lobbying and employment that the Clinton transition team and incoming administration have imposed. The FDA commissionership is among the "60 toughest science and technology jobs in Washington," the Council on Excellence in Government states in the most recent edition of The Prune Book. The council periodically reviews positions that it considers to be most critical to government, but, as underscored in the word-play of the book's title, are also difficult, frequently misunderstood and not fully appreciated. Numerous interviews with previous appointees, industry and professional association officials and other prominent individuals with relevant expertise form much of the research for the book. The council's 750 members are described as "private sector leaders who served in high-level government positions"; the current Prune Book is sponsored by the Carnegie Commission on Science, Technology and Government. Beginning with the assumption that any FDA commissioner candidate should be familiar with food and drug law, the Prune Book suggests that the commissioner "should almost certainly be a medical doctor, preferably one who has taken care of patients." A biomedical research background, "if not imperative, is a distinct asset," as is experience in pharmaceuticals. The next three most important requirements are a close familiarity with the Washington political process, especially with the Congress and a sense of how policy evolves; management and analytic abilities; and communications skills. "And a veteran of the position suggests one further resource that will serve the commissioner well: the hide of a rhinoceros." The current description appears written to fit Commissioner Kessler: he is a hospital medical director and attorney who spent about four years working on a Senate committee. The congressional focus is emphasized by former Commissioner Young, who estimates in the book that about a quarter of his 80-90-hour work week was spent on the Hill. CDRH's Benson is quoted as noting the challenges of being "always under a congressional microscope" and the need for good public relations skills. FDA makes thousands of decisions in the routine course of operations and "so often that fact gets overlooked," Benson is quoted as saying. "But for every thousand good things that get done, one bad thing is what gets the publicity." The "enormity of the tasks facing the FDA and the complexity of its problems defy attempts to draw comprehensive but concise conclusions" on what it is like to run the agency, the Prune Book states. FDA remains "overburdened, understaffed and under- equipped" even "as it appears to be turning some sort of a corner." Kessler is quoted in the book citing increased congressional and administration support as "re-establishing a strong agency." Kessler was approved by the Senate in eight day with a "confirmation" hearing held afterwards and suggests this is a "signal that [Congress is] willing to allow us to get on with the work." Kessler was the first FDA commissioner to have to undergo Senate appointment -- the result of a law supported by Sen. Gore.

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