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Executive Summary

FDA Deputy Commissioner for Operations Jane Henney, MD, is acting as the agency's contact for President-elect Clinton's transition team on health care. Henney has been assigned to answer questions concerning FDA posed by members of the incoming administration. The first task for Henney in the transition will be to focus on compiling a list of urgent and/or politically sensitive issues for the new administration. Those issues could include upcoming legislation, such as supplemental appropriations required to implement user fees. FDA also has to set up the administrative and physical framework for collection and allocation of user fees. Although FDA is trying to get Office of Management and Budget clearance for a couple of dozen pending regulations before the actual change of power, incoming Clinton FDAers may end up dealing with these regs, which include the final rule for accelerated approval of drugs and the food labeling regulations, which are currently the subject of a dispute between HHS and the Agriculture Department. Henney presumably was chosen as FDA's liaison with the Clinton transition team because she oversees the management of FDA's centers, the field and regulatory affairs offices, and because she is the only one of Commissioner Kessler's deputy commissioners who is a career PHS employee and not a political appointee. Henney would be a logical choice to serve as interim commissioner should Kessler resign. Henney has extensive medical and administrative experience. From 1980 to 1985, she was deputy director of the National Cancer Institute. In NCI's Division of Cancer Treatment, Henney served as special assistant for clinical affairs and as a senior investigator. In addition to her medical background, Henney also has received graduate level training in government management at the John F. Kennedy School of Government, Harvard University. Before going to FDA, Henney was vice chancellor for health programs and policy and acting director of the Mid-America Cancer Center at the University of Kansas. Henney will be interacting with the Clinton health transition headed by former Pepper Commission Staff Director Judith Feder, PhD. Atul Gawande, who was Bill Clinton's health policy advisor in Little Rock during the campaign, was also named to the health care group Nov. 12. Feder, who is currently co-director of Georgetown University's Center for Health Policy Studies, played a visible role in Clinton's presidential campaign as one of his D.C. spokespersons on health care. Furthermore, she is familiar with Congress, both as a part of the Pepper Commission and as a frequent witness at congressional hearings on health care. The Pepper Commission report, released in March 1990, recommended a $66 bil. plan that included a "play or pay" mandate on businesses to provide health insurance coverage to the uninsured and an expansion of long-term care benefits. Feder's experience on the bipartisan Pepper Commission could prove most valuable to the Clinton transition effort in that many of the committee's former members will play a role in the shaping of health care reform legislation during the 103rd Congress. Former Pepper Commission members include Senate Finance/Medicare and Long-Term Care Subcommittee Chairman Rockefeller (D-W.Va.) and Ranking Minority Member Durenberger (R-Minn.); Senate Labor and Human Resources Committee Chairman Kennedy (D-Mass.); Senate Special Aging Committee Chairman Pryor (D-Ark.); House Energy and Commerce/Health Subcommittee Chairman Waxman (D-Calif.); and House Ways and Means/Health Subcommittee Chairman Stark (D-Calif.) and Ranking Minority Member Gradison (R-Ohio). Gawande is a Rhodes scholar on leave from Harvard Medical School. He was previously a staffer for Conservative Democratic Forum Health Policy Task Force Chairman Cooper (D-Tenn.), where he worked on the Wyden/Cooper Medicaid outpatient drug rebate bill and several rural health care issues before leaving in 1990. Gawande was also previously an intern of Tennessee Senator and Vice President-elect Al Gore.

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