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Executive Summary

COM. KESSLER, NIH DIRECTOR HEALY RESIGNATIONS EFFECTIVE JAN. 20, as per standard transition protocol. The resignations of FDA Commissioner Kessler and National Institutes of Health Director Bernadine Healy have been accepted by President Bush and become effective at noon on Jan. 20, the White House said Jan. 15. Both Kessler and Healy joined the Bush Administration in 1991. Political appointees subject to Senate confirmation received letters from President Bush on Jan. 14 thanking them for their public service and informing them that their government duties would officially end on Inauguration Day. The notices were sent at the request of the incoming administration. The Jan. 14 notification concludes speculation that Kessler or Healy would remain in their current positions in the Clinton Administration. The short-term replacements for Kessler and Healy have not been announced. HHS Secretary-designate Donna Shalala could recommend that Kessler and Healy stay on in a temporary capacity as special assistants to the department. However, this scenario is unlikely despite pressure to retain Kessler from organizations such as Public Citizen's Health Research Group and AIDS advocacy groups. More likely, Shalala will quickly name acting heads of both FDA and NIH. Political appointees at FDA who do not require Senate confirmation, such as Deputy Commissioner for Policy Michael Taylor and Deputy Commissioner for External Affairs Carol Scheman, also were notified on Jan. 14 that they must submit formal letters of resignation by Jan. 20. Only Deputy Commissioner for Operations Jane Henney holds a career FDA position. NIH's only "second-tier" political appointee, National Cancer Institute Director Samuel Broder, received no such notification from the administration. HHS Assistant Secretary for Health James Mason will accept an appointment as VP for policy development at the Uniformed Services University for the Health Sciences in Bethesda, Md. He will assume his new duties following the inauguration, the Public Health Service said Jan. 15. Clinton transition team Director for Personnel Richard Riley held a meeting Jan. 15 to discuss possible appointees for the assistant secretary for health position. New York City Health Department Commissioner Margaret Hamburg is said to be on the "short list" for the post. In what was probably one of his last public appearances as FDA commissioner, Kessler took a strong public position against the cost of new drugs during an address to a New York audience at the Young Men's & Young Women's Hebrew Association. Kessler declared: "In the end, it doesn't matter one bit whether we get drugs out quickly or not if the pateints who need them don't have access to them -- if they can't afford them." FDA "cannot become an agency only for the very rich who can purchase therapies out of pocket and the very poor who are eligible for Medicaid," Kessler said. "Just imagine the financial implications as AIDS becomes more of a chronic disease." Repeating a statement he made at an appropriations hearing last year, Kessler added: "No one can afford these [AIDS] drugs in Africa, and we ought to be concerned about that." Explaining FDA's history to the group, Kessler noted that the agency has become more proactive than reactive when it comes to drugs for life-threatening or serious diseases. "No more are we sitting back and waiting for someone to knock on our door with an application. We are involving ourselves much earlier in the drug development process." Kessler provided the example of the five- month approval time for Bristol-Myers Squibb's Taxol for ovarian cancer. Kessler also took a mild jab at his boss, President Bush, for failing to counter an assertion that FDA takes 10 years to approve AIDS drugs. Kessler told the audience: "There I was, watching the first presidential debate...when Ross Perot stood up and asserted that it takes FDA 10 years to approve a new drug for AIDS. I knew that we have approved ddI and ddC each in about half a year, and I yelled at the TV, 'George, don't fail me now.'" Bush did not counter Perot's assertion during the debate.

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