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Executive Summary

The FDA commissioner confirmation bill cleared both the House and Senate along with an AIDS bill on Oct. 13 in a health legislation conglomerate entitled the "Health Omnibus Programs Extension of 1988." Compiled by the Senate the day it was passed, the bill (S 2889) also contains a provision for state-administered reimbursement assistance for outpatient immunosuppressive drugs. Title II of the legislation contains Waxman's AIDS bill (HR 5142), which directs the Department of Health and Human Services to encourage Treatment INDs for AIDS therapies through public notices of the potential usefulness of experimental drugs in AIDS patients ("The Pink Sheet" Sept. 26, p. 11). The publicity aspect of the Waxman proposal relates to one of the demands of the AIDS activist group. In general, Title II provides for new AIDS research and training programs and establishes a state block grant program to provide home health services for AIDS patients. The section contains an authorization for federal research grants of $ 40 mil. for fiscal 1989 and "such sums as may be necessary for each of the fiscal years 1990 and 1991." The legislation also requests a report from HHS on the possible advantages of establishing a consortia among businesses and nonprofit research institutions for the development of AIDS drugs and vaccines. Title II establishes two-year formula grants for state assistance to AIDS patients for home and community-based health services including outpatient I.V. drugs, routine diagnostic tests administered at home and durable medical equipment. The amount allotted to states would be determined by a formula. Appropriations for the assistance fund is $ 100 mil. for each of the fiscal years 1989 and 1990. Under Title IV of the legislation, which contains the Organ Transplant Amendments of 1988, a two-year block grant is provided for outpatient immunosuppressive drug therapy. The bill authorizes $ 5 mil. for each of the fiscal years 1988 through 1990 for state-administered assistance for organ transplant patients who are not eligible for reimbursement under Medicare, Medicaid or private insurance. Senate confirmation of the FDA commissioner is contained in Title V of S 2889. The FDA commissioner bill passed the House in July after the Senate had adopted it in February. Sen. Gore (D-Tenn.) and Rep. Waxman were the chief sponsors of the bill. Title V specifies that future FDA commissioners "shall be appointed by the President with the advice and consent of the Senate." While passage of the bill may increase the political pressure on future FDA commissioners, it could increase Com. Young's prospects for staying on if a Bush Administration is formed. As current commissioner, Young may be able to continue without facing confirmation in a Democratic Congress. It he had to face confirmation, he would do so as a known figure.

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