FDA FY 1991 FUNDING OF $717 MIL. URGED

FDA FY 1991 FUNDING OF $717 MIL. URGED by the FDA Council, a Washington, D.C.-based lobbying group composed of pharmaceutical companies and medical societies. "The FDA Council recommends that the Food and Drug Administration be appropriated $717 mil., a$32 mil. increase above the recommended level in the 1991 President's budget request," the group said in a recently-released list of funding options. The appropriation level would also provide for the "restoration" of $157 mil. back in to direct funding for the FDA. The Bush Administration is seeking $157 mil. in its request through user fees ("The Pink Sheet" Feb. 5, p. 10). The FDA Council proposals are being developed as Congress settles down to the fiscal 1991 budget season. FDA budget hearings are scheduled to begin in the House on March 15 and in the Senate March 21 in the respective agriculture appropriations subcommittees. Legislators involved in the budget process have already received joint letters protesting the user fee proposal from the Pharmaceutical Manufacturers Association, the Industrial Biotechnology Association and the Nonprescription Drug Manufacturers Association ("The Pink Sheet" March 5, T&G-2). The FDA Council includes a number of drug companies: Alza, Beecham Labs, Bristol Myers-Squibb, Cambridge BioScience, Genentech, Johnson & Johnson, Merck, Monsanto, Pfizer, Proctor and Gamble, Sandoz and Upjohn. According to the FDA Council, restoration of the $157 mil. assumed for user fees would provide funding for additional FDA personnel to "address the pressing needs" of drug, biologics and medical device review. The funds would also support the National Vaccine Program, allow for establishment of a forensics program to enable FDA to investigate product tampering and fraud and allow for food safety initiatives, the council said. The $32 mil. in extra appropriations sought by the council would be earmarked for "high priority needs within the agency which were not included" in the President's budget request. Those needs include the repair and restoration of existing facilities and completion of the construction of FDA's AIDS research building on the NIH campus; new equipment and instrumentation for FDA labs and field research site and upgraded information and data management systems; and the establishment of new collaborative training programs in regulatory review, "similar to that implemented between the FDA and the National Cancer Institute for oncology drugs."