FDA SALARIES-EXPENSES BUDGET WOULD BE $661.7 IN FY 1991

FDA SALARIES-EXPENSES BUDGET WOULD BE $661.7 IN FY 1991 under the Senate Agriculture Appropriations bill (HR 5268) passed by the Senate Appropriations Committee Sept. 19. The salaries and expenses amount is $94.6 mil. more than the agency's fiscal 1990 budget. The bill reported by the full committee, essentially the same bill as the agriculture subcommittee legislation, is scheduled to go to the Senate floor for a vote Sept. 25. The committee report describes the bill as providing $6.8 mil. more than the FDA appropriations bill in the House for salaries and expenses. However, a proviso in the House bill withholds $157.2 mil. of the funding from FDA until the Administration submits a separate request for the funds without user fees ("The Pink Sheet" July 16, p. 12). Without the $157.2 mil., the House bill only provides $497.6 mil. for salaries and expenses, the same amount as in the President's budget request. The report says the bill "provides an increase of $6.8 mil. above the House recommended level for review, approval, and inspection of foods; human and animal drugs, including orphan drugs; biotechnology-based products; devices; and diagnostics, especially protection of the Nation's blood supply." The Senate bill provides full agency funding without user fees or restrictions on the availability of funds. According to the Senate report, the committee "rejects the administration's proposal to fund [FDA] salaries and expenses of$157.2 mil. through user fees, noting that no authorization has been provided by Congress for user fees, and that the administration's proposal assumes unrealistic collections that would be inadequate to operate the agency." In addition, the report notes that the committee did "not concur with the House in holding in reserve the amount of $157.2 mil. subject to an official budget request, because it does not want to jeopardize vital food, drug and device reviews, and inspections pending a budget request by the administration." The committee directs that "future budget requests be based on current law." Like the Administration request and the House bill, the Senate bill provides $63.2 mil. for AIDS-related activities. The bill also "urges FDA to increase its activities on compassionate use approvals of AIDS-related therapies." In the area of biotechnology, the report states, "The committee is aware of extraordinary new demands placed on FDA for risk assessments, regulatory assistance, and standardization of federal agency food, drug and product reviews and urges funding provided to address these areas." The committee also said it expects a "cooperative biotechnology consortium to be initiated that will provide timely development, review, and approval of biotechnology products originating through U.S. sources." The committee recommends $10.9 mil. for FDA buildings and facilities , an amount that is $2.5 mil. above the House level and $6.1 mil. more than the President's budget request. The committee expects FDA to "continue its site planning and design for consolidation of its headquarters and undertake needed renovations." The agency is to report to the Appropriations Committee by February 1991 on its "completed prospectus for consolidation, including a master site plan and requirements development." The committee also recommends $2.5 mil. for architectural and engineering plans for a cooperative venture in biotechnology at the National Center for Toxicological Research. Rental payments under the bill total $25.6 mil., the same as the fiscal 1990 level, the budget estimate, and the House funding level.