FDA SALARIES-EXPENSES BUDGET FOR FY 1991 IS $655 MIL. IN BILL ADOPTED BY HOUSE COMMITTEE; WHITE HOUSE CHASTISED FOR USER FEE PROPOSALS PRIOR TO AUTHORIZATION

FDA will receive $654.8 mil. to funding salaries and expenses in fiscal 1991 under an appropriations bill adopted by the House Appropriations Committee at a July 13 markup. The House budget for FDA salaries and expenses is the same amount proposed by the Bush Administration; however, the House total does not include user fee revenues. The President's funding request for agency salaries and expenses included $157.2 mil. to be provided by user fees. Although FDA user fees have been included in Administration budget proposals repeatedly in recent years, Congress has regularly ignored the user fee provision and provided the agency with full funding from the general treasury. However, in the latest budget go-round, the House Appropriations Committee has decided not to play the user fee game with the Administration. The House bill specifies that $157.2 mil. of the total will not be available to FDA until the Administration submits another budget request for that amount that does not involve user fees. "The committee has provided that $157,175,000 will be available to FDA only upon receipt of an official budget request by the Administration," the committee report on the "rural development, agriculture and related agencies appropriations" bill states. The report contends that the budget request reflecting the collection of $157.2 mil. in user fees is "unrealistic," pointing out: "These user fees require specific authorization in law which is not now available." Noting that both Bush and Reagan Administrations have repeatedly submitted budget requests that include user fees when user fees have not been authorized by Congress, the report continues: "FDA is the only agency in this bill that does not submit a budget based on current law. In the future, the committee will expect the request to be based on current law." The Administration has sent a legislative proposal for user fees to Capitol Hill but has not yet found a congressional sponsor. Without the separate budget request, the total for FDA salaries and expenses in fiscal 1991 is only $497.6 mil., or nearly $70 mil. less than the $567.1 mil. available to FDA in 1990. If the Administration does submit the additional request, the agency total will be $87.7 mil. above 1990. The committee bill provides "not less than" $11.5 mil. for the orphan drug program and "expects the FDA to provide additional personnel to the orphan drug program during times of peak workload," the report states. "The additional personnel should be used for expedited review of grant proposals and to expedite grant awards." The report also specifically addresses FDA review and approval of factor VIII and IX products. "The committee understands that FDA is reviewing appropriate ways to expedite review and approval of new coagulation products with immediate emphasis on factor IX," the report states. "The committee expects FDA to move forward on a priority basis and to report to the committee by Dec. 31, 1990, on what steps have been taken to accomplish this effort." The bill provides $8.4 mil. for FDA buildings and facilities and $25.6 mil. for rental payments. The appropriation for buildings and facilities is "an increase of $3,598,000 above the budget request." While "FDA and [the General Services Administration] continue to review the issues related to the renovation and consolidation of headquarters facilities," the report notes, "the committee expects the additional resources provided to be used to update and renovate FDA field offices." The report also notes that the committee is "aware" of the need for "state-of-the-art" clinical space for the testing of drugs, devices, biologics and "other necessary components for applying scientific findings to the unique diseases and needs of children." In response, the bill provides $200,000 to prepare a "feasibility study" on the need for a facility at the Children's Hospital of Pittsburgh for use as a clinical research facility in the area of pharmaceuticals and devices."