FDA WOULD RECEIVE $744.1 MIL. IN FY 1993 APPROPRIATIONS UNDER HOUSE BILL

FDA WOULD RECEIVE $744.1 MIL. IN FY 1993 APPROPRIATIONS UNDER HOUSE BILL that cleared the full appropriations committee on June 25. The House fiscal 1993 budget for FDA represents a 2.5% increase (or $18.2 mil.) over fiscal 1992 agency appropriations and includes no provision for user fees. The committee report notes that the "increase above the fiscal year 1992 amount is to cover salary and benefit costs to maintain personnel at the 1992 level." The Appropriations Committee markup provided the first public glimpse of the House budget for FDA in fiscal 1993. The Appropriations/Agriculture Subcommittee met in closed session on June 10 to mark up the 1993 appropriations bill for agriculture, rural development, FDA and related industries. The subcommittee held a hearing on March 24 on the FDA budget ("The Pink Sheet" March 30, p. 17). On the issue of FDA user fees, the report states: "It is disappointing that the Department of HHS and the Office of Management and Budget continue to gimmick the budget request for FDA by assuming collection of user fees." The report adds that "testimony before the Committee indicates that even if FDA had authority for such fees, it would take 18 to 24 months to develop a program to begin collection." The committee report calls the Administration's "assumption" of FDA user fees in its budget "only a shell to mask budget problems." The Administration had sought fiscal 1993 appropriations for FDA of $557 mil., to be supplemented by $200 mil. in user fee revenues. A draft user fee bill is currently circulating on the Hill ("The Pink Sheet" June 15, p. 3). Speaking at the Appropriations Committee markup of the FY 1993 agriculture appropriations bill, Rep. Skeen (R-N.M.). noted that OMB's analysis of the House agriculture appropriations bill was generally favorable. However, he said OMB was critical of the absence of a provision in the bill for FDA user fees. Skeen pointed out that user fees "do require authorization" and that the committee decided to "go with the rules." The House appropriations bill (HR 5487) does not provide the agency with FY 1993 funding for the proposed FDA campus. The bill provides $8.35 mil. for buildings and facilities -- the same amount included in last year's appropriations. The report contains several committee provisions, including a recommendation apparently directed at inadvertent needle sticks that might spread an AIDS infection. The committee said it "supports efforts by FDA to reduce the hazards to users and patients posed by needlebearing medical devices," and recommended that the agency "consider all needle uses,...take action to remove devices with unnecessary needles from the market and...assure that all remaining needle bearing devices have an effective mechanism to protect the user from needlesticks." In addition, the committee said it "is aware of the need to increase the number of trained biomedical scientific personnel in clinical pharmacology and supports the concept of a pilot training program for clinical pharmacology." However, the report adds: "Due to fiscal constraints placed on the committee, it is unable to provide additional funds for this program."