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FDA DEVICE PROGRAM FISCAL 1994 BUDGET OF $153 MIL.

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE PROGRAM FISCAL 1994 BUDGET OF $153 MIL. adopted by the House Appropriations Committee on June 23. If passed by Congress, the measure would give the device program the full funding level requested by the Clinton administration in April ("The Gray Sheet" April 12, p. 3). The figure would represent a $30 mil. increase over device program FY 1993 appropriations of $123 mil. In adopting the FDA budget, the committee approved without change the measure adopted by the House agriculture subcommittee on June 14 ("The Gray Sheet" June 21, In Brief). The Senate Appropriations agriculture subcommittee has yet to mark up an FDA budget proposal. Overall, the House committee measure matches the administration's FDA budget request of $929 mil. The $924 mil. in FDA funding approved by the committee does not include $5 mil. for the agency's insulin and color additive certification program, which funds itself through user fees. The committee measure earmarks the $20 mil. for device evaluation activities and implementation of the Safe Medical Devices Act of 1990 that had been requested by the administration. "The new [SMDA] responsibilities coupled with technological advances, which increase both the number and complexity of product application[s], have caused the FDA to fall significantly short of its regulatory responsibilities," the committee remarks. "Without additional resources, device approvals will continue in a state of gridlock." The committee also meets the administration's request for $10 mil. for implementation of the Mammography Quality Standards Act [MQSA] of 1992. If FDA cannot meet the Oct. 1, 1994 deadline for developing standards and inspecting and certifying facilities, the committee says, "potentially, 11,000 mammography sites would have to shut down" at that time. The House committee "is concerned that adequate staffing levels for development of and inspection activities related to [MQSA] be achieved," the report states. Consistent with previous years, however, the committee spurned the administration's request for $200 mil. in unauthorized user fees from the device, biologics, over-the-counter drugs and foods industries. The committee, in its budget report, "continues to express its belief that user fees for [FDA] are such a significant policy change that [HHS] should work with the appropriate committees of Congress to have them specifically authorized." The committee makes up for the $200 mil. that would have been collected in user fees by approving $200 mil. more in appropriations than the administration had requested. The measure also includes $54 mil. in prescription drug user fees, which FDA is authorized to collect under the Prescription Drug User Fee Act of 1992. The committee-passed bill also contains a provision setting FDA staff level limits substantially above the agency's current level of employment. The measure, which appears aimed at the Office of Management and Budget's hiring freeze, states that "none of the funds provided in this Act may be used to reduce programs by establishing an end-of-year employment ceiling on full-time equivalent staff years below the level" set in the bill. The measure sets FDA's employment ceiling at 9,824 FTEs, a significant increase from both the level specified in the administration's proposed budget (8,539 FTEs) and the number authorized for 1993 (8,694). According to the committee report, the provision is intended to "assure that personnel are compatible with funding levels provided by the Congress." In addition to $10 mil. for MQSA implementation in fiscal 1994, FDA would gain $3 mil. this year under a supplemental FY 1993 appropriations measure approved by the Senate Finance Committee June 22. The Senate committee says it "does concur with the House recommendation and budget request to transfer $3 mil. to FDA" from other federal agencies. The House Appropriations committee adopted a supplemental appropriations bill on May 13 ("The Gray Sheet" May 17, In Brief).
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