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FDA EXPANDED USER FEES DROPPED FROM FY 1994 APPROPRIATIONS

This article was originally published in The Gray Sheet

Executive Summary

FDA EXPANDED USER FEES DROPPED FROM FY 1994 APPROPRIATIONS in a House/Senate conference agreement filed Aug. 3. Senate and House conferees on the FY 1994 Agriculture/FDA appropriations bill agreed to delete the Senate's proposal that $175 mil. of the agency's budget be derived from user fees from regulated products other than prescription drugs, such as medical devices. The FDA budget retains the $54 mil. in prescription drug user fees that was authorized by the Prescription Drug User Fee Act of 1992. The House approved the conference agreement on Aug. 6; the Senate vote may be delayed until after the August recess. Although the Senate Appropriations agriculture subcommittee felt the additional $175 mil. in user fees were necessitated by budgetary constraints, committee members and key Senate health legislators had expressed reservations about the proposal ("The Gray Sheet" Aug. 2, p. 13). Both chambers had approved the $54 mil. in prescription drug fees. The House/Senate compromise meets the administration's request for a $30 mil. increase in the FDA device program budget. The administration sought $153 mil. for device activities, up from $123 mil. in fiscal 1993 ("The Gray Sheet" April 12, p. 3). The budget measure retains a House provision to earmark $20 mil. for device evaluation activities and implementation of the Safe Medical Devices Act of 1990. FDA Commissioner David Kessler said at a Senate budget hearing in May that the device center could add "about 200" full-time equivalent positions with the funds ("The Gray Sheet" May 24, p. 3). The budget agreement also targets $10 mil. for implementation of the Mammography Quality Standards Act of 1992, as requested by the administration. FDA faces an Oct. 1, 1994 deadline for developing standards and ensuring that mammography facilities nationwide are certified. Overall, the conference agreement provides FDA with $867.3 mil. for salaries and general expenses (including the $54 mil. in prescription user fees), $8.4 mil. for buildings and facilities and $48.6 mil. for rental payments.

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