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This article was originally published in The Tan Sheet

Executive Summary

FDA 1994 APPROPRIATIONS MARKUP BEGINS JUNE 9 IN HOUSE Appropriations/agriculture subcommittee. The Clinton Administration has requested a total FY 1994 budget for FDA of $ 929 mil., derived from $ 671 mil. in appropriations plus $ 259 mil. in user fees ("The Tan Sheet" April 12, p. 4). The user fee total includes $ 54 mil. as authorized in the statute for prescription drug and OTC switch user fees and $ 200 mil. from fees that would be newly enacted for other FDA-regulated industries, including the OTC drug and dietary supplement industries. The Senate Appropriations/agriculture subcommittee has not yet scheduled its markup. The Pharmaceutical Manufacturers Association submitted written comments May 28 to the Senate subcommittee saying it is "seriously concerned that the fiscal year 1994 budget request for FDA proposes only $ 671 mil. in budget authority. This represents a reduction of $ 109 mil. from the level of appropriations enacted for fiscal year 1993 and funding for salaries and expenses would be below the threshold required under the Prescription Drug User fee Act of 1992 to implement the collection of prescription drug user fees in the next fiscal year [1994(BRACKET)." In a cover letter to Senate subcommittee Chairman Dale Bumpers (D-Ark.), PMA President Gerald Mossinghoff asked the chairman to "particularly note" that the Administration's request would not meet requirements that user fees may be collected only if they augment appropriations and staffing levels above levels specified by the user fee law. PMA noted that FDA has said that HHS will submit a request to the Office of Management and Budget to waive the current federal freeze on hirings ("The Tan Sheet" May 24, p. 7). The waiver is needed to both meet the user fee law requirements and comply with a directive contained in a House Appropriations Committee report last year that FDA immediately start hiring 200 additional staffers to begin speeding up drug reviews. "There should be no delay in this action," PMA maintained. Despite "the need to hold the line on overall federal spending," PMA asserted, "we believe it is essential that the FDA budget be increased over the current-year level. An FDA budget freeze would result in a staffing cutback and would be completely contrary to the important policy objective of improving access to quality health care for the American people." The association said it supports a recommendation of the FDA Council that FDA should receive $ 842 mil. in FY 1994 appropriations, adding that the $ 54 mil. in user fees also would be collected. At the Senate hearing where the waiver was discussed, Sen. Bumpers termed the Administration's budget request as "suspect" because it includes user fees on other industries that have not been authorized. PMA also urged that the directive of the House Committee to hire 200 additional staffers be written into legislation. Supplemental appropriations legislation permitting FDA to collect $ 36 mil. in prescription drug user fees during the current year was approved by the House May 26 and sent on to the Senate.

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