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FDA COULD SUBMIT USER FEE LEGISLATION WITHIN NEXT 30 DAYS

Executive Summary

FDA COULD SUBMIT USER FEE LEGISLATION WITHIN NEXT 30 DAYS, HHS Deputy Assistant Secretary for Management & Budget Dennis Williams told the Senate Appropriations/Agriculture subcommittee April 7. During the hearing on FDA's fiscal 1993 budget request, subcommittee Chairman Burdick (D-N.D.) pressed department representatives for specifics on the progress of its user fee proposal. "We are working on the draft of the legislation now, and within the next 30 days we would be prepared to submit it," Williams predicted. Noting that last year FDA submitted a legislative proposal providing for "very general" user fee authority, Williams said this year FDA will submit a more detailed bill. He pointed out that the agency proposes to raise revenues through user fees in four separate areas -- product applications, facility registrations, annual product licensing and import inspections ("The Pink Sheet" Feb. 3, p. 12). FDA is proposing to raise $200 mil. of its $791 mil. budget request through user fees. About $69.1 mil. would come from fees on activities related to human drugs and $12.1 mil. from biologics ("The Pink Sheet" March 30, p. 18). Burdick also questioned why the Bush Administration did not request funds specifically for the initiative to consolidate FDA's 32 Washington, D.C.-area facilities into a two-site campus. Congress appropriated $197 mil. for this purpose in FY 1992 through the Treasury/Postal Services appropriations bill ("The Pink Sheet" Oct. 7, 1991, T&G-1). While no specific funds were requested for 1993, FDA Commissioner Kessler responded that the Administration has agreed to provide a plan "within the next several weeks" outlining the next phases of the consolidated campus. FDA reviewed the campus issue with legislators, the White House Office of Management & Budget and the General Services Administration the week of March 30-April 3. Kessler said. Noting that GSA has estimated that costs of the project could reach $1.3 bil. over 10 years, Kessler commented that the Administration needs to "put that in some kind of context." The Administration will "come back [to Congress] with a series of building blocks. Obviously, $1.3 bil. is an enormous amount of money and we may not be able to realize that kind of money." Kessler added: "What we have committed [to do] is to look at what's necessary and the statutory [requirements for the campus]...and we will be returning with a plan within the next several weeks." FDA Associate Commissioner for Management Sharon Smith Holston said the agency and GSA hope to purchase land for the consolidated campus and break ground for the first facility on the campus by the end of this year. That facility, she said, will replace some current antiquated veterinary medicine laboratories. Separately, FDA broke ground this past January for a Center for Biologics Evaluation and Research facility on the National Institutes of Health campus in Bethesda, Md., Holston noted. The $25 mil. facility is targeted for completion in mid-1994. CBER Director Kathryn Zoon, PhD, said the facility will focus on AIDS but also will conduct broader research activities including cytokines and growth factors involved in the immune system. At an April 6 House Appropriations/Ag Subcommittee hearing, Pharmaceutical Manufacturers Association VP, Medical and Regulatory Affairs, John Petricciani, MD, said PMA opposes the user fee proposal. He questioned whether any data are used to determine how much to raise in user fees. Noting Administration suggestions that user fees would help improve FDA services, Petricciani also said that "in point of fact, fee receipts would be used simply to maintain current FDA operations. The total FDA budget request including user fees, does not ever keep pace with inflation," he added.

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