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Executive Summary

Industry groups will ask Congress in upcoming budget hearings to increase FDA's fiscal 1990 budget by $ 50 mil. above the Bush Administration's FY 1990 proposal. The organizations, which include the Pharmaceutical Manufacturers Association (PMA) and the FDA Council, a recently formed D.C. lobbying group, are recommending an FDA FY 1990 budget of $ 620 mil. -- $ 50 mil. above President Bush's request for $ 570 mil. The suggested funding level would be $ 78 mil. above FDA's FY 1989 appropriations of $ 542 mil. The industry proposals do not include a provision for user fees. The Bush Administration has proposed that $ 100 mil. of the $ 570 mil. proposed FDA budget come from user fee revenues from applications for drugs, medical devices, foods and color additives. The FDA Council says it is expecting support for its budget recommendations from several key members of congress. The group is reportedly close to endorsements from Senate Labor & Human Resources Committee Chairman Kennedy (D-Mass.), Ranking Minority Member Hatch (R-Utah), Senate Appropriations/Agriculture Subcommittee Chairman Burdick (D-ND) and Sen. Bumpers (D-Ark.), another member of the agriculture subcommittee. Bumpers also has FDA's National Center for Toxicological Research in his home state. Rep. Waxman (D-Calif.), chairman of the House Energy & Commerce/Health Subcommittee, said at a March 7 House budget hearing that he favored an additional $ 50 mil. in funding for FDA and no user fees ("The Pink Sheet" March 13, p. 14). The FDA Council is recommending that the extra $ 50 mil. go toward "an architectural, engineering and concept study of a consolidated FDA facility," the "restoration" of personnel cutbacks, an upgrade of the agency's computer capabilities/equipment and training grants for regulatory review. The industry witnesses will appear before Agriculture Appropriations Subcommittees in both chambers following appearances by FDA Commissioner Young on April 4 in the Senate and April 10 in the House. On April 13, the House subcommittee will hear from a panel of health industry associations made up of PMA, the Health Industry Manufacturers Association, the Proprietary Association and the Industrial Biotechnology Association. Also scheduled to testify are the FDA Council, the D.C.-based Coalition for FDA Resources and the National Organization for Rare Disorders. Rep. Dingell (D-Mich.), chairman of the House Energy & Commerce Committee, is also expected to testify. The Senate Agriculture Appropriations Subcommittee is scheduling public witnesses for April 13 and 20. The subcommittee expects to receive testimony from many of the same groups. As it has done in the past, PMA is opposing user fees when the revenues from drug applications are not targeted specifically to improvements in the agency's drug review activities. In budget documents developed in support of the Administration's fiscal 1990 proposal, FDA estimates that user fee revenues from applications for human drugs would total $ 59 mil. with NDAs representing $ 44 mil. of that amount. However, only $ 1.6 mil. would reportedly be spent on the drug review program. According to FDA, as it is being proposed by HHS, monies collected from drug application charges would be available only for drug review-related activities. An HHS legislative proposal on FDA user fees has cleared the Office of Management and Budget and is back at HHS awaiting Secretary Sullivan's signature before it's transmittal to Congress. The Administration's proposed FDA budget increase for biotechnology programs is $ 14.5 mil. Of that, an increase of $ 4 mil. is specifically earmarked for drug programs. The President's budget also asks for "not less than" $ 5.1 mil. for orphan drug grants.

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