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Executive Summary

REP. MADIGAN TO INTRODUCE FDA USER FEE LEGISLATION during the week ending May 12 at the request of the Bush Administration. As proposed by the Health and Human Services Department ("The Pink Sheet" April 17, p. 4), the bill will mandate the collection of fees to cover the full cost of processing applications for drugs, biologics, medical devices, foods and color additives. Madigan's bill will embody the HHS proposal. Among other things, the legislation would "credit to the FDA appropriations account that portion of collections based on costs incurred by FDA." The Pharmaceutical Manufacturers Association has continued to express skepticism over whether receipts from user fees would actually be credited to the relevant FDA activities. Madigan's legislation will be referred to the House Energy & Commerce/Health Subcommittee, of which Madigan is the ranking minority member. However, the bill will face substantial resistance from subcommittee Chairman Waxman (D-Calif.), who has publicly opposed user fees. Rep. Dingell (D-Mich.) who chairs the full committee, is also said to be against review charges. HHS is reportedly still looking for a Senate sponsor for its bill.

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