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Executive Summary

FDA USER FEES ARE CLOSE TO GETTING KEY HILL ADVOCATE: REP. DINGELL (D-Mich.) is apparently beginning to turn to user fees as a funding mechanism in lieu of extra appropriations. Dingell is coming to the user fee camp from his series of recent inquiries into FDA regulatory practices and strength. The congressman previously has been an opponent of user fees but recognizes the difficulty of substantially increasing appropriations in a deficit-conscious budget environment. He is concerned that any alternative means to obtaining extra funding for FDA add to rather than substitute for full appropriations and that the revenues be provided directly to FDA rather than the general Treasury. His support for user fees could be an important swing endorsement. Dingell's perspective on FDA funding stems from his House Commerce/Oversight Subcommittee investigations into not only generic drug approvals and drug diversion, but also the agency's performance in inspecting imported and reimported drugs, in reviewing clinical studies of such drugs as Virazole, in inspecting domestic and foreign manufacturing facilities, and in regulating the use of food and drug additives. The congressman has concluded that FDA's performance in such areas has fallen off due to shrinking manpower and funding during the Republican administrations. Rep. Waxman (D-Calif.), who chairs the Commerce/Health Subcommittee, has been a steadfast opponent of user fees on the grounds that payments made to the agency for reviews of industry marketing applications would appear to compromise the process. Waxman has jurisdiction over the legislation necessary to authorize user fees. Dingell, who also heads the full Energy & Commerce Committee, has disagreed with his Health Subcommittee chairman on numerous high visibility legislative proposals, including product liability, clean air and superfund issues. Dingell is expected to discuss the need for increasing FDA funds through user fees or other alternatives at his subcommittee's July 11 hearing on the generic drug investigation (see related item, T&G-1). In April 12 testimony before the House Agriculture Appropriations Subcommittee, Dingell said he had "deep concern that the current situation at the FDA is untenable." If it is allowed to continue, he added, the situation "will threaten the health and safety of our citizens and the competitiveness of our producers and pharmaceutical manufacturers." The agency "does not have the resources it needs to carry out its important mandates as our leading public health agency," Dingell maintained. In mid-April, Dingell was espousing "all possibilities" for increased funding. He said then that he was "particularly" interested in "increased appropriations." He noted that "although this is a difficult time to talk about increasing federal spending, this is one area where I urge my colleagues to be generous."

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