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Executive Summary

REP. DINGELL's FDA BILL SHOULD RETAIN GENERIC FOCUS, PMA ASSERTS in a July 30 press statement. Responding to a report submitted to Congress by the Generic Pharmaceutical Industry Association two weeks earlier, the Pharmaceutical Manufacturers Association said: "The problems of bribery and falsification of safety and effectiveness data have been identified only with regard to generic drugs, and the solution is consequently -- and appropriately -- limited to generic drug manufacturers." GPIA, which has urged that any legislation to enhance FDA enforcement powers apply to all agency-regulated industries, submitted a report citing 62 cases of alleged violations of FDA regs by brandname pharmaceutical manufacturers ("The Pink Sheet" July 30, T&G-12). The report was intended to show that the brandname industry has committed many of the kinds of fraudulent acts attributed to the generic industry and uncovered in the congressional and criminal probes that led to legislation (HR 4810) sponsored by House Oversight Subcommittee Chairman Dingell (D-Mich.). "Essentially, the report consists of newspaper clippings and reports from two books, with some allegations more than two decades old," PMA contended. "These allegations bear no relation to the violations uncovered by the [Oversight Subcommittee] investigators that led to HR 4810." PMA noted that the generic industry violations "included bribery of FDA employees and submission of fraudulent data to gain marketing approval of their drugs." GPIA's report contains no cases of similar violations by the brandname industry, except for charges that involved "outside (contract) researchers who allegedly falsified studies that they performed for brandname companies," PMA said. "In none of these cases was the company itself involved in this alleged fraud, except perhaps as the victim." GPIA's report also referred to several investigations involving brandname drugs by the House Intergovernmental Relations Subcommittee, chaired by Rep. Ted Weiss (D-N.Y.). In several hearings, the subcommittee charged that brandname drug manufacturers failed to report adverse drug reaction information to FDA. Such cases involved Hoechst-Roussel's Merital, J&J's Zomax, SmithKline Beecham's Selacryn, Lilly's Oraflex and Robins' Dalkon Shield.



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