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DINGELL OVERSIGHT HEARINGS ON FDA GENERIC DRUG INVESTIGATION

Executive Summary

DINGELL OVERSIGHT HEARINGS ON FDA GENERIC DRUG INVESTIGATION are scheduled to begin May 3 with two follow-up sessions on May 10 and 11. The hearing dates were announced April 27 by Rep. Dingell (D-Mich.) and Rep. Bliley (R-Va.), the chairman and ranking minority member of the Energy & Commerce/Oversight Subcommittee, which is holding the hearings. The announcement was timed to coincide with the disclosure of two guilty pleas in the criminal investigation of FDA's generic drug approval process (see following story). "While the criminal investigation continues and further action is expected, it is time for the subcommittee to begin its public review of the generic drug approval process at FDA," Dingell said. Some of the testimony on May 3 and 10 may be taken in closed executive session. The May sessions are to be only the "first three days" of hearings, according to the subcommittee. At the hearings, Dingell continued, "this subcommittee intends to air, as fully as needed, the policies, processes, and personnel problems at FDA and the practices of some firms in the generic drug industry which may have contributed to the erosion of the integrity of one portion of a federal agency charged with protecting the public health and safety." Dingell's subcommittee, which initiated its investigation into FDA's generic drug approval process last June, recently expanded its investigation to include interviews with over 60 FDA staff members and the review of information on applications for generic versions of Marion's Carafate (sucralfate), SK&F's Dyazide and Mylan/Lederle's Maxide (triamterene/hydrochlorothiazide) and Ayerst's Premarin (conjugated estrogens). The subcommittee is also looking at data on 12 other compounds ("The Pink Sheet" March 27, p. 7).
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