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FDA GENERIC/ENFORCEMENT HEARING RESCHEDULED FOR JULY 11

Executive Summary

FDA GENERIC/ENFORCEMENT HEARING RESCHEDULED FOR JULY 11 by the House Energy & Commerce/Oversight Subcommittee, Chairman Dingell (D-Mich.) informed Commissioner Kessler in a May 2 letter requesting the agency chief's appearance. HHS General Counsel Michael Astrue and HHS Inspector General Richard Kusserow also are being asked to testify at the hearing, which was postponed from May 1. Dingell also is scheduling hearings for June 5 and June 27. The first hearing will focus on delays in ANDA approvals, the congressman wrote, asking that Center for Drug Evaluation and Research Director Carl Peck, MD, Deputy Director Gerald Meyer and Office of Generic Drugs Director Roger Williams, MD, testify. The hearing will review "the inordinate delays in the generic drug approval process" and will particularly address "the policies and management of" CDER and the generic drugs office. "Much of that hearing will focus on the findings and recommendations of" the FDA panel on alleged agency retaliation against generic industry whistleblowers (see following T&G). The hearing tentatively scheduled for June 27 will review "enforcement problems" found in FDA's San Juan, Newark, and Denver district offices, Dingell said. The Oversight Subcommittee held a hearing March 7 on FDA headquarters' failure to take regulatory actions recommended by Chicago district inspectors ("The Pink Sheet" March 11, p. 7). Dingell's request for documents in preparation for the hearing indicate the nature of the problems to be discussed. He asked for documents from agency headquarters "relating to enforcement actions or the rejection of enforcement actions (from 1985- present) for Biocraft, Zenith, Vitarine, and Pharmaceutical Basics, Inc. (Denver)." The letter asks for similar documents relating to three device firms. An Inspector General report of findings from the Denver and Orlando FDA districts indicates that inspectors in those districts missed discovering serious problems, such as fraud. Firms located in the Denver district that may be cited during the hearing include Cell Technology and Cord Labs, as well as PBI. Four products made by PBI were found to be subject of ANDAs with "discrepancies," according to the report: desipramine, metaproterenol 10 and 20 mg, and amiloride.
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