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Executive Summary

REP. DINGELL HEARING ON FDA-INDUSTRY RELATIONS POSTPONED to Dec. 20 from Dec. 11. Planned witnesses include a Barr Labs executive and FDA official Robert Navazio. House Energy & Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) reportedly wants to obtain testimony to challenge statements made by former FDA Deputy Commissioner John Norris under oath at a previous hearing. Norris testified Oct. 15 about an advisory document he had prepared for Barr in his current capacity as executive VP of the public relations firm Hill & Knowlton ("The Pink Sheet" Oct. 22, p. 9). The former FDAer indicated that the document was not a proposal to establish an ongoing relationship between Hill & Knowlton and Barr to improve the manufacturer's relations with FDA. Barr is expected to be asked its views as to whether Norris Navazio was cited by Norris as a former colleague who had confided that "several" FDA high-ranking officials believed Barr's relations with the agency were counterproductive. Navazio, who was executive secretariat when Norris was deputy commissioner, is expected to have a different recollection of any conversations with Norris. In a letter to Barr, Norris said that "bad relations" between ANDA sponsors and FDA "guarantee delays" in approvals. The letter was released at the hearing, and Rep. Wyden (D-Ore.) commented that the subcommittee was "very concerned" that a former FDA official would suggest that the agency "punishes firms" through regulatory decisions due to poor relationships with the agency. Dingell's hearing to update the Justice Department's investigation of the generic drug industry appears on target for Dec. 19 ("The Pink Sheet" Dec. 3, p. 9). The update will feature two lead prosecutors in the case: U.S. Attorney for Baltimore Breckinridge Willcox and Assistant U.S. Attorney Gary Jordan. The investigation is expected to produce several new indictments. Subcommittee staff has said "generic companies under active criminal investigation to date represent fully half of the production" of all post-1962 generic drugs excluding antibiotics. The hearing also will include a panel of three FDA enforcement officials: Compliance Office Director Daniel Michels, Manufacturing & Product Quality Division Director Edmund Fry and Compliance Office staff member Paul Vogel.

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