Leavitt, Congressional Committee Negotiate on Ketek Documents

-FDA News

03/07/2008 - HHS Secretary Mike Leavitt has gone part of the way toward avoiding a possible contempt of Congress charge from the House of Representatives over his reluctance to comply with a subpoena for documents related to the FDA’s approval of sanofi-aventis’ antibiotic Ketek.

Leavitt initially had refused to produce the documents in response to a subpoena the committee issued Feb. 1. The committee had requested a briefing book and related notes used to help FDA Commissioner Andrew von Eschenbach prepare for a March 22, 2007, hearing on Ketek (telithromycin).

However, in a Feb. 29 letter responding to the contempt threat, the HHS secretary says the agency is “prepared to offer the committee access to the briefing book in a reading room setting within [HHS] facilities … and provide access to FDA staff for the purpose of engaging in further discussions about the contents of the book and how it was prepared.”

The committee could get access to additional materials related to the briefing book in a reading room at a later date and get answers to additional questions on the subject, according to his letter. “Information of the type the committee seeks is rarely provided,” it says.

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