HHS Secretary Mike Leavitt agreed to hand over documents to the House Energy and Commerce Committee that were used to brief Food and Drug Administration Commissioner Andrew von Eschenbach at a hearing last year, avoiding the possibility of being held in contempt by Congress.
In a letter dated Feb. 29 to Committee Chairman John Dingell (D-Mich.), Leavitt said the department was prepared to offer access to von Eschenbach's briefing book and related materials prepared for the March 2007 hearing, where von Eschenbach was accused of misleading members of Congress on the FDA's approval of the antibiotic drug Ketek.
Leavitt said he would also make FDA staff accessible to discuss the contents of the briefing book and how it was prepared. A congressional investigation is under way on the agency's handling of the drug, which is manufactured by Sanofi-Aventis and was approved despite faulty clinical trials.
The Energy and Commerce Committee's Oversight and Investigations Subcommittee in January voted to subpoena von Eschenbach's briefing materials, although Leavitt had previously refused to comply. Energy and Commerce leaders had given Leavitt until close of business today to agree to a compromise on the subpoena, or face a potential motion holding him in contempt. -- by Jennifer Lubell
What do you think? Post a comment on this article and share your opinion with other readers. Submit your letter to Modern Healthcare Online at [email protected]. Please be sure to include your hometown and state, along with your organization and title.