Another chapter in the tale of Sanofi-Aventis’ Ketek has opened with the news that the US Congress is to subpoena documents from members of the government and the Food and Drug Administration in connection with a review of the controversial antibiotic.

The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations has voted 12-0 to approve a motion to subpoena FDA officials over clinical trial data for Ketek (telithromycin), which the agency approved in 2004 despite claims that a key safety trial, known as Study 3014, involved fraudulent data.

Reports of severe liver damage and death in some Ketek users emerged in 2006 and the FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007. However, Sanofi still sells the drug as a treatment for pneumonia.

The subcommittee also unanimously approved a subpoena to the Secretary of the Department of Health and Human Resources Michael Leavitt, for documents related to the briefing book and other materials used to prepare FDA Commissioner Andrew von Eschenbach for testimony given on March 22, 2007. John Dingell (Democrat), chairman of the Committee on Energy and Commerce, said that officials at the HHS and FDA “failed to identify a single legal argument to support their attempt to limit the committee’s ability to conduct a thorough and fair investigation of the Ketek matter”.

Chairman of the subcommittee Bart Stupak (Democrat) added that it is important to ascertain what the FDA and Sanofi knew “and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake”. He added that “the accuracy of testimony by Commissioner von Eschenbach last year regarding the approval of Ketek must also be answered”, claiming that “one would think the Commissioner would be eager to discover the truth, but instead, he has resisted our request for his briefing documents”.