Sanofi Aventis - Ketek: subpoenas ahoy!
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Submitted by PharmaGossip Blog
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.
