By Lisa Richwine, Reuters
WASHINGTON, Jan 29 (Reuters) - A U.S. House of Representatives panel voted on Tuesday to subpoena documents from a member of President George W. Bush’s cabinet for a February hearing on the Ketek antibiotic made by Sanofi-Aventis.
The panel has been investigating how France’s biggest pharmaceutical company and the FDA handled Ketek, which the agency approved in 2004 despite finding that a key safety study, known as Study 3014, was tainted by fraud.
The House Energy and Commerce oversight and investigations subcommittee voted 12-0 to issue a subpoena to Health and Human Services (HHS) Secretary Michael Leavitt, asking him to produce unredacted records prepared for the FDA commissioner’s appearance at a March 2007 hearing on Ketek. Leavitt’s department oversees the FDA.
The FDA and HHS have refused to provide those documents, said Rep. Bart Stupak, a Michigan Democrat and the subcommittee chairman.
The panel also approved subpoenas for two current FDA investigators, one former FDA investigator and a former employee of a company that monitored the controversial study.
Stupak said congressional investigators had interviewed most of those witnesses but needed subpoenas to compel their testimony at a hearing scheduled for Feb. 12.
The panel wants to question the witnesses about “their knowledge of whether Aventis was aware of substantial data integrity problems in Study 3014 at the time of submission to FDA,” Stupak said. Aventis was bought by Sanofi-Synthelabo and merged to form Sanofi-Aventis.
Reports of severe liver damage and death in some Ketek users emerged in 2006. The FDA withdrew Ketek’s approval for sinusitis and bronchitis in 2007 after deciding the drug was too risky for treating those relatively mild infections. Sanofi still sells Ketek to treat pneumonia. More…
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