House committee investigates FDA approval of Sanofi-Aventis’ Ketek

WASHINGTON Democratic leaders of the House Energy and Commerce Committee are investigating current and former investigators for the Food and Drug Administration who might have approved Sanofi-Aventis’ antibiotic Ketek even though they knew of the possible health concerning taking the medication, which has been shown to be liver damage and death, according to Bloomberg.

The committee has already been looking into whether the manufacturer withheld information about the drug’s risks and is now checking to see if top FDA officials disregarded concerns made by low-ranking scientists. The committee is going as high as investigating FDA commissioner Andrew von Eschenbach, by asking for his briefing book, to see if he misled them during testimony last March.

The committee also wants a copy of a report from FDA investigators who reviewed the Ketek approval and looked into whether Sanofi-Aventis “was aware of substantial data integrity problems” in one Ketek clinical trial.

The drugmaker was banned from selling Ketek in the U.S. for bronchitis and sinusitis on Feb. 12, a day before lawmakers began debating the safety of the drug.