At its hearing this morning, the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations voted unanimously to approvea motion to subpoena FDA officials and investigators over clinical trial data for the Sanofi-Aventis antibiotic, which has been linked to liver failure.
The committee has been looking into whether Sanofi withheld info about Ketek risks, and whether FDA officials disregarded concerns raised by lower-ranking scientists when Ketek approved in 2004. The committee also wants the FDA to fork over FDA commish Andy von Eschenbach's briefing book to determine whether he misled the committee during testimony last March. David Ross, a former FDA reviewer who worked on Ketek, last year said Andy's testimony contained inaccuracies.
Committee staffers are frustrated that the FDA redacted an investigative memo from the FDA Office of Criminal Investigations before showing it to the committee. Congressional aides were told the documents summarize the FDA's investigation of whether Sanofi-Aventis was aware of problems with a safety study before it was submitted to an FDA panel. Subpoenas will be issued to two FDA investigators, another to a former agency investigator, and one to a private individual who once worked for a contractor overseeing a study of Ketek, according to this memo the committee sent to the FDA.
Although the FDA was chastened for sloppy review, last fall, the agency criticized Sanofi for failing to ensure investigators were in compliance and for failing to follow-up problems with data analysis and documentation; failing to monitor clinical trials; failing to select qualified investigators; and failing to ensure protocols were followed according to its IND. A key example cited was Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., who apparently viewed her Ketek clinical trial as one big piggy bank.