Wednesday, February 13, 2008

Sanofi Aventis - Ketek: contempt for Leavitt?

Back stories here.
House Democrats on Tuesday threatened to hold a key administration official in contempt for not turning over documents in a probe of a Sanofi-Aventis antibiotic.

The move by Bart Stupak and John Dingell is the latest turn in a year-old investigation of the Sanofi drug, which was linked to death and liver failure in 2006. The Michigan Democrats allege that the Food and Drug Administration approved Ketek despite knowing a key safety study of the drug was plagued by faulty data.

Dingell, who chairs the Energy and Commerce Committee, said he would support holding Health and Human Services Secretary Michael Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee. Leavitt oversees the FDA and other health care agencies.

The documents were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before lawmakers last year. Von Eschenbach testified that FDA did not use the flawed safety study to approve Ketek. Dingell and other Democrats say that statement may be untrue.
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1 comment:

Anonymous said...

There are many differences between US and Canadian FDAs. The differences with europe are even bigger.