Resources for Food and Drug Administration (FDA)

FDA Agent Faults Sanofi-Aventis for Ketek Trial Troubles

blogs.wsj.com

Just when you think it’s all Vytorin all the time in Congress, they change things up a bit. Michigan Democrats John Dingell and Bart Stupak took a Vytorin break today to focus on possible problems in an early safety study of the Sanofi-Aventis antibiotic Ketek.

Douglas Loveland, a special agent at the FDA’s criminal-investigation office, told the House Energy and Commerce investigations subcommittee that the company “should have” known some results were sloppy and fraudulent. He added that there was a “catastrophic failure” of systems to detect and disclose problems, though he said he couldn’t prove beyond a reasonable doubt that the company was aware of fraudulent data.

The study was conducted by Sanofi-Aventis precursor Aventis before the drug was approved in 2004. The doctor who ran the site that enrolled the most patients in the controversial study ultimately pleaded guilty to fraud; the FDA has said it didn’t rely on the trial, which was supposed to answer questions about Ketek’s side effects, in approving the drug. The House subcommittee’s been looking into Ketek for more than a year.

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