Ketek concerns in focus as Congress opens drug safety hearings

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A former employee for a Sanofi-Aventis contractor overseeing a clinical trial of the antibiotic Ketek told Congress the drugmaker knew of a problem with the study before it was discovered by regulators, The Wall Street Journal reported. Ann Marie Cisneros, a former employee of contractor Pharmaceutical Product Development, testified to the House Energy and Commerce Committee that her former employer, as well as Sanofi-Aventis predecessor company Aventis, were informed of concerns about a Web site that enrolled patients in a Ketek safety study in 2004. The doctor who ran the site ultimately pleaded guilty to fraud. In a statement, Sanofi-Aventis said it was “unaware at the time” that what appeared to be deviations at the site “in fact reflected fraud in the conduct of the study.” The company said Aventis “acted in good faith” in conducting the study and has cooperated with investigations. Cisneros’ testimony came as the Congressional committee opened its hearings into how the FDA handles drug safety issues. Committee Chairman John Dingell, a Democrat from Michigan, called the FDA “badly broken,” and Rep. Bart Stupak, another Michigan Democrat and chairman of its investigations subcommittee, said the FDA’s interactions with the drug industry had become “incestuous.” The FDA, which had none of its leaders testifying, said in a statement that it “shares Congress’ commitment to drug safety issues” and the agency has announced a number of recent drug-safety initiatives. The FDA said in The Journal report that it followed “standard procedures in identifying and communicating risks associated with Ketek.” Last Monday, the FDA called on Sanofi-Aventis to revise its product labeling for Ketek, restricting use of the drug to treating pneumonia and not less serious bacterial infections such as bronchitis and sinusitis, as previously indicated. The FDA also said Ketek’s labeling would bear a strong new “black-box” warning, the strongest of its kind, outlining the drug’s risks and safe use. The labeling changes are in line with the December recommendations of an FDA advisory committee which suggested Ketek should no longer be marketed for bronchitis or sinusitis. Ketek labeling already warns of the drug’s risk to the liver. An FDA review released in December cited 13 reports of liver failure in patients treated with the drug. The FDA’s handling of Ketek is also under investigation by the Senate.
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