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Capitol Health Call
March 12, 2008

Subpoenas Refused

JAMA. 2008;299(10):1124. doi:10.1001/jama.299.10.1124-c

The failure to hand over subpoenaed documents from the US Food and Drug Administration (FDA) for a February 12 hearing had a House committee's leadership considering issuing contempt of Congress charges.

The documents requested by the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, centered on how the FDA went about approving the antibiotic telithromycin in 2004 (Ketek, Sanofi-Aventis Inc, Bridgewater, NJ). The committee's leadership wanted to know if the FDA knew at the time of approval that one of the safety studies submitted with the application contained fraudulent data. The FDA has subsequently issued a black box warning for the drug, noting potential serious adverse effects on the liver. Sanofi-Aventis admits its study contained fraudulent data but said it did not know at the time it submitted the antibiotic for FDA approval.

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