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Published on 31 January 2008

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FDA staff subpoenaed over Ketek

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A congressional subcommittee has voted to subpoena former and current Food and Drug Administration (FDA) staff to testify about allegedly fraudulent clinical data that supported the approval of an antibiotic drug.

The FDA approved Ketek, which is manufactured by Sanofi Aventis, in 2004.

However, last February, after receiving reports that some patients treated with the drug had experienced liver failure, the FDA issued a black box warning about the treatment and restricted its use to patients with pneumonia.

The four people who have been subpoenaed conducted their own probe in connection with Ketek’s approval.

For months, officials have alleged that the FDA approved Ketek even though the agency knew the large safety study it required before approval was fraught with data problems.

Sanofi-Aventis has claimed that one of its predecessors, Aventis, was unaware of fraud connected with a key Ketek study until after it was submitted to the FDA.

The agency has also said there was no intention to deceive the public, and that it did not know that the entire study could not be relied upon.

Republican Bart Stupak, the Democratic chairman of the subcommittee on oversight and investigations, said: “Unfortunately, the FDA has been less than forthcoming with either witness or document production in connection with our drug safety investigations.”

Copyright © PA Business 2008

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