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House panel to subpoena FDA officials Author:Unknown Date:03/25/14 Click:

WASHINGTON - A congressional subcommittee voted Tuesday to subpoena former and current Food and Drug Administration investigators to testify about fraudulent clinical data that supported approval of the antibiotic drug Ketek.

Ketek was approved in 2004. It is manufactured by Sanofi Aventis SA. Last February, after getting reports of liver failure in some patients treated with the drug, the FDA issued a black box warning — its sternest — and restricted use to patients with pneumonia.

The four people subpoenaed had conducted their own probe in connection with Ketek's approval. For months, lawmakers 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.

On Feb. 12, the subcommittee will hold its third hearing in connection with Ketek.

"Unfortunately, the FDA has been less than forthcoming with either witness or document production in connection with our drug safety investigations," said Rep. Bart Stupak, the Democratic chairman of the subcommittee on oversight and investigations, which is part of the House Energy and Commerce Committee.

Sanofi-Aventis SA says one of its predecessors, Aventis, was not aware of fraud connected with a key Ketek study until after the study was submitted to the FDA. The agency has also said there was no intention to deceive the public. It did not know then that the entire study should not be relied upon.

A spokeswoman for the Department of Health and Human Services said the department would review the subpoenas before deciding what action to take next. She said FDA staff have been made available for interviews and that the agency has provided the House with more than 80,000 pages of information related to the Ketek investigation.

"Moving forward, we will continue to work with the House toward a solution that is responsive but will not compromise investigations or the ability of senior officials to obtain accurate information and frank advice from their staffs," said HHS spokeswoman Christina Pearson.


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