FDA withholding flu vaccine documents, lawmaker charges

The Food and Drug Administration is withholding for political reasons documents that could help determine whether this year's flu vaccine shortage was preventable, Rep. Henry Waxman, D-Calif., charged in a letter to FDA Acting Commissioner Lester Crawford on Tuesday.

As the flu season--and the presidential election--approach, members of Congress are examining whether the FDA had warnings that vaccines produced in a Chiron Corp. facility in Liverpool, England, were contaminated. The Chiron plant was supposed to provide supply nearly half of the U.S. supply of vaccines, but its manufacturing license was suspended by the British government in early October.

On Oct. 13, House Government Reform Committee Chairman Tom Davis, R-Va., and Waxman asked Crawford to produce records of the FDA's inspections and oversight of the Chiron plant by Oct. 20. After that deadline passed, Crawford asked for an extension because gathering the documents would take time away from the agency's effort to find more vaccines.

Waxman urged Davis to subpoena the documents, but Davis granted the extension. "I am concerned that your push to subpoena the FDA is more about politics than fulfilling our oversight responsibility," Davis wrote in a letter to Waxman, saying that the causes of the problem could be sorted out once the crisis has abated.

But Waxman's letter to Crawford asserts that the documents have already been assembled and were sent to Crawford's office prior to his request for an extension. "According to this communication, you, or someone working for you, made a decision not to release these documents to Congress until after the election," Waxman wrote.

The legislator wrote that his source also informed him that the FDA decided not to release to the media documents requested under the Freedom of Information Act until after the election, and that FDA agency e-mails "can confirm the transfer of documents to your office."

Bill Pierce, a spokesman for the Health and Human Services Department, said Waxman's charges were politically motivated and called the congressman "a political hatchet man," according to several news reports.