Waxman Is Told FDA Is Guarding Vaccine Data

Rep. Henry A. Waxman (D-Los Angeles) said Tuesday that he had been informed by an insider at the Food and Drug Administration that the agency was withholding documents sought by Congress that address whether the FDA could have prevented the flu vaccine shortage.

Waxman said the unidentified FDA employee recently contacted him and said that an array of materials had been prepared for public release by the end of last week, but that an FDA official decided to keep them under wraps until after the Nov. 2 presidential election.

The documents sought by Congress relate to the FDA’s oversight of a flu vaccine factory owned by Chiron Corp., which British regulatory officials shut down this month.

“These are serious allegations,” Waxman wrote in a letter Tuesday to Lester M. Crawford, acting commissioner of the FDA. “Public health, not political expediency, should be guiding FDA’s actions.”

Waxman’s staff provided no further details about the source of the information.

In a statement late Tuesday, Crawford said that the FDA had not finished collecting all the documents. Responding to the vaccine shortage “remains our most immediate public health priority” and “FDA staff are working diligently to provide a complete response to all of the committee’s questions,” Crawford said.

The U.S. government’s oversight of the Chiron vaccine factory in Liverpool has become an increasingly sensitive political issue since British health authorities shut down the plant Oct. 5, slashing this country’s expected vaccine supply for the coming flu season.

An FDA inspection in June 2003 found signs of bacterial contamination at the plant, leading observers to question whether U.S. regulators followed up effectively to make sure the problems had been solved. The factory’s current problems also involve contamination, which Chiron first discovered in August.

Democratic presidential candidate Sen. John F. Kerry has argued it is a failure of the Bush administration, while President Bush recently sought to reassure an audience in Florida that the administration was doing all it could to make sure there would be enough vaccine for those who need it.