FDA Seeks More Time to Hand Over Vaccine Data

Political jousting over the flu vaccine shortage continued Friday as the Food and Drug Administration said it needed more time to provide documents sought by Congress, and Democratic lawmakers accused the administration of holding back the materials to avoid embarrassment.

“What is happening is obvious,” Rep. Henry A. Waxman (D-Los Angeles) said in a letter to Rep. Tom Davis (R-Va.), chairman of the House Committee on Government Reform, urging his Republican colleague to subpoena the documents. “The administration is trying to delay the release of the vaccine documents until after the election.”

The flap was over materials that Davis and Waxman had requested last week related to problems at the British vaccine factory owned by Chiron Corp. of Emeryville, Calif.

The requested materials included results of a June 2003 inspection by the FDA that turned up signs of contamination, and communications between Chiron and the FDA, as well as between U.S. and British health authorities. The lawmakers had asked for the materials by Wednesday, a deadline the FDA failed to meet.

Chiron disclosed in August that it had detected new contamination, which it said was limited to a small amount of the vaccine. But on Oct. 5 British regulators shut down the factory for three months, wiping out almost half of the U.S.’ planned vaccine supply for the coming flu season.

Lester M. Crawford, the FDA’s acting commissioner, Friday asked for more time to provide the materials, explaining that the employees who were needed to compile them were busy responding to the vaccine shortage.

“My team that is working hard to secure more flu vaccine, antiviral medication, and complete its investigational work at Chiron Corp.’s manufacturing plant is the same team that maintains the responsive materials that you have requested,” Crawford wrote Davis in a letter.

Democrats believe the administration is withholding materials related to its regulation of the Chiron factory to avoid political harm.

Late Friday, Davis expressed support for Crawford and chided Waxman for his demands. “Frankly, I am concerned that your push to subpoena the FDA is more about politics than fulfilling our oversight responsibility,” the Republican chairman wrote to Waxman, who is the senior Democrat on the panel.