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FDA Gives Congress Data on Oversight of Flu Vaccine Factory

Times Staff Writer

The Food and Drug Administration has delivered to Congress an array of materials on its oversight of a troubled flu vaccine factory, as investigators assess how the FDA did its job of protecting the public.

The shutdown of Chiron Corp.'s plant in Liverpool, England, by British health authorities Oct. 5 slashed the expected supply of vaccine in the United States, forcing a hurried reorganization of this country’s immunization plans for the current flu season.

On Tuesday, the Centers for Disease Control and Prevention said that 11 million vaccine doses remained out of a total supply of about 61 million, and that it was working closely with state health officials to get the vaccine to those with the greatest need, including senior citizens.

In an interview, Lester M. Crawford, acting commissioner of the FDA, defended his agency’s role as regulator of the Chiron plant, which had been expected to supply almost half of this country’s flu vaccine before evidence of bacterial contamination led to the shutdown.

Asked if he was satisfied with the FDA’s performance after reviewing various documents sought by Congress, Crawford’s response was unequivocal: “Yes. Absolutely.”

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Members of the House and Senate have requested various FDA materials, including the report from its inspection of the factory in June 2003, when bacterial contamination in flu vaccine was first detected, a record of the FDA’s follow-up efforts to that episode and information about the FDA’s response to additional reports of contamination three months ago.

The documents, which include proprietary business information, remained under wraps Tuesday, although much of the material may be released by next week, when the House Government Reform Committee plans to hold another hearing on the shortage.

“What we find in the documents will potentially lead us in the direction of the hearing,” committee spokesman Rob White said.

Meanwhile, panel Chairman Thomas M. Davis (R-Va.) and four committee staffers Tuesday were in Britain, where they planned to meet with British regulators and Chiron officials to discuss the problems.

A Chiron official said Tuesday that the Emeryville, Calif.-based firm welcomed attention from Congress in improving the environment for manufacturing and supplying vaccines.

Flu cases have been reported in 29 states this year, and the season has been less severe than last year’s, CDC Director Julie Gerberding told reporters Tuesday. About 95 million Americans fall into high-risk groups for the flu, while the nation has had 61 million doses of vaccine for this flu season.

“We are working hard to make sure that every dose counts,” Gerberding said.

Much of the remaining 11 million vaccine doses will be allocated by state officials, who have been given some leeway in determining which healthcare providers have the greatest need. The CDC also plans to hold back more than 1 million doses in case new problems require a sudden infusion of vaccine.

Times staff writer Denise Gellene contributed to this report.


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