Vaccine Shortage Probed
Chiron Corp. came under fresh scrutiny Thursday as the House Energy and Commerce Committee sought documents on bacterial contamination at the company’s factory in Britain, which led to the U.S. shortage of flu vaccine.
The request came one day after government inspection reports released by Rep. Henry A. Waxman (D-Los Angeles) revealed that Chiron first discovered bacteria in unfinished batches of vaccine in March and opened an internal investigation into the problem in April. Chiron didn’t announce its contamination problems until August, after it found bacteria in its finished vaccine.
British regulators suspended the license of Chiron’s factory in Liverpool on Oct. 5, preventing the company from shipping more than 45 million doses of flu vaccine, half the anticipated U.S. supply. The Medicines and Healthcare Products Regulatory Agency found numerous deficiencies in Chiron’s manufacturing process and high levels of bacteria in critical areas of the plant.
The agency said in a Sept. 30 report that Chiron’s decision to boost production to 52 million doses from 38 million doses in 2003 exacerbated the company’s contamination problems. Chiron, in a written response, said the contamination was unrelated to increased vaccine production.
The House Energy and Commerce Committee said it wanted to find out whether the shortage was preventable. The committee asked Chiron for internal reports on its Liverpool facility, copies of communications with government regulators and other documents. “We want to see: ‘What did they know and when did they know it?’ ” said Samantha Jordan, spokeswoman for the committee’s chairman, Rep. Joe Barton (R-Texas).
Chiron will cooperate with the committee, said Robert Bennett, the Washington lawyer who represents the biotechnology company based in Emeryville, Calif. The committee also wants documents by Dec. 1 on the flu shot shortage from the Food and Drug Administration and the Department of Health and Human Services.
The FDA has come under criticism for its handling of Chiron’s manufacturing problems. The agency found 20 serious problems at the Liverpool factory during a June 2003 inspection but did not reinspect the factory until after the British closed it last month.
Acting FDA Commissioner Lester Crawford has said that the agency was following procedure in not reinspecting the plant and that it believed from discussions with Chiron that the problems were being resolved. But an FDA inspection last month found that some problems from 2003 -- high levels of bacteria, poor sanitary practices and inadequate remedial efforts -- had not been corrected.
Documents made public by the House Government Reform Committee show that Chiron requested a meeting with the FDA to discuss the 2003 findings, but no meeting was ever held. Waxman said FDA officials told committee staff that the agency frequently declined to meet with companies that had presented acceptable plans for addressing problems.
