While the government has blamed only one company for unsafe production practices in the flu vaccine crisis, federal records show health officials knew for years that vaccine makers were having problems meeting federal health standards.
Since 2000, Food and Drug Administration officials have warned at least three flu vaccine manufacturers that their plants posed health hazards and did not comply with federal regulations, government records show.
In one case, the FDA fined a vaccine maker $30 million for failing to satisfy government standards at two of its plants.
Two of the companies cited by the FDA later stopped making flu vaccine. A third company, Aventis Pasteur, became this year's lone supplier of injectable vaccine in the United States - about 55 million doses - after 48 million doses produced by the American-based Chiron Corp. at its facility in Liverpool, England, were contaminated.
While 25 companies produced various vaccines for the United States 30 years ago, today only five manufacturers are doing so.
Pharmaceutical companies have been abandoning the vaccine business, experts said last week, because of stringent federal regulations that often mean costly plant renovations, rising production costs yielding relatively low profitability, and a legal climate that encourages class-action suits by people who suffer side effects from vaccines.
"I do think profitability is a very big deal," said Harvard University economics professor David Cutler. "It seems like we ought to write into contracts [with vaccine manufacturers] to say that if the manufacturing plants are reliable, we'll pay you more." Cutler said companies that don't make sufficient profits on vaccines are likely to cut corners when it comes to adhering to U.S. safety standards.
A routine June 2003 FDA inspection at Chiron's Liverpool plant revealed problems with bacteria contamination in the flu vaccine process, but no taint in the final product. FDA officials agreed to work with Chiron to correct the problems but did not return to the factory for another inspection until early this month after it was shut down by the British government.
In an April 2001 warning letter, the FDA told Aventis Pasteur that the company's Swiftwater, Pa., plant had "failed to establish appropriate time limits for the completion of each phase of production of influenza virus vaccine to assure quality of the drug product."
The FDA also warned Aventis that it failed to establish and follow written procedures for cleaning and maintaining equipment used to make its flu vaccine. An Aventis spokesman said the problems were subsequently resolved.
Another pharmaceutical company, Wyeth-Ayerst Laboratories of Madison, N.J., stopped making flu vaccine in 2002, two years after the FDA hit it with a $30 million fine. The FDA said Wyeth violated rules that ensure drugs and vaccines remain sterile and of high quality.
Wyeth spokesman Doug Petkus said the company paid the fine and began making corrections at its Marietta, Pa., flu vaccine plant to bring it up to FDA standards but later decided to leave the flu vaccine business. Petkus said the fine did not influence Wyeth's decision to stop making vaccine after 20 years.
In 2000, a third company, Parkedale Pharmaceuticals of Rochester, Mich., received FDA warnings. A September 2000 FDA warning letter to Parkedale said the agency had found "deficiencies in production and process controls for influenza virus vaccine." After finding that a batch of vaccine that Parkedale had readied for market was unsafe, the FDA ordered the company to stop manufacturing until it could comply with government regulations. Parkedale never resumed manufacturing flu vaccine.
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