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Lawmaker blames FDA for vaccine shortage

Waxman: Problems at flu-vaccine plant weren't addressed

Henry Waxman
Rep. Henry Waxman issued a scathing indictment of the FDA.
Food and Drug Administration (FDA)
United States
Great Britain
Flu Season

WASHINGTON (CNN) -- The ranking minority member of a House committee on Wednesday blasted the Food and Drug Administration, saying it failed to properly address problems that may have led to a shortage of flu vaccine.

His comments came at a House Committee on Government Reform meeting that at times deteriorated into a shouting match.

British regulators shut down a Chiron vaccine plant in Liverpool, England, on October 5, losing the United States about half its supply of flu vaccine for this year.

But Henry Waxman, a Democrat from California, said Wednesday the shutdown came as a result of FDA's failure to properly address problems at the facility it knew about as early as June 2003.

"The agency ignored glaring problems at the facility and missed repeated opportunities to correct them," Waxman said. "There is no better example of what's wrong at FDA than its failures at the Chiron vaccine facility."

Waxman -- along with committee chairman Tom Davis, a Virginia Republican -- requested and received more than 1,000 pages of documents from the FDA relating to its oversight of the Chiron plant.

The documents showed a team of FDA inspectors visited the Liverpool facility in June 2003 and found 20 serious problems, including bacterial contamination and poor sanitation, according to Waxman. The FDA experts recommended the agency take action against the company, but the FDA only asked the company to make voluntary reforms. Bacterial contamination of some lots of the vaccine eventually led to the plant's shutdown.

Lester Crawford, acting FDA commissioner, said action was not taken against the plant because the agency believed the problems were being corrected. He said inspectors visited the plant again in August.

Crawford told lawmakers Wednesday that the shutdown in 2004 was unrelated to problems found the year before. In 2003, the vaccine production was completed on schedule and without contamination, he said.

Waxman disagreed, saying, "If FDA had ensured that the problems identified in June 2003 were fixed, this year's flu crisis might never have happened."

Other Democratic committee members agreed. "I think the American people deserve more from FDA," said Rep. Carolyn Maloney, D-N.Y. "I shudder to think if it had been smallpox vaccine."

Crawford said the FDA is not perfect but that the agency made no mistakes because the tainted vaccine never got on the market.

"You're saying to the people of the United States that you all made no mistakes," said Elijah Cummings, a Maryland Democrat. "I've got to go back to my district and explain to them why we've got a federal agency that, to me, made some mistakes and won't admit it."

Crawford said the FDA should have responded earlier in 2003 but that the agency followed its protocols.

Senators briefed on shortage

After a briefing on Tuesday, members of a Senate committee said they are concerned not only about a lack of flu vaccine this year, but also about possible shortages in the future.

"We can't wait until Congress is in session next February to address next year's supply challenges," said Sen. Larry Craig, an Idaho Republican, chairman of the Senate Special Committee on Aging. "By then it will be too late. ... Flu is a worldwide killer and the need for a vaccination is clear -- and yet, the market has dwindled to the point that the pullout of just one company can devastate our supply."

Speakers at the hearing included Crawford and Mitchell Cohen, director of the Coordinating Center for Infectious Diseases at the Centers for Disease Control and Prevention.

About 61 million doses of the flu vaccine are available this year, they told lawmakers, down from a hoped-for 100 million. Last year, the nation used about 85 million doses of the vaccine. By the time authorities found out about the vaccine shortage in early October, 33 million doses had already been distributed.

In the face of the vaccine shortage, the two said the nation is boosting production and supply of antiviral medications as well as medication to treat pneumonia, which can be a side effect of influenza.

In addition, health officials have launched education campaigns concerning flu prevention behavior such as hand washing, the two said.

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