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Contact: Doug Gordon

Statement of Congressman Dennis J. Kucinich On The Flu Vaccine Shortage

Washington, Nov 17, 2004 - Congressman Dennis J. Kucinich (D-OH) issued the following statement today, at a House Government Reform Committee, on the nationwide flu vaccine shortage:

Thank you for the opportunity to speak, Chairman Davis about this critical public health issue that has affected the entire US. While investigations are still underway as to what exactly went wrong that caused the Flu vaccine shortage this year, it is already clear the FDA ignored early warning signs and is circling the wagons in a defensive posture.

In June of 2003, the FDA inspected Chiron’s manufacturing facility in the UK and found 20 major problems, including recurring problems. The FDA then had the option to enforce violations as recommended by their own inspectors but opted to let Chiron handle it alone, preferring to wait until the next required inspection to check for corrections to the violations… in 2005. The FDA could have sent a warning letter to document the violations, which would have reserved the right to initiate enforcement actions later and would have alerted the public. And Chiron might have taken the violations more seriously.

In fact, Chiron sent a letter to the FDA after their inspection requesting a meeting to discuss ways to handle the problems that were found. The FDA refused, which is what they say they usually do with these kinds of requests under normal circumstances. But the circumstances are not normal when the facility has a history of violations and manufactures half of the US Flu vaccine supply and 20% of the British Flu vaccine supply.

In August 2004, the FDA missed another clear warning signal when Chiron announced contamination of 5 million doses of Flu vaccine. But in order to alleviate fears of an impending shortage, Chiron testified to Congress that it would still be able to provide the US with its full vaccine order. The FDA did not travel to the UK to inspect the facility for verification, again relying on Chiron’s word that the problem was being addressed.

To get the FDA to conduct a facility inspection, it took the announcement in October of this year, that Chiron’s British manufacturing license was revoked.

The cumulative impact of the FDA’s failure remains to be seen as the Flu season approaches. At a minimum, earlier knowledge of the threat of a shortage clearly would have allowed the CDC to recommend a delayed distribution of vaccine stock from Aventis, the other major flu vaccine manufacturer. The result would have been more vaccines going to higher risk Americans instead of the lower risk people who were vaccinated before the CDC redirected supplies.

Unfortunately it appears as though the FDA has no interest in learning from its mistakes. In the weeks after the shortage announcement in October, they refused to release documents surrounding their 2003 inspection in which major violations were found. Now that the election is over, the documents have been released and for the first time we are starting to get a picture of what happened. FDA failures appear to be part of a larger culture of deference to industry at the expense of public health. Still, public statements made by the agency declare that, if they had it to do all over again, they wouldn’t change a thing.

I look forward to finding out why that is the case.


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