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Thursday, November 18, 2004

Flu Snafu: FDA Knew


The Washington Post's David Brown reported yesterday that the FDA knew about contamination problems at the Chiron flu vaccine plant a year ago, but did almost nothing -- even though the company asked for help.
FDA managers overruled its inspection team [in 2003] and made its fixes voluntary rather than mandatory.
...
The one FDA action he said was a mistake was the agency's failure to send its full report on the June 2003 inspection to Chiron in September 2003. That was when the FDA decided to make its improvements voluntary, not mandatory. Chiron requested and received the full report in June 2004.
...
The company had asked for a meeting with FDA officials after the 2003 inspection, but the agency never granted one, apparently because it did not view it as necessary.
...
[With minor exceptions], the FDA dealt with Chiron entirely from a distance, through letters, e-mails and telephone calls.
Comparing these latest revelations to press reports from before the election, the news is not so much that the FDA knew about the plant's problems a year ago, but how little action they took. After the election, it's front page news with the headline "U.S. Knew Last Year of Flu Vaccine Plant's Woes." Last month, it was in the business section, with the headline "FDA denies knowing scope of plant's mess."
 
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