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Akron Univ. School of Law

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Friday, November 19, 2004

Congressional Investigation of the Flu Vaccine Shortage

The following provides some informative links to recently released documents from Rep. Henry Waxman's office about what went wrong this year and in previous years with our flu vaccine supply. 

More than 1,000 pages of documents obtained by Rep. Henry Waxman (D-CA) reveal, in striking detail, "that despite being aware of major problems at the [Chiron] vaccine manufacturing facility as early as June 2003, [the Food and Drug Administration] missed repeated opportunities to correct them." (The Chiron facility was located in Liverpool, England,, but Chiron is a California company whose operations are regulated by the FDA.) Sixteen months later, British regulators shuttered the facility because of contamination problems and the United States was left with a massive flu vaccine shortage. The incident draws focus to bipartisan concerns about the impact of the Bush administration's personal and financial ties to the drug industry. Sen. Charles Grassley (R-IA) said, "The kind of mismanagement we've seen this year by the Food and Drug Administration demands tough scrutiny. One of my concerns is that the FDA has a relationship with drug companies that is too cozy. That's exactly the opposite of what it should be. The health and safety of the public must the FDA's first and only concern."

Waxman staff summary of FDA docs at http://democrats.reform.house.gov/Documents/20041117132027-14753.pdf

Washington Post story (Nov. 18th) quoting Grassley (above ) http://www.washingtonpost.com/ac2/wp-dyn/A58470-2004Nov17?language=printer

Highlights provided by the American Progress Fund in its Progress Report for

Nov. 18, 2004

. http://www.americanprogressaction.org/site/pp.asp?c=klLWJcP7H&b=83210

FDA VISITED PLANT IN JUNE 2003, FOUND HIGH LEVELS OF CONTAMINATION: In June 2003, the FDA inspected the plant and "found high levels of overall bacterial contamination." FDA inspectors, in some instances, "found records of bacteria concentrations that were more than a thousand times higher than inspected." The inspectors also "identified poor sanitary practices that could contaminate sterile parts of the production process." Significantly, the FDA found the company was not doing enough to correct the problems.

TOP OFFICIALS REJECT INSPECTORS' RECOMMENDATION FOR MANDATORY ACTION: The FDA team that visited the facility recommended official enforcement action

against the facility. That means issuing a warning letter to Chiron outlining the problems that must be fixed. If Chiron failed to fix the problems, the FDA could have initiated legal action against the company. Instead, FDA officials overruled the recommendation of inspectors and instead submitted a request for voluntary action by Chiron. 

FDA DELIVERS REPORT TO CHIRON NINE MONTHS LATE: Even when it recommends voluntary action, the FDA is "supposed to send the manufacturer the full inspection report to help the manufacturer understand what corrective actions are needed." The report wasn't sent to Chiron until a year later – June 2004 – nine months after it was supposed to have been sent. The biggest problem: by that time "manufacture of the 2004 vaccine supply was already well underway." Chiron requested a meeting with the FDA after the 2003 inspection, but the agency never granted the request.

FOR 16 MONTHS FDA DOESN'T INSPECT THE PLANT: For 16 months, the FDA failed to send inspectors to the plant to see if Chiron had fixed the problem. FDA Commissioner Lester Crawford "defended the decision not to send inspectors into the plant." Crawford claimed that occasional conference calls with the company were "a form of 're-inspection.'" (For more on the Chiron debacle, check out this column.)

CRAWFORD FALSELY CLAIMS THAT 2003 PROBLEMS WERE UNRELATED: At an Oct. 21 press conference, Lester Crawford claimed, "what happened in 2003 has no relevancy for 2004." That isn't true. When the FDA's own inspectors finally visited the facility last month – after it was shut down – they reported that at least three sources of contamination were "not corrected from [the] previous inspection of 2003."   

CRAWFORD SAID HE WOULD DO VIRTUALLY EVERYTHING THE SAME: The FDA's negligence has put the health of tens of millions of Americans at risk. But appearing before the House Reform Committee Crawford testified, "except for the late delivery of its full report, the FDA has done nothing wrong – and would do nothing differently if given the chance." Sound familiar?

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