November 18, 2004 in Nation/World

FDA ignored warnings about flu-vaccine plant

Seth Borenstein Knight Ridder
 

WASHINGTON – The Food and Drug Administration failed to heed repeated warnings of contamination at Chiron’s now-shuttered British flu-vaccine plant and the urging of U.S. inspectors for a crackdown, documents released Wednesday show.

Instead of forcing the company to clean up its Liverpool manufacturing plant as inspectors had recommended, the FDA left it up to Chiron to fix the problem voluntarily.

When British health authorities intervened, they found widespread contamination with a dangerous bacteria at the plant. Last month, the British government yanked the license for the plant, which produced about half the American flu-shot supply.

That created a flu vaccine shortage in the United States.

More than 1,000 pages of FDA, Chiron and British health-authority documents, released at a congressional hearing, show that the agency failed to act after noting contamination problems in 2001, 2002 and 2003.

Chiron Corp. Chief Executive Officer Howard Pien said his company was surprised when British regulators suspended the Liverpool plant’s license. Testifying before the U.S. House Government Reform Committee, Pien said Chiron spent $15 million to clean the plant and is spending $100 million to build a new flu-vaccine plant. Chiron is headquartered in Emeryville, Calif.

During Wednesday’s hearing, Democrats and Republicans sparred over who’s to blame for this year’s shortage.

Democrats pointed to lax FDA oversight while the GOP blamed litigious-happy lawyers.

“FDA’s laxity has had a heavy cost,” said Rep. Henry Waxman, D-Calif., the ranking Democrat on the House Government Reform Committee. “If FDA had ensured that problems identified in June 2003 were fixed, this year’s flu crisis might never have happened.”

Responding to nearly shouted questioning, acting FDA commissioner Lester Crawford said his agency didn’t make any mistakes in handling Chiron in previous years, except for being slow in sending the company a letter detailing the problems it found in 2003.

“We took the right action,” Crawford said.

A 2003 FDA inspection of Chiron’s Liverpool plant raised the most warning flags and prompted the questioning at Wednesday’s hearing.

The FDA inspection team found 20 problems in June 2003, most of them dealing with contamination, and noted that similar problems from 1999, 2001 and 2002 weren’t fixed as Chiron had promised.

The 36-page inspection report repeatedly cited areas where promised fixes and evaluations weren’t undertaken. One major problem was “aseptic” processing conditions, a technique bringing together multiple sterilized items. A quality assurance report in 2002 found a problem with this process, and the 2003 report said “there was little evidence that corrective actions were investigated for sterility failure.”

The FDA, in an inspection report issued last month, cited aseptic processing problems as the likeliest cause for contamination of this year’s flu vaccine.

The June 2003 team that toured the plant recommended that the FDA file an enforcement action, such as a warning letter. Instead, the FDA issued a voluntary request.

Asked by Knight Ridder who at FDA headquarters decided to make only a voluntary request, Crawford said he didn’t know, but that it was done “collegially.”

“FDA’s justification for failing to cite the facility is that the agency thought conditions were improving,” Waxman said. “But conditions weren’t improving; they were deteriorating. Over the next 16 months, as production at the facility increased, the problems found in June 2003 mushroomed. Yet during this entire period, FDA never once revisited the plant to see if Chiron was correcting its problems and making safe vaccines.”

Crawford said the 2003 inspection report had little to do with the contamination problems that created the flu vaccine crisis.

Because flu vaccine is made from eggs, there’s always a biological contamination issue, Crawford said. And the contamination issue varies each year because the flu vaccine is different each year, he added.

Chiron “responded very well. They corrected the (2003) problem. The vaccine production that was ready for that year … turned out to be OK,” Crawford said.

Even though Crawford said the problems of 2003 and 2004 were unrelated, the FDA’s inspection reports suggest otherwise. Four of the 14 problems cited in an Oct. 15 post-plant closing inspection report referred to problems from last year. In addition, the report twice cited problems “not corrected from previous inspection of 2003” and that there was “incomplete corrective action to the previous inspection of 2003.”

One section of the report states: “Failure to adequately address root causes during failure investigations, noted during the inspection of year 2003 has not been adequately corrected.”

Relying on Chiron’s assertions that the problems were fixed, Crawford said that what happened in 2004 were new problems. FDA reports said they involved the same bacteria entering the manufacturing process at the same point.

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