FDA ignored warnings about flu-vaccine plant

By Seth Borenstein
Knight Ridder Newspapers

WASHINGTON (KRT) - 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 Nov. 10 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.

“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.

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 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.

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.