FDA news

OddDuck · Posted: Thu Nov 18, 2004 7:12 am Post subject: FDA news

This might be a little OT, because it's regarding the flu vaccine. But I just saw this news release and thought I'd post it.

It just seems that lately, the FDA "appears" to have had a recent past practice of being a little "lax" shall we say?

You can't help but wonder what in the world is going on there at the FDA? Ya know? (I've highlighted a couple of statements in this news release - the truth of which, of course, can only be guessed at.)

Harry? Care to weigh in? (Do you think there are some major internal politics going on there at the FDA? More than usual, I mean?)

Deb

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FDA Saw Problems at Vaccine Plant in 2003

25 minutes ago

By MARK SHERMAN, Associated Press Writer

WASHINGTON - The Food and Drug Administration said it was taken by surprise when the U.S. supply of flu vaccine was cut in half in October. Democratic lawmakers said the agency should have seen it coming.

Documents provided by the FDA to a congressional committee show that inspectors uncovered contamination and unsanitary conditions at a Chiron Corp. flu vaccine manufacturing plant in England in 2003. Yet the agency did not re-inspect the facility until similar problems caused the loss of roughly 50 million flu shots destined for the United States.

Acting FDA Commissioner Lester Crawford said the 2003 problems and those that tainted this year's vaccine were unrelated. "The proof of that is that the 2003 vaccine production was completed on schedule and none of it was condemned," Crawford told the House Government Reform Committee at a hearing Wednesday.

FDA inspectors who visited the Liverpool plant in June 2003 found records of bacteria concentrations a thousand times the expected level, said a report distributed by committee Democrats.

The preliminary inspection report from last month indicates in three places that deficiencies found in 2003 had not been corrected.

Rep. Henry Waxman, D-Calif., said Crawford's assertion was part of a "pattern of misleading statements." The FDA might have averted or at least mitigated the vaccine shortage if it had been vigilant, Waxman said.

Instead, Waxman said, the FDA rejected its own inspectors' recommendations for a formal warning to Chiron and asked the company to correct problems voluntarily.

Even after Chiron indicated Aug. 25 that several million doses of vaccine had been contaminated, Waxman said, the agency remained passive, relying on weekly conference calls with the company rather than a new inspection.

U.S. officials continued to assure the public that there would be sufficient vaccine as recently as two weeks before they learned that was not the case.

"My criticism is that the FDA didn't do enough to stay on top of this," he said in one of several tense exchanges with Crawford.

British health authorities suspended Chiron's license Oct. 5, citing manufacturing problems at the Liverpool plant. The company had been expected to ship roughly 50 million doses of its Fluvirin vaccine to the United States, about the half the nation's anticipated supply.

So far, federal officials have found a few million additional doses from Aventis Pasteur, the other manufacturer of an injectable vaccine, and MedImmune, which makes a mist that can be inhaled.

The Bush administration is seeking to acquire another 5 million doses from Canada and Europe. State and local governments have identified 750,000 more doses they can buy from wholesalers, but need FDA approval.

Crawford, backed by committee Republicans, strongly defended his agency's actions in inspecting and monitoring conditions at the Chiron plant.

There was no need for FDA inspectors to return to Liverpool after the June 2003 visit because the company "did what we wanted them to do," producing a sterile supply of flu vaccine, he said.

Bacteria is endemic to flu vaccine production because the process begins with chicken eggs, Crawford said. The production process is designed to render the vaccine sterile, and there is no tie between one year's batch and the next one, he said.

Republicans said there was an FDA team at the Chiron facility Aug. 25 for unrelated reasons. When the first word of contamination surfaced, FDA employees looked at the vaccine production line and alerted U.S. authorities, they said.

They said the FDA followed its standard procedures and called Waxman's charges "another partisan attack on the administration."

For his part, Waxman said the FDA's statements prior to the Nov. 2 election were designed to reassure people "about the flu vaccine shortage and the administration's reaction."

Waxman acknowledged in his report that FDA officials said Chiron's decision to increase production by a third, from 38 million doses last year, played a significant role in the magnitude of the contamination at the Liverpool plant.