Maybe he had the flu

Thank God for George W. Bush and his FDA.

SCHIEFFER: New question, Mr. President, to you.

We are talking about protecting ourselves from the unexpected, but the flu season is suddenly upon us. Flu kills thousands of people every year.

Suddenly we find ourselves with a severe shortage of flu vaccine. How did that happen?

BUSH: Bob, we relied upon a company out of England to provide about half of the flu vaccines for the United States citizen, and it turned out that the vaccine they were producing was contaminated. And so we took the right action and didn't allow contaminated medicine into our country.

Except, we didn't take the right action. The British did.

WASHINGTON, Oct 11 (Reuters) - The decision by British authorities to suspend the license of a major influenza vaccine manufacturer just before the vaccine was to be shipped shows a need for better communication, acting FDA chief Dr. Lester Crawford said on Monday.

Crawford declined to criticize British regulators for stopping Chiron Corp.'s license to ship more than 45 million doses of flu shots from its plant in Liverpool.

A Food and Drug Administration team remains in Britain, speaking with Chiron, inspecting the company's vaccine plant and meeting with officials from Britain's Medicines and Healthcare Products Regulatory Agency.

There is a slim hope that a million or so doses of Chiron's Fluvirin vaccine, that had already been shipped to the United States, might be cleared for distribution. There is an even slimmer chance than any of the 46 million or more doses still at the Liverpool plant might escape destruction.

The decision slashed in half the U.S. flu vaccine supply, which was supposed to total 100 million doses this year. Health officials are now asking Americans to defer getting the vaccine, just as flu season starts, to save it for high-risk groups such as the elderly, chronically ill and babies.

Crawford and other health officials hope to avoid this in the future by getting more companies to agree to make vaccine for the U.S. market, finding better ways to make flu vaccine and by increasing demand for the vaccine to create a stronger market.

And, Crawford said, clearer international regulation may help, too.

"I think we might look at that and see if can't have some central sharing of information," Crawford told reporters in a telephone briefing.

Right now, Crawford said, British regulators were legally acting without the U.S. interest in mind.

"As far as the British were concerned it was their jurisdiction. U.S. law seeks to protect the citizens of the United States, so as far as we were concerned it was our responsibility for lots coming to the United States. But the two laws do not recognize each other."

Crawford declined to say what has come of meetings between the FDA and MHRA. Both agencies had inspected Chiron's plant and received regular reports, especially after contamination was found in some lots of the vaccine.

FDA officials have said they were taken by surprise when the MHRA took away Chiron's license just hours before the U.S. agency was to discuss the vaccine's status with the company last Tuesday.

Even if the FDA disagrees with the British agency's decision, there is unlikely to be any way to get Chiron's vaccine, Crawford said.

The MHRA said it found systemic problems at Chiron's plant, not just a simple case of contamination.

Oh, and the address of the headquarters of this "company out of England?"

4560 Horton Street
Emeryville, CA 94608
Phone: (510) 655-8730
Fax: (510) 655-9910