OT: FDA Calls British Action on Vaccine a Surprise

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F.D.A. Calls British Action on Vaccine a Surprise

By ANDREW POLLACK

http://www.nytimes.com/2004/10/12/national/12vaccine.html

Even though bacterial contamination was first reported more than a month

ago at a British flu vaccine factory, the Food and Drug Administration

relied solely on the factory's owner for information on whether the

problems were being resolved, the agency's acting commissioner said

yesterday.

The official, Lester M. Crawford, said the F.D.A. never called British

regulators to talk about the problems at the Chiron Corporation's

factory in Liverpool, even though the F.D.A. had routine communication

with its British counterpart, the Medicines and Healthcare Products

Regulatory Agency, on other matters.

So the F.D.A. was caught by surprise when the British agency suspended

the factory's license on Oct. 5, depriving the United States of nearly

half the 100 million flu shots federal authorities expected to be used

this winter.

" We followed standard procedures and this is the way we have always done

it, " Dr. Crawford said in a telephone news conference.

" It was our expectation, based on our communication with Chiron, that

the problem would be cleared up, " he added. He said it would have been

unusual for the F.D.A. to communicate directly with the British agency.

F.D.A. inspectors are now at the Liverpool factory and Dr. Crawford said

he expected a report this week. He would not comment on the inspection's

findings but said of the British regulators, " We don't have any reason

to believe at this point that they were incorrect " in taking away the

plant's license.

The F.D.A. called yesterday's news conference to " refute as strongly as

possible " news reports suggesting that it had known, or should have

known, about the seriousness of the sterility problems at the plant.

But in reaffirming that the agency was blindsided by the British action,

Dr. Crawford is likely to draw more criticism, already voiced at a

Congressional hearing Friday, that his agency was too lax in following

up on problems at a factory that is so crucial for public health.

It is not clear how much the F.D.A. might have learned had it contacted

its British counterpart. The British agency has said it was prohibited

from telling others it would shut the plant until it first told Chiron.

Dr. Crawford said the F.D.A. did not have an agreement with the British

agency that would have compelled data sharing. Such agreements might be

needed in the future because flu vaccine plants are becoming

" international resources, not just national resources, " he said.

Meanwhile, the Centers for Disease Control and Prevention is expected to

announce as early as today a more concrete plan to distribute the

remaining supplies of vaccines to those who need it most. Virtually all

of that supply, about 55 million doses, comes from Aventis Pasteur,

though more than half of it has already been distributed and some of it

used.

" We've gone through all the priority targets and come to agreements

about who we think can best take the vaccine and get it to the priority

targets, " said Phil Hosbach, a vice president at Aventis Pasteur, part

of the French company Sanofi-Aventis.

The C.D.C. is trying to get vaccine to those most in need, like those

over 65 and children 6 months to 23 months old. The sudden shortfall of

up to 48 million doses from Chiron, a California biotechnology company,

has also led to huge disparities between hospitals and clinics that have

vaccine and those that do not.

The government is also looking for supplies from abroad. A spokesman for

GlaxoKline, a British company that sells a flu vaccine in 70

countries, said yesterday that it was " working with the F.D.A. " to

negotiate a way to bring the vaccine to the United States. F.

Holler, chief executive of ID Biomedical, which sells a vaccine in

Canada, said his company had been contacted by federal authorities.

Such vaccines would have to be approved by the F.D.A. before they could

be sold in the United States and it is not clear that this could be done

in time for this winter. Another option, according to an F.D.A.

official, would be to allow the vaccines to be given on an experimental

basis.

But executives of the two companies said it was much more likely that

their vaccines would reach the American market in the future rather than

this year. They do not have enough excess to make a big dent in this

year's shortfall. Glaxo is not saying how many excess doses it has, but

one industry official said it might be only 200,000. Dr. Holler of ID

Biomedical said his company might have up to 1.5 million excess doses.

Timmons contributed reporting from London for this article.

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