Top One Hundred Countdown -- Anthrax Vaccine Quotes - #97

January 4, 2001

FDA's position on plant closure:

The FDA's position was made clear in a 25 June 2000 article in the Vancouver,

Canada, newspaper The Province. The article quoted below was the result of

an extensive interview with Mr. Mark Elengold, the deputy director for

operations at the FDA's vaccine division, the Center for Biologic Evaluation

and Research. The reporter asked Elengold to explain the significance of the

FDA's March 1997 " Notice of Intent to Revoke " letter to the manufacturer, and

the subsequent closure of the vaccine production line in January 1998:

" In 1997, the FDA gave notice that it would revoke the manufacturer's licence

if it did not comply with regulations...

" ...In the three years I have been in this job, I have done it about three

times, " said Elengold, deputy director for operations for the FDA's Centre

for Biologic Evaluation Research.

" It is a very serious tool. We view it . . . to be equivalent to an

injunction . . .where we get a court to order compliance. "

The company failed to comply completely and a year later still faced the

possibility of losing its licence, according to Elengold.

The FDA held off pulling the licence, in part because it would have left the

U.S. Department of Defence -- which had just announced that all soldiers were

to receive anthrax vaccine -- with no domestic source.

" This is a one-source product so we tend to try to work with firms and put

additional monitoring steps in to avoid revoking the licence, " said Elengold.

The prestigious British medical journal Lancet reported at the time that " a

plea from the Pentagon has prevented an 'eleventh-hour' closure of the only

U.S. producer of anthrax vaccine, " according to an e-mail to DND medical

headquarters in February 1998.

Elengold confirmed the Pentagon sat in on a crucial call to the company in

which he discussed revoking the licence.

(Ann Rees, " Their Dangerous Dose " , The Province [Vancouver, Canada], 25 Jun

2000)

Facts: Speak for themselves

Major L. " Buzz " Rempfer

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