FDA COMPLETES BIOPORT LAB INSPECTIONS 



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Last Updated

06 Nov 2002

Source: Associated Press, December 20, 2001.

FDA Completes BioPort Lab Inspections

By DEE-ANN DURBIN, Associated Press Writer

LANSING, Mich. -- The nation's only maker of anthrax vaccine took a step toward resuming routine production when the federal government completed an inspection that found only a handful of minor problems.

The Food and Drug Administration, which spent the last week inspecting BioPort Corp.'s labs, said Wednesday that the company had satisfactorily addressed most of the procedures it wanted to see fixed before allowing the company to ship the vaccine.

BioPort has been under pressure to win federal approval to distribute the vaccine, which it has been manufacturing since 1988 but has been unable to ship since failing FDA inspections in 1999 and 2000.

The FDA said Wednesday that BioPort wouldn't be fully licensed until an inspection of the company where the vaccine is placed into vials was satisfactorily completed early next month.

On Tuesday, the U.S. Department of Health and Human Services announced that up to 10,000 federal employees who might have been exposed to anthrax at the Capitol or postal facilities may get doses of the vaccine to ward off the deadly spores.

In the past, BioPort has supplied the vaccine only to its own employees and the Pentagon. About 500,000 of the 2.4 million troops the Pentagon wanted to inoculate have received the vaccine, but the military's vaccination program has been put on hold as supplies have run low.

BioPort president Bob Kramer said the corrections required by the FDA are minor compared to problems cited in two earlier inspections, which questioned the sterility of BioPort's labs but not the safety of the vaccine.

Federal officials stressed that the treatment would be experimental, since the FDA hasn't approved the vaccine for use after an exposure to anthrax. Previously, it has been taken as a precaution by soldiers and people who work with anthrax.

BioPort spokesman Kim Brennen Root played down the experimental nature of giving the anthrax vaccine after exposure to the spores. The CDC recommended continuing treatment with the vaccine in a December 2000 report, she said.

"This has been thought of before based on studies that do exist," she said.

Patients being given the option of continued treatment with the anthrax vaccine also are being told they can continue their regiment of antibiotics or end treatment and report any negative symptoms.