http://www.lsj.com/news/local/011024_bioport_3a.html

 

Published 10/24/2001
BioPort officials defend vaccine at Senate hearing
GAO, meanwhile, is critical of company's disclosures to FDA

By Ellyn Ferguson
State Journal correspondent

WASHINGTON - BioPort Corp.'s officials Tuesday defended the company's reputation at a Capitol Hill hearing against what they call myths about the safety of their anthrax vaccine.

"We have the right people doing the right things to get this job done. We will get approval for the renovated facility," BioPort President Robert Kramer told a Senate Appropriations subcommittee.

Lansing-based BioPort, which bought the facility from Michigan in 1998, needs Food and Drug Administration approval on renovations it has made to the labs to sell its vaccine to the Defense Department.

Kramer and other executives received a generally cordial welcome from Chairman Tom Harkin, D-Iowa, who called the hearing to get a better sense of whether a $2.3 billion bioterrorism proposal he and Sen. Arlen Specter, R-Pa., created focuses on the right areas.

Several blocks away at another congressional hearing, Nancy Kingsbury of the General Accounting Office delivered a tough report on BioPort and the Defense Department's dealings with the FDA.

GAO, Congress' investigative arm, said the facility had been slow to tell the FDA about changing materials it used in fermenters - kettles in which a pathogen is cultivated - and filters in the early 1990s to increase vaccine production during the Persian Gulf War. Kingsbury said BioPort told the Pentagon, whose scientists published a 1994 study theorizing that the filter change "altered the composition of the vaccine."

The FDA did not know about the changes until GAO contacted the agency in December 2000. The FDA approved the changes in July. FDA officials did not find out about the 1994 Pentagon report until the GAO contacted them Oct. 15, Kingsbury said.

Still, Health and Human Services Secretary Tommy Thompson told the House Government Reform subcommittee that if BioPort facilities win FDA approval, "they should be operational" by Nov. 22.

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