Anthrax Vaccine Manufacturer Hires Packaging Contractor
Anthrax vaccine manufacturer BioPort Corp. recently announced it will use an outside contractor to bottle and package its vaccine -- an effort the company hopes will boost its chances of winning FDA approval -- and satiate the Pentagon which is eager to deliver the drug to the U.S. military, the AP/Detroit News reports. The troubled company, which was cited by the FDA this month for manufacturing "flaws ... connected to filling and packaging," has abandoned a plan to fix its bottling and packaging facility "in stages while keeping it operational." Instead, it will renovate the entire operation "at once" and hire an "outside contractor to package vials in the meantime." The company said it expects to need "a year or more" to renovate and get federal approval for its filling and packaging area. A BioPort official said he thinks the vaccine-maker's lab might get the FDA's nod "by mid-2001 -- a few months later than projected." Mike Tanner, director of corporate services, said "We've had a little slippage, but not much. We're optimistic we could see final approval by the middle of next year" (AP/Detroit News, 11/10).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.