BioCentury
ARTICLE | Politics, Policy & Law

FDA and biowarfare

February 22, 1999 8:00 AM UTC

The Clinton administration outlined the FDA's role in the nation's plan to ramp up its responses to terrorism and unconventional war. Speaking at a two-day National Symposium on Medical and Public Health Responses to Bioterrorism last week, CBER Director Kathryn Zoon said her agency will "assist in the identification of facilities that may be suited for bioweapons production." FDA also plans to develop techniques for the detection of genetic modifications of microorganisms to make them more toxic or antibiotic resistant.

A significant portion of the $13 million FDA hopes to receive for biodefense activities in fiscal 2000 will be devoted to the development of vaccines, detection technology, and laying out the scientific justifications for rapid approvals of vaccines, Zoon said. FDA plans to publish a final rule this year indicating how animal data can be used to demonstrate safety and efficacy of vaccines that, because of ethical and safety concerns, cannot be fully tested in humans...