The FDA’s Role in the Development of Bioterrorist Countermeasures

Abstract

As the agency that approves drug products used to treat bioterrorist diseases, the FDA plays a significant role in the domestic preparation against a bioterrorist attack. The changes that occurred at the agency in response the AIDS and cancer crises of the 1980’s have served as a blueprint for the changes made in response to the terrorist threat. These changes, often desirable but sometimes not, push even further the agency’s role as a collaborator in drug development. The paper investigates the threat of a biological weapon attack and the changes to the drug approval process that this threat has prompted.