Bioterrorism and the Food Drug Administration: H.R. 3448, Related Legislation, and the FDA’s Expanding Role in Preventing and Responding to Biological Attack

Abstract

This paper examines the potential impact of recent and proposed bioterrorism legislation on the U.S. Food and Drug Administration (FDA). It concludes that at least one such piece of legislation, H.R. 3448, the “Public Health Security and Bioterrorism Response Act of 2001,†would significantly impact the authority and activities of FDA, as well as affecting FDA-regulated entities and other stakeholders. The paper includes recommendations for further FDA action, noting that as the federal agency responsible for the safety and efficacy of food, drugs, medical devices, vaccines, and other biological and non-biological products across the nation, FDA holds a unique and critical position in bioterrorism prevention and response.