Counterterrorism-Related Legislation

The events of September 11, 2001, reinforced the need to enhance the security of the United States.  Since then, Congress has passed several laws to better prepare the nation that have an impact on FDA.  Highlights of these laws, with links providing greater detail, are found below.

The Pandemic and All-Hazards Preparedness Act (PAHPA)
The purpose of PAHPA is to improve the nation’s public health and medical preparedness and response capabilities for emergencies, whether deliberate, accidental, or natural. Among other things, PAHPA amended the Public Health Service Act to establish within the Department of Health and Human Services (HHS) a new Assistant Secretary for Preparedness and Response (ASPR). PAHPA also provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures and called for the establishment of a quadrennial National Health Security Strategy.
 

Public Readiness and Emergency Preparedness Act (PREP Act) 2005
The PREP Act provides immunity from liability claims arising from administration and use of covered countermeasures to manufacturers, distributors, program planners, and qualified persons involved in the administration and use of a covered countermeasure. 
 

The Project Bioshield Act of 2004
The Project Bioshield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.
 

The Bioterrorism Act of 2001
The Bioterrorism Act of 2002 authorizes the Secretary of HHS, acting through FDA, to issue regulations to protect the Nation's food and drug supplies against bioterrorism and food-borne illness.