MCM-Related Counterterrorism Legislation
Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats.
Information on this page:
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA)
- Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)
- Project BioShield Act of 2004
- Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
PAHPRA was enacted in March 2013 to sustain and strengthen our country's preparedness for public health emergencies involving CBRN and infectious disease threats. The law reauthorizes provisions of the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA), including the Special Reserve Fund for MCM procurement, and establishes new authorities and response flexibilities.
PAHPRA also recognizes the key role FDA plays in emergency preparedness and response by including provisions that further FDA’s mission of fostering the development and availability of medical countermeasures (MCMs) for use in these emergencies. PAHPRA codifies and builds on FDA’s ongoing efforts to augment review processes and advance regulatory science for MCM development.
Through new and amended authorities, PAHPRA also enhances FDA’s and stakeholder’s flexibility to respond to public health emergencies involving MCMs.
Related Links (PAHPRA)
- Public Law 113-5—Mar. 13, 2013 (PDF, 284 K)
- Information about PAHPRA
- PAHPRA Q&A (web version)
- PAHPRA Q&A (printable PDF, 762 K)
- Summary of PAHPRA’s medical countermeasure provisions
- MCM emergency use authorities
- Emergency Use Authorization
- Emergency use of approved MCMs
- PAHPRA's provisions related to development of MCMs under the Animal Rule
- Summary of Process for EUA Issuance
- FDA review and professional development activities
Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA)
PAHPA was enacted in December 2006 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 (PHS) 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 related to the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) (PDF, 584 K).
Related Links (PAHPA)
- Public Law 109-417—Dec. 19, 2006 (PDF, 249 K) - PAHPA
Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)
Enacted in December 2005, the PREP Act authorizes the Secretary of HHS (Secretary) to issue a declaration (called a PREP Act declaration) that provides immunity from tort liability (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations. The PREP Act also established a program to provide compensation for serious countermeasure injuries.
Related Links (PREP Act)
- Public Law 109-148—Dec. 30, 2005 (PDF, 584 K) – PREP Act
- PREP Act declarations and amendments
- Health Resources and Services Administration (HRSA) Countermeasures Injury Compensation Program
Project BioShield Act of 2004
The Project BioShield Act of 2004 was designed to provide additional and more flexible authorities and funding to financially support the development and procurement of MCMs against CBRN threats. It also gave the FDA Commissioner the authority to issue Emergency Use Authorizations (EUAs) to authorize the use of unapproved medical products or unapproved uses of approved medical products during CBRN emergencies.
These authorities were further delineated, clarified, expanded, and extended in 2006 by PAHPA, which authorized the establishment of BARDA within HHS, and in 2013 by PAHPRA, which, among other things, reauthorized components of PAHPA and expanded the FDA Commissioner’s authorities to permit the use of unapproved products or unapproved uses of approved products during emergency.
Related Links (Project Bioshield)
- Public Law 108-276—July 21, 2004 (PDF, 192 K)
- MCM emergency use authorities
- HHS Biomedical Advanced Research and Development Authority (BARDA)
Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
Among its provisions to strengthen the nation’s ability to respond to public health emergencies, the Bioterrorism Act addressed the accelerated approval of priority MCMs and the development of a final rule on animal models for when human efficacy studies are not feasible or ethical. The Bioterrorism Act also established the Strategic National Stockpile (SNS) and authorized the Secretary of HHS, acting through FDA, to issue regulations to protect the nation's food and drug supplies against bioterrorism and foodborne illness.