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 In this section:

                MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends? Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          MCM-Related Counterterrorism LegislationMCM Legal, Regulatory and Policy Framework MCM-Related Counterterrorism Legislation
  
  	
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              Gavel and stethoscope, representing medical countermeasure-related counterterrorism legislationSince 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:

Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (2020)
	Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA)
	Public Law 115-92 (2017)
	21st Century Cures Act (2016)
	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)Coronavirus Aid, Relief, and Economic Security Act (CARES Act)

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19.

In addition to the COVID-19 response efforts, the CARES Act includes authorities intended to enhance FDA’s ability to identify, prevent, and mitigate possible medical product shortages by, among other things, enhancing FDA’s visibility into supply chains. Medical product shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Medical product manufacturers provide FDA with most of the shortage information the agency receives, and the agency works closely with them to prevent or reduce the impact of shortages.

The specific authorities to enhance FDA’s ability to identify, prevent, and mitigate drug shortages are summarized on the CDER web page linked below. Additional information about FDA’s work to identify, prevent, and mitigate device shortages is available in the FDA Voices post linked below.

Related links (CARES Act)

H.R. 748 (PDF, 921 KB)
	CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Efforts
	FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program (FDA Voices, July 21, 2021)Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA)

PAHPAIA was enacted in June 2019 to reauthorize and strengthen HHS efforts to respond to disasters and threats from emerging infectious diseases and CBRN threats. PAHPAIA encourages the development of new medical countermeasures (MCMs) and the stockpiling of critical medical products and supplies. PAHPAIA also authorizes a range of regional health care emergency preparedness and response systems, as well as hospital and other health care facility programs.

PAHPAIA furthers FDA’s mission of fostering the development and availability of MCMs, by codifying key provisions related to: (a) maintaining an adequate, safe national blood supply, (b) the ready availability of information regarding MCM regulatory management plans, (c) support for the development and manufacture of countermeasures through the use of MCM master files, (d) a strategy for public health and preparedness and response to address cybersecurity threats that present a risk to national health security, and (e) clarifications to the scope of existing authorities related to Emergency Use Instructions, products held for emergency use, and drug development tools.

PAHPAIA also establishes and recognizes key interagency collaborations between FDA and other interagency partners by formalizing FDA membership, roles, and responsibilities in the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), as well as multiple national advisory committees on disasters.

Related links (PAHPAIA)

S.1379 (PDF, 320 KB)Public Law 115-92 (H.R.4374)

**Amendment to authorize additional emergency uses for medical products to reduce deaths and severity of injuries caused by agents of war, and for other purposes**

Public Law 115-92, enacted December 12, 2017, amended section 564 of the FD&C Act to allow for emergency uses of medical products for threats in addition to biological, chemical, radiological, or nuclear agent(s), to include other agents that may cause or are associated with, an imminently life-threatening and specific risk to the U.S. military forces.  Public Law 115-92 also authorized the Department of Defense (DoD) to request, and FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel.

On January 16, 2018, FDA and DoD announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended for deployed American military personnel.

On November 2, 2018, FDA and DoD announced the signing of a Memorandum of Understanding (MOU), to provide the framework under which FDA and DoD will implement the law.

Related Links (Public Law 115-92)

H.R.4374
	FDA/DoD Collaborations - Enhanced Engagements for Products Relevant to DoD
	Initial Work Plan for Products Relevant to the Department of Defense (PDF, 115 KB, January 2018)
	MOU Concerning Coordination with FDA Regarding DoD Medical Product Development and Assessment (MOU 225-19-001)
	Public Law (PL) 115-92 - information from DoD21st Century Cures Act

On December 13, 2016, the 21st Century Cures (Cures) Act (H.R. 34; PL: 114-255) was signed into law. For more general information about Cures, see the FDA Cures Act main page. Many provisions of the law that are intended to facilitate the development of medical products will facilitate development of medical countermeasures (MCMs).

Related Links (Cures)

H.R. 34; PL: 114-255
	21st Century Cures Act information from FDA
	MCM-Related Cures ProvisionsPandemic 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. PAHPRA provisions focusing on FDA's interactions with government and industry working to develop MCMs help ensure that FDA personnel involved in review of applications for MCMs have sufficient background information, training, and expertise.

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 KB)
	Information about PAHPRA
	PAHPRA Q&A (Archived - PDF, 250 KB)
	Summary of PAHPRA’s medical countermeasure provisions
	MCM emergency use authorities
	Emergency Use Authorization
	Emergency use of approved MCMs
	Emergency dispensing orders and Emergency Use Instructions
	Expiration dating extension
	Summary of Process for EUA Issuance
	FDA review and professional development activities*back to top*

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) [now the Administration for Strategic Preparedness & Response]. 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 KB) - PAHPA*back to top*

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 – PREP Act
	PREP Act information from HHS, including PREP Act declarations and amendments
	PREP Act Questions and Answers (HHS)
	PREP Act Glossary of Terms (HHS)
	Health Resources and Services Administration (HRSA) Countermeasures Injury Compensation Program*back to top*

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 KB)
	MCM emergency use authorities
	HHS Biomedical Advanced Research and Development Authority (BARDA)*back to top*

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.

Related Links (Bioterrorism Act)

Public Law 107-188—Jun. 12, 2002
	Counterterrorism at FDA*back to top*

Related Links

What are Medical Countermeasures?
	Publications and Reports

                                                                                  Content current as of:
      05/12/2023
              
              
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			  21st Century Cures Act of 2016
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			       			    			       Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
			       			    			       Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
			       			    			       Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)MCM Legal, Regulatory and Policy Framework

          
                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends?
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