The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) contains key legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats.
The new law also recognizes the key role FDA plays in public health emergency preparedness and response. Its provisions further FDA’s mission of fostering the development and availability of drugs, vaccines, and devices (also referred to as medical countermeasures, or MCMs) for use in these emergencies. PAHPRA also builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development.
Together, these new authorities for FDA will not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but will also help to facilitate MCM development and the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat. FDA is implementing the new provisions in PAHPRA to support our nation’s preparedness and response capabilities, and continues to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.
PAHPRA Legislative Information
- Public Law 113-5 (PDF, 284K)
- Summary of PAHPRA’s MCM provisions
- PAHPRA Questions and Answers (web version)
- PAHPRA Questions and Answers (printable PDF, 762K)
- PAHPRA information from the HHS Assistant Secretary for Preparedness and Response
Emergency Use of MCMs
- MCM emergency use authorities
- Current Emergency Use Authorizations
- Summary of process for EUA issuance
- Emergency use of approved MCMs
PAHPRA Authorities Related to MCM Development
- FDA review and professional development activities
- PAHPRA’s provisions related to development of MCMs under the Animal Rule
- More Animal Rule information