Emergency Preparedness and Response
About the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) (PDF, 284.20 KB) 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 emergency preparedness and response. It has provisions that further FDA’s mission of fostering the development and availability of medical products, including drugs, vaccines, and devices, for use in these emergencies, also referred to as medical countermeasures (MCMs).
Specifically, PAHPRA clarifies and adds to FDA’s existing authority under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 141.88 KB) to support preparedness efforts and rapid response capabilities for a range of stakeholders, such as federal partners like the Department of Defense and the Centers for Disease Control and Prevention, as well as state and local public health agencies in the event of a CBRN or emerging infectious disease emergency. Amendments to section 564 include the following:
- Refinements to existing Emergency Use Authorization (EUA) requirements, including:
o Provides clearer authority for FDA to issue EUAs--before a CBRN emergency occurs--to enable stakeholders to prepare for use of unapproved medical products, or unapproved uses of approved products, if certain criteria are met (referred to as pre-event EUAs) [Sec. 564(b)(1) of the FD&C Act]
o Allows FDA to issue an EUA based on the HHS Secretary’s determination that there is a potential for a public health emergency involving a CBRN threat agent (not only based on an actual emergency) [Sec.564(b)(1)(C) of the FD&C Act]
o Expands the time period for collection and analysis of information about an MCM’s safety and effectiveness for a reasonable period beyond the effective period of the EUA [Sec.564(e)(1)(B)(iii) of the FD&C Act]
o Expressly permits FDA, as part of issuance of an EUA, to categorize the complexity of an in vitro diagnostic device to indicate whether the test can be performed at a point-of-care setting or only in a more sophisticated laboratory [Sec.564(m) of the FD&C Act]
- Governmental Pre-Prepositioning–Permits federal, state, and local governments to pre-position MCMs in anticipation of approval or clearance, or issuance of an EUA to enable them to better prepare for potential rapid deployment during an actual CBRN emergency [Sec. 564B of the FD&C Act]
- New Authorities for Emergency Use of Medical Products–Establishes streamlined mechanisms to facilitate certain MCM preparedness and response activities without having to issue an EUA (which can be a time- and resource-intensive process). These new tools, applicable to eligible FDA-approved medical products intended for use during a CBRN emergency, include:
o Allowing a designated HHS official/unit to create and issue, and government stakeholders to disseminate, special emergency use instructions about the FDA-approved conditions of use for such MCMs before a CBRN event occurs [Sec. 564A(e) of the FD&C Act]
o Permitting FDA to waive otherwise applicable manufacturing requirements, such as storage or handling, to accommodate emergency response needs [Sec. 564A(c) of the FD&C Act]
o Allowing mass dispensing of MCMs during an actual CBRN emergency event, without requiring an individual prescription for each recipient of the MCM, if permitted by state law or if in accordance with an order issued by the HHS Secretary [Sec. 564A(d) of the FD&C Act]
o Expanding the current waiver authority for risk evaluation and mitigation strategies (REMS) to encompass any element for MCMs to mitigate the health effects of a CBRN emergency [Sec. 505-1 of the FD&C Act]
- Shelf-Life Extension–Expressly empowers FDA, without having to issue an EUA, to extend the shelf-life of an eligible FDA-approved MCM stockpiled for use in a CBRN emergency, and to require appropriate conditions relating to such extensions, such as appropriate storage, sampling, and labeling. [Sec. 564A(b) of the FD&C Act]
Together, these new MCM authorities for FDA will not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but will also facilitate the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat.
PAHPRA also codifies and builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development. New provisions focus on FDA’s interactions with government and industry working to develop MCMs, including by:
- Expanding current Special Protocol Assessment authorities to require FDA to meet with sponsors on the design and size of pivotal animal studies supporting claims of efficacy [Sec. 505(b)(5)(B) of the FD&C Act]
- Establishing a procedure whereby FDA will meet with MCM sponsors developing animal models [Sec. 565(d) of the FD&C Act]
- Ensuring that FDA personnel are appropriately involved in interagency activities related to MCM advanced research and development, and that those who are involved in review of applications for MCMs have sufficient background information, training, and expertise [Sec. 505(b)(3) of the FD&C Act]
- Maintaining teams with expertise on MCMs to help to identify and resolve scientific issues that may present obstacles to product development and approval [Sec. 505(b)(4) of the FD&C Act]
- Finalizing guidance on the development of animal models for purposes of establishing claims of efficacy [Sec. 505(c) of the FD&C Act]
- Developing formal processes for sponsor interactions and the development of Regulatory Management Plans for certain high-priority MCMs [Sec. 565(f) of the FD&C Act]
- Ensuring that pediatric experts are consulted and the needs of pediatric populations are appropriately considered in developing MCMs [Sec. 307 of PAHPRA]
FDA looks forward to implementing the new provisions in PAHPRA to support our nation’s preparedness and response capabilities, and continuing to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.
More information about PAHPRA, FDA’s MCMi, and related questions is available on this Web site or you may contact: AskMCMi@fda.hhs.gov.