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  1. MCM Legal, Regulatory and Policy Framework

Summary of PAHPRA's MCM Provisions


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 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 clarified and added to FDA’s existing authority under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) (21 USC 360bbb-3) 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. 

PAHPRA amendments to section 564 included the following:

Refinements to existing Emergency Use Authorization (EUA) requirements, including:

  • Provided 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 [Sec. 564(b)(1) of the FD&C Act]
  • Allowed 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]
  • Expanded 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]
  • Expressly permitted 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]

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Governmental pre-positioning

  • Permitted federal, state, and local governments to pre-position MCMs in anticipation of FDA 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]

PAHPRA authorities for emergency use of medical products 

  • Empowering FDA to extend the expiration dating/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]
  • Allowed the Centers for Disease Control and Prevention (CDC) to create and issue, and government stakeholders to disseminate, special emergency use instructions (EUI) (also referred to as fact sheets for recipients of an MCM and for health care professionals) about the FDA-approved conditions of use for such MCMs before a CBRN event occurs [Sec. 564A(e) of the FD&C Act]
  • Permitted FDA to waive otherwise applicable manufacturing requirements (current Good Manufacturing Practices (cGMPs)), such as storage or handling, to accommodate emergency response needs [Sec. 564A(c) of the FD&C Act]
  • Allowed emergency dispensing (including mass dispensing at a point of dispensing (POD)) of MCMs during an actual CBRN emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by FDA [Sec. 564A(d) of the FD&C Act]
  • Expanded 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]

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Expiration dating extensions

  • Empowered FDA to extend the expiration dating/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 MCM authorities for FDA not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but 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.

PAHPRA provisions focusing on FDA’s interactions with government and industry working to develop MCMs, including:

  • Expanded 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]  – also see Special Protocol Assessment Guidance for Industry (PDF, 182 KB)
  • Established a procedure whereby FDA will meet with MCM sponsors developing certain animal models [Sec. 565(d) of the FD&C Act]
  • Ensures 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. 565(b)(3) of the FD&C Act]
  • Maintains teams with expertise on MCMs to help to identify and resolve scientific issues that may present obstacles to product development and approval [Sec. 565(b)(4) of the FD&C Act]
  • Finalized guidance on the development of animal models for purposes of establishing claims of efficacy [Sec. 565(c) of the FD&C Act] - - Note: the guidance was finalized in October 2015: Product Development Under the Animal Rule (PDF, 574 KB) - also see Animal Rule Information
  • Developed 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]
  •  Ensures that pediatric experts are consulted and the needs of pediatric populations are appropriately considered in developing MCMs [Sec. 307 of PAHPRA]

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FDA is implementing PAHPRA's MCM-related provisions 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.

For more information, visit our main PAHPRA page, or email AskMCMi@fda.hhs.gov

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