Emergency Preparedness and Response

21st Century Cures Act: MCM-Related Cures Provisions

On December 13, 2016, the 21st Century Cures (Cures disclaimer icon) 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).

Laptop, gavel and stethoscope, representing medical product-related legislationOn this page:

Facilitating development of medical products, including MCMs

Many provisions of Cures Act law that are intended to facilitate the development of medical products will facilitate development of MCMs. Examples include provisions to:

  1. Encourage complex adaptive and other novel trial designs, 
  2. Foster potential use of real-world evidence,
  3. Establish a Limited Populations Antibacterial and Antifungal Drug program,
  4. Encourage medical device innovations, and
  5. Harmonize FDA human subjects protections including waivers of informed consent for minimal risk studies with the Federal Policy for the Protection of Human Subjects (“Common Rule”).

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MCM-specific Cures provisions

In addition, the Cures Act included MCM-specific provisions (Subtitle H). Among other things, these sections include provisions (1) to waive certain requirements of the Paperwork Reduction Act during a public health emergency, (2) to streamline BARDA’s procurement processes, and (3) for BARDA to enter into an agreement with an independent, nonprofit entity to support MCM development.

There are two FDA-specific MCM provisions:

EUA authority

First, section 3088 of the Cures Act amends FDA’s Emergency Use Authorization (EUA) authority (section 564 of the FD&C Act) to permit EUAs that: 

  1. Authorize emergency use of unapproved animal drugs or unapproved uses of approved animal drugs,
  2. Make applicable other emergency use authorities (e.g., to issue emergency dispensing orders, waive compliance with Current Good Manufacturing Practices, make available CDC Emergency Use Instructions, and extend expiration dates) to approved animal drugs, and
  3. Allow unapproved animal drugs to be held for emergency use.

Although the FDA’s guidance Emergency Use Authorization of Medical Products and Related Authorities (2017) does not specifically reference animal drugs, its recommendations apply to this new authority.  FDA intends to address any novel questions or issues over time as we develop more experience with animal drug EUAs.

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MCM priority review voucher program

Draft guidance: Material Threat Medical Countermeasure Priority Review Vouchers issued January 17, 2018. (Federal Register notice)

Also see: FDA In Brief: FDA takes steps to spur development of medical countermeasures needed to protect, prepare for emerging threats to public health and national security (January 17, 2018)

Printable PDF (174 KB)

Second, section 3086 of the Cures Act adds section 565A of the FD&C Act for FDA to establish a new priority review voucher (PRV) program for material threat MCMs. Upon approval of a material threat MCM application, FDA will award a PRV provided certain criteria are met.  The PRV may in turn be used by the sponsor who receives it, or sold to another sponsor who may then use it, to obtain priority review for a product application that would otherwise not receive priority review. When a marketing application receives a priority review designation, FDA’s goal is to take action on that application within 6 months, as compared to 10 months under standard review. Thus, a PRV enables a product developer to potentially bring a product to market sooner than it would under the standard review time, which is valuable to product developers.

To be considered for a material threat MCM PRV, the MCM application must be:

  1. Intended for use to prevent or treat harm from a biological, chemical, radiological, or nuclear agent (or harm caused by an MCM used against such agent) determined by the Department of Homeland Security to be a material threat;
  2. Eligible for priority review;
  3. Approved after the date of enactment of the Cures Act (December 13, 2016); and
  4. For a drug for which an active ingredient has not been previously approved by FDA.

HHS, within its annual Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Strategic Implementation Plan, publishes a list of high-priority threats including those that the Secretary of Homeland Security determines to pose a material threat sufficient to affect national security.  (In the 2017-2018 plan (PDF, 986 KB), high-priority threats are listed on page 8 in Box 1.) For additional information about whether or not a specific CBRN agent is an identified material threat for purposes of assessing whether an MCM may qualify for a PRV under section 565A(a)(4)(i) contact OCET.

Although the material threat MCM PRV program is separate and distinct from FDA’s other PRV programs, FDA intends to implement the law consistently with implementation of the other PRV programs. In fact, some of the diseases listed under FDA’s Tropical Disease PRV program are also identified as material threats. (Note that the statute does not permit the same application to receive a voucher under more than one program.)

FDA issued a draft guidance: Material Threat Medical Countermeasure Priority Review Vouchers (PDF, 174 KB) on January 17, 2018 to address MCM-specific issues.  FDA has also issued guidance to address questions related to the Tropical Disease PRV program (PDF, 193 KB) and to the Rare Pediatric Disease PRV program.

Fee for using a material threat MCM PRV in FY 2019

On September 26, 2018, FDA announced the fee rate for using a material threat MCM PRV for fiscal year (FY) 2019. The FD&C Act, as amended by the Cures Act, authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM PRV.

These vouchers are awarded to the applicants of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM PRV is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY.

The Federal Register notice establishes the material threat MCM priority review fee rate for FY 2019 at $2,457,140 and outlines FDA's procedures for payment of material threat MCM priority review user fees. This rate is effective on October 1, 2018, and will remain in effect through September 30, 2019.

Material threat MCM PRVs issued

 Date PRV issued Voucher number Product Product sponsor* Federal Register notice (when available)
 July 13, 2018 208627

 TPOXX (tecovirimat)

Also see: FDA approves the first drug with an indication for treatment of smallpox

 SIGA Technologies Inc. 

*For purposes of reporting, the product sponsor to whom the PRV was initially awarded is listed here. If the original product sponsor decides to transfer the PRV, it is the responsibility of the original product sponsor, and the sponsor to whom the PRV is transferred, to document the action(s) with a letter of transfer. These letters should be included in the application submitted by the sponsor redeeming the PRV. A transferred PRV cannot be redeemed unless a complete record of transfer is made available to FDA.

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Page Last Updated: 10/01/2018
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