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).
On this page:
- Facilitating development of medical products, including MCMs
- MCM-specific Cures provisions
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:
- Encourage complex adaptive and other novel trial designs,
- Foster potential use of real-world evidence,
- Establish a Limited Populations Antibacterial and Antifungal Drug program,
- Encourage medical device innovations, and
- 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”).
Note: FDA intends to withdraw the relevant guidance document on waivers of informed consent for minimal risk studies after proposed regulations to implement section 3024 of the 21st Century Cures Act become effective. The comment period for the proposed regulations was extended until February 13, 2019 and subsequently reopened until March 7, 2019.
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:
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:
- Authorize emergency use of unapproved animal drugs or unapproved uses of approved animal drugs,
- 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
- 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.
Draft guidance: Material Threat Medical Countermeasure Priority Review Vouchers issued January 17, 2018. (Federal Register notice)
Second, section 3086 of the Cures Act adds section 565A of the FD&C Act (21 U.S. Code § 360bbb–4a) (PDF, 141 KB) for FDA to establish a 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:
- 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;
- Eligible for priority review;
- Approved after the date of enactment of the Cures Act (December 13, 2016); and
- For a human drug, no active moiety (defined at 21 CFR 314.3) of which has been approved in any other application under section 505(b)(1) of the FD&C Act, or for a biological product, no active ingredient of which has been approved in any other application under section 351 of the PHS Act.
Section 565A of the FD&C Act contains a sunset provision. After October 1, 2023, FDA is no longer authorized to award any material threat MCM PRVs. Material threat MCM PRVs that have already been awarded do not expire and may continue to be redeemed after October 1, 2023.
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 PHEMCE Strategy and Implementation Plan 2022 (PDF, 540 KB), published in October 2022, high-priority threats are listed in Appendix B.) 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.
On October 7, 2022, FDA announced the fee rate for using a PRV, including material threat MCM PRVs, for fiscal year (FY) 2023. The FD&C Act, as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat MCM priority review voucher.
These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, 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 priority review fee rate for FY 2023 at $1,524,039 and outlines FDA's process for implementing the collection of priority review user fees. This rate is effective on October 1, 2022, and will remain in effect through September 30, 2023.
|Date PRV issued||Voucher number||Product||Product sponsor*||Federal Register notice (when available)|
|July 13, 2018||208627||TPOXX (tecovirimat)||SIGA Technologies Inc.||FR notice (April 1, 2019)|
|September 24, 2019||25678||Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating||Bavarian Nordic A/S||FR notice (October 9, 2019)|
|October 14, 2020||761169||INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn)||Regeneron Pharmaceuticals, Inc.||FR notice (May 2, 2022)|
|October 22, 2020||214787||Veklury (remdesivir)||Gilead Sciences, Inc.||FR notice (April 29, 2022)|
|December 21, 2020||761172||Ebanga (ansuvimab-zykl)
Also see: FDA approves treatment for ebola virus
|Ridgeback Biotherapeutics, LP|
|June 15, 2021||125730||STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen—dsat)||Stratatech, a Mallinckrodt Company||
FR notice (July 13, 2021)
|August 23, 2021||125742||Comirnaty (COVID-19 Vaccine, mRNA)
Also see: FDA Approves First COVID-19 Vaccine
|BioNTech Manufacturing GmbH||
FR notice (February 17, 2022)
|January 31, 2022||125752||SPIKEVAX (COVID-19 Vaccine, mRNA)||ModernaTx, Inc.||
FR notice (February 17, 2022)
|May 25, 2023||217188||Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use)||Pfizer, 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.
|Product for which MCM PRV was redeemed||Application number||Approval date||Product sponsor||Federal Register notice (when available)|
|Mounjaro (tirzepatide) injection||NDA 215866||May 13, 2022||Eli Lilly and Co.||FR notice (August 29, 2022)|
Note: A voucher can be used to obtain a priority review for a subsequent human drug application, for any product the PRV holder chooses, submitted under section 505(b) of the FD&C Act or section 351 of the Public Health Service (PHS) Act. Thus, the products in the redeemed voucher list may not be MCMs.
- 21st Century Cures Act
- 21st Century Cures Act Deliverables
- 21st Century Cures Act Animal Care and Use in Research (from NIH)
- FDA In Brief: FDA adds four tropical diseases (Lassa fever, chikungunya virus disease, rabies, and cryptococcal meningitis) to priority review voucher program to encourage drug development in areas of unmet need (August 23, 2018)
- What are Medical Countermeasures?