On June 17, 2025, the U.S. Food and Drug Administration (FDA) announced the Commissioner's National Priority Voucher (CNPV) program. Though little information was provided about the logistics of the program, its stated aim is to enhance health interests of Americans and reduce inefficiencies by accelerating drug reviews. Specifically, while this is not a "voucher" in the traditional sense commonly understood in the industry, this "novelty priority program" does represent a potential new and expedited regulatory pathway for eligible drug developers.
CNPV Program in Action
The CNPV program allows developers who receive the voucher to shorten the FDA review process from FDA's approximated 10-12 months to just 1-2 months after submitting a final drug application, with the Agency being able to extend such period if the submitted data is insufficient, incomplete, ambiguous, or complex.
Once a voucher has been granted, it can be designated for a company's specific investigational new drug or granted to a company as undesignated, allowing companies flexibility and discretion in its use. A voucher granted under the CNPV program can also be applied to a product at any stage in development. For example, under the CNPV program, companies will be able to submit the majority of the drug application before a clinical trial is complete.
Once information has been submitted for use with the voucher, a multidisciplinary team of FDA experts will conduct a streamlined, team-based review instead of the traditional method that involves multiple offices. Stated differently, "clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day 'tumor board style' meeting." The CNPV program will also include "enhanced communication benefits" to sponsors throughout the review process and the potential for accelerated approval to be granted if the product for which the voucher is used meets all applicable legal requirements.
Who, What, and When
FDA plans to begin granting vouchers under the CNPV program in 2025, though exact timing has not been provided. FDA will initially offer a limited number of vouchers under the CNPV program during a 1-year pilot phase to companies that align with U.S. national health priorities of:
- Addressing a health crisis in the U.S.
- Delivering more innovative cures for the American people.
- Addressing unmet public health needs.
- Increasing domestic drug manufacturing as a national security issue.
Notably, while the CNPV program can apply to drugs in any area of medicine, it does not currently apply to devices or combination drug-device applications. Additionally, a voucher granted under the CNPV program must be used within two years following receipt from FDA or else it will expire.
Salability and Transferability
As noted, a voucher granted under the CNPV program is not a "voucher" in the traditional sense commonly understood in the industry. In fact, FDA has acknowledged in its FAQs that while the CNPV program contains some of the elements of the priority review programs and Priority Review Voucher, there are distinct differences such as timeline for the review, product designated and product undesignated subtypes, and the "prohibition on the sale of the voucher." Significantly, vouchers granted under the CNPV program are non-transferable, though they will remain valid through changes in company ownership.
How to Qualify and Apply
FDA has not made clear exactly how drug developers can apply for the CNPV program, but states that information will be provided in the near future "on how companies seeking to apply can indicate their alignment with the FDA Commissioner's criteria to meet national priorities." FDA did, however, provide basics on how to qualify for the CNPV program.
To do so, sponsors must submit specific application components at least 60 days prior to the final application submission and also be available for and maintain prompt responses to FDA inquiries throughout the review process.
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