The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced on June 17, 2025, the creation of a new initiative called the "Commissioner's National Priority Voucher" (CNPV) program. Agency leaders have said the program will provide increased communication and a faster regulatory timeline for eligible drugs.
Overview of CNPV Program
According to the agencies' announcement, starting this year, the CNPV program will grant a limited number of vouchers to companies seeking FDA approval for drug products that are "aligned with U.S. national priorities," which include but may not be limited to: addressing a health crisis in the U.S., delivering more innovative cures for Americans, addressing unmet public health needs and increasing domestic drug manufacturing to support national security. The CNPV program intends to reduce review time for new drug products to approximately one to two months following submission of a new drug application – significantly less time than Prescription Drug User Fee Act timelines, which vary from six to 12 months after submission.
The program intends to offer enhanced and accelerated communications to companies who receive a voucher, with the announcement emphasizing that the program will incorporate "team-based" review processes for submissions, pre-reviews of submitted data and information, a one-day meeting of multidisciplinary specialists to weigh in on a submission, as well as post-market communications. Companies that receive a voucher may also qualify for accelerated approval, but only if companies submit certain chemistry, manufacturing and controls (CMC) information and draft labeling to the FDA within 60 days of the final application submission. Companies must also be available for "ongoing" and "prompt" communications with the FDA.
According to an FAQ document posted by the FDA, vouchers granted through the program may be applied to drugs in any area of medicine and to a drug at any stage of development. Devices or combination drug-device applications are not eligible for the CNPV program at this time. Additional information about the application process – including when the application period opens and closes, where and how companies may submit applications, as well as technical information about how a product may meet national health priorities – was not shared in the initial announcement and is expected to be forthcoming. Importantly, vouchers awarded through the CNPV program are non-transferable but would appear to remain valid through changes in company ownership, indicating a substantial chance for increased mergers and acquisitions (M&A) activity moving forward.
Key Considerations
Some details about the program remain unclear. For example, missing from the announcement of the program and subsequent FAQ document is any mention of the statutory authorities the program seeks to operate under or whether the FDA plans to issue implementing regulations. Existing Priority Review Voucher (PRV) programs, including the Tropical Disease PRV1, the Pediatric PRV2and the Medical Countermeasures PRV3, are codified in statute, although two of the three have had their authorities lapse due to congressional inaction on extending the programs.
Given the Trump Administration's efforts to alter drug policies through administrative actions, the announcement of the CNPV program could be a signal to the pharmaceutical industry that the Trump Administration aims to follow through on its promises to improve existing regulatory processes and create new approval pathways to speed Americans' access to new drugs. In particular, the program provides preferences to companies potentially manufacturing or developing their products in the U.S. and for U.S. patients. Nonetheless, several questions about how the program will work remain.
Footnotes
1. FDA Amendments Act of 2007.
2. FDA Safety and Innovation Act (FDASIA) of 2012.
3. 21st Century Cures Act of 2016.
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