FDA Announces Commissioner’s National Priority Vouchers To Facilitate Expedited Access To Certain Drugs

On June 17, 2025, the U.S. Food and Drug Administration (FDA or the Agency) announced its new Commissioner’s National Priority Voucher (CNPV) program. Under the CNPV program, FDA may grant priority review to U.S. drug companies “aligned with U.S. national priorities” that could significantly expedite access to innovative therapies. General details about the CNPV program were made available in a press release, accompanying FAQ, and message by FDA Commissioner Makary posted on X, but more information is expected from the Agency.¹

According to the Agency, a CNPV may be redeemed by a U.S. drug company for priority review of a drug application and enhanced communications with the Agency. This new priority review could shrink the total time to decision of a New Drug Application (NDA) or Biologics License Application (BLA) to 1-2 months. By comparison, the standard review time is 10-12 months or, for FDA’s traditional priority review, six months. FDA provided little information about how it might accomplish this ambitious goal, other than to note that it would:

• Allow the company to submit the majority of its drug application before completing clinical trials.
• Assemble a cross-functional team of reviewers from FDA offices who will pre-review the submitted information before gathering for a one-day “tumor board style” meeting.
• If appropriate, grant the product accelerated approval (i.e., approval based on an effect on a surrogate or intermediate endpoint that is reasonably likely to predict a clinical benefit, and a condition to complete one or more adequate and well-controlled clinical trials to verify and describe the drug’s anticipated clinical benefit).²

A limited number of CNPVs will be issued to U.S. companies that are addressing the “most important U.S. national priorities.” More CPNVs may become available after the first pilot year of the program. To be eligible for a CNPV, companies must:

1. Be aligned with U.S. national health priorities. FDA’s press release recognized priorities such as: (1) addressing a health crisis in the U.S.; (2) delivering more innovative cures for the American people; (3) addressing unmet public health needs; and (4) increasing domestic drug manufacturing as a national security issue. Makary’s video message also named supporting pandemic preparedness as another.
2. Submit a CNPV application to FDA.
3. Submit the chemistry, manufacturing, and controls (CMC) portion of their drug application and draft labeling at least 60 days before submitting their final application.
4. Be available for ongoing communications with FDA during the CNPV review process.

The CNPV that is issued will be designated for a specific investigational new drug or as an undesignated priority review grant that can be used at the company’s discretion and consistent with the program’s objectives. The CNPV will expire two years from the date of receipt. The CNPV program itself is separate and not mutually exclusive with FDA’s existing Priority Review and Priority Review Voucher (PRV) programs. Unlike those congressionally authorized programs, these priority review grants would not be transferrable, except in a change of company ownership. No CNPVs are available for devices or drug-device combination products. The latter is potentially a substantial carveout considering that drugs and biologics increasingly are delivered in devices (e.g., pre-filled syringes), which generally renders them drug-device combination products.³

Reactions from members of Congress have been limited thus far, with many staff awaiting additional details from the Agency regarding implementation. Notably, the Chair of the Senate Health, Education, Labor and Pensions Committee, Sen. Bill Cassidy (R-LA), which has jurisdiction over FDA, called the announcement “great news,” and went on to say that “[c]reating new incentives for drug development while addressing inefficiencies in the review process means Americans will benefit from reliable and innovative treatments that lead to a healthier life.”⁴ FDA officials have maintained that the CNPV program does not need congressional authorization but have said that legislation could make the approach more consistent. While FDA has indicated that the CNPV program is distinct from other PRV programs, the impact on the outstanding reauthorizations of the Pediatric Priority Review and Material Threat Medical Countermeasure vouchers is unclear at this time.

While we await further guidance to be released, given the constraints on Agency guidance-drafting, rulemaking, and communication, we wanted to identify a few key areas of uncertainty that potential CNPV applicants should try to clarify in interactions with the Agency. Although the concept of an additional priority review program is promising, significant legal and procedural questions remain unanswered.

First, it is unclear whether FDA intends to identify “national health priorities” in a transparent manner, free from the political debate surrounding specific interventions such as vaccines. The Agency’s FAQs suggest further information will be forthcoming on that process, and it will be important to see whether the criteria are ones that the Agency can adopt without notice-and-comment rulemaking.

Second, many of the proposed tools seem to be ones that FDA already leverages (e.g., rolling submission is already part of products designated for fast track review and FDA already engages in significant cross-functional review activities) and will be iterated to make progress on shortening review timelines. And, FDA has acted extraordinarily quickly at times in reviewing and approving certain breakthrough products, particularly for smaller populations. That said, given recent staffing and resource constraints at the Agency, it may be difficult for the Agency’s 1-2 month review timeline to be achieved for many products in practice without some compromises in the review process. For instance, FDA notes that proposed drug labeling must be submitted at least 60 days prior to the remainder of the application. However, labeling often changes over the course of a review (which is why label reviews take place toward the end). It is also uncertain whether the review timeline builds in enough time for companies to address any deficiencies or respond to FDA’s requests for additional information. Perhaps the Agency is testing artificial intelligence-based review options to meet these deadlines,⁵ but the specifics of how existing timelines and review goals will be met remain unclear.

Finally, many critical details about the program remain unclear. FDA has not yet disclosed critical operational details or addressed complicated considerations on CNPVs, including:

• Which drug companies qualify as “U.S.”
• How many priority review grants will be available.
• What criteria the Agency will use to prioritize companies and products if the number of eligible companies exceeds supply.
• What information and fees will be required for a CNPV application.
• When can companies expect to receive FDA’s determination after applying.
• How will FDA determine whether to issue a designated or an undesignated CNPV.
• What information will FDA make public about the companies and products selected for the CNPV program, and about how they were chosen.
• What infrastructure or capabilities companies will need to invest in to successfully participate in the CNPV program.
• How the diversion of resources will affect the Agency’s ability to meet its user fee goals for products that have not been selected.

In addition, a number of competitive concerns may be raised as a result of CNPV usage, such as whether a CNPV-approved product will be eligible for regulatory exclusivity and, if so, whether that approval may block the FDA from approving another product already undergoing premarket review. Moreover, companies counting on obtaining the historical value of a transferable PRV under current statutory PRV programs may find that the availability of these FDA-created CNPVs creates lower demand for such vouchers.

We will continue to monitor FDA developments relating to the CNPV program, including information that resolves the open questions. If you have any questions or would like more information, please reach out to one of the authors of this Advisory or your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.