7/8/2025
by Kim Benton
FDA’s announcement of a new Commissioner’s National Priority Voucher (CNPV) program has created a great deal of buzz. The reason is simple: CNPV proposes to reduce the typical 8-month (for priority review) or 12-month (regular review) review clock for BLA and NDA applications to 1- to 2-months. Information on the CNPV is currently limited to FDA’s press release, FAQ, and YouTube video.
CNPV comparison to Priority Review Voucher (PRV) programs
Most in the CGT field are at least somewhat familiar with the existing FDA Priority Review Voucher (PRV) programs, i.e., Rare Pediatric Disease PRV, Medical Countermeasures PRV, and Tropical Disease PRV. A good starting point is identification of the main differences between these programs and CNPV. For the PRVs, a voucher was awarded upon BLA or NDA approval of a product for an indication that met criteria specified in regulation. The PRV recipient could keep the voucher or sell it to another company. The PRV could be used to obtain FDA priority review for a product that would otherwise not qualify. The sale price of PRVs has averaged around $100 million and served as an incentive for developers to pursue approval of products for unmet medical needs.
The CNPV program focuses on shortening the review clock for a product that meets CNPV criteria. A company who receives the voucher cannot sell or transfer the CNPV. However, the CNPV would be valid with change in company ownership.
Criteria for CNPV
We identified differences in the general criteria that must be met to qualify for CNPV.
The FDA press release states that the FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of:
The FAQ states that that the FDA will establish national priorities such as, but not limited to:
Of note, the press release wording in the second bullet of “more innovative cures” is softened in the press release to “potential innovative therapies,” which could be interpreted as requiring a lower threshold of evidence. In the FAQ, the fourth bullet does not specify “increasing domestic drug manufacturing” as part of the point on national security. This is particularly interesting when considering that in the YouTube video, Dr, Makary specifically states that the CNPV program “will support U.S. drug developers who are addressing our most important U.S. national priorities, such as domestic manufacturing, as a national security issue, addressing an unmet public health need, or supporting pandemic preparedness." It is unclear if any of these differences are intentional, and if so, which of the resources should be considered authoritative.
Benefits
The benefits of CNPV include enhanced communication with FDA, ability to presubmit of portions of the data and BLA/NDA application as they become available, and a proposed approval decision within 1 to 2 months once the application is complete. The accelerated approval pathway may be used if applicable legal requirements are met.
Differences in data submission and FDA review approach
In addition to the pre-submission of portions of data, changes to the FDA review approach are proposed to achieve the review decision in 1 to 2 months. The proposal is convening “experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices” and that “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.” It will be a requirement to submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submission of the final portions(s) of the application.
FDA acknowledges that the 1- to 2-month timeline may not be feasible in all cases and “reserves the right to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex.”
Other points
FDA plans two categories of vouchers: product designated and product undesignated. A product designated voucher would be directed by the FDA towards a specific investigational new drug of a company. An undesignated voucher “would allow a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.” We interpret an undesignated voucher scenario as a company developing multiple qualifying product candidates receiving a CNPV, and once a lead product is identified the company would apply the voucher to that program.
The CNPV program will be implemented in 2025 and in the first year a limited number of vouchers will be awarded. Vouchers will expire within two years.
Application process
The FAQ states that information will be provided in the near future on how companies “can indicate their alignment with the FDA Commissioner’s criteria to meet national priorities” and request a CNPV.
Take homes
The CNPV program combines elements of other FDA expedited review programs with novel elements and an ambitious goal of 1 to 2 months to reach a decision on BLA and NDA applications. We eagerly await an FDA guidance document or other resources to clarify the eligibility criteria, application process, and number of vouchers that will be available in the first year of the program. We are aware that at least one company has issued a press release on their submission of a CNPV request. DHC is ready to help clients explore whether the time is right to submit a CNPV request for their products.
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