On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug developers to participate in a priority review process aimed at reducing the review time for a final drug application to 1-2 months after submission. While we await additional details and mechanics, we break down the components of this program below.
Who Is Eligible to Participate?
With a roll-out later in 2025, FDA Commissioner Marty Makary M.D., M.P.H. will grant a limited number of vouchers to companies aligned with national health 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. The program is open to "drugs in any area of medicine," but does not apply to devices or combination products.
Once a CNPV is granted, the sponsor will receive "enhanced communication benefits" and interim reviews throughout the remainder of the regulatory process. In exchange, sponsors must uphold their end of the bargain by being available for "ongoing communication with prompt responses to FDA inquiries" throughout the review process, which is similar to sponsor obligations under other existing expedited review programs like breakthrough therapy designation.
How Will the CNPV Review Process Unfold?
According to the press release, under the CNPV process, "[c]linical 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." However, at least 60 days before this official review begins, sponsors will be required to submit the chemistry, manufacturing, and controls portion of the application, meaning that the entire review will be targeted for completion in 3–4 months.
Is CNPV Really a "Voucher" Program?
Despite sharing a similar name, the FDA-created CNPV has little in common with FDA's three priority review voucher (PRV) programs designed to powerfully incentivize novel treatments for rare pediatric diseases (21 U.S.C. § 360ff), tropical diseases (21 U.S.C. § 360n), and material threat medical countermeasures (21 U.S.C. § 360bbb-4a) that Congress established. Critically, according to the CNPV program's FAQs webpage, unlike the three PRV programs, the CNPV vouchers cannot be transferred to another company and expire within two years of issuance. Use of the CNPV appears in most cases to be limited to the product that has been designated—however, in an interesting wrinkle, the FDA stated that it can issue an undesignated voucher, giving the company its choice of what new drug it will use the voucher for, provided it is consistent with the program's objectives. Without the market incentive that transferability of a PRV creates, the incentive-based model underlying the statutory PRV programs is absent here, as is a direct connection to any specific (or articulated) public health treatment gap. Congress may have something to say about this.
Also worth noting, is that the CNPV is intended to supplement rather than replace other existing programs and incentives, meaning that a single product could qualify for accelerated approval, be eligible to receive a PRV, and be selected for the CNPV program.
The Mechanics of the Program Are Forthcoming
While the aim of the CNPV is admirable, it has the potential to create tension between the aggressive review timelines and the FDA's responsibility to carefully evaluate the safety and efficacy of each new drug and biologic application before release to patients. For context, FDA's original "priority review" program negotiated under the PDUFA framework (also instituted by Congress through direct negotiations between the Agency and industry leadership) utilizes a 6-month review. In its press release, the FDA indicated it will have discretion to extend CNPV deadlines as needed to consider complex issues and resolve missing data, and presumably, the Commissioner could also elect to omit certain products from the program if they are deemed too complex for the CNPV review cycle. We are interested to see how these timelines unfold.
Another interesting question is whether being designated for CNPV could potentially satisfy the requirement of being designated for priority review that is a prerequisite for each of the three PRV programs, or whether a sponsor receiving a CNPV would also need to be designated for priority review to be eligible for a PRV (in which case a sponsor could achieve the mind-boggling trifecta of a priority voucher, priority review, and a priority review voucher).
And finally, many operational aspects are unknown, including how and when companies can apply for a voucher, how many vouchers may be awarded, and how the FDA will articulate the eligibility criteria and evaluate applications against it. The FDA indicated it will provide additional details "in the near future," and we look forward to finding out what Commissioner Makary has in mind and whether this program is formalized in FDA guidance, rulemaking, or embedded in legislation on Capitol Hill. While the press release of this important program is exciting news for FDA-regulated product developers, the details matter before this becomes a core component of your regulatory strategy.
With over 17 years of experience with PRVs—having a leading role in the tropical and material threat medical countermeasure programs—our legal team is ready to support your ongoing analysis of this announcement and the existing statutory programs. Our Medical Device and Food and Drug Law Groups will monitor all developments related to the CNPV program and will provide new updates as new information becomes available. Please contact the authors today with any questions.