Overview
On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to significantly expedite the drug review process from the current timeline of approximately 10 to 12 months to as little as one to two months for a limited number of drugs and biologics that “align with U.S. national interests.” Voucher recipients will benefit from expanded opportunities for direct engagement with FDA subject matter experts. The CNPV pilot intends to lay the groundwork for a new and distinct fast-track review process for select pharmaceutical and biologic innovators. While the launch heralds significant opportunities for the industry, important questions remain regarding eligibility, implementation, and the potential legal and regulatory implications, which we outline below.
In Depth
Background
Since joining the FDA in April, Commissioner Marty Makary, MD, MPH, has emphasized the need for more agile, responsive review models, even suggesting that the agency could adopt what he described as “rapid or instant reviews” modeled on the accelerated review processes proven for COVID-19 vaccines under Operation Warp Speed. The CNPV is part of the FDA’s broader strategy to modernize regulatory frameworks and improve the efficiency of drug approval processes. The pilot introduces a team-based approach to reviewing drug and biologics applications. Unlike the standard review process (where applications are passed between multiple FDA offices over several months) the CNPV will bring together a multidisciplinary team of FDA experts to conduct a comprehensive review across a single day. Commissioner Makary compared the CNPV model to “tumor boards,” the fast-paced collaborative sessions between arrays of healthcare specialists that he and other oncologists rely on when determining vital treatment plans for patients.
Key features of the CNPV program
The FDA’s FAQ document describes the CNPV pilot as distinct from existing expedited review pathways and the Priority Review Voucher system. While the CNPV incorporates elements of Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review Designation, it does not replace them. Unlike these programs, the CNPV pilot will offer a unique one- to two-month timeline for review, excludes devices and combination drug-device applications from eligibility, and prohibits the sale of pilot vouchers. Although CNPVs are nontransferable, they remain valid through changes in company ownership. The CNPV pilot also introduces a novel feature: Companies may receive either a directed voucher tied to a specific investigational new drug or an undesignated voucher not linked to any particular product, which may be used at the company’s discretion before its expiration within two years. While undesignated vouchers may offer companies greater flexibility in leveraging program benefits, the FDA has yet to provide details regarding administration.
Commissioner Makary stated that the CNPV program is designed to accelerate review of critical drug applications that address urgent public health needs or strengthen the nation’s biomedical infrastructure. The FDA will award a limited number of vouchers to companies developing products that serve key US national priorities. To qualify for a voucher, a sponsor’s product or operations must support at least one of the priority areas listed below, each of which is accompanied by pertinent FDA guidance:
- Addressing a US public health crisis. One example could include developing a universal vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential.
- Delivering more innovative cures for the American people. The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body’s immune system to fight multiple diseases or transforming mental health care through a novel treatment for post-traumatic stress disorder.
- Addressing a large unmet medical need. This includes a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing the United States’ chronic disease crisis.
- Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen US supply chain resiliency. Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the US or a clinical trial that maintains robust US enrollment to support generalizability for Americans against the US standard of care.
- Increasing affordability. One example could include a company that lowers the US price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs.
Sponsors seeking a CNPV voucher must submit the Chemistry, Manufacturing, and Controls portion of a drug or biologic application and the draft labeling at least 60 days before submitting a final application for approval. The FDA emphasizes that CNPV can be applied to drug products or biologics at any stage of development. The program aims to streamline efficiencies by allowing most of the product marketing application to be submitted before clinical trials conclude. If the voucher is granted during the investigational new drug phase, the company will receive the benefits of the CNPV’s enhanced communication with sponsors. Sponsors are expected to maintain ongoing communication with the FDA throughout the CNPV review process, reflecting the agency’s emphasis on transparency and collaborative engagement. Interim reviews throughout the process will not only ensure prompt responses from the FDA but also provide drug manufacturers with opportunities to respond and correct any issues before the completion of clinical trials. The FDA reserves the right to extend the review window if the application is incomplete or if the trial results are ambiguous.
Next steps
By submitting CNPV applications that align with the FDA’s listed priorities, drug and biologic companies may benefit from expedited review processes and expanded, real-time engagement with agency experts. The FDA intends for the year-long pilot to serve as a proof of concept for innovative marketing review models and broader industry interaction frameworks that could inform a future fast-track pathway. Many questions remain, such as how the agency will apply selection criteria, the transparency of the process, and whether there will be a mechanism to review unfavorable decisions, among others. Although the FDA has pledged to issue further guidance, basic details such as the estimated number of vouchers expected through the pilot remain undisclosed. Without clear, published standards, sponsors may struggle to assess whether their product or company qualifies as a viable candidate, especially given that final discretion rests with the commissioner. Finally, the CNPV pilot may face familiar concerns tied to accelerated approval models. Some stakeholders have raised safety questions about drugs reviewed on compressed timelines, particularly in light of FDA resource constraints. Nonetheless, the FDA states that safety and efficacy standards will not be compromised under the CNPV.
McDermott will continue to monitor the rollout of the year-long CNPV pilot, including additional guidance, potential extensions of the initiative, or the establishment of a permanent national priority pathway. For more information on applying for a CNPV or about FDA review processes, please contact a member of McDermott’s Food, Drug & Medical Device Regulatory Group.
Amanda Lee, a summer associate in the Washington, DC, office, also contributed to this article.
