And We’re Off: FDA Announces That the Commissioner’s National Priority Voucher Program is Open for Applications
July 23, 2025We blogged recently about the new Commissioner’s National Priority Voucher (“CNPV”) program, noting that we were eagerly awaiting additional details. On July 22, 2025, FDA announced some of these additional details and opened the CNPV program for applications.
These additional details are to be found on FDA’s new webpage for the CNPV program, along with a program submission form and an updated FAQ. As a reminder, the CNPV pilot program is designed to reduce application review times to 1-2 months following final submission of an application. The voucher also entitles the company to benefits such as enhanced communication and rolling review, which would enable the shorter review time once the application is submitted.
The new webpage provides further color on the reasons for the CNPV program. The webpage describes high rates of obesity and other health conditions among American youth and overreliance on China for active pharmaceutical ingredients and drug components as two examples of “severe threats to U.S. national security and the ability of Americans to live prosperous, healthy lives” that require FDA and the pharmaceutical industry to “act with appropriate urgency to advance transformative products and secure our critical supply chains.” The webpage also highlights the fact that the CNPV program is not limited to rare diseases and is intended to “advance the broader America First agenda by accelerating cures and meaningful treatments with historic public health impact for Americans, especially including common chronic conditions and high prevalence diseases.”
The specific national health priorities that would qualify for a voucher have been described before, but the webpage provides more description and examples of how each could be met:
- Addressing a U.S. public health crisis. Example: A universal flu vaccine.
- Delivering more innovative cures for the American people. This priority focuses on “transformative impact that far outstrips the threshold for breakthrough therapy designation.” Examples: A novel immunotherapy to enable the immune system to fight multiple diseases; a novel treatment for PTSD.
- Addressing a large unmet medical need. Examples: Drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis.
- Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. Examples: Companies with new manufacturing establishments that shift manufacturing of “essential medicines (such as generic sterile injectables)” from foreign facilities to those within the U.S.; a “clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.”
- Increasing affordability. This priority was not included in the original list of priorities, but it was mentioned by Commissioner Makary in an interview on Bloomberg TV. Examples: A company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation (“MFN”) pricing; a product that reduces other downstream medical utilization to lower overall healthcare costs.
To be eligible for a CNPV, the company must demonstrate alignment with one or more of these priorities. Vouchers can be granted for review of a specific drug or be granted to a company as an undesignated voucher, which would allow a company to use the voucher at its discretion subject to consistency with the program’s objectives.
To request to participate in the CNPV program, a company must submit FDA’s program submission form. In completing this form, a company must select from a drop-down menu the primary national health priority the program addresses. A company must submit a brief description (350 words or fewer) of how the program aligns with the selected national health priority. This description should also include information about the disease or condition, the potential impact of the drug, the current stage of development (with relevant clinical data), any unique aspects of the company’s approach that make it particularly relevant for the chosen priority, and any specific issues for which enhanced communication is sought. This strikes us as a lot of information to squeeze into 350 words, but given the interest within industry for this program, we understand the attempt to limit the amount of work necessary to evaluate what is certain to be a flood of requests.
At this time, a company is limited to submitting one application. The submission will be evaluated by a senior, multi-disciplinary review committee/council led by the FDA’s Office of the Chief Medical and Scientific Officer (an office held by Vinay Prasad, the Director of CBER). The council will select scientific and medical experts from relevant FDA offices and divisions for a team-based priority review. Companies should be prepared to respond promptly to any FDA inquiries regarding the submission, and FDA may contact companies directly to request an informational meeting for submissions showing initial promise as part of the selection process. A company will only be notified (by email) if additional information is needed to evaluate a submission or if a company has received a voucher. FDA has established an email address for questions (CommissionerVoucher@fda.hhs.gov) and noted that the FAQ will be updated regularly as questions arise.
The review council intends to select no more than five pilot participants during the initial year based on the specific priorities and application readiness (e.g., companies demonstrating the ability to move forward towards a marketing application). The number of vouchers granted may be increased in future years. Vouchers will be awarded on a rolling basis. Even if not included in the initial selections, FDA may follow up with other companies that have expressed interest over time.
As mentioned, this program has generated considerable interest within industry. Given the various national priorities that the CNPV program is trying to incentivize, many companies likely have arguments that they qualify for a voucher. Although we would encourage any company that believes it qualifies to apply for a voucher, the current limitation of one application per company means that companies should be thoughtful about how they choose to proceed, particularly because application readiness is a consideration for the selection of pilot participants, and it is not clear when a company might be allowed another shot at the CNPV.
We would also caution companies not to forget about the existing expedited programs in the excitement of this new program. Given the likely intense competition for the first five vouchers at this early stage, the chances of selection for any individual company are slim. Even if the CNPV program were to expand, its resource demands are likely to limit the number of applications selected in the future. So don’t forget those fast track, breakthrough therapy, and RMAT designations!
We look forward to seeing how the CNPV program progresses and which drug development programs receive vouchers, if/when they are identified.