The U.S. Food and Drug Administration (FDA) has released new information about the Commissioner's National Priority Voucher (CNPV) pilot program, which offers a small number of participating U.S. drug companies highly expedited (1-2 month) review of their drug or biologics marketing application and enhanced communications with the agency.1 Details surrounding CNPVs had been limited at the time of FDA's announcement last month (which we discussed in our June 2025 Advisory). FDA has now provided some clarity as it begins to accept company nominations for the pilot phase of the CNPV program. Perhaps most notably, FDA has explained that it intends to achieve this expedited review by lifting the selected applications out of their review divisions within the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER), and instead reviewing them as part of a review committee led by FDA's Office of the Chief Medical and Scientific Officer. FDA hopes the CNPV pilot program will help advance transformative products and secure the country's critical supply chains in the face of severe threats to U.S. national security (e.g., the reliance on sources in China for active pharmaceutical ingredients and drug components; obesity and other health conditions afflicting young Americans).
Eligibility Criteria
A company that is interested in participating in the CNPV pilot program must demonstrate alignment with one or more of the following priorities:
- Addressing a U.S. public health crisis
- Delivering "more innovative" cures (i.e., those with "transformative impact" that would "far outstrip" the existing breakthrough therapy designation threshold)
- Addressing a large unmet public medical need
- Onshoring drug development and manufacturing to advance the administration's domestic manufacturing priorities
- Increasing affordability (e.g., reducing the price of drugs to align with Most Favored Nation (MFN) pricing or reducing other medical utilization to lower overall healthcare costs)
This list aligns with the initial list of criteria published last month, except for the addition of the priority on increasing affordability — which has been a controversial move in light of FDA's longstanding position that the agency does not regulate drug pricing. However, its addition comes as no surprise. FDA Commissioner Makary made recent remarks contemplating that the CNPV program may be available to companies that promise to equalize the price of their drug or biologic product(s) to those in similarly developed countries.
Submission Process
An interested company should submit a statement of interest to FDA that:
- Provides the company contact information
- Identifies the primary priority that its drug development program addresses
- Provides a brief description (capped at 350 words) of how the identified drug development program aligns with the identified priority, including information about the targeted disease or condition, the potential impact of the drug, the current stage of development and relevant clinical data highlights, any unique aspects of the company's approach that make it particularly relevant to the selected priority, and any specific issue(s) for which the company is seeking enhanced communications with the agency to facilitate the drug program's development2
A company may only submit one application at this time. Upon doing so, the company must be prepared to respond in a timely manner to any FDA inquiries regarding its submission.
Before the agency officially began soliciting statements of interest, one company announced that it had submitted its preservative-free ketamine product for the CNPV program after filing its Abbreviated New Drug Application in June 2025.
FDA Selection Process
FDA plans to select no more than five companies on a rolling basis to participate in the CNPV pilot program. Specifically, a senior, multi disciplinary review committee within FDA's Office of the Chief Medical and Scientific Officer will evaluate the companies, while a "council" will make selection decisions (although the makeup or function of such a council is unclear). The council intends to base its final decisions on the extent to which the applications align with identified priorities, as well as application readiness (i.e., the extent to which the program appears ready to move forward toward a marketing application). As part of the evaluation, FDA may request an informational meeting with the company.
FDA explains that the five CNPVs will be given out in 2025, and that the number of CNPVs may increase in future years. The agency will notify companies that have been selected for participation in the CNPV pilot program via email.3 The agency previously stated that a company cannot transfer a CNPV, but that CNPVs will remain valid through changes in company ownership.
We will continue to monitor FDA developments relating to the CNPV program, including information that resolves remaining open questions.
Footnotes
1. U.S. Food & Drug Admin., Commissioner's National Priority Voucher (CNPV) Pilot Program (updated July 22, 2025).
2. U.S. Food & Drug Admin., Commissioner's National Priority Voucher (CNPV) Pilot Program Submission (updated July 22, 2025).
3. U.S. Food & Drug Admin., FAQs: Commissioner's National Priority Voucher Pilot Program (updated July 22, 2025)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
