As part of the U.S. Food and Drug Administration’s continuous quality improvement efforts, the agency today published a Federal Register Notice seeking public comment on the Commissioner’s National Priority Voucher pilot program. The agency also announced a public hearing on June 12, to allow stakeholders to present information and views about the program.
The public hearing, consistent with 21 CFR § 15.1 et seq., will seek feedback about the program’s eligibility criteria, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV Review Council, and other aspects of program implementation.
The CNPV pilot program was established in June 2025 to address critical public health needs by providing an ultra-fast review pathway for drugs and biological products of strategic national importance while maintaining the FDA’s rigorous scientific and regulatory standards. So far, the agency has awarded vouchers for 18 products and granted four approvals, including two approvals for oncology drugs delivered 44 and 55 days after filing.
“National priority vouchers are a game changer for patients waiting for life-changing therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “As a clinician who has been frustrated at the bedside by a lack of available treatment options, I’m excited about the potential of this program’s future following a very successful first year. As with all of our new initiatives, we are seeking input on how we can better meet the needs of the American people.”
Companies that are awarded a national priority voucher have a product that aligns with one or more national health priorities, including bringing innovative therapies to the American people, addressing large unmet medical needs, promoting domestic manufacturing, and increasing affordability. Recipients are issued a nontransferable “voucher” entitling them to expedited FDA review of a single application with enhanced regulatory engagement. The program radically increases efficiency by reducing idle time, while maintaining safety as the top priority.
Key features include:
- Expedited pre-filing period.
- Target of 1-2 months from filing to action (compared to nearly a year).
- Enhanced pre-submission engagement, which facilitates earlier correction of issues (e.g., chemistry, manufacturing, and controls (CMC) and inspection) that can lead to review cycle extensions.
- Multidisciplinary review approach culminating with a CNPV Review Council meeting with senior leadership and lead review staff.
The June 12 public hearing will be held at the FDA’s White Oak Headquarters with both an in-person and virtual option for participation. The FDA panelists will include subject matter experts from the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence, as well as a presiding officer. Requests to speak are due by May 1. The FDA is also soliciting written comments until June 27. For more information about the hearing: https://www.fda.gov/news-events/commissioners-national-priority-voucher-cnpv-pilot-program-public-hearing-06122026.
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