Washington, D.C. — The U.S. Food and Drug Administration (FDA) today announced the first nine recipients of the Commissioner’s National Priority Voucher (CNPV) pilot program, which fast-tracks the review of drugs and biologics with the potential to address critical national health and economic priorities.
Each selected product demonstrates significant potential to meet urgent needs—such as tackling major unmet medical conditions, reducing long-term health costs, addressing public health crises, strengthening domestic manufacturing, or increasing drug affordability under Most Favored Nation pricing.
Voucher recipients will receive an FDA decision within one to two months after submitting a complete application, along with enhanced communication throughout the development and review process. The FDA retains the authority to extend the timeline if applications are incomplete or manufacturing issues arise.
President Donald Trump praised the announcement, highlighting the infertility treatment Pergoveris as a key step toward lowering costs for patients:
“This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly.”
FDA Commissioner Dr. Marty Makary described the initiative as part of a broader modernization effort:
“We must modernize the review process and try new approaches to meet the needs of the American people.”
The CNPV model condenses the standard 10–12 month review timeline into an accelerated multidisciplinary process, culminating in a one-day “tumor board–style” meeting to finalize decisions.
The initial CNPV awardees are:
- Pergoveris – Infertility treatment
- Teplizumab – Type 1 diabetes
- Cytisinicline – Nicotine vaping addiction
- DB-OTO – Deafness
- Cenegermin-bkbj – Blindness
- RMC-6236 – Pancreatic cancer
- Bitopertin – Porphyria
- Ketamine – Domestic manufacturing of general anesthesia drugs
- Augmentin XR – Domestic manufacturing of a common antibiotic
Each FDA division nominated a product aligned with the program’s mission, and sponsors may apply for future consideration. The agency expects to announce additional voucher recipients later this year.
About the Author
