FDA Announces Inaugural Products To Receive Commissioner's National Priority Vouchers

• The U.S. Food and Drug Administration (FDA) announced on Oct. 16, 2025, that it would award the first-ever Commissioner's National Priority Vouchers (CNPV) to nine recipients across various disease states and conditions.
• The nine awardees represent a mix of products at various stages in the research and development pipeline, with some previously approved by the FDA to treat diseases and conditions, and others still in the investigational phase. Each of the nine products selected represent products that meet a large public health need.
• The FDA intends to announce another group of CNPV recipients in the coming weeks.

The U.S. Food and Drug Administration (FDA) announced in June 2025 the establishment of a new Commissioner's National Priority Voucher (CNPV) program and began accepting applications, promising those selected an accelerated review process for drug or biologic applications of one to two months and enhanced communication for sponsors, featuring a more teams-based review approach and a "tumor style" group meeting that brings together FDA staff from review offices.

The goal of the CNPV program is to accelerate the review of products that align with national priorities by meeting four criteria as outlined by the FDA. Drugs and biological products selected to receive a CNPV are those that meet large emerging public health needs such as those that address a public health crisis, provide innovative cures, address a large unmet medical need or enhance national security by onshoring drug development and manufacturing to advance the health interests of the U.S.

Inaugural 9 Awardees

On Oct. 16, 2025, the FDA announced the inaugural nine products to receive the CNPV, including:

• pergoveris for infertility, announced in tandem with the third drug pricing agreement with a leading manufacturer of fertility medications
• teplizumab for Type I diabetes
• cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• cenegermin-bkbj for blindness
• RMC-6236 for pancreatic cancer
• bitopertin for porphyria
• ketamine for domestic manufacturing of a critical drug for general anesthesia
• augmentin XR for domestic manufacturing of a common antibiotic

Three of the nine recipients – DB-OTO, RMC-6236 and bitopertin – are investigational products that are likely to seek FDA approval using the CNPV. Two of the recipients – ketamine and augmentin XR – are drugs previously approved by the FDA to treat various indications and have generic competition. Their inclusion in the first group is designed to bolster domestic manufacturing of the medicines, with no domestic manufacturer of ketamine currently operating in the U.S. The remaining four products – pergoveris, teplizumab, cytisinicline and cenegermin-bkbj – are either approved for use in countries outside the U.S., approved for indications other that those listed indicating a label expansion or are close to submitting application materials to the FDA for review and approval.

Interestingly, the CNPV awards appear to be connected. Notably, pergoveris – an injectable fertility medication – has been approved by and is available in more than 70 countries around the world, but not the U.S. The product's receipt of a CNPV came in tandem with President Donald Trump's announcement that he had struck a third drug pricing agreement with the manufacturer of pergoveris. As part of the agreement, the manufacturer of pergoveris will make the product available through the TrumpRx.gov website, which intends to connect beneficiaries with lower-cost medicines. The manufacturer will also make the product available at most-favored-nation (MFN) prices when selling directly to beneficiaries through direct-to-consumer models. In his announcement that pergoveris received a voucher, FDA Commissioner Marty Makary noted that treating infertility is a priority of the White House.

Receipt of a CNPV does not guarantee FDA approval of the drug, and it will be notable if the products selected to receive a CNPV – especially for products that are still in investigational phases – ultimately receive FDA approval. In addition, it will be important to monitor whether the FDA is able to meet accelerated timelines and perform the tumor board review as the government shutdown enters its fourth week. It is unclear whether FDA reviewers funded by industry user fees will be allowed to move away from current projects to work on the CNPV applications.

Unlike the FDA's other priority review voucher (PRV) programs, the CNPV is not established by specific congressional legislation. Tacitly acknowledging this gap in authority, the FDA affirms on the program's webpage that its statutory authority to establish and operate the CNPV derives from "its general authority to implement the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) consistent with its mission to promote and protect the public's health." Specifically, the FDA also refers to its authority to review applications submitted for a drug under Section 505 of the FDCA or a biological product under Section 351 of the PHSA. It is possible litigation may occur in this area, and the potential for additional mergers and acquisitions activity is substantial, as the CNPV may be transferred only through changes in ownership.

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