On October 16, 2025, FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. The following 9 products were selected:
- Pergoveris for infertility
- 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
- Zongertinib for HER2 lung cancer
- Bedaquiline for drug-resistant tuberculosis in young children
- Dostarlimab for rectal cancer
- Casgevy for sickle cell disease
- Orforglipron for obesity and related health conditions
- Wegovy for obesity and related health conditions
The new voucher program was criticized in this NEJM article “Flaws in the FDA’s New Priority Voucher Program” by Carpenter, Hwang, and Kesselheim. The authors argue that while the program seeks to promote innovation and address public health needs, it has significant shortcomings. They note that regulatory review already represents a small portion of total drug-development time and that past voucher programs have shown little evidence of spurring innovation while straining FDA resources. The paper warns that the CNPV program, created without congressional authorization and with vague eligibility criteria, risks politicizing FDA decisions, fostering conflicts of interest, and undermining public trust. Moreover, the compressed review timelines could compromise drug safety and overburden staff. The authors suggest that if implemented, the program should focus on generic drugs where expedited review could have tangible benefits, and should incorporate strong transparency, conflict-of-interest safeguards, and legislative oversight to maintain the integrity of the FDA’s regulatory process.
In a previous post, the FDA's Priority Review Voucher (PRV) programs were discussed. Here’s a side-by-side comparison table summarizing the key similarities and differences between the Commissioner’s National Priority Voucher (CNPV) and the Priority Review Voucher (PRV) programs such as the Rare Pediatric Disease PRV:
| Feature | Commissioner’s National Priority Voucher (CNPV) | Priority Review Voucher (PRV) – e.g., Rare Pediatric Disease |
|---|---|---|
| Origin / Authorization | Created by the FDA Commissioner in 2025 as a pilot program without explicit congressional authorization. | Created by Congress through legislative action (e.g., the 2012 FDA Safety and Innovation Act for rare pediatric diseases). |
| Purpose | To accelerate review for drugs aligned with U.S. national health priorities, including unmet needs, national security, innovation, and affordability. | To incentivize development of drugs for neglected or rare conditions (e.g., tropical or rare pediatric diseases). |
| Review Time Benefit | Shortens FDA review time for selected drugs to 1–2 months, much faster than any existing program. | Converts a standard 10-month review to a priority 6-month review for another drug application. |
| Eligibility Criteria | Broad and somewhat opaque—drugs must align with “national priorities,” such as public health crises or domestic manufacturing. | Clearly defined by statute—applies to drugs for designated rare pediatric diseases (or other legislatively defined conditions). |
| Voucher Transferability | Nontransferable (can only be used by the same sponsor; valid if company ownership changes). | Transferable—can be sold or traded to another company, often for hundreds of millions of dollars. |
| Voucher Expiration | Expires after 2 years if unused. | Does not expire. |
| Selection and Oversight | Controlled by the FDA Commissioner’s office, raising concerns about political influence and conflicts of interest. | Statutory oversight and criteria limit discretion; implementation and tracking are agency-administered but legislatively mandated. |
| Scope / Eligible Products | Focused on drugs supporting U.S. national interests (innovation, security, affordability). | Focused on drugs addressing specific rare or neglected diseases. |
| Impact on FDA Workload | Could significantly burden FDA staff due to extremely short review timelines and unfunded mandates. | Adds workload but within a manageable 6-month priority window, and user fees help fund FDA resources. |
| Pilot Structure / Limits | Initially limited to five awardees in the first year; long-term limits unclear. | Ongoing statutory program with defined eligibility and reporting mechanisms. |
| Evidence of Effectiveness | No evidence yet; experts predict limited impact on overall development time and potential risks to review quality. | Empirical studies show limited evidence of incentivizing innovation but measurable market and financial impacts. |
| Key Concerns | Politicization, conflicts of interest, safety risks from rushed reviews, lack of transparency, and legal vulnerability due to lack of statutory basis. | Limited innovation incentive, windfall profits for some sponsors, and added workload, but more transparent and regulated. |
| Suggested Improvements | Apply to generic drugs, establish clear criteria, ensure independent review, legislative authorization, and transparency. | Better alignment between voucher incentives and public health impact; continue to monitor postmarket safety. |
While both CNPV and PRV programs aim to accelerate access to important therapies, the CNPV is a politically driven, non-statutory pilot emphasizing national priorities, with potentially risky acceleration timelines and limited oversight. In contrast, the PRV system—though imperfect—has a clear legislative framework, defined eligibility, and established oversight mechanisms that maintain greater regulatory transparency and accountability.
