Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

The FDA awarded a second round of six Commissioner's National Priority Vouchers (CNPVs) on November 6, 2025, bringing the program's total to 15 recipients so far53.

This recent round included large companies such as Eli Lilly, Novo Nordisk, and Vertex, with therapies for obesity (Wegovy, orforglipron), HER2 lung cancer (zongertinib), rectal cancer (dostarlimab), sickle cell disease (Casgevy), and drug-resistant tuberculosis in young children (bedaquiline)51.

CNPVs are designed to accelerate FDA review for drugs aligned with U.S. national priorities—such as addressing public health crises, unmet needs, affordability, or national security—by shortening review timelines from about 10–12 months to as little as 1–2 months357.

The program uses a novel 'tumor board style' review where multidisciplinary experts meet for a single day to discuss and make recommendations on applications, instead of the traditional multi-meeting approach253.

Pressure has mounted on both companies and FDA staff to meet ambitious timelines, raising concerns about whether there is sufficient opportunity to address safety or labeling issues with such condensed reviews3.

Critics have questioned the transparency and purpose of the selection criteria, especially because five of the six most recent vouchers went to drugs already marketed elsewhere, and some decisions followed government drug pricing agreements3.

The program, though authorized under several federal acts, has come under scrutiny regarding its legal framework and the potential risk of trading regulatory rigor for speed, with internal FDA disagreements and high-level personnel changes reported35.

FDA leadership maintains that the program aims to quickly bring meaningful treatments to patients by aligning incentives with broad national goals, insisting that safety and effectiveness will not be compromised5.

Sources:

1. https://www.statnews.com/2025/11/06/fda-priority-review-vouchers-granted-eli-lilly-novo-nordisk-vertex/

2. https://www.fiercebiotech.com/biotech/fda-announces-second-round-priority-voucher-winners-including-glp-1-leaders-lilly-and-novo

3. https://www.biospace.com/fda/pressure-on-purpose-questioned-as-second-round-of-fda-priority-review-vouchers-revealed

5. https://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers

7. https://www.biopharmadive.com/news/fda-national-priority-review-voucher-awards-2025/803076/