FDA Reportedly Shelves Commissioner’s National Priority Voucher Pilot as Existing Reviews Continue

The FDA has quietly shelved its Commissioner’s National Priority Voucher (CNPV) pilot program, a speedy review process launched by former agency head Marty Makary, MD, MPH, according to Fierce Pharma. The outlet cited a Reuters report based on six sources and internal documents.¹

Fierce also reported that the agency appears to have paused publishing complete response letters after briefly halting, and then resuming, the practice in July.

The CNPV was designed to accelerate reviews for drugs and companies that support US national interests, such as meeting large unmet medical needs and onshoring development and manufacturing. The process shortens the FDA’s review from the regular 10 months to one to two months.

Since its rollout in June 2025, the pilot has drawn concerns ranging from political favoritism and lack of transparency to strain on the FDA’s bandwidth. Twenty-two drug programs have received the voucher, with 12 approvals and one rejection.

What the reports say has stalled

The FDA is still accepting CNPV applications but is not reviewing or granting new ones, Reuters reported, citing one person familiar with the process. The most recent grants appear to be for a trio of psychedelics in April and one disclosed in May for Partner Therapeutics’ cholangiocarcinoma drug Bizengri. There is no public record of new vouchers since Makary resigned as FDA commissioner in mid-May.

The council of FDA leadership responsible for critical CNPV decisions has gone dormant, Reuters asserted, citing internal documents. Review documents for Revolution Medicines’ pancreatic cancer drug Rasonque do not show the council’s involvement. The Oncology Center of Excellence decided the review under the pre-existing real-time oncology review framework.

The pause does not appear to be permanent. A spokesperson for the Department of Health and Human Services (HHS) told Fierce that work under the CNPV is “ongoing,” and that, at least for programs that already hold a voucher, the FDA is committed to executing on the promised timeline.

“FDA career staff continue to evaluate applications granted a CNPV, meet commitments for accelerated review and enhanced engagement, and assess best practices emerging from the pilot program,” the spokesperson said.

Controversy that built before the pause

Concerns flared in May, when Sanofi reportedly asked that Tzield be withdrawn from the CNPV track after Tracy Beth Høeg, MD, PhD, then director of the FDA’s Center for Drug Evaluation and Research, tried to overturn staff’s recommendation for approval.

At a public hearing in June, existing CNPV beneficiaries voiced support. The medical and academic communities were more critical. Peter Lurie, MD, a former FDA employee and president of the Center for Science in the Public Interest, called for the agency to shut down the pilot due to concerns about “politicization in voucher selection and review, strained agency resources and lack of transparency.”

How the program was designed to work

Applied Clinical Trials examined the CNPV program in May. It was built around a multidisciplinary, “tumor board-style” review model, an approach Makary drew from his background as a surgical oncologist. Instead of the sequential review of a standard New Drug Application (NDA), a designated team of FDA physicians and scientists conducts a pre-review of submitted materials, followed by a single collaborative meeting to evaluate the data and reach a decision.²

To qualify, sponsors must submit the chemistry, manufacturing, and controls section of their application and draft labeling at least 60 days before filing the complete application, which means manufacturing has to reach commercial readiness earlier than a standard NDA requires. The FDA retains the right to extend review if data are incomplete, ambiguous, or unusually complex.

In an exclusive interview with ACT, John Kirk, principal regulatory strategist at Veristat, described what the program demanded of sponsors and contract research organizations at the operational level.

“Sponsors who successfully navigate these compressed timelines integrate their biostatistics, regulatory, and medical writing teams from the outset, creating a unified approach where data flows seamlessly from analysis through narrative to submission, rather than treating these as sequential handoffs,” Kirk said.

References

1. FDA appears to pause controversial speedy review program, complete response letter disclosures. Fierce Pharma. November 12, 2026. https://www.fiercepharma.com/pharma/fda-appears-pause-controversial-speedy-review-program-complete-response-letter-disclosures
2. Inside the FDA's Commissioner's National Priority Voucher Program: Promise, Pressure, and Operational Reality. Applied Clinical Trials. May 22, 2026. https://www.appliedclinicaltrialsonline.com/view/fda-commissioner-national-priority-voucher-program-promise-pressure-operational-reality