FDA Reportedly Shelves National Priority Voucher Pilot and Pauses CRL Publication

FDA has effectively shelved its Commissioner’s National Priority Voucher (CNPV) pilot program, which promised drug and biologic reviews in as little as one to two months, according to an exclusive Reuters report citing six sources and internal documents.¹˒² The agency also appears to have paused publishing complete response letters (CRLs), with no new entries added to its public CRL database in roughly three months, Fierce Pharma reported.¹

A Department of Health and Human Services (HHS) spokesperson disputed that the program had been shelved, telling Fierce Pharma that work under the CNPV is “ongoing.”¹ “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.¹

What is the CNPV program?

FDA announced the pilot in June 2025 under former Commissioner Marty Makary, MD, as a pathway to dramatically reduce review times for drug and biological product applications.³ Products must align with one of five national priorities: public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, or affordability.³ The target review time is one to two months, compared with six months or more under FDA’s other priority review programs.³ Review teams share recommendations with a multidisciplinary, “tumor board-style” CNPV Review Council, while the final approval decision remains with the relevant FDA center.³

Twenty-two drug programs have received vouchers, with 12 approvals and one rejection to date.¹ No new vouchers have been awarded since Makary resigned in mid-May, and the review council has gone dormant, according to Reuters.¹˒² FDA is still accepting applications but is not reviewing or granting new ones, Reuters reported, citing one person familiar with the process.¹ Nine drugs remain in the program, and FDA career scientists have resumed overseeing their review timelines, Reuters reported.²

How have biologics fared under the program?

Biologics account for several of the program’s approvals. In May, FDA announced the seventh approval under the pilot, Partner Therapeutics’ bispecific antibody Bizengri (zenocutuzumab-zbco), for adults with NRG1 fusion-positive cholangiocarcinoma, the first approved drug for that population.⁴ Other biologics approved with vouchers include Johnson & Johnson’s Tecvayli plus Darzalex, Regeneron’s gene therapy Otarmeni, Vertex’s cell therapy Casgevy, and GSK’s Jemperli (dostarlimab), according to an independent tracker of the program.⁵ Merck’s antibody-drug conjugate sacituzumab tirumotecan also holds a voucher but has not yet been filed.⁵

The program has also drawn controversy over a biologic. In May, Sanofi reportedly asked that its monoclonal antibody Tzield (teplizumab) be withdrawn from the CNPV track after then-acting director of FDA’s Center for Drug Evaluation and Research, Tracy Beth Høeg, MD, PhD, tried to overturn staff’s recommendation for approval.¹ Critics have also cited political favoritism, limited transparency, and strain on agency resources, and Rep. Jake Auchincloss (D-Mass.) questioned FDA’s statutory authority for the program.¹

Compressed timelines also put pressure on manufacturing readiness. In a BioPharm International® panel discussion last November, one expert warned that with a potential 30- to 60-day review, there is no time to fix compliance gaps once a file is submitted. In a BioPharm International Drug Digest video interview, Steven Quay, MD, PhD, founder and chief executive officer of Atossa Therapeutics, said, “You don’t think that an expedited pathway that can get you an approval faster allows you to do less work.”

What is happening with CRL publication?

In July 2025, FDA published more than 200 CRLs issued from 2020 through 2024, with Makary saying the move would reduce the “guessing game” for drug developers and investors.⁶ The agency later began publishing CRLs in real time, but law firm Covington & Burling argued in a citizen petition filed in April that the practice could violate federal confidentiality protections.¹ FDA has since asked Congress, in its fiscal year 2027 budget request, for clear statutory authority to disclose CRL information.¹ The most recent entry in the database is a manufacturing-related CRL for ITM Isotope Technologies Munich’s radiopharmaceutical candidate ITM-11 in early August.¹

“The FDA remains committed to the proactive release of Complete Response Letters and will continue to publish appropriately redacted CRLs,” an FDA spokesperson told Fierce Pharma.¹

What happens next?

FDA has been without a permanent commissioner since Makary’s departure in May.² HHS said FDA will continue advancing reforms aimed at improving efficiency and accelerating scientific review, and that the agency is reviewing feedback from a June public hearing to refine the pilot.¹˒²

References

1. Liu A. FDA appears to pause controversial speedy review program, complete response letter disclosures. Fierce Pharma. Published November 12, 2026. Accessed November 13, 2026.
2. Wingrove P, Abutaleb Y. Exclusive: US FDA shelves commissioner’s voucher program for speedy drug reviews, sources say. Reuters. Published November 12, 2026. Accessed November 13, 2026.
3. Commissioner’s National Priority Voucher (CNPV) pilot program. US Food and Drug Administration. Updated October 19, 2026. Accessed November 13, 2026.
4. FDA grants seventh approval under the national priority voucher pilot program. News release. US Food and Drug Administration; May 8, 2026. Accessed November 13, 2026.
5. CNPV dashboard. PRV Watch. Accessed November 13, 2026.
6. Cole C. FDA publishes more than 200 complete response letters. Pharmaceutical Technology. Published July 11, 2025. Accessed November 13, 2026.