FDA Shelves Priority Voucher Pilot, Stalling Fast-Track Drug Reviews

The FDA has shelved the Commissioner’s National Priority Voucher pilot program, the fast-track review initiative launched under former Commissioner Marty Makary.¹ No new vouchers have been awarded since Makary left the agency in May. The executive council of political appointees that oversaw reviews under the program has also gone dormant.

The program launched in June 2025.² It aimed to compress final application reviews from 10-12 months to 1 to 2 months for products aligned with national priorities, such as urgent unmet health needs. At launch, Makary said, in the press release,² “Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies.”

Of the 22 drugs given a voucher, a dozen have been approved, including 5 since Makary’s departure.¹ For several products, the program sped approval by 8 months or more. 2 sources said FDA career scientists have resumed overseeing review timelines for the 9 drugs still in the program.

Is the Voucher Program Over or on Hold?

FDA leadership told companies the agency is not moving forward with the program but is keeping applications open; once submitted, those applications do not advance.¹ Rich Danker, former assistant secretary, Department of Health and Human Services, said the initiative is quietly being phased out following the departure of its top administrator. Emily Hilliard, Department spokesperson, said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing to refine the framework.

The 2 most recent voucher applications cleared for new drugs, Merck’s cholesterol pill Lipfendra and Revolution Medicines’ pancreatic cancer drug Rasonque, were not vetted by the executive council.³ Merck KGaA’s fertility treatment Pergoveris received a voucher under a drug-pricing agreement with the administration.¹ It remains unapproved 3 months after the FDA accepted its final application.

Why Does This Matter?

The program’s compressed timeline required sponsors to have their CMC packages and quality systems inspection-ready before submission.² Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science, said,⁴ “When review windows shrink from 10 to 12 months to as little as 1 to 2 months, the entire model for launch readiness changes.” Sponsors that restructured launch planning around voucher timelines may now be working against conventional review schedules.

Holly Fernandez Lynch, health policy professor, the University of Pennsylvania, described the program as “the worst of both worlds.”¹ She pointed to risks of political influence and limited practical benefit, since many drugs might have qualified for other expedited pathways. The review of Sanofi’s diabetes drug Tzield shows the council’s role. Former acting drug center director Tracy Beth Hoeg withheld her approval and raised safety objections at 3 council meetings between October 2025 and April. After she and Makary left, agency staff granted accelerated approval in June. Hoeg stated that the trial showed “minimal at most”¹ benefit weighed against safety risks. Sanofi claimed the FDA concluded the drug’s benefits outweighed the risks.

The uncertainty reflects broader instability at the agency.⁵When Makary resigned, many of his acceleration initiatives had not gone through formal rulemaking, which left them open to reversal. The FDA has since replaced the acting heads of its drug and biologics review centers.⁶ It has been without a commissioner since May.

References

1. Reuters. Exclusive: US FDA shelves commissioner’s voucher program for speedy drug reviews, sources say. November 12, 2026. Accessed November 12, 2026. https://www.reuters.com/world/us-fda-shelves-commissioners-voucher-program-speedy-drug-reviews-sources-say-2026-11-12/reuters
2. FDA. FDA to issue new commissioner's national priority vouchers to companies supporting U.S. National Interests. News release. June 17, 2025. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
3. U.S. FDA approves Revolution Medicines’ RAS(ON) inhibitor daraxonrasib. News release. Revolution Medicines. August 26, 2026. https://ir.revmed.com/news-releases/news-release-details/us-fda-approves-revolution-medicines-rasonquetm-daraxonrasib
4. Cole C. Ready or not: biopharma alignment for CNPV’s rapid review. Pharmaceutical Technology. November 20, 2025. Accessed November 12, 2026. https://www.pharmtech.com/view/ready-or-not-biopharma-alignment-for-cnpvs-rapid-review
5. Abutaleb Y. Makary resigns as FDA commissioner after turmoil. Reuters. May 12, 2026. Accessed May 12, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/fda-commissioner-makary-is-resigning-politico-reports-2026-05-12/
6. Peebles A. FDA shuffles top drug, biologics leaders in latest shakeup. CNBC. May 15, 2026. https://www.cnbc.com/2026/05/15/fda-shuffles-top-drug-biologics-leaders-in-latest-leadership-shakeup.html