Logo Image
News|Articles|November 12, 2026

FDA Reportedly Shelves Commissioner's National Priority Voucher Program

Listen
0:00 / 0:00

Key Takeaways

  • Eligibility hinged on alignment with five national priorities, and vouchers were nontransferable, product-specific, and paired with rolling review, intensified FDA interactions, and a multidisciplinary council review process.
  • Twenty-two vouchers were awarded and twelve products approved, with several approvals reportedly accelerated by eight months or more, including Wegovy HD, Otarmeni, Foundayo, and Lipfendra.
SHOW MORE

No new vouchers have been awarded since former FDA Commissioner Marty Makary left the agency in May, though HHS maintains the pilot is ongoing.

The FDA has shelved the Commissioner's National Priority Voucher (CNPV) pilot program, the fast-track review initiative launched under former FDA Commissioner Marty Makary, MD, MPH, according to a Reuters report.

The Department of Health and Human Services (HHS) disputes that characterization, with a spokesperson stating that the pilot is ongoing.1

Initially announced in June 2025, the CNPV pilot intended to cut review times for drug and biological product applications from 10 to 12 months to 1 to 2 months for products deemed to be aligned with national health priorities.1,2 Of the 22 drugs that were awarded vouchers, 12 have been approved, including 5 since Makary left the FDA in May. For several drugs, the program sped approval by 8 months or more.1

The program drew scrutiny over possible preferential treatment for companies that met demands from President Donald J. Trump, such as offering drugs at lower prices.1 The FDA held a public hearing on June 4, 2026, to gather feedback on the pilot.2 Reuters reported that HHS spokesperson Emily Hilliard said that the pilot is ongoing and that the FDA is reviewing feedback from the June hearing to refine the program’s framework.1

How the Program Worked

To qualify for the program, a product had to align with at least 1 of 5 national priorities: public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, or affordability. Vouchers were granted for a specific product application and were nontransferable.2

Voucher holders received enhanced communication with FDA staff, enhanced presubmission requests, and rolling review. Review teams developed independent recommendations, which then went to the CNPV Review Council, a multidisciplinary "tumor board–style" panel that discussed them with senior agency leadership. The relevant FDA center retained the final approval decision, and applications were held to the same statutory and regulatory approval standards as non-CNPV applications.2

Approvals under the program included higher-dose semaglutide 7.2 mg (Wegovy HD; Novo Nordisk); lunsotogene parvec-cwha (Otarmeni, formerly DB-OTO; Regeneron Pharmaceuticals, Inc), the first gene therapy for genetic hearing loss; exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals), orforglipron (Foundayo; Eli Lilly), the first glucagon-like peptide-1 receptor agonist pill without time, food, or water restrictions; and enlicitide (Lipfendra; Merck), the first oral PCSK9 inhibitor for lowering low-density lipoprotein cholesterol.2-6

What the Report Found

According to the Reuters report, no new vouchers have been awarded since Makary's departure, and the FDA has been without a commissioner since May. One source said FDA leadership told companies that the agency is not moving forward with the program but is keeping applications open; applications that are submitted do not advance.1

The 2 most recent voucher drugs cleared since Makary left—enlicitide and daraxonrasib (Rasonque; Revolution Medicines, Inc), for adults with metastatic pancreatic adenocarcinoma7—were not vetted by the program's executive council, according to Reuters.1 Daraxonrasib was approved on a timeline typical of breakthrough cancer therapies under existing oncology review mechanisms. For the 9 drugs that still remain in the program, FDA career scientists have resumed overseeing review timelines.1

Implications for Psychedelic Candidates

The CNPV pilot featured prominently in the administration's push to accelerate psychedelic drug development. Following an April 18, 2026, executive order targeting posttraumatic stress disorder (PTSD), depression, and substance use disorders, the FDA issued vouchers to 3 companies for psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for PTSD.8,9 At the time, the vouchers were expected to shorten review from the traditional 6 to 10 months to 1 to 2 months in certain cases.9

The Reuters report does not specify the status of those applications. None of these agents is currently FDA approved, and the standard safety, efficacy, and quality requirements apply.1,9

What This Means for Pharmacists

For pharmacists who are tracking the drug approval pipeline, Reuters suggests that anticipated launch dates for voucher-holding products may be less predictable, with review timelines for remaining applications now overseen by career scientists rather than the CNPV council. Pharmacy and therapeutics committees and health-system formulary planners may want to revisit expected approval dates for pipeline products that had been tied to the program's 1- to 2-month review target.1

REFERENCES
  1. Wingrove P, Abutaleb Y. Exclusive: US FDA shelves commissioner's voucher program for speedy drug reviews, sources say. Reuters. 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/
  2. Commissioner's National Priority Voucher (CNPV) pilot program. FDA. Updated October 19, 2026. Accessed November 12, 2026. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
  3. Halpern L. FDA Approves Higher-Dose Semaglutide Under Accelerated Review Program. Pharmacy Times. March 19, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/fda-approves-higher-dose-semaglutide-under-accelerated-review-program
  4. McGovern G. FDA Grants Accelerated Approval to Otarmeni, First and Only Gene Therapy for Genetic Hearing Loss. Pharmacy Times. April 23, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/fda-grants-accelerated-approval-to-otarmeni-first-and-only-gene-therapy-for-genetic-hearing-loss
  5. McGovern G. FDA Approves Orforglipron, First GLP-1 Pill Without Time, Food, or Water Restrictions. Pharmacy Times. April 1, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/fda-approves-orforglipron-first-glp-1-pill-without-time-food-or-water-restrictions
  6. Antrim A, Halpern L. FDA Approves Enlicitide, the First Oral PCSK9 Inhibitor for High Cholesterol. Pharmacy Times. Updated July 17, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/fda-approves-enlicitide-the-first-oral-pcsk9-inhibitor-for-high-cholesterol
  8. Halpern L. Trump executive order seeks to accelerate psychedelic drug development for PTSD, addiction. Pharmacy Times. April 20, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/trump-executive-order-seeks-to-accelerate-psychedelic-drug-development-for-ptsd-addiction
  9. McGovern G. FDA announces regulatory actions to accelerate psychedelic development for serious mental health conditions. Pharmacy Times. April 24, 2026. Accessed November 12, 2026. https://www.pharmacytimes.com/view/fda-announces-regulatory-actions-to-accelerate-psychedelic-development-for-serious-mental-health-conditions

Related to this article

View more