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
