> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # FDA Shutters Makary's Priority Voucher Program: Reuters - URL: https://www.fdaweb.com/fda-shutters-makarys-priority-voucher-program-reuters/ - Published: 2026-11-12T15:33:36.000Z - Updated: 2026-11-12T15:33:36.000Z - Author: David McFarland - Tags: Drugs FDA has effectively shelved former commissioner **Marty Makary**'s Commissioner's National Priority Voucher (CNPV) pilot program, which was promoted to speed selected drug reviews to one or two months. An 11/12 Reuters investigation reported the reversal, following months of criticism from former agency officials, congressional lawmakers and regulatory policy experts over the initiative's scientific rigor, political oversight and unusually compressed drug review timelines. Citing six sources familiar with the matter and internal FDA documents, [Reuters reported](https://www.reuters.com/world/us-fda-shelves-commissioners-voucher-program-speedy-drug-reviews-sources-say-2026-11-12/?ref=fdaweb.com) that FDA has awarded no new vouchers since Makary's departure in May, the senior-level council established to oversee the program has become inactive, and new applications are not advancing through regulatory processes. However, HHS disputed the characterization that the program has been halted. Department spokesperson **Emily Hilliard** told Reuters that the pilot continues while FDA evaluates feedback received at a June public hearing. FDA has made no formal announcement terminating the initiative, and its [program Website](https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program?ref=fdaweb.com) continues to describe a process for submitting statements of interest. The reported suspension comes nearly five months after ***FDA Webview*** reported that the agency had already disbanded the program's review board and removed commissioner-level involvement in selecting voucher recipients. ### **Former FDA Drug Chief Warned of Unrealistic Timelines** At the DIA Global Annual Meeting in Philadelphia in June, former FDA Office of New Drugs (OND) director **Peter Stein** sharply criticized the program's one- to two-month review timetable, describing it as unrealistic and potentially damaging to the scientific review process. As [***FDA Webview*** noted 6/22](https://www.fdaweb.com/former-fda-drug-chief-questions-future-of-priority-voucher-program/), Stein said the expedited review timeline was “almost like an insult to the FDA reviewers,” according to reporting by the Regulatory Affairs Professionals Society (RAPS). “It takes many, many years, 7 to 12 years to develop products. It takes FDA some months to review it,” Stein said. “To expect it to be reviewed in two months is an unreasonable expectation.” Stein, who directed OND from 2018 until his departure during FDA workforce reductions in 2025, argued that the program placed reviewers in conflict with agency leadership by pressuring them to complete complex scientific evaluations within an unusually short period. The same conference discussion raised doubts about the program's future following Makary's departure in May. **Kate Rawson**, senior editor at Prevision Policy, said FDA had removed the word “Commissioner's” from the program's name, disbanded its review board and eliminated commissioner-level involvement in candidate selection, according to RAPS. Rawson suggested the agency might phase out the program after completing reviews of existing participants or incorporate elements of the initiative into broader real-time review procedures. Those observations preceded Reuters' recent findings that the voucher review council had become inactive and new awards had stopped. It remains unclear whether the board described at the June conference and the council referenced by Reuters were the same body or represented different stages of the program's oversight structure. ### **Scientific and Political Concerns Emerged at Launch** Concerns about the program's scientific rigor and independence arose almost immediately after Makary announced it in June 2025. University of Pennsylvania Perelman School of Medicine associate professor of medical ethics and law **Holly Lynch** questioned whether FDA could conduct adequate reviews of drug safety and effectiveness within one or two months, particularly amid staffing reductions and increasing workloads. In a [6/24/2025 ***FDA Webview*** report](https://www.fdaweb.com/makarys-fda-voucher-program-questioned/), Lynch noted that FDA already had mechanisms for accelerating reviews, including rolling applications, breakthrough therapy procedures and Real-Time Oncology Review. She questioned whether the new voucher initiative could substantially improve on those programs without compromising review quality. Lynch also raised concerns about political involvement in voucher selection and whether career scientists would feel free to challenge sponsors or request additional information if doing so delayed an approval decision. “Will CNPV teams be willing to question sponsors or seek more information if it means slowing down a decision?” she asked. “Will they listen to career staff who raise concerns?” She also questioned whether vouchers might become political favors awarded to sponsors aligned with the administration. Lynch's concerns were prospective rather than findings of misconduct, but they anticipated some of the questions about review independence and oversight that have followed the program. ### **Congressional Democrats, Brookings Raised Additional Questions** The program subsequently drew scrutiny from congressional Democrats who questioned its legal authority, transparency and potential for political influence. As [***FDA Webview*** previously reported](https://www.fdaweb.com/democrat-lawmakers-probe-fda-voucher-program/), Democratic lawmakers sought additional information about the selection of voucher recipients and the role of political officials in determining which products would qualify for expedited review. Policy researchers also questioned whether the program's incentives would accomplish its stated objectives. An earlier [***FDA Webview*** report on a Brookings Institution analysis](https://www.fdaweb.com/brookings-questions-fdas-new-voucher-program/) described concerns about whether the initiative would meaningfully encourage domestic pharmaceutical manufacturing or reduce drug prices. The analysis also questioned whether the advertised one- to two-month review period accurately reflected the full regulatory process, given the substantial presubmission work, inspections and manufacturing assessments that could precede a formal application review. The criticisms reflected different concerns about the initiative but converged on a central question: whether FDA could dramatically accelerate drug approvals while preserving scientific independence, regulatory transparency and adequate review resources. ### **Uncertain Future for Voucher Recipients** The voucher program was introduced in June 2025 as a mechanism for expediting reviews of drugs aligned with national priorities, including unmet medical needs, innovative treatments, domestic manufacturing and affordability. It offered participating companies enhanced communications with FDA reviewers, rolling submissions and a targeted review period of one to two months. FDA maintained that the shortened timelines would not alter the statutory standards for establishing drug safety and effectiveness. Reuters reported that the program had awarded vouchers covering 22 drugs and that 12 had received approval. The news organization also described internal disagreements over certain reviews, raising further questions about how the program balanced accelerated decision-making with scientific oversight. The immediate uncertainty is whether FDA will resume awarding vouchers, revise the program's operating procedures or allow the initiative to expire after completing reviews of existing participants.