Drugs

Former FDA Drug Chief Questions Future of Priority Voucher Program

Former FDA Office of New Drugs (OND)director Peter Stein sharply criticized the agency's National Priority Voucher (NPV) program at the DIA Global Annual Meeting in Philadelphia last week, arguing that its one- to two-month review timeline undermines the rigor of FDA's drug review process. Speaking during a panel discussion, Stein said the expedited review timeline is "almost like an insult to the FDA reviewers," who are tasked with conducting thorough scientific evaluations of new therapies, according to a report by the Regulatory Affairs Professionals Society (RAPS). Stein oversaw OND from 2018 until his departure during FDA workforce reductions last year.

The voucher program, launched in 2025 under former FDA commissioner Marty Makary, offers participating companies enhanced interaction with FDA officials, accelerated review timelines, and non-transferable priority vouchers for products aligned with national health priorities. FDA has awarded more than 20 vouchers and approved seven products under the program.

Stein contrasted the program's review goals with traditional FDA reviews, which he described as intensive, data-driven evaluations developed over decades. "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 contended that the two-month timeline “is almost like an insult to the FDA reviewers,” and pits reviewers against the commissioner and senior officials urging them to speed through the review, RAPS reports.

Panelists noted that the program's future remains uncertain. Kate Rawson, senior editor at Prevision Policy, said FDA recently removed the word "Commissioner's" from the program name, disbanded its review board, and eliminated commissioner-level involvement in candidate selection, according to RAPS. Those changes suggest the agency may be attempting to depoliticize the initiative and move it closer to existing expedited review models such as the Real-Time Oncology Review program.

Rawson said one possibility is that FDA ultimately phases out the voucher program after current participants complete review, while another is that elements of the initiative evolve into broader real-time review processes across multiple product centers.

Despite the criticism, some panelists highlighted potential benefits. Lawrence Liberti of the University of Southern California said research indicates that facilitated regulatory pathways, including the voucher program and other FDA expedited programs, can meaningfully reduce review times for certain products, according to RAPS.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome