Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns

Drug manufacturers, patient advocates and policy experts used the first FDA public hearing on the Commissioner’s National Priority Voucher (CNPV) program to urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation.

The 6/4 hearing marked the first formal opportunity for stakeholders to publicly weigh in on the controversial expedited review pathway launched last year by former FDA commissioner Marty Makary. The program allows selected drugs and biologics deemed aligned with national priorities to receive FDA decisions in as little as one to two months, compared with the agency’s traditional review timelines.

According to multiple reports from the hearing, many speakers supported the goal of accelerating access to important therapies but argued that the program’s design lacks sufficient transparency and could expose FDA decision-making to political influence. While few stakeholders called for eliminating the program outright, many urged the agency to clarify selection criteria, formalize governance structures and strengthen safeguards protecting scientific review.

“The need for a fiercely independent, reliable and credible FDA is more critical now more than ever,” Janet Krommes of Doctors for America told the agency during the hearing, according to BioSpace. Krommes and other speakers argued that physicians and patients had little input into the program’s creation and that the criteria for awarding vouchers remain unclear.

STAT reported that most speakers asked FDA to pause the program and restart it through a more formal regulatory process that would include public notice and comment requirements. Critics said the program was launched without sufficient stakeholder engagement and that its broad definition of “national priorities” creates uncertainty about how voucher recipients are selected.

Among the sharpest critics was Peter Lurie, president of the Center for Science in the Public Interest and a former FDA associate commissioner. Lurie urged the agency to "wind down this pilot," citing concerns about politicization, resource constraints and a lack of transparency, according to FierceBiotech. He argued that recent voucher awards to several psychedelic drug developers illustrated the potential for political influence to affect program decisions and warned that FDA approvals must remain grounded in scientific evidence rather than external political considerations.

Lurie also criticized the structure of the CNPV review council, which includes the FDA commissioner and other senior agency leaders, and called on FDA to place greater authority in the hands of career scientists and subject-matter experts. He further questioned the agency's rationale for awarding vouchers under broad priorities such as drug pricing and domestic manufacturing, arguing that those issues fall largely outside FDA's traditional regulatory mission.

"There's a taint here of political involvement," Lurie said during the hearing, arguing that factors unrelated to a product's safety and effectiveness should not influence review decisions.

Industry participants, however, generally voiced support for maintaining the program while improving its implementation. Supporters of the initiative pointed to its early results. FDA has reported awarding 18 vouchers and granting multiple approvals through the program, including oncology products reviewed in less than two months. The agency has described the program as a way to bring important therapies to patients more quickly through enhanced sponsor engagement and multidisciplinary reviews.

In announcing the hearing earlier this year, FDA said it sought public feedback on eligibility criteria, voucher selection processes, sponsor responsibilities, review procedures and overall program implementation. FDA officials have not indicated whether they will pause the pilot but said the public hearing and comment process are intended to inform potential changes to the program going forward.

Written comments will be accepted through 6/29.