The US Food and Drug Administration (FDA) will convene a public hearing intended to obtain feedback on its Commissioner’s National Priority Voucher (CNPV) pilot programme, a framework that has garnered mixed reception since launching in mid-2025.
The hearing, which will take place on 12 June 2026, will see the public offer their opinions across a range of topics related to the CNPV programme. Alongside the in-person event at the FDA’s headquarters in Maryland, those wishing to provide comment can also do so virtually until the end of June.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
FDA commissioner Marty Makary launched the CNPV programme in June 2025. The regulatory framework allows biotechs and pharma companies who receive a voucher to have a shortened FDA review time for a new drug application of up to two months, down from the usual 10-12 month timeframe.
To gain a voucher, companies must demonstrate US-focused potential, such as addressing a health crisis in the country, providing an innovative cure for US patients, meeting public health needs or increasing domestic drug manufacturing as a national security issue. Affordability was added as an additional consideration later in the pilot programme.
However, experts interviewed by Pharmaceutical Technology have highlighted the framework’s opacity. An ex-FDA reviewer said both the eligibility and voucher selection criteria are “unclear.” Given that the initiative was not passed through Congress and instead was established at the whim of FDA senior leadership, there are some concerns that the award process is not objective.
Analysis by Pharmaceutical Technology found that, of the 18 vouchers awarded since June 2025, 10 have gone to big pharma companies – all of which have pricing agreements with the White House.
Seeking to gather formal feedback on the scheme, the FDA will aim to cover eight, and potentially more, topics at the public event. These include the eligibility criteria, voucher selection process, regulatory benefits, and timeline reviews, amongst others.
Officials from several FDA offices will be present on a panel, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research and the Oncology Center of Excellence.
Grace Graham, the FDA’s deputy commissioner for policy, legislation, and international affairs, said in a notice: “We are holding this public hearing to obtain feedback and perspectives regarding the CNPV Pilot Program, including feedback on the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.”
The CNPV pilot has coincided with several leadership changes at the FDA – some departed due to disagreements with the agency’s new direction. Additionally, the workforce was reduced as part of a White House initiative to streamline government agencies. Industry leaders are therefore monitoring whether the FDA, following a period of staffing changes, will be able to meet the shortened review timelines under the CNPV framework. The public hearing should provide greater clarity on this.
There have been several product approvals via the CNPV framework, such as Boehringer Ingelheim’s lung cancer drug Hernexeos (zongertinib), although the overall efficiency of the new voucher framework is yet to be determined, given that other companies have experienced delays.
