The US Food and Drug Administration (FDA) appears to have quietly paused the Commissioner’s National Priority Voucher (CNPV) pilot programme, a controversial expedited review framework established by former agency chief Marty Makary.
The programme’s shelving was first reported by Reuterswhich cited six sources familiar with the matter and internal documents.
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The FDA’s CNPV scheme, which was launched in June 2025serves as a speedy drug approval process for pharma companies prioritising US interests. It shortens FDA review time for a new drug application from 10-12 months to up to two months.
Pharma companies needed to demonstrate US-centric potential for the drug to qualify for the programme. The drug would need to address a health crisis in the country, produce an innovative cure for American patients, meet public health needs, or increase domestic drug manufacturing as a national security issue. It marks a stark contrast to existing voucher frameworks used for rare paediatric disease and tropical diseases.
However, of the 22 drugs given a voucher, slightly more than half were approved. These include MSD’s infertility treatment Pergoveris, Sanofi’s type 1 diabetes drug Tzield (teplizumab), and a gene therapy developed by Regeneron for congenital deafness.
There was a lack of transparency regarding the programme’s incumbents, however. Analysis by Pharmaceutical Technology identified that a large proportion of the first 15 recipients of a voucher were big pharma companies. Many of these have pricing agreements with the White House.
Experts interviewed by Pharmaceutical Technology earlier this year questioned the award process. A former FDA reviewer said that the tight approval timelines meant “easy, low-hanging fruit” would be selected over first-in-class drugs with a high profile.
No new drugs have been equipped with a voucher since Makary’s resignation in May 2026. Department of Health & Human Services (HHS) secretary, Robert F Kennedy (RFK) Jr, has previously praised the speed of two approvals granted via the CNPV scheme, though his public comments on the framework have been scarce recently.
An HHS spokesperson did not immediately respond to Pharmaceutical Technology for comments on the programme’s status, but they have told other outlets that CNPV activities are “ongoing”.
HHS spokesperson Emily Hilliard said that the FDA is reviewing feedback from a June public hearing on it to refine the framework, as per Reuters.
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Source: www.pharmaceutical-technology.com
