The U.S. Food and Drug Administration’s Commissioner’s National Priority Voucher (CNPV) program, launched in June 2025 to speed up drug review times, continues to draw scrutiny for its lack of transparency, according to experts and lawmakers. The issue was highlighted on March 23 when concerns about the program's opaque selection criteria were raised following recent approvals and rejections under the initiative.
The CNPV program is intended to address urgent medical needs by reducing review periods from the standard 10–12 months down to just one or two months for selected investigational products. However, some biopharma leaders and policymakers say that the FDA has not clearly outlined how drugs are chosen for this expedited pathway, making it difficult for companies to determine eligibility.
Rep. Jake Auchincloss (D-MA) wrote directly to the agency stating his concerns about how the program has been “shrouded in secrecy.” He said, “The public must have transparency about the ‘voucher’ program, under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership.”
Kinnari Patel, CEO of RTW Institute, commented on the potential benefits of fast-track reviews: “In theory, the benefits look great,” she told BioSpace. Still, Patel pointed out uncertainty around what constitutes an unmet medical need as defined by FDA Commissioner Marty Makary: “we don’t know what that means.” She added that “the criteria for selection is not as transparent and standardized as we would like,” noting decisions appear largely at the discretion of senior leadership.
Since its inception last summer, four products have received approval through CNPV within two months: Novo Nordisk’s Wegovy HD; Johnson & Johnson’s Tecvayli/Darzalex combination; USAntibiotics’ Augmentin XR; and Boehringer Ingelheim’s Hernexeos. One candidate—Disc Medicine’s bitopertin—was rejected after a four-month review period. At least thirteen applications remain pending.
Some selections have surprised industry observers due to unclear prioritization criteria. Jama Pitman of Rose Hill Life Sciences noted only a minority of accepted products fit her understanding of urgent unmet need cases: "About five or so . . . were true investigational new agents that didn’t have an approval in the U.S. or outside." Meanwhile, analysts at Truist Securities called Disc Medicine's rejection "surprising," while BMO Capital Markets observed it showed selection does not guarantee faster reviews or approval.
While there are no formal regulations codifying CNPVs beyond a press release posted online last year, a staff manual guide with more details was published by FDA in January 2026. The agency plans a public meeting in June where stakeholders can provide feedback on improving clarity around CNPV procedures.
Looking ahead, experts suggest ongoing stakeholder engagement will be crucial if trust is to be restored in expedited regulatory pathways such as CNPV.
