The U.S. Food and Drug Administration’s Commissioner’s National Priority Voucher (CNPV) program is facing scrutiny from lawmakers over its transparency and legal foundation. Rep. Jake Auchincloss (D-MA) raised concerns in a letter to the agency, highlighting that the process for awarding vouchers and approvals under this scheme lacks openness.
“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,” Auchincloss wrote in his letter, as reported by the Associated Press. He added that the program has been “shrouded in secrecy” due to the regulator’s failure to respond to multiple Congressional inquiries.
The CNPV program was launched in June 2025 with the aim of accelerating regulatory review for drugs aligned with national priorities, such as reducing drug prices under directives like Most Favored Nation. Companies granted these vouchers can receive decisions on their applications within one or two months instead of waiting 10–12 months.
Auchincloss pointed out that Congress did not approve this initiative and noted that financial disclosures for eight senior FDA officials involved in awarding these vouchers have not been made public. Members of this decision-making panel include Vinay Prasad, Director of the Center for Biologics Evaluation and Research, and Tracy Beth Høeg, Director of the Center for Drugs Evaluation and Research.
At a townhall meeting on Tuesday, FDA officials told employees that final approval decisions remain with agency reviewers and scientists rather than political appointees involved in granting vouchers, according to STAT News.
To date, two rounds of CNPV tickets have been distributed. Recipients include Sanofi for its type 1 diabetes drug Tzield; Regeneron for its gene therapy DB-OTO targeting congenital deafness; Eli Lilly for its obesity pill orforglipron; Vertex Pharmaceuticals and CRISPR Therapeutics for their sickle cell disease therapy Casgevy.
In December 2025, Johnson & Johnson received a voucher from the agency while Merck was being considered for two more—even though neither company had applied. That same month saw GSK’s antibiotic Augmentin XR become the first product approved under CNPV; USAntibiotics manufactures a generic version domestically.
The FDA has not yet replied to Auchincloss’ letter. BioSpace has also not obtained a copy of it. Auchincloss serves on the House subcommittee on health.
