Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss.
The FDA’s Commissioner’s National Priority Voucher program could be on shaky legal ground, according to Rep. Jake Auchincloss (D-MA), who, in a letter to the agency, flagged the lack of transparency around how the scheme awards its tickets and approvals.
“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, according to a Tuesday report from the Associated Press. The program, he added, has been “shrouded in secrecy” because the regulator has failed to respond to several inquiries from Congress.
Launched in June last year, the Commissioner’s National Priority Voucher program rewards companies that align with certain national priorities—such as lowering drug prices in accordance with the Most Favored Nation directive. The program aims to drastically shorten review times. Companies that use these vouchers can receive their regulatory verdicts within 1–2 months, as opposed to the usual 10–12 months.
Such a scheme, however, did not receive congressional approval, Auchincloss pointed out in his letter, according to the AP. The representative also noted that the FDA hasn’t yet made public financial disclosures for eight senior officials who decide which drugs get awarded the Commissioner’s vouchers.
Among the members of this high-level panel are Center for Biologics Evaluation and Research Director Vinay Prasad and Center for Drugs Evaluation and Research Director Tracy Beth Høeg. In a townhall meeting also on Tuesday, FDA officials assured employees that the final decision of whether or not an application gets approved still rests with the agency’s reviewers and scientists, not the political appointees in the voucher-granting group, according to reporting from STAT News.
The FDA has so far handed out two batches of tickets under the CNPV program. The awardees include Sanofi’s type 1 diabetes drug Tzield, Regeneron’s gene therapy DB-OTO for congenital deafness, Eli Lilly’s obesity pill orforglipron and Vertex Pharmaceuticals and CRISPR Therapeutics’ sickle cell disease therapy Casgevy.
In December 2025, the agency also awarded a voucher to Johnson & Johnson and was considering granting two to Merck—even though the companies had not applied for them. That same month, the agency granted its first CNPV approval, which went to GSK’s antibiotic Augmentin XR, a generic version of which is produced in the U.S. by manufacturer USAntibiotics.
The FDA has yet to respond to Auchincloss’ letter, according to the AP. BioSpace has not been able to obtain a copy of Auchincloss’ letter. The representative is a member of the House subcommittee on health.
