The FDA hasn’t been transparent and open enough with how it has implemented the Commissioner’s National Priority Voucher program, patient, industry and trade groups said Thursday.
Several representatives from various patient, industry and trade groups called for a temporary pause to the Commissioner’s National Priority Voucher program, citing concerns about the scheme’s transparency and the risk of political involvement.
“The need for a fiercely independent, reliable and credible FDA is more critical now more than ever,” said Janet Krommes, a medical doctor and chair of the FDA task force for the medical professional organization Doctors for America. Krommes was part of a public session on Thursday held by the FDA to collect input from various stakeholders on the CNPV program.
“Everyday patients and physicians serving their communities have not been a part of the creation of the CNPV, yet arguably, we see the greatest impact,” she said during the session. Among the concerns is the limited transparency with which the program was launched and has been implemented, as well as the vagueness of the criteria by which the awards are given out.
In this context, Krommes said, “We believe that a pause in the CNPV program . . . is vital and warranted.”
BioSpace has reached out to the FDA for comment on the matter.
Former FDA Commissioner Marty Makary first announced the CNPV program in June 2025 and the agency piloted the scheme a month later—all without opening it up for public comment and deliberation. The program can drastically speed up approvals for companies that align with certain national priorities, though it remains unclear how exactly the FDA chooses its awardees.
In February, Rep. Jake Auchincloss (D-MA) raised similar concerns around transparency. “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,” he wrote to the regulator. He added that CNPVs have been “shrouded in secrecy” since the agency has failed to respond to Congressional requests for information—something that could possibly carry criminal liability.
Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner at the FDA, echoed Krommes’ and Auchincloss’ concerns during the session.
In particular, Lurie pointed to the “politicization of the voucher selection process by the inclusion of national priorities that clearly fall outside the remit of the FDA” and the “involvement of political appointees in a dominant fashion in the review decision.”
In February, Disc Medicines was hit with a rejection for its rare blood disorder drug bitopertin after winning a CNPV just months earlier. Vinay Prasad, former director of the Center for Biologics Evaluation and Research, had reportedly been skeptical of the drug. Last month, Sanofi requested to withdraw its diabetes drug Tzield from the CNPV program after reported interference from Tracy Beth Høeg, ex-acting director of the Center for Drug Evaluation and Research.
Lurie also took issue with how the vouchers dramatically accelerate decisions, which he said could pose “dangers to consumers,” as well as with the lack of transparency surrounding the program.
Amid these concerns, variations of which have been expressed repeatedly in recent months, Makary left the FDA in May after a tumultuous 14-month tenure. HHS has told BioSpace that regulatory initiatives started by Makary, including the CNPV program, will carry on in his absence.
The FDA has approved four products under the CNPV program, including Eli Lilly’s obesity pill Foundayo and Regeneron’s hearing loss gene therapy Otarmeni. The regulator has given out 21 vouchers so far.
