FDA Faces Calls to Pause 22-Drug Voucher Program as Critics Cite Political Interference
Updated
Updated · Chemical & Engineering News · Jun 5
FDA Faces Calls to Pause 22-Drug Voucher Program as Critics Cite Political Interference
3 articles · Updated · Chemical & Engineering News · Jun 5
Summary
Twenty-two CNPV awards are now under sharper scrutiny after experts and former FDA staffers told a public hearing the program should be overhauled or paused.
Critics said the voucher system uses vague “national priority” criteria, an opaque selection process and political appointees, arguing issues like drug pricing and domestic manufacturing fall outside the FDA’s core remit.
Peter Lurie said nearly half of voucher recipients had also reached White House drug-pricing deals, and speakers pointed to April’s three psychedelics vouchers issued days after President Donald Trump ordered faster psychedelics research.
The vouchers do not guarantee approval—the FDA rejected Disc Medicine’s bitopertin from a fast-track pathway in February—but several witnesses said robust public guidance is needed before the pilot continues.
Acting Commissioner Kyle Diamantas has reportedly told rare-disease groups he would shield reviewers from political interference, suggesting the agency may revisit a program launched last June under former commissioner Marty Makary.