FDA Shelves the Commissioner's National Priority Voucher Program, Reuters Reports - 22 Drugs Got Vouchers, 12 Were Approved
The program that promised one-to-two-month drug reviews has issued no new voucher since Commissioner Marty Makary left in May, and its political-appointee council has gone dormant, per six sources and internal documents. HHS says on the record that the pilot is ongoing.
One of the Trump administration's signature drug-policy experiments is being wound down in silence, Reuters reported Thursday. The Food and Drug Administration has shelved the Commissioner's National Priority Voucher program - launched in June 2025 by former Commissioner Marty Makary to slash drug review timelines to one to two months for therapies addressing national priorities - according to six sources familiar with the matter and internal documents seen by the wire. The agency has been without a commissioner since Makary left in May.
The program's numbers are real, which is part of the argument now surrounding it. Of the 22 drugs handed a voucher, 12 have been approved - five of them since Makary's departure - and for several, the voucher sped approval by eight months or more. But no new drug has received a voucher since May, the executive council of political appointees that oversaw reviews and drove the speed has gone dormant, and one source told Reuters that companies have been informed the agency is not moving forward with the program even though applications nominally remain open. Former HHS official Rich Danker called it an initiative 'quietly being phased out.'
The official word contradicts the quiet one. HHS spokesperson Emily Hilliard told Reuters the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing to refine the framework; the agency did not answer questions about the program's departed lead administrator or a replacement. The critics' case was stated as bluntly at that June hearing as it is now: University of Pennsylvania health policy professor Holly Fernandez Lynch described the program to Reuters as 'the worst of both worlds' - political influence risked for speed many drugs could have won through existing fast pathways. Reuters' account of Sanofi's diabetes drug Tzield shows the machinery in action: objections raised by the council's acting drug-center director at three meetings across six months, then accelerated approval granted in June, after she and Makary had left.
What remains is a residue rather than a program. Two recent voucher drugs - Merck's cholesterol pill Lipfendra and Revolution Medicines' pancreatic cancer drug Rasonque - were cleared without the council's vetting, Rasonque on timelines typical of the agency's preexisting oncology mechanisms; Merck KGaA's Pergoveris, rolled out at the Oval Office as a priority, remains unapproved three months after its final application was accepted. For the nine drugs still holding vouchers, Reuters reports, FDA career scientists have resumed overseeing the timelines - the ordinary process, quietly restored, while the voucher that promised to replace it gathers dust.
