FDA Shelves Makary-Era Fast-Track Drug Review Voucher, Sources Say
The US Food and Drug Administration has shelved the fast-track drug review programme launched under former Commissioner Marty Makary, Reuters reported on Thursday, citing six sources familiar with the matter and internal documents.
A programme built for speed
Launched in June 2025, the Commissioner’s National Priority Voucher (CNPV) programme was designed to compress the FDA’s review of selected medicines from the usual 10 to 12 months to just one or two. Vouchers were aimed at drugs that served national priorities, including urgent unmet medical needs and bringing drug development and manufacturing back to the United States.
The pilot drew criticism from the start, with questions over political favouritism, transparency, and the strain on the agency’s staff.
No new vouchers since May
No new voucher has been awarded since Makary left the agency in mid-May, Reuters reported. An executive council of political appointees that oversaw reviews under the programme has gone dormant, according to internal documents reviewed by the news agency.
Two of the council’s members — former acting drug centre director Tracy Beth Hoeg and former biologics chief Vinay Prasad — have since left the FDA. For the nine drugs still in the programme, career scientists have resumed overseeing review timelines, two sources said.
Twelve approvals, and a dispute over what ‘shelved’ means
Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary’s departure. Among them are Eli Lilly’s GLP-1 pill Foundayo, Merck’s cholesterol pill Lipfendra, and Revolution Medicines’ pancreatic cancer drug Rasonque. Fierce Pharma, which also covered the Reuters report, noted one voucher drug has been rejected.
The two most recent approvals — Lipfendra and Rasonque — were not vetted by the executive council, Reuters reported.
Rich Danker, a former assistant secretary at the Department of Health and Human Services, said the initiative is “quietly being phased out”, pointing to the departure of the programme’s top administrator. One source told Reuters that FDA leadership had told companies the agency is not moving forward with the programme, while keeping applications open — but applications submitted now do not advance.
The department disputes that characterisation. HHS spokesperson Emily Hilliard said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing to refine the framework. An FDA spokesperson told BioSpace: “FDA’s commitment to its core mission remains unchanged, and work under the Commissioner’s National Priority Voucher (CNPV) Pilot Program is ongoing.”
What happens next
The programme’s future now rests with the agency’s next leadership. Kyle Diamantas has served as acting FDA commissioner since Makary’s resignation, and Heidi Overton’s nomination to lead the agency permanently awaits a Senate vote in the lame-duck session.
RBC Capital Markets analysts told investors on Thursday that there has been no official guidance from the FDA on the programme, “nor is it clear the extent to which this may impact companies with an existing CNPV rather than new applicants to the program”, according to BioSpace.
Two voucher holders, Compass Pathways and Usona Institute, have recently submitted applications for psychedelic-based treatments, including COMP360 for treatment-resistant depression, and their fate is now uncertain.
The agency has continued to use other accelerated pathways, including a fast-track designation for a children’s sleep drug, and in a separate decision it approved Sunharbo, a stroke-prevention medicine. Fierce Pharma also reported that the agency appears to have paused publishing complete response letters — the notices it sends drugmakers when an application is not approved.
For drugmakers that built launch plans around one-to-two-month reviews, the voucher programme’s quiet end means a return to the standard timetable — and a wait for the next commissioner to say so publicly.
The episode comes as drug development itself is changing fast: researchers recently unveiled a DNA model that predicts the effects of genetic variants, a tool that could reshape how new medicines are found.
