FDA has stopped advancing fast-track drug voucher programme, Reuters reports; agency says pilot continues

The US Food and Drug Administration has stopped advancing its Commissioner's National Priority Voucher programme, a pilot designed to cut drug reviews to one or two months, Reuters reported on Thursday, November 12, 2026, citing six people familiar with the matter and internal documents. The FDA and the Department of Health and Human Services dispute that account and say the pilot is continuing.

What was reported

According to Reuters, as reported by BioSpace and Pharmacy Times, agency leadership has told companies that the FDA is not moving forward with the programme but is keeping applications open. One source told Reuters that applications already submitted are not advancing.

Reuters also reported, according to BioSpace, that an executive council of political appointees that had overseen reviews under the programme "has gone dormant," citing internal documents. For the drugs still in the programme, FDA career scientists have resumed overseeing review timelines, two sources told Reuters, according to Pharmacy Times.

These accounts rely on unnamed sources; the FDA has not announced any change to the programme.

The agency's response

An FDA spokesperson told BioSpace by email that "work under the Commissioner's National Priority Voucher (CNPV) Pilot Program is ongoing" and that "FDA career staff continues to evaluate applications granted a CNPV." The spokesperson said the agency would "meet commitments for accelerated review and enhanced engagement" while it assesses lessons from the pilot.

HHS spokesperson Emily Hilliard said "the pilot is ongoing," according to Pharmacy Times, and HHS said the FDA was reviewing feedback from a June 4, 2026 public hearing to refine the framework.

The programme's record

The programme was launched in June 2025 under former FDA Commissioner Marty Makary, who left the agency in May 2026. It offered faster reviews, with targets of one to two months instead of the usual ten to twelve, for products tied to national priorities such as public health crises, unmet medical needs, domestic manufacturing and affordability, Pharmacy Times reported.

Twenty-two drugs have received vouchers and twelve of them have been approved, five since Makary's departure, according to BioSpace and Pharmacy Times. No new vouchers have been awarded since he left, both outlets reported. Pharmacy Times reported that nine drugs remain in the programme. Approved voucher holders include Novo Nordisk's higher-dose Wegovy, Eli Lilly's Foundayo (orforglipron), Merck's Lipfendra (enlicitide) and Revolution Medicines' Rasonque (daraxonrasib), according to Pharmacy Times.

The FDA has been without a confirmed commissioner since Makary's departure. A Senate committee vote on the nomination of Heidi Overton to lead the agency is scheduled for November 18, BioSpace reported.

What it means for drugmakers

RBC Capital Markets said there had been no official FDA guidance on the programme and that it was unclear how any change would affect companies that already hold a voucher, according to BioSpace. Among recent applicants holding vouchers are Compass Pathways and the Usona Institute, which have submitted psilocybin-based treatments for depression, BioSpace reported.