FDA Has Shelved Makary's Fast-Track Voucher Program, Six Sources Tell Reuters. HHS Says It Is Ongoing

Since Marty Makary launched the Commissioner's National Priority Voucher program in June 2025, the FDA has handed out 22 vouchers and approved 12 of the drugs that received them. Now the program itself appears to have stalled. Six sources familiar with the matter and internal documents told Reuters, in an exclusive published today, Nov. 12, that the agency has shelved it.

HHS disputes that. Spokesperson Emily Hilliard said the pilot is ongoing and that the FDA is reviewing feedback from a June public hearing to refine the framework.

What the program promised

The pilot was meant to cut final review of an application from the usual 10 to 12 months down to one to two months. A product had to align with at least one of five national priorities: public health crisis response, innovative breakthrough therapies, large unmet medical needs, onshoring and supply chain resilience, or affordability.

Vouchers were nontransferable and tied to a specific product. Companies could submit most of an application before a clinical trial finished.

At launch, Makary said in an FDA press release: "Using a common-sense approach, the national priority review program will allow companies to submit the lion's share of the drug application before a clinical trial is complete so that we can reduce inefficiencies."

By the numbers, it delivered speed. Of the 22 drugs that received vouchers, 12 have been approved, five of them since Makary left the FDA in May. For several drugs, the program cut approval time by eight months or more. Approved products include Wegovy HD, Otarmeni, Foundayo and Lipfendra.

What changed after May

The FDA has had no commissioner since Makary's departure. According to Reuters' sources and internal documents, no new voucher has been awarded since then. The executive council of political appointees that oversaw reviews and played a central role in speeding approvals has gone dormant.

One source familiar with the process told Reuters that FDA leadership told companies the agency is not moving forward with the program but is keeping applications open. Once companies submit, the source said, the applications do not advance.

Rich Danker, a former assistant secretary at HHS, said the initiative is quietly being phased out and pointed to the departure of the program's top administrator. He also said no new vouchers have been awarded.

The FDA did not respond to Reuters' questions about the departure of the program's lead or whether a new coordinator has been named.

Two sources said FDA career scientists have resumed overseeing review timelines for the nine drugs still in the program. Reuters' sources also said recent approvals of enlicitide and daraxonrasib bypassed the executive council, making them look like conventional expedited pathways.

The criticism was there from the start

The program drew fierce criticism from regulatory experts over the handpicking of drugs and the makeup of the council. That body included former acting drug center director Tracy Beth Hoeg and former biologics chief Vinay Prasad. Both left the FDA earlier this year.

Critics also pointed to possible preferential treatment for companies that met demands from President Trump, such as offering drugs at lower prices. No source in the reporting has produced evidence that any specific approval was granted as a trade for pricing concessions.

Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, described the program as "the worst of both worlds."

The argument on the other side is the program's own record. Compressed reviews got drugs to patients months sooner, and the agency's stated aim was cutting inefficiency. The same discretion that produced speed is what critics objected to. Who got a voucher was decided by a small group of political appointees, not by a published rule.

That design is also why the program may be easy to unwind. It was a pilot run by a commissioner's office, not a regulation, and it depended on a single leader and a council that has since gone quiet.

The psychedelics question

The stakes are specific for some sponsors. President Trump signed an executive order on April 18, 2026, directing HHS to accelerate access to treatments for serious mental illness. Psilocybin programs for treatment-resistant depression and major depressive disorder, and a methylone program for PTSD, were positioned to benefit from vouchers.

None of those products is approved. How they will be reviewed under standard evidentiary requirements is unclear, and HHS has not said.

What comes next

The FDA held its public hearing on the pilot on June 4, 2026. HHS says it is reviewing that feedback. It has not said when a refined framework would be released, whether new vouchers will be awarded, or who will run the program now.

For the nine drugs still enrolled, the question is concrete. Sponsors built manufacturing and launch plans around one-to-two-month reviews, and Reuters' sources say those timelines are now in the hands of career staff.