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FDA Shelves the Psychedelic Fast-Track It Opened in April

FDA Shelves the Psychedelic Fast-Track It Opened in April

The FDA has reportedly stopped awarding the vouchers that promised one- to two-month reviews, including to three psychedelic drugs. HHS says the program is ongoing.

By TDR StaffNovember 13, 20263 min read

The Food and Drug Administration has reportedly shelved a program built to cut some drug reviews to one or two months. This spring, the administration had opened that psychedelic fast-track to three experimental drugs.

Reuters reports that the agency has awarded no new vouchers since former Commissioner Marty Makary left in May. For that report, the outlet cited six sources and internal documents.

The executive council of political appointees that oversaw the accelerated reviews has gone dormant. Instead, career FDA scientists now oversee timelines for the nine drugs still in the program, two sources told the outlet.

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What the psychedelic fast-track promised

The FDA launched the Commissioner’s National Priority Voucher program in June 2025. It promised to shrink a typical 10- to 12-month review to one or two months for drugs tied to “national priorities.”

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Psychedelics joined that list through Executive Order 14401, signed April 18. The agency then issued vouchers for psilocybin for treatment-resistant depression, psilocybin for major depression, and methylone for PTSD.

However, none of the drugs on the psychedelic fast-track is approved. In fact, the FDA has never approved a classic psychedelic for any condition. The last to reach a decision was MDMA therapy for PTSD. It failed in 2024 after agency advisers voted 10 to 1 that its benefits did not outweigh its risks.

Meanwhile, the voucher program drew criticism well beyond psychedelics. Holly Fernandez Lynch, a University of Pennsylvania health policy professor, called it “the worst of both worlds.” She told Reuters it paired serious risks of political influence with limited practical benefit.

HHS says the voucher program continues

However, the Department of Health and Human Services disputes the report. A spokesperson told Reuters the pilot is ongoing. The FDA is reviewing feedback from a June public hearing to refine it, the spokesperson said.

Still, the reported halt concerns the special accelerated review process. It does not establish that the applications on the psychedelic fast-track have stopped, and Reuters did not report on their status.

A call to apply the same standard to marijuana

The Foundation for Drug Policy Solutions welcomed the reported end of fast-tracking psychedelics and urged the administration to take the same approach to marijuana rescheduling.

“This reported reversal is welcome news for public health and safety, and we urge the Administration to keep going,” said Dr. Kevin Sabet, the group’s president. “No drug application should receive rushed or preferential treatment to satisfy political demands or enrich investors. Patient safety must come first.”

Sabet said the administration “should apply that same principle to marijuana and shut down its rushed rescheduling effort, which has similarly put industry interests ahead of public health.”

Similarly, that effort has already hit its own speed bumps. In September, a DEA judge paused the rescheduling proceeding to weigh a federal watchdog report on how agencies make scheduling decisions. Earlier, the FDA official in charge of the rescheduling review testified that for PTSD, marijuana’s risks outweigh its benefits.

The psychedelic fast-track has reportedly gone quiet. Whether the same caution reaches marijuana is the next test.

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