What a new federal green light means for psychedelic research

• Veterans have emerged as a leading group campaigning to take psychedelic therapy mainstream.

Catch up quick: Trump's weekend executive order on psychedelics research, which instructed the FDA to provide priority vouchers, gives the FDA an avenue to accelerate the review of whether the compounds can be approved as medicine, researchers say.

• The FDA announced it was issuing the vouchers to three companies studying psilocybin (the compound behind "magic mushrooms") for treatment-resistant depression and for major depressive disorder, as well as methylone, similar to MDMA, for PTSD.

Reality check: Trump's order didn't immediately make these drugs accessible or change how they're scheduled under U.S. law, and researchers note there's a long regulatory road ahead.

• Melissa Lavasani, the founder and CEO of the Psychedelic Medicine Coalition, tells Axios she thinks an FDA approval for a psychedelic treatment is possible within six months.
• But then, she says, "we need doctors that are trained in what psychedelics are ... how you handle them, how you administer them, what kind of setting they need to be in" and "we need to let the public know that this is not a miracle cure."

Why psychedelics?

Research has highlighted the promise of psychedelic compounds in treating mental illness — like depression, anxiety and post-traumatic stress disorder — with research picking up in recent years.

• These compounds could "increase the brain's capacity for change," per the Massachusetts General Hospital Center for the Neuroscience of Psychedelics, opening doors for symptom relief.

Bob Jesse, an adviser to the UC Berkeley Center for the Science of Psychedelics, tells Axios he feels an underlying "sense of inevitability" that this progress would come.

• Lavasani echoed that sentiment, saying, "I think it would have happened with any president that sat in that Oval Office, just because so much work has gone into this field and into this space."

Still, psychedelics like ibogaine, psilocybin, MDMA and LSD remain Schedule I substances, meaning they are not currently accepted for medical use and carry a high abuse potential. In 2024, the FDA declined to approve MDMA for treating PTSD.

The long, strange trip

Trump's order signals a broader shift in the fraught relationship between the U.S. government and psychedelics, which were largely banned under President Nixon's Controlled Substances Act, which also stymied research.

Yes, but: In the last decade, the FDA has granted Breakthrough Therapy designation, an avenue to speed up review of drugs meant to treat serious conditions, to multiple psychedelic-assisted therapies.

• In 2023, it released historic draft guidance outlining considerations for researchers looking into psychedelic treatments for medical conditions.
• And the next year, the VA announced it would fund a study on MDMA-assisted therapy, a first since the 1960s.

What's next?

Lavasani says the "real strength" behind Trump's order was that it signaled to the rest of the government that it has tools to expedite review.

• Jesse tells Axios the vouchers could trim the timeline for new drug application review from roughly ten months to under two.

The bottom line: But "even after the FDA says 'yes,'" Jesse said, "that by itself does not generate trained clinicians and physicians who are prepared to administer a drug and be with somebody during a very powerful experience."

• He continues, "This is not a drug like penicillin ... it's going to create an acute, profound experience, which requires a certain kind of support."

Go deeper: Mushrooms are the most commonly used psychedelic, study finds