A new executive order directing federal agencies to increase researchers’ access to psychedelics for psychiatric conditions was hailed by scientists, clinicians, and advocates, who said it is a long-overdue acknowledgment of the compounds’ potential as a treatment for psychiatric illness.

Signed by President Donald J. Trump on April 18 in a White House ceremony, the order seeks to speed studies of such drugs as Lysergide (LSD), psilocybin, 3,4-methylenedioxymethamphetamine (MDMA), and ibogaine, all of which are classified as Schedule I controlled substances.

Trump’s action could lift existing legal roadblocks to psychedelic studies, allocate research funding to support the development of psychedelic-based therapeutics, and direct the FDA to provide National Priority Vouchers to psychedelic drugs that have received Breakthrough Therapy designation.

Matthew W. Johnson, PhD, professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine, Baltimore, said he expects the order to streamline bureaucracy for researchers like him. Johnson’s studies of psilocybin have been largely funded with the support of National Institute of Drug Abuse (NIDA) grants.

“For years, there was a political fear that if you stuck your neck out as an institute director and funded some of this stuff, there could be blowback,” Johnson told Medscape Medical News, adding that this move signals a political shift that encourages the National Institutes of Health and other agencies to support psychedelics research.

The American Psychiatric Association (APA) said in a statement that while the focus on new therapeutics is welcome, “there is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies.”

The organization “supports a disciplined, evidence-first approach to exploring psychedelic therapies — one that protects patients and ensures psychiatrists remain central to the evaluation and delivery of any emerging treatments,” APA President Theresa Miskimen Rivera, MD, said.

Far-Reaching Order

The order was written in a week, primarily by US Department of Health and Human Services (HHS) Deputy General Counsel Matthew Zorn said Centers for Medicare and Medicaid Services Administrator Mehmet Oz, MD, at the briefing.

Zorn was previously co-counsel on a 2022 petition filed by the Seattle-based Advanced Integrative Medical Science (AIMS) Institute asking the US Drug Enforcement Administration (DEA) to reschedule psilocybin so it could be used by terminally ill patients to ameliorate depression and anxiety. The lawyer joined the administration in early 2025 and has since recused himself from anything relating to that case or psychedelics advocacy.

The order allocates at least $50 million from existing HHS funds and directs the agency to partner with states that are developing programs to advance psychedelic drugs for serious mental illnesses. The measure also encourages collaboration among the FDA, the Department of Veterans Affairs, and the private sector to increase trial participation, data sharing, and real-world evidence generation.

Johnson said that kind of streamlining could potentially eliminate what he called a “crazy dance” among agencies to secure trial approval. Procuring drugs for trials, usually from the NIDA, has also been difficult.

“I’ve been caught up for more than 6 months at times looking for a drug supply for a study,” he said.

Under the order, the DEA will initiate and complete a review of any psychedelic that is currently Schedule I and has completed phase 3 trials for a serious mental health disorder. The DEA is also ordered to find a way to increase access to psychedelics, including ibogaine, under the federal Right to Try Act.

Reactions Both Hopeful and Tempered

The nonprofit group Americans for Ibogaine, which had members of Congress and former Texas Governor Rick Perry (now board chairman) in its corner, also celebrated. “The federal prohibition of psychedelic medicine in America is over,” said CEO W. Bryan Hubbard at the signing.

The Multidisciplinary Association for Psychedelic Studies (MAPS), which pioneered efforts to bring psychedelics to the FDA for approval, said that the order represented a “meaningful shift” in the federal government’s psychedelic policy.

“As federal agencies move to reduce longstanding barriers to research, it is essential that progress across this broader class of compounds remains grounded in rigorous science, careful evaluation, and a commitment to patient safety,” said MAPS Co-Executive Director Ismail L. Ali, JD, in a statement.

In its response, the APA stressed the importance of ensuring that clinical trials are led only by trained experts in controlled clinical settings and that “near-term efforts are grounded in sound study design, strong patient protections, and thoughtful interpretation of the findings,” the organization said.

Clinical trials should be led by trained experts in controlled clinical settings, the statement continued, with studies subject to the “same regulatory and ethical standards should be applied to these studies as to all promising treatments in medicine.”

Quick FDA Action Expected

FDA Director Marty Makary, MD, said at the ceremony that the agency would approve National Priority Vouchers for three psychedelic medications as early as this week and that it had also approved an investigational new drug application for ibogaine, which would allow for the first human trials in the US.

Medications that have received breakthrough therapy designations are eligible for the National Priority Voucher program.

So far, that includes:

• CYB003, a version of psilocybin for major depressive disorder from Helus Pharma (formerly Cybin)
• COMP360, a psilocybin formulation for treatment-resistant depression from Compass Pathways
• PSIL102, a version of psilocybin for major depressive disorder from Usona Institute, Fitchburg, Wisconsin
• LSD d-tartrate (MM-120; Mind Medicine) for generalized anxiety disorder
• BPL-003 (mebufotenin benzoate) nasal spray for treatment-resistant depression
• Luvesilocin for postpartum depression from Reunion Neuroscience
• MDMA for posttraumatic stress syndrome, from Lykos Therapeutics, which was rejected by the FDA in 2024

Makary said that medications that received vouchers should result in FDA decisions later this summer. 

Johnson reported consulting for Ajna Labs, Beckley Psytech, Clarion Clinics, Definium Therapeutics (Formerly MindMed), Negev Capital, Otsuka Pharmaceutical Development & Commercialization, and Reunion Neuroscience. He also reported having equity or stock options with Ajna Labs, Atai-Beckley, and Definium Therapeutics. Tucker disclosed that her advocacy work is supported by philanthropic donors.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.