Psychedelics
Washington is racing to turn hallucinogens into medicine before the evidence is in. FDPS is making the case for science first: real trials, real standards, and no shortcuts, for veterans or anyone else.
- 1. TrialsPhase 3 under wayPsilocybin for depression and MDMA for PTSD are the most advanced programs.
- 2. FDA reviewFast-tracked, not provenVouchers in April 2026, a guidance in July, a hearing in September. No psychedelic has met the approval standard.
- 3. ApprovalNone so farThe FDA rejected the MDMA application in August 2024 and asked for another trial.
- 4. AccessStates are not waitingOregon, Colorado and New Mexico run psilocybin programs with no FDA approval at all.
Psilocybin, MDMA, LSD and ibogaine are being promoted as breakthrough treatments for PTSD, depression and addiction. The need for better treatments is real. So far, the evidence is not. The Foundation for Drug Policy Solutions is pressing the FDA, Congress and the states to hold psychedelics to the same standard as every other drug, which is what a science-based psychedelics policy requires.
Psychedelics policy: where things stand
Three forces are shaping psychedelics policy at once. The federal government is accelerating, the states are improvising, and an industry with billions on the line is shaping the story.
Executive Order 14401
In April 2026 President Trump ordered federal agencies to speed up psychedelic research and approvals. The FDA then issued national priority vouchers to three programs (psilocybin for treatment-resistant depression, psilocybin for major depression, and methylone for PTSD), finalized a psychedelic drug development guidance on July 14, 2026, and held a public hearing on September 14, 2026.
Federal Register, July 14, 2026 · FDPS statement on the order
Medicine by ballot measure
Oregon has run psilocybin “service centers” since 2023 and Colorado licenses “healing centers” under Proposition 122, with no FDA approval, no prescription and no diagnosis required. New Mexico passed a medical psilocybin law in April 2025 and New Jersey funded a hospital pilot in January 2026. Massachusetts voters said no in November 2024.
State statutes and program reports, compiled September 2026
Big Psychedelics
Billionaire donors and Silicon Valley investors have spent years shaping public opinion for an industry they are invested in. A 2025 investigation by Psymposia and Truthdig documented a coordinated campaign to push the FDA to approve Lykos Therapeutics’ MDMA application over the objections of the agency’s own advisory committee.
Claim vs. evidence
The case for fast-tracking psychedelics rests on a few claims that do not survive contact with the FDA’s own record.
MDMA-assisted therapy is a proven treatment for PTSD.
In June 2024 the FDA’s advisory committee voted 9 to 2 that the pivotal trials did not show the treatment worked, and 10 to 1 that its benefits did not outweigh its risks. In August 2024 the FDA declined to approve it and asked for another Phase 3 trial.
The trials are rigorous.
Participants can usually tell whether they received a psychedelic or a placebo, which breaks the blind and inflates the results. In the MDMA program about 40 percent of participants had used MDMA recreationally before enrolling, which the FDA flagged as selection bias. Across a dozen recent MDMA, psilocybin and LSD trials, a third or more of participants had often used the study drug before.
Psychiatry is on board.
The American Psychiatric Association’s position is that there is “inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder” outside approved investigational studies. The independent Institute for Clinical and Economic Review rated the MDMA evidence “insufficient.”
American Psychiatric Association position statement, July 2022; ICER final evidence report, June 2024
A voucher or “breakthrough” designation means the FDA thinks it works.
The FDA’s own hearing notice says the opposite: “Neither national priority voucher issuance nor Breakthrough Therapy designation constitutes an FDA determination of safety or effectiveness, and neither is a substitute for marketing approval.” These are procedural accelerants, not findings.
91 Fed. Reg. 43,096 (July 14, 2026)
The cost of the hype
When the federal government signals that a Schedule I hallucinogen is medicine, people act on it long before any approval. The harms of a hype-first psychedelics policy are already showing up in poison center data and emergency rooms.
Increase in psilocybin-related poison center calls involving children between 2019 and 2023. Calls involving teens rose 317 percent and calls involving adults 201 percent.
University of Colorado Anschutz, 2025, via the FDPS psychedelics fact sheet (PDF)
Of psilocybin users rated the experience as one of the five most challenging of their lives. Eleven percent said they put themselves or others at risk of physical harm.
Time between an off-duty pilot’s psilocybin use and the October 2023 flight on which he tried to shut down a jet’s engines mid-air. He described the episode as a lasting effect of the drug.
How long after use Hallucinogen Persisting Perception Disorder can return: visual disturbances, disorganized thinking, paranoia and mood changes in a sober person who once took a hallucinogen.
Psychedelics policy, 2022 to 2026: from “inadequate evidence” to an executive order
- July 2022The American Psychiatric Association finds inadequate evidence to endorse psychedelics for any psychiatric disorder.
- June 4, 2024The FDA’s advisory committee votes 9 to 2 that MDMA-assisted therapy was not shown to work, and 10 to 1 that its risks outweigh its benefits.
- August 2024The FDA rejects the MDMA application and asks Lykos Therapeutics for another Phase 3 trial.
- November 2024Massachusetts voters reject a ballot question to legalize psychedelics.
- April 2025New Mexico becomes the first state to create a medical psilocybin program by statute rather than ballot measure.
- October 2025A Psymposia and Truthdig investigation documents the Silicon Valley campaign to push MDMA through the FDA. FDPS summary
- April 2026Executive Order 14401 directs agencies to accelerate psychedelic approvals. The FDA issues national priority vouchers to three psychedelic programs. FDPS condemns the order.
- July 14, 2026The FDA finalizes its psychedelic drug development guidance and announces a public hearing on delivering psychedelic therapies.
- August 2026The VA launches a five-site psilocybin trial. FDPS files comments urging the FDA to build safety and evidence first. Read the comments (PDF)
- September 14, 2026FDA public hearing on the future therapeutic use of psychedelic drugs. Written comments are open until October 5, 2026.
- Late 2026Compass Pathways says it will file the first new drug application for psilocybin.
Where FDPS stands on psychedelics policy
FDPS is not against research. It is against pretending the research is finished. Its psychedelics policy asks for one thing: the same evidence standard that every other medicine has to meet.
What we support
- Rigorous, adequately controlled research into new treatments for PTSD, depression and addiction.
- FDA approval on the same standard as every other drug: substantial evidence from adequate and well-controlled trials, and an adequate showing of safety.
- Safety monitoring, provider credentialing and data systems built before any approval, not bolted on afterward.
- Honest communication about what vouchers and “breakthrough” labels do and do not mean.
- Proven treatments for veterans, delivered now.
What we oppose
- Fast-track approvals that lower the bar to fit a political timeline.
- Medicine by ballot measure or statute, with no clinical evidence review.
- State “service centers” that sell hallucinogens with no diagnosis, no prescription and no FDA oversight.
- Using veterans and people in crisis as test subjects for unproven drugs.
- An addiction-for-profit psychedelics industry writing its own rules.
Psychedelics policy resources
The documents behind the FDPS psychedelics policy, from its FDA filing to a fact sheet you can hand to a legislator.
Fact sheetPsychedelics: the risks and the record (PDF)HPPD, poison center trends, the Lykos rejection and where states stand, with sources.
White paperIbogaine: what the evidence says (PDF)The Schedule I compound at the center of the executive order, its cardiac risks and reported deaths.
StatementFDPS condemns the executive order on psychedelicsApril 20, 2026. “This order elevates politics and hype over sound science.”
VideoShould society legalize psychedelics? The Intelligence Squared debateDr. Kevin Sabet makes the case for evidence first.
BriefingsFDPS Drug FactsPlain-language briefings on psychedelics, kratom, marijuana and more.
Psychedelics policy: frequently asked questions
Are psychedelics legal in the United States?
Psilocybin, MDMA, LSD and ibogaine are Schedule I controlled substances under federal law. Oregon and Colorado allow supervised psilocybin use at state-licensed centers, Colorado has decriminalized personal possession, and New Mexico is building a medical psilocybin program, all without FDA approval. Federal law has not changed.
Has the FDA approved any psychedelic as a medicine?
No. The only application to reach a decision, MDMA-assisted therapy for PTSD, was rejected in August 2024. Esketamine, a ketamine-derived nasal spray approved in 2019 for depression, is not a classic psychedelic and went through the full approval process.
Does FDPS oppose psychedelic research?
No. FDPS supports rigorous, well-controlled research. What it opposes is approving or promoting these drugs before that research shows they are safe and effective, and designing state programs and federal shortcuts that skip the question entirely.
What psychedelics policy does FDPS want?
Approval on the same standard as every other drug, safety systems built before approval rather than after, honest communication about what vouchers and designations mean, and proven treatments for veterans now. FDPS supports the research and opposes the shortcuts. The full position is in its comments to the FDA (PDF).
What about veterans?
Veterans with PTSD deserve treatments that work, and they deserve them now. Promoting unproven hallucinogens to a population already at elevated risk, before the evidence exists, is not care. It is a shortcut with the risks shifted onto the people the policy claims to help.
What is ibogaine?
Ibogaine is a Schedule I hallucinogen derived from an African shrub, promoted as a treatment for opioid addiction. It carries documented cardiac risks and has been linked to deaths in unregulated clinics abroad. It is a focus of the April 2026 executive order and of a $50 million state-funded research effort in Texas. FDPS’s white paper reviews the evidence.
What does the April 2026 executive order do to psychedelic policy?
Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” directs federal agencies to speed research, review and approval of psychedelic compounds and related treatments. It does not approve any drug, and the FDA’s own notices say that vouchers and designations issued under it are not findings of safety or effectiveness.
Tell the FDA: science first.
The FDA’s psychedelics docket is open for written comments until October 5, 2026. Then tell your members of Congress that psychedelics policy starts with the approval standard, and the standard is not negotiable.
