Quick Facts

• Trump’s executive order directs $50 million in federal funding to accelerate psychedelic drug access for mental health treatment
• FDA will issue priority review vouchers for three psychedelics next week, potentially cutting approval time from 6-10 months to 1-2 months
• Over 14 million Americans have serious mental illness, with 21 million experiencing major depression according to federal data

President Trump signed an executive order directing the FDA to fast-track approval of psychedelic drugs including psilocybin and ibogaine for mental health treatment. The order allocates $50 million through the Advanced Research Projects for Health program.

FDA Commissioner Marty Makary announced three priority review vouchers will be issued next week for serotonin 2a agonist psychedelics. He said decisions could come as soon as this summer. The directive cuts standard FDA review timelines from 6-10 months to 1-2 months for drugs with breakthrough therapy designation.

The mental health crisis affects over 14 million American adults with serious mental illness. At least 21 million Americans have experienced major depression, according to the National Institute of Mental Health. Veterans face particular risk, with suicide rates nearly twice the general population.

Psilocybin and ibogaine remain Schedule I substances alongside heroin, classified as having no accepted medical use and high abuse potential. Only Oregon and Colorado have legalized psilocybin therapy. The order directs the Attorney General to review rescheduling these drugs upon FDA approval.

Seven FDA phase 3 studies are currently underway, including two for ketamine and five for psilocybin. World-leading institutions including Stanford, Harvard, and Johns Hopkins are conducting psychedelic therapy research. The Department of Veterans Affairs participates in at least five trials across New York, California, and Oregon.

Stock markets responded positively. Compass Pathways jumped 53% while AtaiBeckley surged 37%. GH Research rose 34% and Definium Therapeutics gained 16%.

Safety concerns remain significant. Ibogaine has caused irregular heart rhythms and links to over 30 deaths in medical literature. Real but rare risks include psychosis, mania, and suicidality, requiring medical oversight during treatment.

The FDA rejected MDMA for PTSD treatment in 2024 due to study design flaws. A 2025 Journal of the American Medical Association study showed single-dose LSD eased anxiety and depression for months.

‘The opportunity now is not hype, it’s execution: rigorous science, disciplined safety standards, physician-led protocols and real-world outcome data,’ said Tom Feegel, CEO of Beond clinical neurohealth center.

Frederick Barrett from Johns Hopkins said objective scientific research would help determine if these compounds offer better psychedelic therapy options. Most experts estimate realistic implementation timelines of 2 to 4 years despite the accelerated review process.

Read more: Psychedelics May Soon Become Easier to Get. Is That Good?