President Donald Trump signed an executive order in April aiming to fast-track research and approval of psychedelic drugs for treating serious mental illness — a move that could fundamentally reshape America’s mental healthcare system.
The order seeks to “accelerate innovative research models and appropriate drug approvals” for psychedelic substances that administration officials believe could reverse the nation’s mental health crisis.
“Speeding [up] access is welcome. But psychedelic-assisted treatment is neither conventional drug therapy nor conventional psychotherapy, and decades of Schedule I restrictions have left most clinicians with little training in it.”
CATO Institute Senior Fellow Jeff Singer told the Daily Caller News Foundation the challenge now is building a framework that reflects the unique nature of these treatments.
Singer pointed to significant potential upsides for patients with conditions like PTSD and depression who haven’t responded to existing therapies. But he warned regulators may focus so heavily on controlling access that they make treatments unnecessarily expensive and difficult to obtain.
Psychedelic therapy uses substances like MDMA, LSD and psilocybin — the key ingredient in magic mushrooms — to promote psychological healing in carefully controlled clinical settings, according to Palo Alto University.
A 2013 University of South Florida study found that psilocybin may promote the growth and repair of brain cells in the hippocampus, the brain’s center of emotion and memory. Mice treated with psilocybin showed a greater ability to overcome fear conditioning than those given a placebo — supporting the hypothesis that the substance could help break trauma cycles in PTSD patients.
Compass Pathways Chief Patient Officer Steve Levine welcomed the executive order as a clear signal the White House recognizes millions of Americans aren’t well served by current options.
“This is potentially a whole new paradigm of care, one that has very promising science behind it.”
Levine noted these treatments work differently in the brain and body compared to existing psychiatric drugs — representing a mechanistically new class rather than variations on old formulas.
But he acknowledged a critical gap: that level of rigorous evidence hasn’t been generated for psychedelics yet. Compass Pathways supports maintaining the same evidentiary standards for approval to ensure treatments are science-backed and safe.
Psychedelics can heighten the risk of exacerbating psychotic disorders in some individuals, according to True North Psychology. Some patients may also face difficult after-effects including existential distress and mood difficulties.
Three states have legalized some form of psychedelic medicine and 19 others are considering legislation, according to a September 2025 Yale University report.
Singer raised concerns about whether the FDA approval framework developed for conventional drugs is appropriate for therapies that depend so heavily on set, setting, and guided support. Informed consent is highly challenging in psychedelic-assisted psychotherapy scenarios, according to Psychiatry Online.
