Washington — Federal health officials are moving quickly to expand access to treatments for serious mental illness following a new executive order from President Donald Trump.
According to information released, Trump on April 18 issued an executive order directing the U.S. Department of Health and Human Services to accelerate access to treatments for patients with serious mental illness, including complex and treatment-resistant conditions.
Building on that directive, the U.S. Food and Drug Administration announced a series of regulatory actions aimed at supporting the development of serotonin-2A agonists and related products, a class of perception-altering psychedelic medications.
“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” said Health and Human Services Secretary Robert F. Kennedy, Jr. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”
“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” said FDA Commissioner Marty Makary, M.D., M.P.H. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
The FDA also announced it is issuing national priority vouchers to three companies studying treatments including psilocybin for treatment-resistant depression and major depressive disorder, along with methylone for post-traumatic stress disorder.
In addition, the agency is allowing an early-phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug submission. The drug is being studied as a potential treatment for alcohol use disorder.
The FDA emphasized that allowing the study to proceed does not mean the drug has been approved or proven safe or effective. Officials say research and data review will continue as new information becomes available.
“There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.”