FDA Accelerates Action on Treatments for Serious Mental Illness

Following President Trump’s directive on April 18 to accelerate access to treatments for patients with serious mental illness, the U.S. Food and Drug Administration (FDA) announced a series of regulatory actions to support the development of serotonin-2A agonists and related products, a class of perception-altering psychedelic medications.

In the Executive Order, the president stated that “despite massive Federal investment into researching potential advancements in mental healthcare and treatment, our medical research system has yet to produce approved therapies that promote enduring improvements in the mental health condition of these most complex patients. Innovative methods are needed to find long-term solutions for these Americans beyond existing prescription medications.”

“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., in a statement.