FDA Seeks to Accelerate Review of Medications for Serious Mental Illnesses

April 27, 2026

The FDA announced it’s looking to fast-track regulatory process for certain drugs that may help conditions like depression and post-traumatic stress disorder (PTSD) that have been notoriously difficult to treat.

Last week, the White House issued an executive order seeking to accelerate the review of certain psychedelic medications to treat serious mental illnesses. The executive order also calls on the federal government to allocate at least $50 million to partner with states that have or are developing programs to advance psychedelic drugs for this purpose.

In a statement following the executive order, the FDA issued national priority vouchers to three companies studying:

• Psilocybin for treatment-resistant depression
• Psilocybin for major depressive disorder
• Methylone for PTSD

“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. “As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence.”

The agency also announced it is allowing an early phase clinical study of noribogaine hydrochloride to advance. The study will evaluate the drug as a potential treatment for alcohol use disorder. The FDA’s decision allows the study to proceed but does not mean the drug has been approved or found to be safe or effective, officials said.

Additional information is available online.