FILE PHOTO: Psilocybin or “magic mushrooms” are seen in an undated photo provided by the U.S. Drug Enforcement Agency (DEA) in Washington, U.S., May 7, 2019.
DEA | Reuters
The US Food and Drug Administration on Friday announced a series of measures aimed at accelerating the development of psychedelic treatments for serious mental illnesses.
This comes after President Donald Trump signed an executive order on Saturday directing federal health agencies to expand access to emerging therapies.
The move marks a significant shift toward supporting psychedelic medications for conditions such as treatment-resistant depression, post-traumatic stress disorder and other substance use disorders, the FDA said.
“Under President Trump’s leadership, we are accelerating research, approval, and responsible access to promising mental health treatments,” Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services, said in the statement. “The FDA will prioritize therapies with the Breakthrough Therapy designation, for which early evidence shows significant improvement.”
As part of the announcement, the FDA said it would issue National Priority Vouchers to companies studying psilocybin for depression and methylone for PTSD.
The agency also authorized an early-stage clinical trial of noribogaine hydrochloride, an ibogaine derivative, as a potential treatment for alcohol use disorder. This is the first time a compound like this has been approved for study in the United States.
“These medications have the potential to address the nation’s mental health crisis,” FDA Commissioner Marty Makary said in the release. “It is essential that their development is based on solid scientific data and rigorous clinical evidence.”
The FDA said allowing these studies to continue does not mean the drugs are approved or proven safe and effective. Officials said the data will be closely monitored as the research advances.