President Donald Trump has ordered the FDA to perform priority reviews of psychedelic drugs as part of a push to clear barriers to access to treatments for serious mental illnesses.
The executive order tasks the FDA with giving Commissioner’s National Priority Vouchers “to appropriate psychedelic drugs” with Breakthrough Therapy designations. At a press conference about the order on Saturday, FDA Commissioner Marty Makary said the agency will soon issue priority review vouchers to three serotonin 2a agonists, a class that covers psychedelics such as LSD and the active ingredient in magic mushrooms.
Makary has yet to reveal which companies will receive the vouchers. Still, the announcement was warmly received by U.K.-headquartered Compass Pathways, which is developing a synthetic form of psilocybin, a molecule found in magic mushrooms.
“We commend the administration’s executive order on psychedelic treatment, which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have,” Compass CEO Kabir Nath said in an April 18 statement. “Today’s announcement aligns regulatory urgency with patient need, and we applaud the administration for taking this important step forward in accelerating access, without compromising rigorous science.”
Nasdaq-listed Compass reported another phase 3 win for its candidate, COMP360, in treatment-resistant depression in February. The company is working with the FDA on a rolling approval submission that, as of last month, it was on track to complete in the fourth quarter.
Definium Therapeutics, which plans to publish data this year from three phase 3 trials of its formulation of LSD, also “applaud[ed]” the executive order.
Trump ordered the FDA and the Drug Enforcement Administration to establish a pathway for patients to access investigational psychedelic drugs that are under FDA review. The president named ibogaine compounds as psychedelic drugs that could be accessed via the pathway.
Ibogaine is a naturally occurring psychedelic drug that researchers have studied as a potential treatment for opioid dependence and for depression and anxiety among veterans with traumatic brain injuries. The podcaster Joe Rogan recently discussed ibogaine in a conversation with the U.S. Health Secretary Robert F. Kennedy Jr., noting that Texas had passed (PDF) a law to support studies of the psychedelic.
Rogan was at the Oval Office press conference for the signing of the executive order. The podcaster said he recently sent data on ibogaine use in opioid dependence to Trump. According to Rogan, the president replied: “Sounds great. Do you want FDA approval? Let’s do it.”
