President Donald Trump has signed an executive order meant to fast-track government approval of certain psychedelics for therapeutic use. Compounds like psilocybin and MDMA, which are still illegal at the federal level, have shown promise in the treatment of severe mental health conditions like post-traumatic stress disorder (PTSD) and anxiety.
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“Today’s order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life,” Trump said during a press conference.
The president added that his directive will help “dramatically accelerate” access to potential treatments, especially for the country’s “cherished veterans.”
“If these turn out to be as good as people are saying, it’s going to have a tremendous impact,” he said.
The order directs the Food and Drug Administration (FDA) to issue national priority vouchers for certain psychedelics designated as Breakthrough Therapy. So far, this includes variations of psilocybin, MDMA, and LSD.
The vouchers will allow the drugs to be approved quickly “if they are in line with national priorities.” This means review times could be cut from several months to weeks. It marks the first time the FDA has offered fast-track review for psychedelics, nearly all of which are classified as Schedule I substances.
Once Phase 3 clinical trials are successfully completed, the administration is to complete rescheduling in a “timely manner.”
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The order will also allow the FDA to conduct the first human trials of ibogaine in the U.S. The plant-derived compound, used ceremonially in parts of Africa, has gained popularity as an alternative treatment for substance use disorder.
The compound has raised concerns among some researchers over its potential risks. There have been a number of fatal cardiac events linked to ibogaine use.
Trump was joined by several Cabinet members, including Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., a vocal proponent of psychedelic medicine. Marcus Luttrell, a former Navy SEAL who has said he found relief from PTSD through psychedelic therapies, attended, along with podcaster Joe Rogan.
Rogan said he texted Trump information on ibogaine, and the president responded, “Sounds great. Do you want FDA approval? Let’s do it.”
Trump’s order also directs the HHS to dedicate $50 million to states that have enacted or are developing programs to support psychedelic therapies. The administration describes the effort as a federal-state partnership to provide funding, technical assistance, and data sharing.
So far, three states have approved psilocybin for therapeutic use. Several others are considering similar measures, while some have created task forces to study the potential benefits of psychedelic compounds.
The executive order is likely to be welcomed by supporters of psychedelic therapies, but the drugs still face a long path to federal approval.
