Trump signs executive order directing FDA to review psychedelics designated as breakthrough therapy drugs

President Donald Trump signed an executive order Saturday that he said “directs the FDA to expedite their review of certain psychedelics already designated as breakthrough therapy drugs.”

“The executive order I’m signing, we’re actually signing the executive order today, is really a moment,” Trump said. “These treatments are currently in the advanced stages of clinical trials to ensure that they’re both safe and effective for the American patients.”

The president said the executive order would implement “historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs.” 

“In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression, including our cherished veterans,” Trump said, citing the veteran suicide rate.

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“And the nice part is we’re actually doing this early, but it has been going on. Research has been going on for quite some time. But, you know, usually with things like this, nothing ever happens, no matter how the research ends up, but we’re changing that. This order will clear away unnecessary bureaucratic hurdles, improve data sharing among the FDA and the Department of Veterans Affairs, and facilitate fast rescheduling of any psychedelic drugs that become FDA approved,” Trump continued.

The president said “in 2024, a study from Stanford University, 30 special operation veterans with traumatic brain injuries underwent — it’s called ibogaine treatment — ibogaine, remember the name,” noting that they “experienced an 80 to 90% reduction in symptoms of depression and anxiety within one month.”

“In Texas, Republican leaders have already committed $50 million to the ibogaine research. And today, the federal government is making a $50 million research investment in its own. And so that was just approved just last night,” Trump announced.

“We’re also opening a pathway for ibogaine to be administered to desperately ill patients under the right to try law,” Trump said.

“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, just lead a happier life,” he added.

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A paper published in the journal Chronic Stress said ibogaine is a “psychoactive indole alkaloid which is extracted from the Tabernanthe iboga rainforest shrub and has been used for centuries in Central Africa for initiatory rituals.”

“Ibogaine treatment is reported to alleviate a spectrum of mood and anxiety symptoms and is associated with self-reported improvements in cognitive functioning in individuals with substance-use disorders. During treatment, ibogaine allows the evocation and reprocessing of traumatic memories and occasions therapeutic and meaningful visions of spiritual and autobiographical content, which are of central relevance in addressing PTSD-related psychological content,” it added.

“Under the executive order, HHS will accelerate research approval and access to new mental health treatments, including psychedelic therapies such as ibogaine. We’re taking this decision, this decisive step to confront one of the most urgent public health challenges facing our nation – the mental health crisis,” Health and Human Services Secretary Robert F. Kennedy Jr. said. “More than 14 million Americans live with serious mental illness, and 1 in 4 adults experiences a diagnosable disorder each year. Suicide has risen by more than 30% over the past two decades, with another peak in recent years. Among veterans, more than 6,000 died by suicide each year since 2001. We have lost far more veterans to suicide than to combat.”

“At the same time, millions of Americans living with depression, PTSD, addiction and other conditions do not respond to existing treatments. We owe it to our warfighters and veterans to turn over every stone to alleviate the emotional and mental health blowback from their deployments,” he added.

Podcaster Joe Rogan, who was in the Oval Office with Trump on Saturday, also said “I want to say that I’m here because of the man to my left, Bryan Hubbard [CEO of nonprofit Americans for Ibogaine] and former Texas Gov. Rick Perry came on my podcast.”

“They told me how impactful this medicine is. And having that conversation with them, millions of people got a chance to hear their story, hear the stories of all the different people that have had life-changing experiences from it,” Rogan said.