Trump signs order on psychedelics to ease FDA restrictions
Published in Political News
President Donald Trump signed an executive order to expedite research and access to psychedelics used outside the U.S. to treat post-traumatic stress disorder.
“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 in an Oval Office ceremony Saturday.
The order directs the U.S. Food and Drug Administration to issue new guidance to researchers on ibogaine, a psychedelic compound extracted from the iboga plant in Africa that’s used to treat depression, anxiety and PTSD for military veterans. The hallucinogen is considered a Schedule I controlled substance and is prohibited for use in the U.S.
While the order doesn’t reclassify the drug for medical use, Trump urged the health professionals arrayed behind him at the event to reclassify it quickly.
“These treatments are currently in the advanced stages of clinical trials to ensure that they’re both safe and effective for the American patient,” Trump said.
Trump’s directive calls for a $50 million federal research investment into ibogaine, and opens an opportunity for terminally ill, or “desperately” ill, patients to try the drug under the Right to Try law passed during his first term.
Ibogaine has been shown in small studies to reduce opioid withdrawal symptoms and help treat traumatic brain injuries, though clinical evidence remains limited. Its classification has made ibogaine almost impossible to study in the U.S. It’s also known for serious medical risks, particularly heart complications.
Health Secretary Robert F Kennedy Jr., a vocal proponent of psychedelic therapy, said it was “disturbing” to him and Trump that U.S. veterans have to travel to Mexico and other countries to experiment with intervention drugs.
“This executive order will remove the legal impediments that block American researchers, scientists, physicians and clinicians on properly studying these medicines and where appropriate, establishing protocols for their safe therapy,” Kennedy said Saturday.
Momentum is already growing at the U.S. state level. Texas lawmakers recently committed $50 million toward funding FDA-approved clinical trials of ibogaine as a treatment for opioid addiction and PTSD.
Arizona approved $5 million in funding and Colorado is looking to expand a law that allows for supervised use of psilocybin to include ibogaine. States including California, Indiana and Mississippi have also opened the door to studying ibogaine.
Under former President Joe Biden’s administration, the FDA rejected an MDMA-assisted therapy for PTSD from Lykos Therapeutics, citing the quality of research and questions over the clinical trial design.
Psychedelic therapy has gained momentum in recent years, with some studies suggesting benefits of using hallucinogens. In recent years, Australia became the first country to legalize and regulate the use of MDMA to treat PTSD and researchers have reported positive outcomes, the New York Times reported.
One goal of Trump’s order is to aid U.S. military veterans, who “often suffer in greater measure from this tragedy” of suicide and serious mental illness.
“For over 20 years, there have been more than 6,000 veteran suicides per year, and the current veteran suicide rate is more than twice as much as the non-veteran adult population,” according to the order.
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(With assistance from Madison Muller.)
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