What to Know About Trump’s New Executive Order on Psychedelic Drugs
On April 18, President Donald Trump signed an executive order intended to accelerate the development of psychedelic drugs as medical treatments. The order calls for the Food and Drug Administration (FDA) to give expedited consideration to psychedelics that meet certain criteria. It also calls for the Department of Health and Human Services to direct $50 million to match investments made by state governments into researching psychedelics as treatments for mental-health conditions.
Many psychedelics, including LSD, MDMA (known as “Molly”), and psilocybin, are federally banned. However, research suggests that some of these substances may help in alleviating treatment-resistant depression and PTSD, among other conditions. While the new executive order doesn’t fundamentally change the evidence on safety and efficacy the FDA would need to see, experts say it’s a symbolic act that signals the administration’s unusual openness to considering scheduled substances as potential treatments.
“Psychedelics being mentioned in the Oval Office, getting such prioritized attention from a president, is pretty unprecedented,” says Mason Marks, a senior fellow of the Project on Psychedelics Law and Regulation at Harvard Law School's Petrie-Flom Center. The substances were, of course, squarely in the public spotlight more than half a century ago, when then-President Richard Nixon banned them as part of his “war on drugs.” But Trump’s announcement struck quite a different tone. “Can I have some, please?” he joked during the event.
What does this mean for psychedelics as treatments?
It has not always been easy to perform research on the medical uses of psychedelics; nor has pinning down a practical, evidence-based therapy using psychedelics. Two years ago, the FDA rejected an application to approve MDMA as a treatment for PTSD, asking for further study. Late last year, the FDA decided against granting accelerated consideration to Compass Pathways’ synthetic psilocybin treatment for severe depression, STAT reported.
But this new executive order is positive news for the budding industry. “We are very pleased to see that the grounding for the executive order was the need to get new treatment options to patients who are urgently in need of them,” Kabir Nath, CEO of Compass Pathways, tells TIME.
Read More: There Are No Good Treatments for PTSD. MDMA Can Change That
“It really represents shifting attitudes towards psychedelics, and that could have a much larger impact in the future,” says Marks. He points to the $50 million dollars in matching funds as an interesting development. In states where lawmakers might be on the fence about a bill aiding research on psychedelics, “they might see this as a sign of favorable federal conditions that might make them feel a little bit better about moving forward.”
On the other hand, is it a possibility that, with pressure from the White House, treatments might be rushed through approval that should not be? “That is a concern. That wouldn't be good for anyone,” says Marks. “It could really set back what progress has been made.”
What is ibogaine, and why did Trump mention it?
President Trump said the order was prompted by conversations with podcast host Joe Rogan, who was present at the signing of the executive order, about ibogaine. This psychedelic drug, derived from the root of an African shrub, has been studied for its potential to aid in treating PTSD and traumatic brain injuries, among other uses.
Ibogaine can cause fatal cardiac arrhythmias, however, and research on it was halted in the U.S. in the 1990s. Studies elsewhere in the world, including in Mexico, where ibogaine clinics operate, have been relatively small.
Ibogaine owes its sudden rise to visibility on the national stage to a vocal community of activists. “Supporters of ibogaine treatment have really tapped into a lot of concern for veterans, and there's a very real need,” says Marks. “Hopefully something very positive and helpful and useful comes out of it.”
What will this executive order change?
The White House asked the FDA to direct their attention to determining what psychedelics might be given vouchers for accelerated consideration on the path to approval. The manufacturers of these substances would have the option of having their dossiers of supporting evidence examined by regulators within 1 or 2 months, rather than 6 to 12 months more typical of the FDA approval process.