FDA Commissioner Marty Makary breaks down Trump's executive order on psychedelics

Added: 2026-05-05

[00:00:00]psychedelic drugs for mental health treatment. The president said the federal government will invest $50 million in research. The order eases restrictions on studies of psychedelics including ibogaine, a drug used in some countries to treat post-traumatic stress disorder.

[00:00:16]Today's order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and and lead a happier life.

[00:00:27]Ibogaine remains a schedule one substance, which is the government's most restrictive category for illegal high-risk drugs with significant potential for abuse. Officials say the order maintains full government oversight and does not legalize or reclassify the substances. For more, we're joined by FDA Commissioner Dr. Marty Makary. Doctor, thank you for being here. Good to be with you. Does this executive order specifically address ibogaine or are other psychedelic drugs included? It's the entire class of psychedelics. They've been studied increasingly over the last few years and have potential promise for people who have severe debilitating conditions like PTSD and addictions, opioid use disorder, and other problems for which there's been no treatment to date, traumatic brain injury. So, we're hopeful. Of course, we have to look at the scientific data when it comes in the door. We did announce with President Trump on Saturday the first ever FDA investigational new drug clearance for ibogaine. That will pave the way for clinical trials. Other psychedelics are further down the pipeline and we'll see what those results show. We expect those applications to arrive at the FDA this summer. Do we know why these psychedelics or even specifically ibogaine can help with those conditions like PTSD and addiction? What does it do to the brain? We don't know exactly why, but there are theories in the category of neuroplasticity. In other words, it may reset the nerves in the brain. And we have to really, I think, look at the adverse event rates and the results to make a decision because we don't know exactly how this class of medications will would works. But that's not unusual for modern medicine. There are medicines that we don't know why they work, but they do work. Prednisone, for example, a common steroid used in therapeutics. And lithium for bipolar. We don't know exactly how those drugs work, but we do see results. Now, we do hear dramatic stories of those who are treated who have some type of reconciliation or reliving experiences that were traumatic in the past. And that perhaps that might be a clue as to what the mechanism might be. Do you know how this research will be conducted?

[00:02:37]We set aside $50 million in President Trump's executive order for new research. Many of much of it will be phase two and phase three clinical trials, research in veterans, a population that's been hit very hard. If you think about it, we've lost more veterans to suicide since the Iraq and Afghan wars than from the actual Afghan and Iraq wars. That's pretty remarkable.

[00:03:00]So, for many of these veterans they're the the wars are over, but the men and women are still dying. The battle may rage inside their brain. So, we want to understand better what's going on and why these medications might potentially help them.

[00:03:16]>> I know there ibogaine at least can cause some heart rhythm disturbances. Do you know of any other risks and what needs to happen from the research point of view to see ibogaine or any of these other psychedelics move toward FDA approval for treating something like PTSD? So, the reason why we have a formal phase one, two, and three FDA approval process is exactly to understand those potential risks. The risk of adverse events. Ibogaine may have the highest risk profile.

[00:03:46]Individuals have died from ibogaine.

[00:03:48]It's believed to cause some changes to electrolytes in the heart and even sudden death. Which is why clinical study needs to be really the foundation. Now, there are controlled settings in which ibogaine has been given in other countries where you're basically in an ICU and they provide emergency care available and an IV while somebody experiences the therapy. It is, of course, worth noting that these drugs are not considered addictive because it is such a traumatic and rough experience on the body. And if they are FDA approved, these are not drugs you can pick up at a pharmacy.

[00:04:24]These are drugs that would be administered in a very controlled and supervised medical clinical setting.

[00:04:30]Well, Dr. Marty Makary, we know a lot of people are suffering out there and could use some help with potentially some new medicine. So, we'll see what happens with these research trials. Thank you.

[00:04:40]Thanks, Lindsey.