JUANA SUMMERS, HOST:
Psychedelics were front and center at the Food and Drug Administration today. The agency held a much-anticipated hearing on the future of these drugs and their potential in mental healthcare. That comes as the Trump administration has signaled it's behind this psychedelic movement. NPR health correspondent Will Stone watched the hearing and is with us now. Hi there.
WILL STONE, BYLINE: Hey there.
SUMMERS: Will, so tell us why this hearing was so important.
STONE: Well, it comes at a critical moment. A lot is happening in this space. The federal government is taking steps to accelerate research and investment. And biotech companies have poured millions of dollars into drug trials, and those focused on using psychedelics for treating various mental health conditions like depression, anxiety and PTSD. So this hearing was a rare moment when everyone was in the same room. You had key figures from the FDA and other agencies listening and dozens and dozens of stakeholders - clinicians, advocates, researchers, investors. All of them were making their pitch for how they want this to roll out.
SUMMERS: What were some of the issues that came up?
STONE: One big theme that emerged is how will psychedelics actually be administered in the real world? These treatments need to be given in a space where patients are safe and supported while they're under the influence of what are powerful drugs like psilocybin, LSD and MDMA. One person who spoke to this issue was Dr. Lida Fatemi. She's a hospice physician in New Mexico and started a program that does psychedelic training for healthcare providers.
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LIDA FATEMI: These are not medications you simply prescribe and dispense as doctors. The psychedelic care touches perception, memory, identity, profound and vulnerable territory.
STONE: So Fatemi and many others who spoke stress that providers need adequate training specifically with psychedelics. There should be standards because this looks very different than other therapies.
SUMMERS: Interesting. Do we know what psychedelic therapy is going to look like?
STONE: So it will depend on the drug that gets approved. Generally, this is done in a controlled setting - so not at home. There's supervision. A patient can lie down. Maybe there's some music. But these trials also pay a lot of attention to safety and monitoring. And trying to replicate all of that in the real world could be expensive and onerous, and that could ultimately mean fewer people have access. Edward Jacobs is a researcher at Johns Hopkins University, and he argues the FDA should try to keep the same kind of safeguards in place.
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EDWARD JACOBS: It's better to start with stronger protections and adjust them as the evidence accumulates than to start with weaker protections and tighten them after harm.
STONE: So there's tension here, and this was evident during the hearing, about what restrictions the FDA decides to implement.
SUMMERS: So nothing was decided today, but it sounds like there's a lot's going on. How soon we could see treatments become a reality?
STONE: Pretty soon - FDA has approved treatment with another psychoactive drug, ketamine, but that's it so far. There was an effort to get MDMA approved about two years ago that was ultimately unsuccessful. The situation is a lot different now, though. Research has moved forward. For example, one company called Compass has been running trials on a synthetic form of psilocybin, the active ingredient in magic mushrooms, for people with treatment-resistant depression. They are publicly saying they could launch that as soon as next year, assuming they win FDA approval.
And another shift is the Trump administration is throwing its weight behind the psychedelic renaissance. The president recently signed an executive order on psychedelics, and prominent figures like Health Secretary Robert F. Kennedy Jr., who oversees FDA, has repeatedly talked about wanting to see these drugs get approved.
SUMMERS: NPR's Will Stone, thanks so much.
STONE: Thank you.
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