Did the FDA destroy the psychedelic medicine movement?

In the Psychedelic Renaissance, MDMA had main character energy. That’s primarily attributed to Rick Doblin, now widely considered one of the most influential figures in psychedelic science’s second wave, and the founder of the psychedelics research organization the Multidisciplinary Association for Psychedelic Studies (MAPS). In 1986, about 15 years after Richard Nixon signed the Controlled Substances Act into law, making shrooms and LSD federally illegal—and shutting down most research into the therapeutic potential of psychedelics, Doblin, at the time an eager young researcher with a big dream, decided MDMA was best suited to be the trojan horse of a psychedelic therapy revival. His reasoning, after observing the compound’s potential for conditions such as post-traumatic stress disorder, is that it’s generally a gentler experience than more classic psychedelics—and it comes with less cultural baggage. 

Doblin wasn’t the only one with a big dream. Over the decades, he assembled a team of loyalists—from therapists to big-time investors such as the Founder of GoDaddy Bob Parsons, Republican donor heavyweight Rebekah Mercer, and others—who wanted to support him and MAPS in the vision to not only legalize MDMA therapy, but to use the legalization of MDMA therapy to open the minds of regulatory bodies and the medical community to a new world of psychedelic treatments for mental health.

Scott Shannon was among them. A psychiatrist who worked on MAPS’ clinical trials, he hoped MDMA would usher in "a paradigm shift away from materialism, from a healthcare system that sees people as soulless and heartless, toward a system that understands people have a spiritual reality." 

And for the last decade, particularly in the last few years, it looked like that may happen: As MAPS established a for-profit arm, called Lykos, that continued to raise millions of dollars; MDMA therapy received positive press from legacy news outlets such as The New York Times; and the FDA showed every indication that they understood its promise. 

Then, summer of 2024 was a waterfall of bad news. First, a report from an insurance group doubted that MDMA therapy worked; an FDA advisory board pulled apart the rigor of the study design; and several articles received significant attention accusing MAPS of negligence and ethical violations. The bad press was in large part instigated by Psymposia—a research non-profit known for publishing journalistic investigations on harm caused within psychedelics—and a podcast they put out with New York Magazine called “Power Trip.” In their coverage, much debated among psychedelic stakeholders, the group called MAPS a "therapy cult," criticizing Doblin’s character and highlighting sexual assault on a patient by a therapist named Richard Yensen during an MDMA trial from years before. Not long after, an equally critical feature came out in Business Insider, expanding upon Psymposia’s work while also critiquing the culture of MAPS. 

Following all of this, on August 9, the FDA rejected the MDMA application, saying they needed to see another Phase 3 trial with a different study design. "Without Psymposia and Richard Yensen, this gets passed," Shannon says.

In response, this fall, psychedelic gatherings felt like wakes. At my local Psychedelic Professionals meetings, groups of therapists, PTSD patients, and passionate psychonauts expressed shock and deflation. MAPS communication director Betty Aldworth called the decision "heartbreaking." The Healing Advocacy Fund called it "unconscionable." Zach Haigney of The Trip Report compared the decision to a plane crash. 

"It's a terrible bummer, especially for the PTSD patients for whom other treatments haven't sufficiently helped," Doblin, who quit the Lykos board this summer, tells me. "And it didn't have to be." 

Lykos responded to the vote of the Advisory Committee that recommended MDMA not be approved with an overly political approach, Doblin says. Lykos didn't fight back enough against scientific critiques of the study design—elements that, Doblin stresses, were created with FDA input. Lykos didn't bring up a Dutch advisory board, which came to the opposite conclusion of the FDA advisory committee shortly after. The Dutch advisory board, says Doblin, investigated the MAPS clinical trial data deeply and released a statement, following their assessment, that “The government must act swiftly to enable the therapeutic use of MDMA.” (In October, the Dutch government followed the report's recommendations and moved forward with a program of limited access to MDMA for some patients.) 

Even more, Doblin says, Lykos is moving potential new trial sites away from private practices like Scott Shannon's—where some of the best results were achieved—toward more institutional sites—and they may deprioritize the therapeutic component, which he feels makes a major contribution to the healing process. "I'm frustrated that MDMA is this beautiful drug with incredible potential when combined with therapy," Doblin says, "and it's in the hands of traditional pharma people who would rather be a drug company than a drug plus therapy company." 

The fallout from the FDA decision was deep and wide. 

Lykos' CEO Amy Emerson resigned. Lykos laid off 75 percent of its staff of about 100 people. MAPS laid off about a third of its staff, about 18 people. Lykos also hired a former Johnson & Johnson executive named David Hough to lead the company’s continued clinical development program and engagement with the FDA. 

In a statement, Lykos tells DoubleBlind they’re still working toward FDA approval of MDMA. 

"Lykos is focused on pursuing all available regulatory pathways to bring a potential new treatment to the 13 million Americans who live with PTSD, a condition that has not had new treatments available for nearly 25 years," a Lykos representative writes in an email. "We have been engaged with the FDA throughout this process and will continue working with them to resolve scientific disagreements and concerns, with the ultimate goal of FDA approval for midomafetamine capsules to be used in PTSD treatment."

To continue on the path to FDA approval, Lykos will need to raise additional tens of millions of dollars, and the study will take three years, maybe more. "Even very fast-moving, well-funded companies in the biotech space, it takes them four to five years to get a Phase 3 program through," Dr. Sam Clark, CEO of Terran Biosciences, a biotech company, tells me.

Yet—from New York to Santa Cruz, researchers continue to voice broad optimism. "No one is going to stop psychedelics," says Shannon. "Psychedelic therapeutics are inevitable," says Clark. "Lykos will eventually succeed," Doblin says. 

One thing has definitely changed, though: MDMA is no longer the main character of the Psychedelic Renaissance. Local decriminalization and legalization efforts march forward across the country, with a fast-growing underground market of products and services centered around psilocybin, but also featuring DMT, LSD, and a number of more obscure psychoactives.

At the FDA, there’s ongoing studies looking to get psychedelic therapy to market with compounds including psilocybin, LSD, and 5-MeO-DMT. There also continues to be dozens of drug development companies looking to optimize or tweak more well-known psychedelics in an attempt to make them shorter-acting or more tolerable (i.e. reducing the potential for a bad trip, a strategy not all psychedelic advocates agree with). 

Several of these trials are poised to put their drugs up for approval before Lykos can redo their MDMA study. Up at the top of the list is Compass, shepherding psilocybin for depression. Others include LSD for anxiety (being put forth by MindMed) and 5-MeO-DMT for depression (being investigated by GH Research). But don't look for these any time soon. Despite the millions of dollars spent developing them, Clark says he doesn’t anticipate approval for about four years. 

“It’s now clear that the path for desperately needed access to psychedelic-assisted therapies will not run through Washington, D.C,” the Healing Advocacy Fund said in a statement. "States must take the lead to bring people the care they need and deserve."

Psychedelic therapy "needs to go to the citizenry," said Bessel van der Kolk, Dutch psychiatrist and author of the best-selling book The Body Keeps the Score. 

In more than a dozen jurisdictions that have decriminalized natural psychedelics, this has already happened through initiatives that allow for “growing, gifting, and gathering.” The idea is that if someone can grow mushrooms, they won’t need to rely on a regulated entity to provide them. That gets a bit trickier when it comes to synthetic compounds such as MDMA, but Doblin thinks he may have a solution.

MDMA can be synthesized from an oil—safrole—distilled from plants that are legal to grow. Doblin is working on plans to grow the plants in greenhouses in the U.S., collaborating with Ford Smith, founder of Ultranative, a venture capital platform investing in alternative medicine. Smith tells me that he and his team have been working with lobbyists and philanthropists to develop a framework that can support a state-regulated safrole-derived MDMA supply chain. 

Advocates would work through the political process to legalize MDMA-assisted therapy, the same as Oregon and Colorado did with mushrooms. Smith tells me he's not sure which state they'll try first, but that the plant-derived MDMA route solves one logistical hurdle for states. Still, several sources tell me that a state-level MDMA initiative could be tricky, given the shift in public mood about psychedelics and how complicated synthetic drugs are to make. 

"I don't see any way to get MDMA or any other synthetic legalized except through the FDA," Matthew Baggott, co-founder of Tactogen, a pharma startup developing MDMA-like medicines, says. "States don't have the know-how to regulate chemical synthesis. So, for now, it seems like the FDA is the game we have to play.”

Sentiments on whether the rejection of MDMA will impact the ability of pharmaceutical entities to get psychedelic medicines through the FDA more broadly vary. "Some companies had hoped approval of MDMA would bring investment money to the whole sector," Baggott says. "That certainly didn't happen."

Daniel Goldberg, co-founder of Palo Santo, one of the largests funds investing in psychedelics, however, hypothesizes psychedelic pharma might get easier, not harder, after the Lykos failure. "Other drug sponsors will have the benefit of learning from what happened with Lykos," Goldberg says. "If you attend a conference truly focused on the science and healthcare side of the equation, nobody is really fazed by the Lykos news." 

💌 If you loved this email, forward it to a psychonaut in your life.

Editorial Process

DoubleBlind is a trusted resource for news, evidence-based education, and reporting on psychedelics. We work with leading medical professionals, scientific researchers, journalists, mycologists, indigenous stewards, and cultural pioneers. Read about our editorial policy and fact-checking process here.