Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. “The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
As the FDA doubles down on efforts to establish a regulatory pathway for psychedelic therapies, medical experts and other stakeholders urged the agency in a public hearing Monday to set clear standards for safety and access in the burgeoning field.
The “overall tone of the hearing was constructive,” Jefferies analysts wrote in a note to investors on Monday, with a majority of comments in support of a psychedelic pathway at the FDA, while some experts urged the agency to consider making further risk assessment and adverse event monitoring a part of any approval.
Indeed, two drug developers in particular are quickly approaching that stage. Compass Pathways’ psilocybin-based depression candidate COMP360 could launch early next year, while Definium Therapeutics notched a third Phase 3 win Monday for its oral LSD candidate DT120. These companies and others hope to follow in the footsteps of Johnson & Johnson’s esketamine-based depression drug Spravato, originally launched in 2019 to become a “key franchise” for the pharma giant, with Jefferies recently putting peak sales estimates above $5 billion.
During Monday’s hearing, experts touted Spravato’s time on market and evidence from other late-stage trials, as well as decades of unregistered psychedelic use in the lives of patients with severe mental health conditions such as depression and post-traumatic stress disorder (PTSD). However, they encouraged the FDA to pave the way for safe and responsible administration of these therapies, which comes with challenges unique to the class.
Now, with psychedelics-friendly leadership at the FDA helm—including Center for Drug Evaluation and Research (CDER) director Michael Davis, who previously served as chief medical officer at psychedelics research organization Usona Institute—those practical details have come to the fore, dominating the four-hour meeting at which Davis was present.
Building a strong foundation
Experts on Monday—including physicians, psychiatrists, nurses and pharmaceutical leaders—encouraged regulators to consider factors beyond the psychedelic treatments themselves, taking into account the vulnerability and potentially altered state of the patient during a therapy session. Precautions should be built into the system from the outset, many said.
“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,” said Edward Jacobs, associate director of HOPE – The Hub at Oxford for Psychedelic Ethics.
Others, like Laurel Kilgour, an attorney with the nonprofit Psychedelic Bar Association, said too much regulation could also be a risk, noting that “an overly zealous risk mitigation framework can undermine safety by pushing people toward underground alternatives with no oversight or foreclosing access altogether.”
Many of the experts in attendance on Monday pointed to the positive effects psychedelic therapies have had on patients with conditions such as depression and PTSD, but only under the direct supervision and guidance of a therapist or psychiatrist trained specifically in psychedelic use. They urged FDA officials to detail those requirements within the language of potential approvals for the sake of clarity and consistency across markets.
“The medicine opens the door. Preparation gives it direction. The therapeutic relationship gives it safety. Integration gives it durability,” Michaela Vogt, co-founder of the Colorado natural healing center NeuroAlchemy, said during the hearing. “The future of psychedelic medicine will not be defined only by the medicines we approve, but by the professionals we prepare to steward them.”
To that end, leaders like Jeremy Rudy, CEO of the Sabba Collective, which builds training programs to bring psychedelic therapies into mainstream healthcare, said administrators of these medications “require demonstrated competence, not practice or training hours,” which are difficult to verify.
Above all, despite the outpouring of support for a regulatory pathway for psychedelics, many experts advised restraint to protect both current patients and the future of the field through trustworthy data. Several referred to the “training gap” that makes the difference between an effective treatment session and one that doesn’t live up to the potential of psychedelic therapy.
“Closing the training gap is not an accessory to safe access,” said Lida Fatemi, founder of the Conscious Physicians Psychedelics Academy. “It is the foundation.”
Data that matter
Collecting data around psychedelic compounds for both safety and efficacy, as well as effectiveness in real-world treatment settings, has been a challenge, according to those speaking at the hearing. Therefore, several experts encouraged the FDA to set those standards early on in the regulatory journey.
These data must also be consistent to be of any use, said Shanetha Marable-Lewis, executive director of patient group Veterans Initiative 22 and member of the advisory board for the Maryland Task Force on Responsible Use of Natural Psychedelic Substances.
“The point is not simply more data, but compatible data designed from the start to be interoperable,” Marable-Lewis said.
For the FDA, that means setting the standard among what is currently a disparate group of stakeholders both in drug development and patient care.
“Trial data and real-world evidence collected now are not compatible. Every sponsor, every real-world operator is collecting something different,” said Maksim Tsvetovat, CEO of clinical trial software company Research Lambda. “It’s a table that only you, the FDA, can set.”
Defining access
Looking beyond an FDA greenlight, stakeholders expressed that approvals without the appropriate infrastructure and workforce in place for safe and responsible access to psychedelic treatment would result in a broken system that fails to serve many of the patients who need these therapies.
“Efficacy is what a drug does in a trial. Effectiveness is what it does in the real world. The gap between them: infrastructure,” said Amna Aslam, applied research specialist at Radial Health. Aslam noted that Spravato, backed by one of the largest pharma companies in the world, “took five years to get to scale. The science did not change. The infrastructure caught up.”
Particularly vocal at the hearing were representatives of the U.S. armed forces, including veterans whose experiences with PTSD led to psychedelic treatment they said was more effective than other therapies. Many of them had to leave the country to receive treatment.
“Veterans should not have to be forced to choose between suffering, going underground or leaving the country and crossing international borders just for standard care,” said Eric Jansen, a U.S. Marine Corps veteran and government affairs coordinator for the Balanced Veterans Network.
Overall, stakeholders wanted to be sure that federal regulations account not just for the drugs but for how they are distributed in the real world.
“Approval alone will not create access,” said John Eaton, vice president of complex care for the Wounded Warrior Project. “Federal partners must prepare now, so warriors are not left waiting for systems to catch up.”
