Experts Assess Landscape Surrounding Law and Psychedelics
The evolving legal, medical, and policy landscapes surrounding psychedelic substances were the focus of a recent expert panel discussion, “Psychedelics: Law, Health, & Emerging Regulatory Trends,” hosted by the Solomon Center for Health Law and Policy4.
The discussion featured leading experts: Dr. Reshma Ramachandran of Yale School of Medicine as the commentator; Cat Packer, director of drug markets and legal regulation at the Drug Policy Alliance; Dr. Mason Marks, a professor at Florida State University College of Law; and Dr. Javier Muniz, a psychiatrist and former Food and Drug Administration official.
Dr. Mason Marks provided historical and legal context, noting that while psychedelics have been used for thousands of years, Western research began in the mid-20th century before facing regulatory backlash. The Controlled Substances Act of 1970 classified psychedelics as Schedule I drugs, halting research. However, interest resurged in the 2000s, with ongoing studies on MDMA, LSD, mescaline, and psilocybin for PTSD and depression.
Dr. Javier Muniz outlined the federal regulatory landscape, emphasizing the roles of the FDA and DEA. The FDA assesses clinical and scientific evidence, while the DEA determines scheduling. Muniz noted that breakthrough therapy designation (BTD) has expedited MDMA and psilocybin research, but challenges remain, including safety concerns and regulatory gaps regarding psychotherapy components.
Cat Packer highlighted the intersection of drug policy, medicine, and social equity, drawing comparisons to cannabis regulation. She warned of commercialization pitfalls, industry interests conflicting with consumer protections, and disparities in drug enforcement. Packer stressed inclusive policymaking and continued education to avoid replicating past inequities.
Dr. Ramachandran examined BTD’s implications, noting its frequent use as a marketing tool. She raised concerns about regulatory oversight, insurance coverage, and clinical trial ethics. The panel also discussed the FDA’s recent decision on Lykos Therapeutics' MDMA-assisted therapy for PTSD, where safety concerns and regulatory ambiguity set a precedent for future approvals.
During the Q&A, panelists addressed clinical trial inclusion criteria, regulatory bias, and harm reduction. A question referencing a New York Times5 article by Rachel Nuwer sparked debate on advocacy groups like the Drug Policy Alliance (DPA) in regulatory meetings. Muniz refuted claims of DPA influencing MDMA approval, while Packer stressed the need for consumer advocates: “When the allegation is that it’s anticapitalist folks from the left, then who is advocating for consumers? If that’s the type of thing that can happen so early on, once this market gets consolidated, we’re in trouble,” she said.
Dr. Ramachandran reflected on managing conflicts of interest. “We’ve talked about ways we can better manage COI with advisory committees … even though it did not affect FDA’s decision-making, it did change the political economy around this.” She also warned against villainizing other mental health treatments, such as SSRIs, and emphasized Congress’s role in regulatory standards.
Panelists also addressed concerns about monitoring individuals prescribed psychedelics, particularly those at risk of adverse effects. Packer emphasized harm reduction, while Ramachandran called for robust post-approval data collection. Muniz, echoing medical ethics, cautioned: “First, as a physician, do no harm … because these drugs are so powerful, they can do harm, especially to the vulnerable.”
The discussion underscored the need for careful regulation balancing innovation with public health and equity considerations, according to the panelists. It was a robust exchange with many enthusiastic students eager to engage with the panel. The event concluded with a call for continued interdisciplinary collaboration to navigate the future of psychedelic medicine. As Dr. Mason Marks summed up: “The drug policy space needs enthusiastic people.”
