Multidisciplinary Association For Psychedelic Studies Eyes State-Level Legalization After FDA Denial Of MDMA Therapy

The Multidisciplinary Association for Psychedelic Studies (MAPS) is pivoting its focus to state-level initiatives following the U.S. Food and Drug Administration's (FDA) recent denial of MDMA-assisted therapy. As recently reported by Double Blind, MAPS gathered a panel of experts to discuss what comes next after the federal setback. This shift signals a new chapter in MAPS’ advocacy efforts, aiming to legalize psychedelic therapy through state-led ballot measures rather than waiting for federal approval.

Shifting Focus

The press conference followed the FDA and Reagan-Udall Foundation's public meeting on PTSD, which included discussions on psychedelic therapy. Among the expert panel were well-known figures such as Dr. Bessel van der Kolk, author of The Body Keeps the Score; Michael Mithoefer, a principal investigator in MAPS' FDA trials; US Army veteran Darron Smith and Dave Rabin, host of The Psychedelic Report podcast. The discussion, moderated by MAPS director of communications Betty Aldworth, shed light on MAPS' next steps.

Aldworth expressed disappointment over the FDA’s decision to deny Lykos Therapeutics’ Novel Drug Application for MDMA-assisted therapy. "It's heartbreaking," Aldworth stated. However, she emphasized that the organization would now direct its attention to states like Colorado and Oregon, which have already passed laws legalizing psychedelic therapy. With Massachusetts voting on psychedelics legalization in November, Aldworth noted, "Voters in those states… have decided it is time to move beyond the FDA process that is currently failing many patients living with PTSD."

Expert Voices On State-Led Approaches

Dr. van der Kolk echoed the sentiment, stating that "the next step is for the FDA to get overruled by state law." However, he also expressed cautious optimism regarding Massachusetts, warning that it might be too early to count on the bill's passage. Van der Kolk criticized the FDA panel’s scientific understanding of psychedelics, saying, "The FDA panel was scientifically out to lunch."

Smith pointed out that efforts are also underway in North Carolina, where lawmakers have advanced a bill to fund research into psilocybin and MDMA. He also mentioned Utah's pilot program that allows doctors in hospital settings to administer psychedelic treatments. "Given that the Mormon church runs Utah's legislature, that's very good," Smith said.

Broad Advocacy For Psychedelic Therapies

MAPS's shift aligns with statements made by other advocacy organizations. The Healing Advocacy Fund, a nonprofit championing state-regulated psychedelic programs, released a statement on August 9 calling for state-level leadership in the absence of federal action. "With an undeniable mental health crisis… we can't afford to wait for an ineffective federal bureaucracy to catch up. States must take the lead," the organization stated.

The panel closed with a reminder that underground MDMA therapy is already occurring, with many individuals accessing the treatment informally. As Smith put it, "The cat's out of the bag," stressing the need for community-based efforts to expand access to these therapies, particularly for people of color. Van der Kolk agreed, emphasizing the importance of formalizing the process, saying, "We can only learn when it goes overground, and we can study and research it."

Cover image made with AI