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MAPS Wants Voters to Legalize MDMA Therapy If the FDA Won’t

After the FDA’s denial, MAPS is shifting its focus to state-level initiatives, signaling a new direction in its advocacy efforts.

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On Friday, September 6, MAPS assembled a panel of experts during a press conference to discuss what comes after the recent FDA denial of MDMA-assisted therapy. The press conference followed on the heels of the FDA and Reagan-Udall Foundation’s public meeting on PTSD earlier that day, which featured an extended discussion of psychedelic therapy. 

Featuring an impressive lineup of The Body Keeps the Score author Bessel van der Kolk, principal investigator in MAPS’s FDA trials Michael Mithoefer, US Army veteran Darron Smith, and “The Psychedelic Report” podcast host Dave Rabin, the MAPS panel was moderated by Director of Communications Betty Aldworth, and provided some useful insights into where the organization is shifting its efforts following the federal denial of MDMA de-scheduling in August. 

Aldworth began the conversation by calling the FDA’s denial of Lykos Therapeutics’ Novel Drug Application for MDMA-assisted therapy “heartbreaking.” She then shifted the conversation to states like Colorado and Oregon that have already implemented models of legalized psychedelic therapy, while noting that MAPS is hopeful that Massachusetts, which will vote on psychedelics legalization this November, will follow suit. Aldworth’s statement signified that MAPS’s strategy going forward will focus more on state-level ballot measures to legalize psychedelic therapy, instead of waiting for the federal government to do so.

“Voters in those states, the people, have decided it is time to move beyond the FDA process that is currently failing many patients living with PTSD,” Aldworth said. 

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Van der Kolk agreed that “the next step is for the FDA to get overruled by state law,” although he noted that MAPS might be too optimistic about the Massachusetts bill passing. “This needs to go to the citizenry because the FDA panel was scientifically out to lunch, and nobody seems to have known anything about psychedelics or trauma,” he said. 

Smith chimed in, remarking that he is working to get some inroads in North Carolina, where lawmakers last year advanced a bill that would provide $5.4 million in grants towards psilocybin and MDMA research. Utah was also mentioned in the conversation as another state that quietly pushed through a pilot program this year, where doctors at the state’s two largest healthcare systems will be allowed to dose patients with psilocybin and MDMA in hospital settings. “Given that the Mormon church runs Utah’s legislature, that’s very good,” Smith quipped. 

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Healing Advocacy Fund, a nonprofit advocating for state-regulated psychedelic programs that was not part of the panel, released a statement on August 9 expressing a similar intent to pursue legalization on the state level. 

“It’s now clear that the path for desperately needed access to psychedelic-assisted therapies will not run through Washington, D.C,” the organization said. “With an undeniable mental health crisis in this country, we can’t afford to wait for an ineffective federal bureaucracy to catch up. States must take the lead.” 

The panel concluded with the panelists agreeing that MDMA therapy is already happening in the underground and that people are already accessing these treatments. 

“The cat’s out of the bag,” said Smith, stressing the need for community-based funding, and partnerships with organizations to make psychedelic therapies more accessible especially to people of color. “If this culture continues in the underground only, we’ll learn nothing,” van der Kolk said. “We can only learn when it goes overground, and we can study and research it.”

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