STAT+: Don't write off MDMA yet: How the FDA got on board with psychedelics

Days after an advisory committee resoundingly voted for the Food and Drug Administration to reject MDMA as medical treatment, the founder of the company that applied for approval was ebullient. Rick Doblin, who has spent decades driving forward MDMA research, told a psychedelics conference in the Netherlands that his dream was not simply possible, but likely. There was “substantially more than a 50/50 chance” that the FDA would dismiss its advisers’ perspective and approve the first currently prohibited psychedelic come August, he said at the Interdisciplinary Conference on Psychedelic Research.

This optimism may seem misguided given the extensive criticisms and questions voiced by mental health practitioners on the advisory committee, but Doblin’s prediction is grounded in more than just a sunny disposition. He and other psychedelic evangelists have been working to win over regulators since the 1980s, and those relationships helped persuade the agency to sign off on psychedelic research despite methodological challenges.

The FDA approves treatments roughly one-third of the time when advised not to by their expert panels and, amid intense cultural pressure and growing frustration about the lack of new mental health therapies, Doblin may well be proven right. Even if not, the last-minute stumbling block for MDMA is a sign of how the agency is now more accepting of psychedelics than many others in psychiatry. That’s a seismic shift, and an examination of the history of regulatory decisions around psychedelics shows just how much Doblin’s and others’ work has paid off.

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