The FDA’s decision on MDMA-assisted psychotherapy: A call for pragmatism and scientific rigor

The FDA's negative decision about current US MDMA licensing has triggered a plethora of online reactions. The OPEN Foundation's thoughtful response and contrasting with the much more positive recommendations of the Dutch State Committee on MDMA is particularly interesting. They write: "What is particularly surprising is the stark contrast between the FDA’s decision and the conclusions reached by the Dutch State Committee on MDMA. Based on the same body of evidence, the Dutch committee (consisting of scientists, psychiatrists, legal experts, drug prevention and harm reduction specialists) arrived at a radically different conclusion: MDMA-AT is promising, effective, relatively safe and warrants more scientific research to further explore its therapeutic potential. The committee even concluded that based on the relatively low potential for harm, MDMA could be down-scheduled: moving the compound from List 1 to List 2 of the Opium Act. Finally, the Committee advised the Dutch government to start a naturalistic study to allow patients access to this new therapy form, while also allowing scientists to collect more data on an ongoing basis, all the while gaining important clinical experience in delivering this novel treatment form. These diverging perspectives raise important questions about the interpretation of scientific data and the role of cultural and institutional factors in regulating novel therapeutic approaches. The Dutch committee’s recommendation reflects a nuanced understanding of both the risks and benefits associated with MDMA-AT. They recognize that while methodological and ethical concerns remain, the potential therapeutic benefits of MDMA-AT cannot be ignored. This discrepancy between the FDA and the Dutch committee highlights the need for international dialogue and collaboration in the evaluation of novel therapies. Want to learn more about the Dutch State Committee Report? Click here."

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