On August 9, 2024, the FDA rejected the application for MDMA-assisted therapy to become an approved treatment for PTSD. The FDA’s decision came as a shock to many who have been working to bring this promising treatment to patients in need. How can the world go from believing this was the solution to all its problems to thinking it was all nonsense? Despite extraordinary clinical results demonstrating its effectiveness, the rejection highlights the scientific, cultural, and bureaucratic obstacles that still stand in the way of psychedelic therapy. To me, most of the discussion around this feels very superficial, weak, and unbalanced. I have followed this process closely and listened to both critics of MAPS and key figures involved. Here is an overview of the main reasons for the rejection, based on my understanding of it:
1. The challenges of double blind design
One of the reasons for the rejection was that participants could guess whether they had received MDMA or not. One of the biggest challenges in the studies was ensuring that participants and researchers remained “blind” to the treatment being given. MDMA produces clear physical and emotional effects, making it easy for most participants and therapists to determine whether they received MDMA or a placebo.
Attempts to address this issue, such as using low doses of MDMA as an active placebo, led to other problems. Participants who received low doses often experienced discomfort, and their outcomes were worse than those who received a placebo. This highlighted the difficulty of balancing blinding with therapeutic effectiveness, which became a central focus of the FDA’s criticism. MAPS (now Lykos) had been discussing this challenge with the FDA for years, and they eventually reached a solution that both parties considered the best possible approach.
2. Changes in Regulatory Expectations
At the beginning of the process, MAPS and the FDA had agreed on how the studies should be conducted. The MDMA study by MAPS was granted “Breakthrough Therapy” status by the FDA, meaning MAPS and the FDA would collaborate and adjust the protocol as needed to ensure a faster approval process. However, when new leadership took over the FDA’s psychiatry division, several requirements changed. For example, stricter rules were introduced, such as requiring lead therapists to hold MD or PhD degrees and mandating that a physician be physically present during sessions rather than just being available, as was previously allowed.
These requirements had no clear support from research data in terms of improving safety or effectiveness but seemed more like an expression of caution. These changes increased costs and further delayed the process.
3. Negative media narratives
During the final phase before submission, MAPS and Lykos prioritized their collaboration with the FDA and adopted a “quiet media phase,” opting not to actively respond to public criticism. This strategic decision was based on the assumption that regulatory approval was largely procedural at that stage and that media discourse would not significantly influence the FDA’s assessment. However, this approach allowed critical narratives to gain traction unchallenged. Notably, Psymposia—a vocal organization opposed to the commercialization of psychedelics—published a series of articles questioning the study design, therapy protocols, and the overall safety of MDMA-assisted therapy. These critiques, despite substantial clinical evidence demonstrating the therapy’s efficacy and safety, contributed to an atmosphere of doubt that may have influenced public and institutional perception of the treatment’s validity.
A major mistake was failing to highlight positive developments during this period, such as the Dutch state committee’s assessment of the same data. The committee in the Netherlands concluded that MDMA-assisted therapy was both effective and safe, recommending its use in controlled settings for PTSD treatment. Without these positive counter-narratives, criticism dominated the public discourse, shaping the perception of MDMA therapy in a way that may have influenced the regulatory process.
4. FDA’s scepticism of psychotherapy
The FDA approves medications but has never before approved a protocol that combines a drug with psychotherapy. MDMA-assisted therapy relies on a specific therapeutic protocol, which the FDA seemed uncomfortable evaluating. The agency questioned whether the therapy itself could be responsible for the positive outcomes, despite decades of data demonstrating MDMA’s unique therapeutic potential.
This misunderstanding of the interaction between the substance and the therapy became a key factor in the rejection.
5. Public scepticism of commercial cooperations
MAPS faced criticism for its partnership with Lykos, a commercial entity created to finance and scale clinical trials. Critics claimed that MAPS had “sold out,” and this skepticism contributed to eroding trust in the process.
However, this partnership was necessary to meet the financial demands of the approval process. Such costs—typically amounting to billions of kroner—far exceed what can usually be raised through donations alone. Despite this, the partnership was often misunderstood as an ethical issue, which weakened public support.
6. Political and bureaucratic challenges
Despite significant progress in reducing the stigma around psychedelics, cultural and political barriers still remain. Some members of the FDA’s advisory committee expressed concerns about the broader societal implications of such an approval.
Additionally, it seems that lower levels within the FDA are more inclined to reject controversial treatments, partly due to a fear of being held responsible for potential negative outcomes. The FDA has faced significant criticism in recent years, including backlash over its approval of the Alzheimer’s drug Aduhelm and the painkiller Vioxx, the latter which was pulled from the market after being linked to an increased risk of heart attacks and strokes. The agency has also been heavily criticized for its handling of the OxyContin crisis in the U.S. This increased institutional caution likely played a role in the decision as well.
The Path Forward for MDMA-Assisted Therapy
The rejection is a setback, but it is not the end. MAPS and Lykos are already considering how to address the FDA’s concerns and conduct the necessary additional studies. At the same time, international developments provide hope. In the Netherlands, authorities have already moved forward with recommendations for the use of MDMA therapy in controlled settings, and Australia has already approved both psilocybin and MDMA for strictly regulated clinical use.
The decision also highlights the need for public education and cultural engagement. MAPS and others in the field must work to regain control of the narrative in the media and ensure that both the public and policymakers understand the strong evidence supporting MDMA-assisted therapy and the life-changing impact it can have.
The path to approval may take longer than expected, but the goal remains the same: to make MDMA-assisted therapy a widely accessible, evidence-based treatment for PTSD. The journey now continues—not just in the laboratory, but also in the public sphere, where culture and science intersect to shape the future of medicine.
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