Expanded access to psychedelic treatments: comparing American and Canadian policies

Author: mycolabadmin
2/19/2025
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Summary

This article compares how the United States and Canada allow patients with serious health conditions like PTSD and depression to access experimental psychedelic treatments outside of clinical trials. Canada’s program has allowed over 200 patients to access psilocybin and MDMA treatments since 2022, while the US has only approved 50 patients for MDMA. The authors argue that Canada’s approach is more ethical and accessible, and suggest the US should streamline its process to help more patients who have failed conventional treatments.

Background

The FDA’s August 2024 determination requiring an additional phase III study for midomafetamine approval may delay access to this PTSD treatment by several years. Both the FDA and Health Canada have pathways for expanded access to investigational psychedelic treatments, but they differ significantly in implementation and accessibility. Canada’s Special Access Program has authorized over 200 patients to access psilocybin and MDMA since January 2022.

Objective

This commentary compares the American FDA expanded access pathway and the Canadian Special Access Program for psychedelic-assisted treatments, examining differences in accessibility, patient reach, and alignment with biomedical ethics principles. The authors assess how these regulatory approaches impact patient access to psychedelic therapies for serious conditions.

Results

Canada approved psilocybin access for 176 patients (78% approval rate) and MDMA for 41 patients by February 2024, with no serious adverse events reported. In contrast, the USA approved MDMA access for only 50 patients at 10 sites from 2020 to present. Canada’s program demonstrates faster patient enrollment and broader geographic/condition coverage while maintaining safety monitoring standards.

Conclusion

Health Canada’s Special Access Program better aligns with biomedical ethics principles of justice, autonomy, beneficence, and non-maleficence compared to the FDA’s expanded access pathway. The authors recommend the FDA streamline and increase transparency in its expanded access process to improve equitable patient access to psychedelic treatments.

Published in:General Psychiatry,
Study Type:Policy Analysis and Comparative Review,
Source: PMID: 39980867, DOI: 10.1136/gpsych-2024-101894