Title & Introduction

  • Paper Title: Expanded Access to Psychedelic Treatments: Comparing American and Canadian Policies
  • Published In: General Psychiatry
  • Publish Date: February 19, 2025
  • Authors: Jérémie Richard, Albert Garcia-Romeu, Jack E. Henningfield
  • Objective: To compare the regulatory frameworks for expanded access to psychedelic-assisted therapy in the United States and Canada, examining barriers and opportunities for patient access.
  • Importance: With the growing recognition of psychedelics as potential treatments for PTSD, depression, and anxiety, understanding policy differences can inform future regulatory improvements to expand patient access.

Summary & Takeaways

Key Takeaway: Canada’s Special Access Program (SAP) facilitates broader patient access to psychedelic-assisted therapy than the U.S. FDA’s Expanded Access Program, which remains highly restrictive.

Practical Application:
Regulatory agencies in the U.S. could adopt elements of Canada’s SAP to make psychedelic treatments more accessible to patients while still maintaining safety oversight and data collection.

Key Background Information

  • Context: The demand for psychedelic-assisted therapy is rising, but access remains restricted due to regulatory barriers. Canada has implemented a more flexible access model compared to the U.S.
  • Hypothesis: The Canadian SAP model provides a more effective framework for balancing access, safety, and data collection than the U.S. Expanded Access pathway.

Methodology

  • Study Design: Policy analysis comparing Canadian and American regulatory frameworks.
  • Participants: Not applicable (policy review).
  • Intervention/Exposure: Review of expanded access pathways for psilocybin and MDMA in both countries.
  • Controls: Not applicable.
  • Duration: Analysis of policies from 2020 to 2025.

Key Findings

Primary Outcomes:

  • In Canada, the SAP allows healthcare practitioners to request psilocybin or MDMA for patients with treatment-resistant conditions.
  • As of February 2024, Health Canada had approved over 200 applications for psychedelic therapy via SAP.
  • The U.S. FDA’s Expanded Access Program remains difficult to navigate, with only 50 patients granted access to MDMA for PTSD treatment between 2020 and 2025.
  • Canada’s program requires post-treatment reporting, ensuring continuous safety monitoring, while U.S. policies impose heavier administrative burdens that discourage participation.

Secondary Outcomes:

  • The Canadian Senate is advocating for a large-scale research program on psychedelic therapy for veterans, given the high prevalence of PTSD in military populations.
  • The Right to Try Act in the U.S. theoretically allows patients to access experimental treatments, but psychedelic therapy remains largely inaccessible under this law.
  • Preliminary data suggest that psychedelic therapy under SAP leads to significant reductions in PTSD and depression symptoms, aligning with clinical trial outcomes.

Interpretation & Implications

  • Conclusion: Canada’s regulatory model for psychedelic therapy is more effective in providing access while maintaining safety oversight compared to the restrictive U.S. framework.
  • Implications: U.S. policymakers should consider adapting elements of Canada’s SAP, such as streamlined application processes and broader eligibility criteria, to improve patient access.
  • Limitations: This study is a policy analysis and does not include direct patient outcome data. Further empirical research is needed to assess the long-term effectiveness of expanded access programs.

Researchers & Publication

Share this post