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A Review of the Food and Drug Administration Pipeline and Proposed California Legislation on Medicinal Psychedelics

Summary

Psychedelic compounds like psilocybin and ketamine show promise in treating serious mental health conditions including PTSD and depression. The FDA carefully evaluates these drugs through multi-phase clinical trials to ensure they are safe and effective. While California has proposed making psychedelics more widely available through legislation, the FDA’s thorough approval process provides important protections by identifying potential risks and ensuring proper medical oversight.

Background

Psychedelic and empathogenic compounds show promise for treating various psychiatric conditions. The FDA has approved esketamine for treatment-resistant depression and designated MDMA-assisted therapy for PTSD as a breakthrough therapy. California has proposed multiple legislative initiatives to expand access to psychedelics outside traditional FDA approval pathways.

Objective

To review eight late-phase medicinal psychedelic studies in the FDA approval pipeline, examine the FDA’s denial of the MDMA-assisted therapy NDA for PTSD, and discuss California legislative proposals to legalize psychedelics, evaluating the appropriateness of FDA oversight versus alternative regulatory pathways.

Results

Five psilocybin phase 3 trials are ongoing for major depressive disorder and treatment-resistant depression. Two ketamine phase 3 trials are studying alcohol use disorder and disorders of consciousness. The FDA denied the MDMA NDA in August 2024 citing flawed study design, selection bias, inadequate blinding, and insufficient safety data. California’s legislative efforts to legalize psychedelics have been defeated or withdrawn due to patient safety concerns.

Conclusion

The FDA remains the appropriate regulatory authority for evaluating medicinal psychedelics due to rigorous safety assessment requirements. While some clinical trials show promising outcomes, serious adverse effects including psychosis, suicidality, and neurologic complications warrant continued vigilance. Federal funding through programs like the VA’s new psychedelic research initiative is preferable to state-based legalization approaches.
  • Published in:The Permanente Journal,
  • Study Type:Review,
  • Source: 10.7812/TPP/24.171
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