Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty.
Holly Fernandez Lynch, Xinping Hu, Alison Bateman-House
The Journal of Law, Medicine & Ethics 2026 DOI: 10.1017/jme.2025.10183 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Cannabis |
| Keywords | Australia Canada Colorado Expanded access Oregon Psychedelics |
| Citations | 2 |
| Key findings | Policymakers should balance evidence, patient safeguards, and speed by supporting research, avoiding hindrances, improving pre-approval access, and preventing political FDA approvals. |
Abstract
Psychedelic medicines hold the promise of therapeutic benefit for many suffering from serious unmet mental health needs, leading to substantial demand even before these drugs receive FDA approval based on demonstrated safety and effectiveness for particular conditions. Recognizing FDA approval as the ideal path for psychedelics intended for medical use and drawing on lessons from medical marijuana, we encourage policymakers to balance the need for evidence, the importance of patient safeguards, and the desire for speed. They should increase support for psychedelic research, reject approaches that could inhibit that research, explore improvements to FDA's existing pre-approval access pathway, and avoid politically motivated FDA approval of psychedelic medicines.
Comparable studies
Other narrative reviews on cannabis, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Causal association between cannabis and psychosis: examination of the evidence | 2004 | Review | |
| Cannabis sativa: A comprehensive ethnopharmacological review of a medicinal plant with a long history. General (historical and pharmacological review) | 2018 | Review | |
| Psychiatric effects of cannabis | 2001 | Review | |
| Beyond THC: The New Generation of Cannabinoid Designer Drugs | 2011 | Review | |
| Cannabidiol, a Cannabis sativa constituent, as an antipsychotic drug | 2006 | Review |
Citations in the library
Cited by 3
- The Psychedelic Therapies Executive Order JAMA July 1, 2026
- Psychedelic-assisted pharmacotherapy: clinical applications and regulatory considerations Expert Opinion on Pharmacotherapy March 24, 2026
- Ethics of psychedelics in clinical research: a state-of-the-field review JME Practical Bioethics October 9, 2026
Cites 21
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- Single-Dose Psilocybin Treatment for Major Depressive Disorder JAMA August 31, 2023
- Adverse effects of psychedelics: From anecdotes and misinformation to systematic science. Journal of Psychopharmacology February 2, 2022
- Psychedelic Drug Legislative Reform and Legalization in the US JAMA Psychiatry December 7, 2022
- Preparing for the Bursting of the Psychedelic Hype Bubble. JAMA Psychiatry October 1, 2022
and 16 more in the library