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Mason Marks

Harvard Law School.

8 papers in the library · 277 citations · publishing 2021-2025

Papers

The varieties of psychedelic law

Neuropharmacology December 21, 2022 Mason Marks 59 citations

After decades of prohibition, psychedelics are drawing intense public and private interest. Scientists are researching their therapeutic properties, and mounting evidence supports their ability to treat a variety of mental health conditions. Dozens of cities and states are proposing or enacting psychedelics legislation to promote research, increase therapeutic and non-therapeutic access, and decrease criminal penalties. This article is the first to produce a typology of state and local psychedelic laws, which fall into five categories: decriminalization, supported adult use, medical use, clinical research, and policy analysis. It defines each category and explains how some jurisdictions create hybrid laws blending multiple elements. Following enactment, government agencies can shift laws from one category to another during rulemaking.

DOI: 10.1016/j.neuropharm.2022.109399 Ayahuasca Psilocybin Controlled substance regulation Psychedelics policy reform +4

Essentials of Informed Consent to Psychedelic Medicine

JAMA Psychiatry April 10, 2024 Mason Marks, Rebecca Weintraub Brendel, Carmel Shachar et al. 46 citations

As interest in psychedelics for mental health treatment grows, legal reforms and regulatory approvals are advancing faster than standards for informed consent. Psychedelics pose unique challenges for consent, including perceptual disturbances, personality changes, altered metaphysical beliefs, risks of abuse or coercion, and the role of touch and data collection. Current consent documents in clinical trials often overlook these elements. Seven essential components for psychedelic informed consent are identified, and sample language and procedures are proposed to address the gap.

DOI: 10.1001/jamapsychiatry.2024.0184 Informed consent Psychology Medline Psychiatry +4

Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement.

JAMA network open June 3, 2024 Amy L McGuire, I Glenn Cohen, Dominic Sisti et al. 41 citations

A consensus statement from a 2023 meeting of 27 experts identifies 20 points of consensus across five ethical issues for integrating psychedelic medicines into mainstream medical practice: reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping. The meeting included clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists. The statement focuses on government-approved medical use in the US and abroad, emphasizing that policymakers must address challenges ahead while acknowledging the hopeful moment.

DOI: 10.1001/jamanetworkopen.2024.14650 Full text Psychedelic therapy Psychedelic medicine Psychedelic treatment Psychedelics +15

Psychedelic Medicine Exceptionalism.

The American journal of bioethics : AJOB January 1, 2025 I. Glenn Cohen, Mason Marks 22 citations

Psychedelic medicines are undergoing a research revival, prompting debate over whether they require unique regulatory and ethical treatment or should be held to the same standards as other medical interventions. This article analyzes the arguments for and against special consideration, examining how psychedelics are researched, regulated, commercialized, and administered. It concludes that while psychedelics present distinct features, they do not inherently warrant a separate regulatory framework; instead, existing standards can be adapted to address their specific risks and benefits.

DOI: 10.1080/15265161.2025.2434398 Full text MDMA Psilocybin FDA Informed consent +7

Psychedelic Therapy Scrutinized by FDA Advisory Committee?

JAMA July 30, 2024 Mason Marks 20 citations

The Psychopharmacologic Drugs Advisory Committee's decisions on MDMA-assisted therapy carry significant implications for the future of psychedelic research. The committee's evaluations highlight the complex regulatory and scientific challenges facing this emerging treatment modality. Their rulings may shape how subsequent studies are designed, what endpoints are considered acceptable, and how safety and efficacy data are interpreted. The analysis suggests that these decisions could either accelerate or hinder the development of psychedelic therapies, depending on how the field responds to the committee's concerns about trial methodology, blinding, and potential for abuse.

DOI: 10.1001/jama.2024.13370 Advisory committee Family medicine Management