Research

The Project on Psychedelics Law and Regulation (POPLAR)

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is engaged in a three-year initiative to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics. Launched in summer 2021 with a generous grant from the Saisei Foundation, the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School advances evidence-based psychedelics law and policy. The work expanded in 2023 with additional funding from the Gracias Family Foundation.

Background

Despite a longstanding prohibition on psychedelics dating back to the 1960s and 70s, scientific and public interest in these substances is growing. Clinical trials increasingly demonstrate the promise of substances such as psilocybin, lysergic acid diethylamide (LSD), and 3,4-Methylenedioxymethamphetamine (MDMA) for treating mood, anxiety, and substance use conditions.

In 2017, the FDA designated MDMA a breakthrough therapy for post-traumatic stress disorder; in 2018 and 2019, the agency identified psilocybin as a potential breakthrough for treatment-resistant depression and major depressive disorder. In 2024, the FDA gave this designation to LSD for treating generalized anxiety disorder and to an analog of psilocybin for treating major depressive disorder. These designations reflect FDA’s belief that psychedelic medicines could eventually be substantial improvements over existing treatments for mental illness.

While psychedelic medicines make their way through the drug development pipeline, about two dozen US cities and one US state have decriminalized them. In 2020, Oregon voters legalized the supported adult use of psilocybin. The state’s regulated psilocybin industry opened in the summer of 2022. Later that year, Colorado voters approved similar legislation to allow supervised psilocybin consumption while simultaneously decriminalizing plants and fungi containing five psychedelic substances.

Due to their therapeutic and commercial potential, the US market for psychedelics has been projected to reach $6.85 billion by 2027, attracting many for-profit companies and investors. However, despite the proliferation of clinical research centers, increasing investment in drug development, and widespread state and local policy reform, there is a relative lack of research on the ethical, legal, and social implications of psychedelic research, commerce, and therapeutics.

POPLAR is the first academic initiative focused on psychedelics law, policy, and ethics, positioned to be a global leader for research and education in this space.

The Project

POPLAR focuses on promoting safety, innovation, and equity in psychedelics research, commerce, and therapeutics.

Faculty Director I. Glenn Cohen and Senior Fellow Mason Marks teach Psychedelic Law & Policy at Harvard Law School.

While this list is not exhaustive, POPLAR research addresses the following key areas:

Ethics in Psychedelics Research, Therapeutics, and Commerce
Challenges at the Intersection of Psychedelics and Intellectual Property Law
Opportunities for Federal Support of Psychedelics Research
Access to Psychedelic Therapies and Equity in Emerging Psychedelic Industries
The Role of Psychedelics in Healing Trauma

The POPLAR team addresses these issues by publishing academic research; hosting academic events and roundtables with experts from industry, government, and academia; educating courts, legislators, government agencies, and the public; partnering with clinical researchers to help them navigate legal and ethical roadblocks in their work; and training the next generation of thought leaders in this emerging field.

In 2024, the Petrie-Flom Center annual conference highlighted POPLAR and The Law and Policy of Psychedelic Medicine. The event opened with a fireside chat Speaking of Psychedelics: A Conversation with Ayelet Waldman (HLS ’91), the New York Times best-selling author of A Really Good Day.

Please find examples of POPLAR publications and legal commentary below.