Studies back the potential of psychedelics to treat disorders such as depression and post-traumatic stress disorder, yet the regulatory outlook for these substances remains uncertain. Scholars from Baylor College of Medicine, the University of Pennsylvania, American University, and Harvard Law School advocate for imaginative and cooperative efforts by government entities at the national and local levels to create guidelines for the management and utilization of psychedelics, as well as a dedication to generating a sound foundation of evidence regarding their effectiveness and security.
A group of experts in bioethics, law, and policy have proposed solutions to three regulatory challenges in anticipation of the Food and Drug Administration's approval of psychedelics for medical use in the near future. Their paper was published in the journal Science and is part of the Ethical Legal Implications of Psychedelics In Society (ELIPSIS) program at Baylor's Center for Medical Ethics and Health Policy, as well as the Project on Psychedelics Law and Regulation (POPLAR) at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. The ELIPSIS program seeks to address ethical and policy concerns regarding the use of psychedelic medicine, while POPLAR, established in 2021, focuses on examining the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics.
Dr. Amy McGuire, the lead author and Leon Jaworski Professor of Biomedical Ethics, as well as the director of the Center for Medical Ethics and Health Policy at Baylor, stated that there is a significant opportunity to provide individuals with legal access to psychedelic treatment. She emphasized the importance of anticipating, recognizing, and discussing the regulatory challenges and potential risks associated with this treatment. The goal is to enable all parties involved to plan and collaborate in order to ensure that patients have ethical and equitable access to these therapies as soon as they become accessible.
The authors of the paper stress the necessity of implementing regulations for the therapeutic environment surrounding psychedelic medicine. The psychological mindset and physical setting during therapy are widely accepted as crucial elements of the psychedelic experience, and studies have focused on the use of psychedelics in the context of assisted psychotherapy. Although the FDA regulates drugs, it typically does not oversee conditions of use. Therefore, the authors suggest that the FDA should contemplate risk evaluation and mitigation techniques to establish guidelines for safe usage, which may also boost effectiveness. They also recommend that the FDA collaborate with state-level agencies to establish certification and qualification requirements for practitioners.
Additionally, the paper advocates for cooperation among federal and state governments, state licensing boards, and professional associations in the effort to decriminalize psychedelics for both medical and non-medical use. Furthermore, it highlights the importance of safeguarding space for traditional and religious uses of psychedelics.
Glenn Cohen, co-author of the paper and James A. Attwood and Leslie Williams Professor of Law, as well as deputy dean at Harvard Law School, emphasized that regarding psychedelics as medicine necessitates a novel approach to regulation, both for the FDA and for the regulation of medical practice by states. The authors aim to assist these entities in charting an appropriate course while also respecting the long-established use of psychedelics by indigenous communities.
The authors of the paper caution against following the state-by-state legalization approach used for marijuana, as it has not provided adequate incentives for the gathering of the necessary safety and efficacy data required for FDA approval. Holly Fernandez Lynch, co-author and assistant professor of medical ethics at the University of Pennsylvania's Perelman School of Medicine, stated that while there is a great deal of enthusiasm surrounding the use of psychedelics for therapeutic purposes, it is critical to ensure equitable access. However, it is also essential to ensure that the usage of these drugs outside the FDA's regulatory framework does not impede the collection of vital evidence concerning their effectiveness as a treatment option for certain patients.
The authors of the paper also emphasize the importance of innovative approaches in regulating both synthetic and natural psychedelics. Naturally occurring psychedelics are heterogeneous, making them challenging to study in clinical trials and challenging to produce consistently for commercial purposes. Synthetic psychedelics, on the other hand, are simpler to manufacture and patent, making them more commercially lucrative. However, these drugs, which are made with isolated active ingredients, may not have the beneficial effects found in natural psychedelics. Therefore, the authors urge for the provision of funding and support for clinical trials aimed at generating data and establishing a pathway for the approval of naturally occurring psychedelics.
Dr. Lewis A. Grossman, co-author and professor of law and affiliate professor of history at American University Washington College of Law, commented that in an era when scholars and policymakers are grappling with how to adapt FDA's traditional regulatory approaches to innovative technologies such as gene therapy and machine learning, this paper underscores the similarly daunting regulatory obstacles presented by a product from the opposite end of the spectrum: a naturally occurring botanical product with a centuries-long history of use. (PB/Newswise)