An increasing amount of research is showing psychedelics as promising treatments for a variety of mental health conditions, however, a group of experts have emphasised the need for collaborative and creative policies to maximise their potential.
Experts from Baylor College of Medicine, the University of Pennsylvania, American University and Harvard Law School say creativity and collaboration at the federal and state levels is needed in developing policies for the use and oversight of psychedelics.
In their paper published in Science, the experts in bioethics, law and policy also call for a commitment to developing a strong evidence base for efficacy and safety and propose solutions to three regulatory challenges in anticipation of Food and Drug Administration (FDA) approval of psychedelics for medical use in the coming years.
Dr. Amy McGuire, lead author and Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor stated: “We are clearly on the brink of a major opportunity to help people legally access psychedelic treatment.
“Therefore, the need has never been greater to anticipate, identify and discuss challenges, regulations and risks. We hope this dialogue helps all parts of the system prepare and coordinate so patients can access these treatments in an ethical, equitable way as soon as they become available.”
Regulations and collaboration
The authors call for regulations to help maximise the potential of psychedelic therapies.
A participant’s mindset and the setting in which they take the medicine are vital components of psychedelic therapy. The authors highlight that, while FDA regulates drugs, the agency does not ordinarily regulate conditions of use.
They therefore propose that the FDA consider risk evaluation and mitigation strategies specifying conditions for safe use, which also may help promote effectiveness, and work with agencies at the state level to enact practitioner certifications and requirements.
Additionally, they call for collaboration between federal and state governments as well as state licensing boards and professional societies on decriminalising psychedelics for both medical and non-medical use, as well as a need to preserve space for traditional and religious uses of psychedelics.
The authors warn against following the state-by-state legalisation model used for cannabis, which has not provided adequate incentives for the collection of safety and efficacy data necessary for FDA approval.
“Considering psychedelics as medicine will require new ways of thinking about regulation, both for FDA and for the regulation of the practice of medicine by states – we hope to help them set an appropriate course while also respecting long-standing use by indigenous populations,” said I. Glenn Cohen, co-author and James A. Attwood and Leslie Williams Professor of Law and deputy dean at Harvard Law School.
Holly Fernandez Lynch, co-author and assistant professor of medical ethics at the University of Pennsylvania’s Perelman School of Medicine, added: “There is a lot of excitement around the use of psychedelics for therapeutic purposes, and equitable access will be critical, but we have to make sure that allowing these drugs to be used outside FDA’s regulatory pathways doesn’t inhibit the generation of essential evidence about whether, when, and for whom these drugs will serve as strong treatment options.”
Creative solutions
Creative solutions in regulating synthetic and natural psychedelics are needed also, say the authors.
They highlight that naturally occurring psychedelics are heterogenous and therefore harder to study in clinical trials and difficult to produce consistently for commercial use.
Synthetic psychedelics are easier to produce and patent, making them more commercially profitable, but these drugs made with isolated active ingredients may lack the beneficial effects found in natural psychedelics.
To tackle this issue, the authors call for funding and support of clinical trials to generate data and ensure a pathway for 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, stated: “During an age when scholars and policy makers are struggling to adapt FDA’s traditional regulatory modalities to cutting edge technologies, such as gene therapy and machine learning, this paper highlights the comparably daunting regulatory challenges posed by a product from the other end of the spectrum – a naturally occurring botanical product used for millennia.”
The publication is part of the Ethical Legal Implications of Psychedelics In Society (ELIPSIS) programme at Baylor’s Center for Medical Ethics and Health Policy and the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
ELIPSIS aims to address ethical and policy issues surrounding the use of psychedelic medicine. POPLAR, launched in 2021, examines the ethical, legal and social implications of psychedelics research, commerce and therapeutics.
