The US Food and Drug Administration’s (FDA) recent guidance on psychedelic drug development is a “policy landmark” and a step in the right direction yet there is room for improvement in areas related to psychological support and adverse event reporting, according to a new perspective published in the New England Journal of Medicine.
The authors — Mason Marks and I. Glenn Cohen — offered their perspectives on FDA’s June 2023 draft guidance proposing a framework for clinical investigations and drug development programs for psychedelic drugs (RELATED: FDA issues first psychedelic drug trial guidance, Regulatory Focus 28 June 2023).
Marks, who is an MD and a professor of law at Florida State University, is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at Harvard Law School, and a visiting fellow at the Information Society Project at Yale Law School. Cohen is a professor of law at Harvard Law School and the director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics…
