Psychedelics, Psychosocial Support, and Psychotherapy: Why It Matters for the Law, Ethics, and Business of Medical Psychedelic Use

Abstract

We may be on the cusp of a sea change in the relationship of psychedelic substances (hereinafter “psychedelics”) and the modern medical-industrial complex and clinical practice for certain disorders and medical needs. Although in August 2024, the Federal Drug Administration (FDA) issued to Lykos Therapeutics a “complete response letter” rejecting the company’s application  for approval for MDMA for PTSD after a contentious meeting for the Psychopharmacologic Drugs Advisory Committee (the “Advisory Committee”). It is possible that the company will be able to collect and submit new data to achieve approval in the future and certainly several other companies are pursuing approval for other psychedelics for other indications. Most of the public discourse has centered on whether a psychedelic will enter clinical practice with approval for medical use, while this Essay will discuss how that medical use will be described, understood, and implemented. 

Specifically, I am interested in contrasting the legal and ethical ramifications regarding psychedelics as drug therapy versus their use as a part of psychotherapy. This topic is an active area of commercial debate with companies almost literally making “bet the company” assumptions on what the regulatory paradigm will look like.

This Essay, Part of a Symposium on Drug Law for the 21st Century, proceeds as follow. Part I briefly describes how vociferous this debate has become among advocates for the medical use of psychedelics. Part II discusses why this choice matters, legally and ethically. This includes a discussion of the potential FDA approval process for psychedelics, implications for cost and access (including insurance), what it might mean for professionalization and licensure, and the future of supported adult use frameworks we have seen in states like Oregon.

Keywords: psychedelics, FDA, drugs, psychotherapy, REMS, decriminalization