Time to Break Tradition: Unbundling Psychedelics from Psychotherapy

Abstract:

In the midst of a psychopharmacology crisis, psychedelics have re-emerged as a potential gamechanger for combatting the mental health epidemic. The FDA has granted breakthrough therapy designation to specific development programs including MDMA for PTSD and psilocybin for depression. These programs all involve psychedelic-assisted psychotherapy (PAT), a bundled model that includes preparatory, dosing, and integration sessions with a psychotherapist. By giving breakthrough therapy designation to a bundle of drugs and psychotherapy, the FDA departed from its focus on evaluating drugs alone, and essentially mandated psychotherapy for those seeking psychedelics in a medical setting. This paper questions the default presumption in favor of mandating PAT. While PAT has been the dominant delivery model, we argue that researching and regulating psychedelics as a standalone treatment would be clinically, regulatorily, and ethically preferable. Section I describes the current debate about the necessity of a bundled PAT model. In Section II we critically examine the two primary reasons that PAT is deemed by some to be clinically essential: safety and efficacy. Ultimately, neither reason is sufficient to justify mandatory inclusion of psychotherapy. In Section III we argue that unbundling PAT would be advantageous from a regulatory standpoint. In this section, we review FDA’s prior history and legal authority and discuss how the inclusion of psychotherapy obscures FDA’s authority and creates a situation where PAT is not fully regulatable without the creation of new regulatory regimes. In Section IV, we argue that not requiring PAT is ethically advantageous in that it promotes autonomy, expands access, improves resource allocation, and moves away from unsupported psychedelic exceptionalism. In Section V we briefly outline various policy options in the absence of mandated psychotherapy. In discussing the utility of several models, we propose on-site patient monitoring, rather than PAT, as our recommended minimum level of support.