Substance and Protocol: Federalist Regulation of Psychedelic-Assisted Therapy

Logan Fahrenkopf

ABSTRACT

The psychedelic renaissance is here—after decades in darkness, two psychedelic assisted therapies are approaching FDA approval. The therapies combine a high dose of psychedelics with psychotherapy to treat intractable mental illnesses. This modality presents a novel regulatory landscape. Traditionally, FDA regulates drugs while state governments oversee the practice of medicine. Psychedelic-assisted therapy straddles that line; one component (psychedelics) is clearly a drug, while the other (psychotherapy) falls under the practice of medicine. With approval rapidly approaching, it is imperative to delineate which level of government has jurisdiction over each component to promote availability, safety, and efficacy of these treatments.