Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration

Introduction

Oram situates the paper in the context of vigorous clinical investigation of LSD in the 1950s and early 1960s, when many psychiatrists explored the drug as an adjunct to psychotherapy and some studies reported promising outcomes (for example, a 1950s Canadian study reported a 50% improvement rate in treatment‑resistant alcoholics). Growing public recreational use of LSD in the mid‑1960s generated political alarm and a sequence of increasingly strict laws culminating in LSD's placement in Schedule I in 1970. Many historians have therefore attributed the near‑cessation of LSD psychotherapy research by the mid‑1970s to punitive federal regulation that effectively shut down legitimate research. This article challenges that standard narrative. Oram examines how the Food and Drug Administration (FDA) implemented the investigational drug (IND) regulations created by the Drug Amendments of 1962 and traces how those administrative rules, together with actions by the drug manufacturer Sandoz and changing norms for pharmaceutical research, altered the landscape for LSD psychotherapy. The paper aims to show that LSD research was not simply prohibited by the federal government; rather, the combination of formalised IND requirements, manufacturer control over proprietary data, and later methodological and funding difficulties better explains the decline in research.