Food and Drug Administration

The Food and Drug Administration is the institutional threshold between promising psychedelic research and treatments that might be approved for clinical use. In the book, its actions mark a striking reversal: after psychedelic therapy had been pushed out of sanctioned medicine, the agency approved late-stage MDMA trials and designated MDMA a breakthrough therapy, even as the scientific and regulatory fit of experience-based treatment remained unsettled.

Regulation and the problem of evidence

The agency’s significance lies not only in individual approvals but in the standards that govern which treatments can advance. The book places psychedelic research against the rise of the double-blind, placebo-controlled trial as the accepted benchmark for drug testing after the thalidomide scandal. That design is unusually difficult to apply to psychedelics: participants and guides can often tell whether psilocybin or a placebo was given, while the effects of the drug are difficult to separate from expectation, the treatment setting, and the therapists’ presence.

This creates a challenge for conventional evaluation. Psychedelic therapy may work partly by administering an experience, rather than through an effect that can be isolated from its psychological and social context. The book therefore presents regulation as a problem of method as well as permission: evidence must meet prevailing standards, yet those standards may have difficulty capturing the treatment being studied.

From clinical promise to a new trial phase

The return of psychedelic therapy to research did not begin with the agency. The book describes researchers as resuming work interrupted by cultural pressure and rebuilding the evidence under contemporary scientific requirements. Charles Grob’s pilot study of psilocybin for cancer anxiety helped clear a path for larger studies at New York University and Johns Hopkins. Their results drew renewed interest from universities, funders, and the medical establishment, but the trials were small and would need replication at larger scale before the government would consider rescheduling psilocybin and approving the treatment.

The distinction between research authorization and approval for routine treatment is consequential. In 2017, phase-three trials meant multiple sites, hundreds of volunteers, and costs potentially reaching tens of millions of dollars. The book notes that pharmaceutical companies had shown little interest in financing this work: psilocybin is naturally occurring, the LSD patent had long expired, and a treatment that might be used only once offers a different commercial prospect from medication taken every day. Regulatory progress thus depended on more than encouraging early results; it also required the resources and institutional support to complete large studies.

MDMA: a regulatory opening

The clearest agency action in the account concerns MDMA. In 2016, the Food and Drug Administration approved phase-three trials of MDMA-assisted treatment for post-traumatic stress disorder. The following year, it designated MDMA a breakthrough therapy, clearing the way for expedited review. These steps made the agency an active participant in the revival of psychedelic research, not merely a distant authority invoked at the end of clinical development.

At the 2017 Psychedelic Science conference in Oakland, the approval of phase-three trials was presented as evidence that a previously marginal field had moved close to mainstream clinical consideration. Yet the next steps remained conditional: successful results would still have to support regulatory review and, potentially, changes in how the drugs were legally classified. The book treats the agency’s decisions as openings in a longer process, not as proof that psychedelic treatment had already become routine or universally accepted.

The treatment model under review

The regulatory question also concerns what, exactly, is being evaluated. At the conference, former National Institute of Mental Health director Tom Insel praised the approach as psychedelic-assisted psychotherapy rather than the simple administration of a drug, while warning that regulators accustomed to evaluating medicines in isolation might find the paradigm difficult. The distinction matters: a session lasting several hours, often with two therapists present, is not easily represented as a conventional prescription or a single pharmacological variable.

The book sets this emerging clinical model beside competing visions of access. Some researchers and advocates see medical acceptance as a first step toward wider cultural acceptance; others worry that limiting psychedelics to patients and physician-prescribed settings would narrow their possible uses. Whatever model prevails, the author emphasizes the need for well-trained guides and for integrating the experience afterward. The Food and Drug Administration’s place in this debate is therefore both practical and symbolic: its decisions can advance a treatment through the clinical system, while the system itself must reckon with whether an experience-based therapy can be adequately tested and regulated using familiar categories.