FDA

The FDA appears in the history of psychedelic research as both gatekeeper and, at moments, an unexpected source of institutional encouragement. Its authority shaped who could study LSD and psilocybin, under what conditions, and which questions investigators could pursue. The pattern is not a simple progression from prohibition to acceptance: permissions enabled early experiments, regulatory standards complicated their methods, and a sweeping 1966 intervention closed most American programs. Decades later, the agency’s response to promising cancer-trial results helped redirect research toward depression, while leaving the larger questions of evidence, medicalization, and public use unresolved.

Authority and Early Research

Before 1962, researchers commonly took investigational drugs themselves. The practice reflected an ethical expectation that a clinician should understand the effects of a substance before giving it to patients. Congress’s 1962 law gave the FDA authority to regulate new investigational drugs, changing the institutional setting in which such work could proceed. The book places that change against an earlier period when researchers’ own experiences with LSD were part of how they tried to understand its effects and the patients they treated.

Al Hubbard’s work shows how access to research authorization could intersect with the informal networks that moved psychedelic practice across institutions. After obtaining a large supply of LSD from Sandoz, Hubbard became the exclusive distributor of the drug in Canada and later secured an Investigational New Drug permit from the FDA for clinical research in the United States. The account emphasizes the contrast between the permit and Hubbard’s conventional qualifications: he had a third-grade education, a criminal record, and a PhD reportedly purchased from a diploma mill. His access did not arise from a standard academic career, but from his connections, persistence, and position within a network of researchers and therapists.

A later authorized project grew from a different institutional arrangement. In 1961, Myron Stolaroff left Ampex to pursue psychedelic research full-time and, with Willis Harman, established the International Foundation for Advanced Study in Menlo Park. The foundation sought to investigate whether LSD could enhance personality and creativity, rather than limiting research to treatment of illness. It hired psychiatrist Charles Savage as medical director, psychologist James Fadiman, and Don Allen, who left Ampex to become a screener and guide. With an FDA drug-research permit and supplies of LSD and mescaline obtained through Hubbard, the foundation processed about 350 people over six years. Its permit made a program focused on healthy participants possible, even as the purpose of that work tested the boundary between clinical research and personal development.

Standards, Methods, and Professional Boundaries

The agency’s regulatory role formed part of a broader argument about what counted as scientific evidence. The rise of the double-blind, placebo-controlled trial as the drug-testing “gold standard,” following the thalidomide scandal, created a methodological challenge for psychedelic research. Participants and guides could often tell whether psilocybin had been administered, making effective blinding difficult. Researchers also had to contend with set and setting: the surrounding environment, the therapist’s presence, and volunteers’ expectations could not easily be separated from the drug’s effects. A regulatory framework built around isolating variables thus encountered a treatment whose effects appeared inseparable from the circumstances of its administration.

The difficulty was not only technical. Psychedelic therapy involved a guided, high-dose experience and often drew on spiritual language and practices. That model challenged psychiatric categories that more readily accommodated LSD as a temporary imitation of psychosis or as an adjunct to conventional psychoanalysis. A therapy oriented toward a single intense session, with the possibility of a conversion-like experience, asked investigators to reconsider the customary roles of patient and therapist. Critics objected that researchers who took the drugs themselves risked bias, while researchers with no personal experience could interpret the effects chiefly as psychosis. The regulatory ideal of controlled evidence therefore sat within a dispute over who could credibly interpret psychedelic experience and whether its spiritual dimension belonged inside scientific medicine.

The FDA’s later engagement with research did not remove those problems. Psychedelic trials still raised questions about whether a drug effect could be isolated from therapeutic support or expectation, and whether a treatment described partly as spiritual could be evaluated within ordinary medical categories. Those tensions mattered to the agency’s practical task: decisions about permits and trial pathways also helped determine which forms of psychedelic use could be presented as legitimate investigation. The account treats this as a boundary problem rather than a settled dispute, with scientific rigor, therapeutic context, and institutional credibility all at stake.

The 1966 Shutdown

By the end of 1966, the first major period of psychedelic science had largely collapsed. In April, Sandoz withdrew LSD-25 from circulation amid the controversy surrounding the drug, transferring most of its remaining stocks to the U.S. government. Many of the seventy research programs then underway shut down. The withdrawal of a commercial supply and the subsequent regulatory action together transformed research access: scientific work could no longer rely on the distribution arrangements that had supported it.

In May, Timothy Leary and Sidney Cohen testified at Senate hearings on LSD, attempting to defend research and distinguish legitimate medical use from the black market. Senator Robert F. Kennedy questioned FDA regulators about plans to cancel remaining projects, arguing that useful research should not be lost because of illicit use. The appeal did not change the outcome. In October, roughly sixty researchers across the United States received FDA letters ordering them to stop their work. The agency’s intervention converted a public controversy into an immediate institutional rupture.

The closure of the International Foundation for Advanced Study is rendered through a striking moment of timing. James Fadiman had just dosed four participants in a problem-solving session when the letter revoking the project’s FDA approval arrived. He read it in the next room while the four men were already under the drug’s effects. The staff delayed treating the notice as received until the following day; then the foundation’s program closed, along with virtually every other psychedelic research program underway in the country. The scene makes regulatory authority tangible: a letter arrived not at the abstract beginning of a project, but in the middle of a session, after the participants had been dosed and the work had begun.

One large program continued at the Maryland Psychiatric Research Center at Spring Grove, where research on LSD and psilocybin carried on until 1976. The book notes that the reasons it survived while many others were closed remain uncertain. Former staff members attributed its endurance in part to director Albert Kurland’s strong standing with federal officials and his Washington connections, which helped keep the center operating and obtain LSD, including some from the government. Spring Grove’s continuation shows that the 1966 contraction was severe but not absolute; institutional access and relationships could still matter within the regulatory landscape.

A Cautious Research Revival

In the renewed clinical research of the 2010s, the FDA’s role shifted from terminating projects to considering how promising results might be tested at greater scale. The New York University cancer study and a parallel study at Johns Hopkins found clinically significant reductions in anxiety and depression in about 80 percent of participants, with effects lasting at least six months. The studies were small, involving eighty subjects in all, and their results required replication before they could support rescheduling psilocybin or approval of a treatment. Still, they drew wider interest from the mental health field and helped make psychedelic therapy newly discussable within mainstream institutions.

Early in 2017, Roland Griffiths and Stephen Ross brought their cancer-trial results to the FDA seeking approval for a larger phase 3 trial focused on cancer patients. According to Ross’s account, FDA staff, impressed by the data, asked the researchers to expand their aim and investigate psilocybin as a treatment for depression in the general population. The researchers had concentrated on cancer because they believed it would be easier to obtain permission to study a controlled substance among people already seriously ill or dying. The regulators’ reported response was therefore a consequential reversal of scale: the evidence gathered in a narrowly defined patient group was taken as a reason to investigate a broader and more pressing problem. The FDA declined to confirm or deny the account, explaining that it does not comment on drugs under development or regulatory review.

The request did not amount to proof of efficacy or approval of treatment. The book stresses that the cancer studies were small and that promising signals should not be mistaken for definitive evidence of a cure. Nor did the agency’s interest settle how a treatment combining a drug, psychological support, and a potentially spiritual experience should be tested. Its response marked a reopening of the research path, not an end to the debates about blinding, causation, or the role of therapeutic context.

The Limits of Medical Acceptance

The FDA’s actions illuminate the difference between permitting research and deciding what psychedelic use should mean. In the early period, authorized projects included Hubbard’s clinical work and the International Foundation for Advanced Study’s investigation of creativity among people described as healthy. After the 1966 closures, the research agenda that returned was framed more cautiously through clinical indications, measurable outcomes, and staged trials. That shift offered a route back into medicine, but it also raised the possibility that legitimate use would be defined primarily as treatment for illness.

Researchers and advocates in the book disagree about whether medicalization should be the final destination. Bob Jesse worries that treating medical acceptance as the only legitimate pathway would be a mistake; Rick Doblin favors broader legalization, while Katherine MacLean and Jesse imagine more controlled forms of access. These positions do not describe FDA policy, but they reveal the cultural stakes attached to the agency’s regulatory decisions. Permission to test a treatment can lend credibility to a field, yet it cannot by itself resolve whether the experience should remain confined to clinical care, or how people should be supported before and after it.

The FDA’s place in this history is consequently neither that of a mere bureaucratic obstacle nor that of a guarantor of therapeutic truth. Its authority could open a research route, set demanding evidentiary conditions, or close projects at a moment when participants were already in session. In the revival, the agency’s reported encouragement to broaden inquiry suggested that regulatory judgment could also help widen the questions researchers were allowed to ask. Across those changing roles, psychedelic science remains a test of how medicine evaluates an experience whose effects depend not only on a molecule, but also on the human and institutional setting in which it is encountered.