Part 1 of this dissertation analyzes the historical development and current status of
the regulation of medical research with psychedelic drugs and marijuana. The analysis is
based on interviews with current and former government officials, review of published and
unpublished documents, and on-going discussions with all known researchers who have
filed applications within the previous fifteen years seeking permission to conduct any
human studies with psychedelics, or studies with marijuana in patient populations. A
special analysis is made of the creation in 1989 and dissolution in 1995 of FDA's Pilot
Drug Evaluation Staff, an extraordinary bureaucratic experiment that, among its many other
accomplishments, established FDA's current policy of evaluating psychedelic and
marijuana protocols with the same standards FDA uses for the review of all other studies.
Part 2 analyzes regulatory, ethical and methodological issues involved in the design of the Phase III studies that FDA requires to evaluate the safety and efficacy of the medical uses of psychedelics and marijuana. The standard of proof that FDA uses to evaluate data about other drugs, comparison to placebo, is determined to be optimal for the review of data about psychedelics and marijuana. A two-arm protocol design comparing psychedelic psychotherapy against psychotherapy alone is concluded to be "adequate and well-controlled." Taking into account political considerations, a four-arm study is proposed comparing three groups receiving high, medium or sub-threshold (placebo) doses of psychedelic psychotherapy with an unblinded group receiving the best alternative treatment. The economic implications of this enhanced design are determined not to impose an excessive burden on research sponsors.
Part 3 is an exercise in policy design for the regulation of the hypothetical prescription use of psychedelic psychotherapy. The legal basis for FDA's authority to impose special restrictions is reviewed, as is the regulation of thalidomide, methadone, GHB, and electroconvulsive therapy. The proposed system restricts prescribing authority to specially-licensed and trained psychiatrists working within clinical settings meeting minimum standards. Distribution is directly to psychiatrists through the mail from one centralized production and distribution facility. A national registry of patients is proposed to track all treatment sessions.