Regulatory challenges involved in developing psychedelic-assisted psychotherapy through the FDA/EMA process
My talk will focus on the regulatory challenges involved in developing psychedelic-assisted psychotherapy through the FDA/EMA process. Issues to be discussed will be the initial reasons behind the strategy of working through the FDA/EMA process, the rationale for why MAPS is prioritizing MDMA as the psychedelic and PTSD as the clinical condition to move first into Phase 3 trials, standardizing the therapeutic method with treatment manual and adherence criteria, how we approached the double-blind issue, the importance of an outcome measure that is administered by Independent Raters and the procedure we’ll use to minimize bias, how we reached out to the Department of Defense and Department of Veterans Affairs National Center for PTSD, the issue of the FDA’s Risk Evaluation and Mitigation System (REMS) to regulate MDMA-assisted psychotherapy post-approval, and the FDA’s data exclusivity program and MAPS’ sustainability plan through our MAPS Public Benefit Corporation.
Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). He received his doctorate in Public Policy from Harvard’s Kennedy School of Government, where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his Master’s thesis on a survey of oncologists about smoked marijuana vs. the oral THC pill in nausea control for cancer patients. His undergraduate thesis at New College of Florida was a 25-year follow-up to the classic Good Friday Experiment, which evaluated the potential of psychedelic drugs to catalyze religious experiences. He also conducted a thirty-four year follow-up study to Timothy Leary’s Concord Prison Experiment. Rick studied with Dr. Stanislav Grof and was among the first to be certified as a Holotropic Breathwork practitioner. His professional goal is to help develop legal contexts for the beneficial uses of psychedelics and marijuana, primarily as prescription medicines but also for personal growth for otherwise healthy people, and eventually to become a legally licensed psychedelic therapist. He founded MAPS in 1986, and currently resides in Boston with his wife and one of three children (two in college).