Waiting for a Miracle: Medical Psilocybin and Mdma under 'Right to Try'

For individuals with life-threatening, potentially incurable illnesses, surviving each day is itself a victory and simultaneously an increased chance they will live to see new, novel, potentially life-saving treatments. Unfortunately for these people, Mick Jagger’s oft chanted refrain does not ring true: time is not on their side. There exists an auspicious, and often tantalizingly elusive, period where new treatments show efficacy but remain unapproved for general use. Patients’ rights advocates have fought for—and won—new laws and regulations expanding treatment access for those most in need. “Right to Try” (RTT) laws represent one of these victories. In 2014, Colorado became the first state to pass RTT legislation. In short, RTT laws provide severely ill patients a statutory avenue permitting access to medicines in the Food and Drug Administration’s (FDA) phased trial process. Operating alongside a nearly identical FDA program called “Expanded Access,” RTT creates a “right” to access investigational drugs outside of an ongoing clinical trial. Like “Expanded Access,” RTT’s design, and limitations, single out individuals who are suffering from a life-threatening or serious illness, and who have exhausted alternative treatment options. Since 2014, forty-one state RTT laws have been enacted. In 2018, President Donald Trump signed into law the federal RTT Act, creating a national route to access experimental medicines. Roughly ten years ago, after a generation of dormancy, research institutions began applying for new authorizations to investigate substances once considered among the most promising tools in psychotherapy: psilocybin and 3,4-Methelyenedioxymethamphetamine (MDMA). Both compounds saw widespread clinical use during the 1960s, 1970s, and 1980s. Both were effectively barred from any continued study and use when each was placed on Schedule I of the Controlled Substances Act (CSA). In the psychedelic medicine renaissance of the 2010s, both psilocybin and MDMA have demonstrated unprecedented and unparalleled success treating stubborn, pervasive psychological disorders that currently contribute to the American mental health crisis: Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Each substance is currently at a different stage of FDA clinical trials, and each for a different disorder: MDMA in Phase III for PTSD, and psilocybin in Phase II for MDD. A number of hurdles remain before these safe and efficacious treatments can be widely accessed. Longstanding, and problematic, legal inconsistencies account for many of these hurdles. Despite each substance having proven safety for human consumption, and no known toxicity, they both remain on the CSA’s Schedule I: reserved for substances deemed unsafe for human consumption under medical supervision. Though both substances have received national and international attention for their treatment efficacy—leading to popular ballot referendums and legislation to decriminalize these compounds on local and state levels —both remain among the most restricted substances. Most researchers and advocates have been content to wait out the long FDA trial process for rescheduling. But this process is not exclusively bound by science, and the American mental health crisis can ill afford slow-walking safe and effective treatments. This Note proposes that RTT statutes are a suitable legal avenue ensuring substances like psilocybin and MDMA reach people who are suffering, both apart from and in conjunction with the standard FDA progression. Determining this requires a comprehensive understanding of both psilocybin and MDMA’s long research histories, as well as substantive and illustrative statutory and case law analysis. Part I reviews the historical benchmarks from over a century of medical psychedelics research. Part II delves into the situationally conflicting provisions contained in the federal RTT Act of 2018 and The CSA of 1970. The RTT Act applicable to medical psilocybin and MDMA, and the CSA simultaneously barring those drugs from medical use. These two statutes, even in the context of controlled substances, are reconcilable: the CSA remaining effective for federal enforcement purposes, and RTT having enough breadth to allow therapeutic access to certain controlled substances, in this case psilocybin and MDMA. Part III analyzes two relevant Supreme Court decisions animating this Note’s fundamental legal argument. The analysis centers on two core issues addressed by the Supreme Court: deference standards for agency statutory and regulatory interpretations when promulgating interpretive rules, and the Constitutional bounds of the CSA when used as a mechanism to override state medical policies. Part IV explains the importance and urgency of the moment, and why there is value in pursuing this path towards therapeutic access. Part V proposes that the State of Vermont has a unique, achievable avenue to advance therapeutic access through modified state RTT legislation. As one of eight states to never pass a RTT law, Vermont is well positioned to introduce this legislation declaring certain treatment resistant psychological disorders “life-threatening” illnesses.