A summary of where we have been, where we are, and where we’re going with psychedelics in the U.S.
Psychedelics, put simply, refers to a class of psychoactive substances that produce changes in sensory perception, processing, and mood. Common examples of psychedelic compounds include psilocybin (i.e., magic mushrooms), lysergic acid diethylamide (i.e., acid or LSD), peyote, mescaline, and dimethyltryptamine (DMT). Although initial research on psychedelics demonstrated promising potential to alleviate an array of psychological, spiritual, and health ailments, psychedelics were criminalized in the U.S. in the early 1970’s.
Nixon signed the Controlled Substances Act in 1970, classifying psychedelics as schedule I substances, meaning the compounds are considered to have no accepted medical use and a high potential for abuse. Narrow exemptions exist for specific psychedelics to be used in religious contexts, such as the sacramental use of peyote, but for most intents and purposes psychedelics remain federally illegal.
Despite decades of prohibition, psychedelic policy reform has taken off over the past five years. In the United States, at least 28 municipalities have passed local decriminalization (i.e., deprioritization of law enforcement) measures, two states have adopted regulated access models for psilocybin, at least initially, and a sprinkling of states have begun to consider decriminalization for small amounts of certain psychedelics or have enacted reduced penalty statutes applicable to limited, personal use. In 2023 alone, eight localities passed decriminalization initiatives and at least a dozen states introduced psychedelics-focused legislation. Several states have also adopted laws requiring the establishment of working groups to study the potential medical uses of psychedelics and/or have designated funds for academic institutions and other organizations to engage in psychedelic research. For example, Arizona, Minnesota, Nevada, and Washington all passed legislation establishing committees to study psychedelics further in 2023. In other states, proposed legislation continues to face resistance and has been unsuccessful.
At the federal level, the Multidisciplinary Association for Psychedelic Studies (MAPS) continues to spearhead clinical research. MAPS has investigated ibogaine to treat opiate dependence, LSD for improving anxiety surrounding life threatening illness, and most notably MDMA in treating patients with PTSD. MAPS completed its second phase-three clinical trial on MDMA-assisted therapy as a treatment for PTSD and applied for FDA approval of a new drug application (NDA) in December 2023. On February 9, 2024, MAPS PBC (now Lykos Therapeutics) announced that the FDA accepted its NDA and granted priority review. Lykos anticipates that it will receive FDA drug approval as soon as August 2024. Aside from Lykos, there are currently over 200 clinical trials underway involving the study of specific psychedelic compounds, with most in phase II. Phase II determines the effectiveness of a substance for a specific condition in roughly 100 to 300 participants. Although no psychedelic compounds have received FDA approval for use in medical treatment in the United States to-date, MDMA and psilocybin have received breakthrough therapy designations from the FDA for the treatment of PTSD and treatment resistant depression (TRD), respectively.
At the state level, as of February 2024, Oregon and Colorado are the only two states that have enacted legal, controlled access programs regulating psychedelics. In November 2020, Oregon voters approved Measure 109, the “Psilocybin Mushroom Services Program Initiative,” and on January 2, 2023, it began accepting applications for participation in its state legal psilocybin program. Measure 109 authorizes adults twenty-one (21) years of age and older to purchase psilocybin at state-licensed treatment centers for on-site use under the supervision of a state-licensed facilitator. It is estimated that over 700 people have already accessed regulated psilocybin services in Oregon.
In November 2022, Colorado voters approved Proposition 122, the “Natural Medicine Health Act” (NMHA). Colorado’s measure includes both a statewide decriminalization component as well as a framework for regulated access to psilocybin and, eventually, other “natural medicines.” In May 2023, Governor Polis signed Senate Bill 23-290 to implement the NMHA, which took effect on July 1st, 2023. The Department of Regulatory Agencies and Department of Revenue, the regulatory bodies which govern the facilitator program and natural medicine business licenses, respectively, are required to begin accepting application on or before December 31st, 2024. It is expected that both agencies will commence official rulemaking for implementation of the program within the next two months.
Other states are also seeking to establish regulatory programs for psychedelic assisted therapies. On February 5, 2024, Senator Scott Wiener introduced The Regulated Psychedelic-Assisted Therapy Act, HB 1012, in response to Governor Newsom’s rejection of Senate Bill 58. The Natural Psychedelic Substances Act may also appear on the Massachusetts ballot this upcoming election cycle. Legislators in New York and Washington State have also introduced similar legislation, and we can expect to see dozens of similar and related bills introduced throughout the year. 2024 is projected to be a remarkable year for psychedelics policy reform.
If you are interested in understanding more about the legal landscape and the opportunities for participation in this blossoming industry, please email Courtney Barnes at cbarnes@feldmanlegaladvisors.com
