The Regulatory Landscape of Psychedelic Medicine
Humans have been harnessing psychedelics for mental, emotional and spiritual healing for hundreds, possibly thousands, of years. Though known to affect sensory perception; increase introspection and self-awareness; alter sense of time; facilitate mystical experiences; and induce a blissful, joyous or euphoric state, psychedelics’ therapeutic potential has only regained respect in mainstream psychiatric circles in recent years. However, a growing body of research supports psychedelics’ promise in the treatment of depression and post-traumatic stress disorder (PTSD), and they are increasingly considered potentially important resources in a pharmaceutical environment that has been slow to find novel solutions for mental health conditions. Consequently, legislative change to allow psychedelic use is blooming across the United States.
In 2019, Denver became the first U.S. jurisdiction to decriminalize the possession of psilocybin, the active component in magic mushrooms. And as of June 2022, communities across the country—including Washington, DC, several Boston suburbs, Seattle, Washington and others—have decriminalized at least some psychedelics. But most of these policies do not focus on psychedelic therapy. Rather, they stop at decriminalization, meaning they allow people to possess and use small amounts of psychedelics but have not built a system for legal therapeutic consumption. As the evidence supporting psychedelic medicine grows and media coverage of their benefits proliferates, more and more Americans may turn to them to improve mental well-being. As this happens, legislators seeking to support therapeutic psychedelic use will need to consider how regulation can ensure patients have access to safe products and services that are of consistent, evidence-based quality.
Oregon: A Case in Point
Fortunately, U.S. jurisdictions interested in launching regulated therapeutic psychedelic markets do have one educational example: In 2020, Oregon not only decriminalized psychedelics alongside a slew of other substances (Measure 110) but also created a system for the legal use of psilocybin to treat mental health disorders (Measure 109).
Measure 109 requires that clients undergo a preparation session with a “psilocybin service facilitator” before being allowed to purchase, possess and consume psilocybin at “psilocybin service centers.” And while Oregon is still developing its systems for regulating medical psilocybin, the bill establishes the Oregon Health Authority as the primary licensing and regulatory body for psilocybin manufacturing, transport, delivery, sale and purchase as well as for providing psilocybin-related services.
The state already has some precedent for regulating health care delivery systems, from emergency medical services to complementary and alternative medicine (CAM), such as naturopathic medicine. But there are several areas where the regulation of psilocybin will require forging new territory.
First, state policymakers will need to address challenges to establishing a medical framework around psilocybin provision: Specifically, psilocybin remains illegal and thus unregulated at the federal level. Psilocybin and other classic psychedelics are designated as Schedule I substances according to the Controlled Substances Act, implying they have a high potential for abuse and no medical use. Furthermore, psilocybin is not approved by the Food and Drug Administration (FDA) to treat any medical condition and has only recently been granted “breakthrough therapy” status. In contrast, most CAM therapeutics are generally both legal in the United States and at least somewhat regulated by the FDA. This means that state health authorities can lean on federal regulators to ensure that medicines on the market are at a minimum safe and, in the best case scenario, clinically effective. Because psilocybin service centers are a foundational aspect of this legislation, the Oregon Health Authority will be tasked with ensuring patients have a safe, consistent supply of psilocybin. This will mean developing proper dosing recommendations, establishing quality-control standards and even building a robust in-state supply chain.
In addition, Oregon must develop a regulatory framework for the therapeutic programs in which psilocybin will be used. The state will have to establish guidelines designating the types of practitioners that can provide psychedelic treatments and the specialized qualifications that will be required to do so. This work is not outside the purview of the Oregon Health Authority, but best practices for the treatment of mental health disorders with psilocybin are still in development. Furthermore, most clinical trials follow a similar protocol for treatment, but the time-intensive and highly specific standard regimen may not translate well to a community setting. These barriers may exacerbate concerns about ensuring equitable access to this novel treatment.
Finally, the setting in which clients receive psilocybin-assisted treatment can affect access, intervention success and client safety. As such, Oregon may need to establish building codes to ensure that psilocybin service centers provide an optimal environment for treatment or create funding mechanisms to support programs in areas that have traditionally lacked sufficient mental health resources. However, because the ideal setting remains poorly defined and may look different for different clients, the state will need to balance flexibility with the provision of quality-control standards.
Given the growing body of promising evidence for psychedelics’ efficacy in treating select psychiatric conditions, it is no surprise that lawmakers and the public are taking note. But any state or smaller community that opts to create a legal system for the therapeutic use of the substances will face the challenges discussed above. Fortunately, one state offered to be the guinea pig. Going forward, others must look to Oregon for lessons about overcoming the current federal policy environment and fledgling state of the science on best practices for psychedelic medicine.