Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service centers. This Update provides further details on Oregon's nascent state program and new developments in other jurisdictions.
Oregon's Psilocybin Services Act
Psilocybin is a Schedule I psychoactive substance that is illegal at the federal level. Notwithstanding this federal illegality, psilocybin's potential medical uses are being explored in medical research centers, and the substance is currently undergoing phase III clinical trials, having been twice designated by the U.S. Food and Drug Administration (FDA) as a breakthrough therapy.
As part of a series of state initiatives aimed at improving access to mental healthcare, Oregon passed the Psilocybin Services Act (PSA) as a ballot measure in 2020. To access psilocybin pursuant to the PSA, adults must first participate in a preparation session. These preparation sessions are conducted with a licensed facilitator and must be completed before an administration session, where psilocybin is consumed at the psilocybin service center. After the administration session, the client may take part in an optional follow-up session to learn about additional peer support and other resources.
As of the date of this Update, the Oregon Health Authority (OHA) has granted four service center licenses and 23 facilitator licenses.
Colorado's Natural Medicine Health Act
While Oregon was the first state to implement a psilocybin access program, Colorado is following suit with a program of its own. Colorado passed the Natural Medicine Health Act (NMHA) as a ballot measure in 2022, which decriminalized personal use of certain substances (including psilocybin) in the state and called for a regulated program to access these "natural medicines." The Colorado governor has formed a Natural Medicine Advisory Board to advise on the development of the state's regulated access program, which may face issues similar to those of Oregon's program. Colorado's forthcoming regulations to implement the NMHA are expected in 2024.
Other Jurisdictions
In California, legislators are considering a bill (SB 58) that would allow for the facilitated use of psilocybin as well as certain other hallucinogenic substances. The bill has passed the California Senate and is pending in the Assembly.
Other states have also funded research into the potential therapeutic benefits of psilocybin. For example, Texas enacted legislation that requires the study of the therapeutic benefits of psilocybin as well as other psychedelics. Research participants are treated for mental health disorders and other medical conditions, including depression, anxiety, post-traumatic stress disorder (PTSD), bipolar disorder, and chronic pain. As of March 2023, Texas is considering three additional bills that would expand these research efforts. Arizona and Connecticut have also authorized state-funded studies on the therapeutic benefits of psilocybin. Kentucky is considering the same.
Similarly, Washington state recently approved a psilocybin therapy services pilot program. The University of Washington will facilitate a study to explore psilocybin and will focus on first responders and veterans. In addition, a new psilocybin task force will provide a report to the governor by December 1, 2023, detailing, among other things, a review of available clinical information.
Elsewhere, a case in the U.S. Court of Appeals for the Ninth Circuit is set to consider a challenge to the placement of psilocybin in Schedule I. With co-counsel, Perkins Coie represents a Seattle physician and his clinic in an administrative appeal to the denial of a petition to the U.S. Drug Enforcement Administration (DEA) to reschedule psilocybin from Schedule I to Schedule II. The matter will see oral argument in the coming months, and the petitioners' opening brief is available here.
Takeaways
Oregon's nascent psilocybin program is continuing to develop, with the state issuing licenses to four new service centers in recent months. Similarly, Colorado is organizing its own psilocybin access program, and other states are funding studies into the promising therapeutic uses of psilocybin.
Companies looking to comply with any state program regarding psilocybin should pay close attention to developing regulations in this area and note that these programs remain illegal under federal law.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
