Vicente LLP Psychedelics & Emerging Therapies Update: October 2023
Oct 26, 2023
State Updates & Insights
Coming into the sixth month of work, Colorado’s regulated natural medicine program is starting to take shape. Answers to big-picture questions – such as what the scope of practice for a licensed facilitator is, and whether Indigenous practitioners can be compensated under the ceremonial use exemption – have begun to emerge from the collective consciousness of the Board and the broader psychedelic community. The subcommittees are meeting with experts and integrating their knowledge. With rulemaking set to begin in early 2024, the NMAB seems to be on track for its first major deadline – presenting initial draft recommendations on October 20, 2023. Their suggestions will take a range of forms, from best practices to proposed regulatory rules and recommendations of new legislation to the General Assembly. Read Bulletin #4 to learn more about what happened last month.
- View the Colorado Natural Medicine Health Act Tracker
- View Colorado Natural Medicine Advisory Bulletin #1
- View Colorado Natural Medicine Advisory Bulletin #2
- View Colorado Natural Medicine Advisory Bulletin #3
One of the most significant structural changes SB23-290 made to the original Natural Medicine Health Act was the creation of the Natural Medicine Division (“NMD”) within the Colorado Department of Revenue (“DOR”). While the training and licensing of Facilitators remains within the purview of the Division of Professions and Occupations within DORA, the newly-created NMD will oversee all other aspects of the regulated natural medicine program.
As part of the pre-rulemaking process, the NMD began holding “Listening Sessions” in October to gather information from the public at large. The October sessions consisted of five, one-hour, online meetings focused on specific topics announced in advance. Unlike meetings of the NMAB, public attendees of listening sessions are welcome to share their opinions and information and ask questions. Read a summary of each listening session in this article from Vicente LLP and Psychedelic Alpha.
Join the Movement to Support Safe, Equitable Access to Psychedelic Medicines in Colorado
Healing Advocacy Fund Colorado (HAF) exists to support safe, equitable and effective implementation of the Natural Medicine Health Act, with the hope that Colorado can serve as a model for thoughtful and ethical reform. Grounded in values of safety, inclusivity, equity and responsibility, the organization intends to foster opportunities for community participation as this implementation journey unfolds.
- Sign up for HAF’s newsletter for news, updates, events and research around the implementation of the NMHA
- Interested in being a part of the Proposition 122 Implementation Coalition? Fill out this brief survey from HAF
- Donate to HAF. Your charitable donation supports safe, equitable access to psilocybin therapy for those who need it.
Gov. Newsom recently vetoed a bill that would have legalized the personal possession and use of some psychedelics including “magic mushrooms” in California. In his veto, Gov. Newsome said, “California should immediately begin work to set up regulated treatment guidelines -replete with dosing information, therapeutic guidelines, rules to prevent against exploitation during guided treatments, and medical clearance of no underlying psychoses.” Read more.
Eureka, California Passes Resolution to Deprioritize Law Enforcement of Psychedelic Plants and Fungi
Eureka’s City Council recently announced its adoption of a resolution effectively deprioritizing state law enforcement for adult personal use, cultivation and possession of psychedelic plants and fungi. The measure approved on October 17 specifically decriminalizes possession, planting, cultivating, purchasing, transporting, distributing and engaging in practices with entheogenic plants and fungi, or their extracted compounds on the federal Schedule I status. Read more.
Portland, Maine’s city council recently voted 6-3 to pass a resolution deprioritizing prosecution for possession of psychedelic plants, like mushrooms. The move does not decriminalize psychedelics, but sets official city policy to put those crimes at the lowest priority for prosecution. Read more.
Federal Updates & Insights
FDA Releases Warning to Patients and Healthcare Providers About Potential Risks Associated with Compounded Ketamine Products for the Treatment of Psychiatric Disorders
FDA recently released guidance related to the potential risks associated with the at-home use of compounded ketamine products, including oral formulations, for the treatment of psychiatric disorders. Patients and healthcare providers should be aware that the FDA has identified potential safety concerns and the FDA encourages compounders, patients, and healthcare providers to report adverse events associated with compounded ketamine products to FDA’s MedWatch Adverse Event Reporting program.
Federal Court Hears Case Challenging DEA Decision To Deny Psilocybin Rescheduling Petition Without Consulting Health Officials
Since at least 2020, Dr. Sunil Aggarwal has been working to find a way to legally obtain psilocybin for patients in palliative care. Last week, a federal appeals court panel heard arguments in the case Aggarwal v. DEA, 22-1718, which is the doctor’s challenge to the denial of the formal petition he filed with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA). Read about the recent case in this article.
The hearing of the House Veterans Affairs’ Subcommittee on Health was set to be the first time federal lawmakers ever convened a formal hearing primarily to discuss how entheogenic substances such as psilocybin and MDMA could help address an epidemic of veteran suicides. It’s not clear when the rescheduled event will take place. Read more.
An Iowa church that offered ceremonial ayahuasca to its members has standing to sue the IRS for tax-exempt status, psychedelic plant advocacy groups told the US Court of Appeals for the D.C. Circuit. The Chacruna Institute for Psychedelic Plant Medicines and the Sacred Plant Alliance filed an amicus brief in support of the church’s rights.
The Study of Psychedelics in Society and Culture will approach the field from a range of humanistic and social scientific viewpoints including law, policy, ethics, religion and spirituality, the nature of consciousness, and art and literature.
Roland Griffiths, an internationally revered researcher of psychedelic and mood-altering drugs, whose research helped kickstart a new era of psychedelic study and led to the creation of the nation's first psychedelic research center, at Johns Hopkins, died on Monday, Oct. 16, at age 77. Read about Roland and his contributions to the field.
Read this New York Times article, which features a Marine Corps veteran's experience receiving services in Oregon. This article came to fruition with the help of the Healing Advocacy Fund.
Support the Cause!
Non-profit organizations Reason for Hope and the Veteran Mental Health Leadership Coalition (VMHLC) are leading a coordinated federal and state advocacy strategy to accelerate access to psychedelic "Breakthrough Therapies" for suicide prevention, specifically for the treatment of PTSD, treatment-resistant depression, and major depressive disorder. These organizations are supporting the BTA. One way you can support the cause is by donating to Reason for Hope or VMHLC.
October 21 | Psychedelic Missouri Freedom Conference
Joshua Kappel recently spoke on the panel “Decriminalizing & Commercializing Psychedelics” at the Psychedelic Missouri Freedom Conference in St. Louis.
October 31 – November 2 | Inc. 5000 Conference & Gala
The Inc. 5000 Conference & Gala, the most prestigious event in entrepreneurship, is coming to San Antonio Oct. 31 – Nov 2, 2023 and features many A-list speakers and renowned business experts. On the second day of the conference, Vicente founding partner Joshua Kappel will speak on a dynamic panel focused on the future of psychedelics and how those substances can help entrepreneurs.
November 9 – 11 | Wonderland
Presented by Microdose, Wonderland is coming to Miami November 9-11, 2023 and Vicente partner Shawn Hauser will be there! Shawn’s panel on Nov. 9 will focus on psychedelics in Oregon and Colorado, and will discuss these historic votes, how the states are implementing the laws, what services will look like, and who will have access.
Save 20% on your ticket by registering with this link: wonderlandconference.com/speaker/Shawn-Hauser?coupon-code=SHAWNH20