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Plans to Limit Psychedelic Use in Colorado, Australian Medical MDMA & Psilocybin, U.S. Drug Scheduling Reform
Group aims to amend Colorado psychedelic law, Australia approves limited medical use of MDMA & psilocybin, proposals to reform U.S. drug scheduling, mysteries of CO Natural Medicine Advisory Board
Amending Colorado’s Psychedelic Law
While legislators in several states sponsor bills to reduce criminal penalties associated with psychedelics, some groups are advocating for new restrictions. Last month, I wrote about Oregon’s legislative proposal (House Bill 2831) to overturn Measure 110, which partially decriminalized psychedelics and other controlled substances.
I recently learned that some Coloradans are concerned about Proposition 122, the Natural Medicine Health Act, and plans are in motion to amend the Act’s personal use section.
Proposition 122, which voters approved in November, has two main parts. The regulated access section allows adults to consume psilocybin under professional supervision. But before that can happen, a Governor appointed advisory board must help Colorado’s Department of Regulatory Agencies (DORA) create rules for the psilocybin program.
The other part of Proposition 122, the personal use section, reduced criminal penalties associated with five psychedelic substances (and the plants and fungi that contain them). However, a coalition of Colorado stakeholders hopes to amend the personal use section of Proposition 122. It includes an organization called Colorado Counties, Inc. (CCI), the Office of the Attorney General, and various other stakeholders who are working with Colorado’s General Assembly.
Within the General Assembly, efforts to amend Proposition 122 are reportedly being led by Senate President Steve Fenberg and Representative Judy Amabile. On the evening of February 13, 2023, Amabile and Fenberg hosted a town hall meeting in Boulder, CO to discuss their plans to refine the Natural Medicine Health Act (watch the recording here).
According to CCI’s website, the non-profit organization exists to promote interest in the administration of county government. CCI has dozens of corporate members from many different industries, including healthcare, energy, telecommunications, construction, and higher education. High profile examples include Amazon, Xcel Energy, Equifax, and Anthem Blue Cross & Blue Shield.
Eric Bergman, Policy Director at CCI, says the coalition does not aim to overturn voters’ will by eliminating personal possession. Instead, the group plans to introduce clear limits on possession and home cultivation of psychedelics.
Proposition 122 allows people to cultivate or possess psychedelics in amounts necessary to share the substances “within the context of counseling, spiritual guidance, beneficial community-based use and healing, supported use, or related services.” This ambiguous “necessary to share” language was criticized when Proposition 122 was introduced because it leaves people guessing what the actual limits are.
The personal use section tasks law enforcement with determining whether people possess more than the amount “necessary to share.” This lack of clarity could lead to unequal interpretation across the state, at least until courts weigh in on the issue. In the meantime, people could exceed the limit without realizing it.
The coalition seeking to amend Proposition 122 hopes adding clear limits on home cultivation and possession will minimize the diversion of psychedelics to illicit markets and reduce the risk of intoxicated driving.
As written and approved by voters, Proposition 122 prohibits the sale of psychedelics outside the regulated program governed by DORA. It allows home cultivation if substances are stored in locked containers out of reach of minors. Consumption is prohibited in public spaces.
Psychedelic Week reader Jimmy Smrz shared the following video regarding CCI: Dark Money Stealing Psychedelic Medicine in Colorado. Though I have not fully evaluated the video, and do not endorse its contents, I aim to share materials provided by readers whenever possible. If you would like to share something, please comment at the end of an article or on Psychedelic Week’s Twitter account.
Australia Allows Limited Medical Use of MDMA and Psilocybin
On February 3, Australian regulators announced they will allow limited medical use of two psychedelics (if you consider MDMA a psychedelic) starting on July 1. Specifically, approved psychiatrists will be allowed to prescribe MDMA for treating post-traumatic stress disorder and psilocybin for addressing treatment-resistant depression.
Australia’s Therapeutic Goods Administration (TGA) has re-categorized the substances from Schedule 9 (prohibited substances) to Schedule 8 (controlled drugs). This change applies only to formulations administered in healthcare settings by approved physicians.
Psychiatrists hoping to administer MDMA or psilocybin must be approved under the TGA’s Authorized Prescriber Scheme. It remains unclear how difficult it will be for physicians to obtain approval, how the psychedelics will be sourced, and how accessible the therapies will be to patients.
Apart from the potential benefit this change might bring Australian patients, the move has symbolic value for those fighting to increase societal acceptance of psychedelics. Nevertheless, people immediately expressed concerns. Will the Australian program make psychedelics accessible enough? How will the substances be sourced?
These are important questions. But what interests me most are the potential implications of this development for rescheduling psilocybin and MDMA in the United States. Australia’s actions arguable establish a currently accepted medical use for psilocybin and MDMA, which adds to other facts suggesting that Schedule I is an inappropriate category for them.
By definition, substances in Schedule I can have no currently accepted medical use. Once a currently accepted medical use is established, the substances must be rescheduled.
The Controlled Substances Act, which governs the U.S. scheduling system, does not define currently accepted medical use. So, the Drug Enforcement Administration (DEA) created a set of criteria, which was later revised in two federal court cases, Alliance for Cannabis Therapeutics v. DEA and Americans for Safe Access v. DEA.
In Alliance for Cannabis Therapeutics, the court adopted a five-part test for currently accepted medical use. The test requires that a substance’s chemistry is known and reproducible, that there are adequate safety studies, that there are adequate and well-controlled studies proving efficacy, that the drug is accepted by qualified experts, and that the scientific evidence is widely available.
Studies proving safety and efficacy have generally been a significant obstacle for rescheduling psychedelics, as well as their lack of acceptance by qualified experts. However, now that phase 3 trials have been completed for MDMA, and are now underway for psilocybin, there is significant clinical evidence demonstrating their safety and efficacy (Note that FDA approval is not a legal requirement for rescheduling). Moreover, the increasing clinical availability of psilocybin in Canada and Australia (and in several U.S. states) supports a finding that the substance has gained acceptance by qualified experts.
Reforming the U.S. Drug Scheduling System
Speaking of rescheduling, my colleague Carmel Shachar and I recently published an article in Nature Medicine on the U.S. drug scheduling system. We describe Schedule I as a regulatory black hole because once substances are sucked in, they almost never come out. If they do, it’s usually in the form of proprietary formulations developed exclusively with private funding.
Rescheduled formulations become commercially available and can be prescribed, while others, including naturally occurring versions, remain prohibited due to their continued inclusion in Schedule I. Substances get stuck in Schedule I in part due to an asymmetry between the information used to schedule them and the data required to reschedule them. Small amounts of anecdotal information suffice to place a substance in Schedule I, but large amounts of robust data from Phase 2 and Phase 3 clinical trials is arguably required to remove them. Even worse, courts and the DEA seem to substitute the requirements for FDA approval for the requirements for rescheduling even though these processes have different standards and serve different purposes.
We recommend the following:
Requiring more robust scientific evidence to schedule substances in the first place, especially in Schedule I.
Increasing federal funding for research on Schedule I controlled substances.
Taking a broader view of controlled substance scheduling to consider its social impact, including its effects on research and access to life saving medicines. Efforts to place the Southeast Asian plan kratom in Schedule I illustrate the societal risks of scheduling substances too hastily. The challenges of conducting research on marijuana and psychedelics illustrate how scheduling negatively impacts scientific progress and therapeutic innovation.
Mandating periodic review of Schedule I controlled substances, and potentially those in lower schedules, for reclassification.
Educating lawmakers and regulators on the differences between FDA approval and drug rescheduling, emphasizing their distinct purposes and requirements.
Expanding the types of evidence used in rescheduling proceedings to include surveys, case reports, and other forms of real-world data. These kinds of data are often used to place substances in Schedule I but are commonly disregarded when considering whether to rescheduling them.
Colorado’s Mysterious Natural Medicine Advisory Board
Last month, I profiled the members of Colorado’s recently appointed Natural Medicine Advisory Board. This fifteen-member board will advise the Department of Regulatory Agencies (DORA) on rules for the state’s regulated psilocybin program.
After Governor Polis announced his board selections, people expressed surprise that few appointees appeared to have expertise regarding psychedelics. Further, few were known to members of Colorado’s psychedelic advocacy communities.
Last Monday, Chris Walker of Denver’s 5280 Magazine wrote that board appointees were off limits to the media. Conor Cahill, Governor Polis’ press secretary, reportedly told Walker the governor’s office would prohibit press interviews with board members, even after they begin their work, to preserve the board’s integrity.
This exchange makes one wonder how transparent Colorado’s rulemaking process will be. In Oregon, psilocybin board members could speak to the media if they informed the state health authority beforehand. Even then, concerns were frequently raised regarding conflicts of interest and a lack of transparency.
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*The views expressed on Psychedelic Week do not represent the views of POPLAR at the Petrie-Flom Center at Harvard Law School or the Florida State University College of Law. Psychedelic Week is an independent project unaffiliated with these programs and institutions.
Mason Marks, MD, JD is the Florida Bar Health Law Section Professor at the Florida State University College of Law. He is the senior fellow and project lead of the Project on Psychedelics Law and Regulation (POPLAR) at the Petrie-Flom Center at Harvard Law School and an affiliated fellow at the Information Society Project at Yale Law School. Marks teaches drug law, psychedelic law, constitutional law, and administrative law. Before moving to Florida, he served on the Oregon Psilocybin Advisory Board where he chaired its Licensing Subcommittee. Marks has drafted drug policies for state and local lawmakers. His forthcoming book on psychedelic law and politics will be published by Yale University Press. He tweets at @MasonMarksMD and @PsychedelicWeek.