In 2023, psychedelics policy became a major issue. Advocates were able to celebrate multiple victories as the drug reform movement expanded beyond marijuana on a local, state, and federal level.
The year was marked by many firsts. There were the historic federal laws mandating clinical trials for psychedelics, the first ever FDA guidance on conducting research with entheogenic drugs, a unique congressional hearing, new psilocybin service openings in Oregon, and an opportunity to legalize MDMA prescriptions, just to name a couple.
What began as a small local decriminalization initiative has rapidly grown into one of the fastest-growing sectors in the modern drug policy reform movement. It’s also notable that this renaissance is increasingly shaped within a bipartisan framework. Republicans are often leading the charge on the issue at state and federal legislatures.
Advocates did experience some setbacks in 2023, including the governor of California vetoing an psychedelics bill that had narrowly passed through the California legislature. The reform coalition grew and matured in 2023, and activists are planning to use this momentum for the New Year.
Here is the list of top psychedelic moments in 2023:
Biden signss defense bill requiring psychedelic clinical trials for military personnel
Late December, President Joe Biden approved the 2024 National Defense Authorization Act. This act included provisions that were championed and supported by GOP House members to fund Department of Defense mandatory clinical trials for active duty service members exploring the therapeutic potential of some psychedelics.
Morgan Luttrell, a former military officer who disclosed earlier this year that his experience of receiving 5-MeO DMT and ibogaine treatment was partly responsible for his advocacy on the issue.
Biden did not comment on the psychedelics component of the NDAA. However, its passage is one of the biggest reforms of the year. It highlights the bipartisan interest to tap into the healing power of entheogenic drugs.
According to the law, DOD must establish a procedure by which servicemen with post-traumatic disorder (PTSD) and traumatic brain injuries can participate in clinical studies involving psilocybin MDMA, ibogaine, and 5-MeO DMT.
DOD must facilitate this process within 180 calendar days after the law’s enactment. The $10 million funding can be used to partner with federal or state agencies as well as with academic institutions in order to conduct clinical trials.
was also added to the House version of a large defense spending bill in this year. It remains to be determined whether it will make it into the final agreement sent to President Obama following the bicameral talks early next year.
The “Validating Independence for State Initiatives on Organic Natural Substances” (VISIONS Act) was sponsored by Reps. Robert Garcia, D-CA and Earl Blumenauer, D-OR. This bill would prevent federal intervention in jurisdictions which legalize psilocybin mushroom.
Blumenauer and Rep. Nancy Mace, (R-SC), filed a bill in March to clarify that the federal “Right to Try,” (RTT), laws allow seriously ill patients to access Schedule I drugs , including marijuana, psychedelics such as psilocybin, and MDMA.
The first ever psychedelic hearing in Congress is held amid new bills
In November, the House Veterans’ Affairs Subcommittee on Health hosted a historic hearing that focused on how substances such as psilocybin or MDMA can help military veterans who are facing mental health issues.
The hearing, entitled “Emerging Therapies – Breakthroughs in Suicide Prevention,” featured a number of witnesses from the scientific and advocacy community as well as VA officials. They spoke about the VA’s work on psychedelics and their expectations for future clinical applications.
Rep. Mariannette Miller-Meeks (R-IA), chair of the subcommittee, said in her opening remarks that “psychedelic-assisted therapy is a groundbreaking clinical procedure that has the potential to transform the way we look at mental health care.”
Rep. Jack Bergman, cofounder of the Congressional Psychedelics Advancing Therapies Caucus , that relaunched in March this year, stated at the hearing that the committee’s goal is to “take down the temperature, get rid the fear-mongering, and get straight into the realistic research, and the outcomes we know that are potentially available.”
FDA releases research guidelines on psychedelics
The FDA published a draft guidance document in June that was the first of its kind. It outlined the “unique considerations” researchers should consider when studying psychedelics . According to the FDA, these drugs show “initial potential” as possible therapies.
This development occurred just two days after a bipartisan group of congressional members filed a bill that would direct the release of this guidance. The 14-page document was released in response to the request.
The FDA said that it published the draft guidance to help outline the challenges involved in designing programs for psychedelic drug research and development, as well as provide information about how to overcome these challenges. The goal is to assist researchers in designing studies that produce interpretable results, which will support future drug applications.
The FDA’s draft guidance “describes the basic considerations that must be taken into account throughout the drug development cycle, including trial conduct and data collection, as well as subject safety, new drug application requirements, and new drug applications.”
Members of Congress from both sides of the aisle praised the new development. They expressed optimism that this would usher in an era for psychedelics research that could help inform future drug developments.
Submit a federal MDMA review application
After extensive clinical trials, a psychedelics drug development company formally requested FDA review an application to to approve MDMA for prescription as a medication to treat PTSD.
MAPS Public Benefit Corporation, which is a non-profit organization, announced that in December it had submitted a new drug application to FDA. The agency was requesting accelerated review because the psychedelics were previously classified as breakthrough therapies.
The Drug Enforcement Administration (DEA), if the NDA were to be approved, would have to reschedule MDMA. It would be the first time in history that a psychedelic was approved as a drug, administered along with psychotherapy or other supportive services.
MAPS reported the results of a Phase 3 trial published in Nature by MAPS , in September. The study found that MDMA significantly reduced PTSD symptoms compared to placebo therapy.
In 2017, FDA designated MDMA as ” breakthrough treatment” on the basis of previous MAPS sponsored trials. The organization claims that findings from 18 of their Phase 2 and Phase 3 clinical trials were the basis for the NDA they submitted to FDA.
First psilocybin service centers open in Oregon, as Colorado prepares for legalization rollout
Since then, hundreds have used the centers. Since then, hundreds of people have used the centers. they are attracting a waiting list of potential participants despite criticism that the services were prohibitively expensive.
After the voters’ approval of its legalization in 2020, the Oregon Health Authority (OHA), moved quickly to implement this psilocybin programme in 2023.
They accepted, for example, the nation’s the first state-licensed facilitators who administer psilocybin in the regulated facilities. Also, a testing lab for the psychedelic was approved. In March, regulators approved the state’s first ever license for a manufacturer of psilocybin.
The implementation of Oregon’s psilocybin program has not been without its hiccups.
The question of local access is a big one, since more than 100 cities in the state have implemented two-year bans that prohibit the establishment of service centers within their jurisdictions.
In Colorado, meanwhile, Gov. Jared Polis (D) has signed a law in May that creates a regulatory framework to legalize psychedelics as part of a voter-approved initiative for 2022. This year, basic legalization provisions were also implemented for adults.
The law establishes policies for “healing centres” where adults over 21 can receive psychedelic treatments. It also tightens rules regarding cultivation and facilitators.
Some supporters of the proposal have expressed a tentative support for the basic framework, while others are strongly opposed to the proposal due to what they see as excessive regulations.
Colorado officials who oversee the state’s psychedelics-legalization program also hosted a series listening sessions earlier this year . This was one of the initial steps towards implementing the regulated access provisions in the voter-approved legalization legislation.
California governor vetoes psychedelics legalization bill
California Gov. Gavin Newsom, (D), disappointed advocates after vetoing Sen. Scott Wiener’s (D) bill which would have legalized the possession of certain psychedelics in limited quantities while promoting a regulated-access framework.
In his veto, the Governor did state that he wanted the legislature to submit a new bill to him next year which would establish guidelines for regulated access to therapeutic psychedelics. He also stated that he was considering a “potential framework” for future decriminalization. He said that he would not sign the bill as it was passed by the Legislature.
He said that California should begin immediately to establish regulated treatment guidelines. These guidelines would include dosing instructions, therapeutic guidelines, rules against exploitation in guided treatments and medical clearance for no underlying psychoses. This bill would criminalize possession before these guidelines are in place. I therefore cannot sign it.
In November, the Senate sponsor announced that along with an Assembly Republican he would be filing a revised bill next year that will focus regulated therapeutic access. In December, Wiener stated that California appeared to be at a “turning point” in psychedelics legislation. He expressed confidence that modified legislation that he is drafting would fare differently when it reaches the governor.
States legislators and advocates promote psychedelics legislation
In 2023, additional reforms to psychedelic policy were implemented in several states.
Arizona
The governor of Arizona, in May, signed into law a budget bill that included provisions for funding research into the potential medical benefits of psilocybin mushroom.
The Arizona Psilocybin Research Advisory Council, which was created under the bill, met for the first meeting in December in order to begin the process of providing grant funding in the millions of dollars to support research.
Massachusetts
In December, Massachusetts activists reported that local election officials across the state had certified they submitted more than enough valid Signatures in order to force a legislative consideration of the psychedelics-legalization initiative.
This measure would establish a framework that allows for a lawful, supervised and controlled access to psychedelics in licensed facilities. The measure would legalize possession and gifting psychedelics like ayahuasca and psilocybin, but would not allow for retail commercial sales.
Massachusetts Gov. Maura Shealey (D), has introduced separate legislation which includes provisions to Create a psychedelics Working Group to Study and Make Recommendations About the Potential Therapeutic Benefits of Substances like Psilocybin or MDMA for Military Veterans.
Minnesota
This year, the governor of Minnesota approved a health bill that included provisions to establish a task force to prepare Minnesota for possible legalization.
The taskforce met for the very first time in November. The task force must submit a report with recommendations and findings on psilocybin MDMA and LSD to the state by January 1, 2025. At least one lawmaker plans to introduce a reform legislation shortly after.
Nevada
In June, Nevada Gov. Joe Lombardo, (R), signed a bill creating a new working group that will study psychedelics. The group will also develop a plan for regulated access to psychedelics.
The measure was introduced with the intention of legalizing psilocybin, promoting research into psychedelics, and encouraging studies on MDMA — , but it has been significantly scaled down in a Senate Committee.
The Psychedelic Medicines Working Group is examining the use of entheogens in “medicinal, therapeutic and improved wellness”. Activists met with the staff of the Governor’s Office to discuss the importance of making timely appointments to allow the group to get started with its work.
Washington State
Washington State Governor Jay Inslee signed a measure into law in May. Jay Inslee, a Democrat, signed into law a measure to encourage research into psilocybin as well as create a pilot program to provide access to psychedelics for mental health treatments.
was introduced earlier in this session and would have legalized psilocybin more broadly, allowing those 21 years old or older to access it under the supervision of licensed facilitators. The Senate committee diluted the bill to include only a taskforce and advisory group that would study the reform.
Rep. Nicole Macri, (D), modestly expanded the now-enacted law with a committee amendement to include the pilot program that allows the University of Washington to provide the psychedelic to military veterans and first-responders for the treatment of Post-traumatic Stress Disorder (PTSD) as well as mood and substance-use disorders.
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In addition to Connecticut, Illinois and Iowa, legislators in New Hampshire, New Mexico, New York as well as North Carolina, Oklahoma, Texas Vermont, Wisconsin, North Carolina have all pushed for reforms of the psychedelics laws this year.
Local decriminalization movement expands
Locally, in many cities in the United States, lawmakers and advocates have taken steps to decriminalize the use of psychedelics. This is a continuation of the localized movement which began in Denver, Colorado, in 2018.
Eureka, Ferndale, Jefferson County and Portland are the jurisdictions which have decriminalized psychedelics in 2023.
Federal court rejects doctor’s push to force DEA psilocybin schedule review as agency proposes two psychedelics ban
A federal appellate panel in December denied a request by attorneys for a Washington State physician to reschedule psilocybin as a controlled substance under the federal Controlled Substances Act.
A three-judge panel of U.S. Court of Appeals, Ninth Circuit has rejected the doctor’s application for a rehearing of a previous court decision which returned the matter back to DEA.
Although the October ruling technically went against DEA the court didn’t send the rescheduling request to FDA for a review as the lawyers for the doctors had requested.
The DEA has re-evaluated its proposal to schedule two psychedelics after abandoning it last year. This is a new battle with advocates and researchers who believe the compounds have therapeutic potential.
In a notice published in the Federal Register in December, DEA again proposed placing 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I of the Controlled Substances Act (CSA).
The DEA will also be looking to increase domestic production of cannabinoids and delta-9 THC for research purposes in the coming year. It will also maintain high levels of psychedelics due to growing scientific interest.
Federal officials encourage research on psychedelics as studies highlight their therapeutic potential
In the past year, there was a new wave of research that showed psychedelics have significant therapeutic potential. This is especially true for mental health conditions like depression and PTSD.
The results of a clinical study published by the American Medical Association in December , for example, “suggest efficacy” and “safety” of psilocybin assisted psychotherapy as a treatment of bipolar disorder II, a mental illness often associated with difficult to treat depressive episodes.
Researchers at Johns Hopkins University (JHU), Ohio State University (OSU) and Unlimited Sciences published research in September showing an link between psilocybin and “persistent reductions” of depression, anxiety, and alcohol abuse, as well as increased emotional regulation, spiritual wellness, and extraversion.
The authors of the study stated that these results “were highly consistent with an increasing body of clinical trials, behavioral pharmacology and epidemiological data about psilocybin.” These data are a valuable window into the current resurgence in public interest in classic psychoactives, and the results of concurrent increases in naturalistic use of psilocybin.
In August , AMA published a separate study showing that major depressives experienced a “clinically significant sustained” reduction in symptoms after only one dose of psilocybin.
A peer-reviewed article published in Nature found that patients with mild to moderate PTSD experienced a reduction in symptoms after treatment with MDMA. These results could lead the FDA to approve the substance as early as next year.
A study published in August showed that administering small doses of MDMA with psilocybin or LSD appeared to reduce feelings like guilt or fear, which are often side effects when consuming magic mushrooms or LSD.
In June, a first-of its-kind analysis revealed novel insights on the mechanisms by which psychedelic assisted therapy helps people who struggle with alcoholism.
The National Institute on Drug Abuse at the federal level has begun soliciting proposals to support a series research initiatives that aim to investigate how psychedelics can be used to treat addiction.
In May, NIDA director Nora Volkow said that new evidence is emerging that psychedelics have “significant potential” to treat certain mental conditions. This topic is of “great interest for researchers .
Bipartisan and bicameral lawmakers in Congress filed an updated version of the bill to streamline federal rescheduling for “breakthrough therapies” such as psilocybin or MDMA to promote drug research and development.
In 2024, expect more psychedelic reforms
Support for psychedelics is growing in 2023 and there’s a bipartisan coalition that wants to build on the progress made. Advocates are in a good position to continue their work in 2019.
The federal policy on psychedelics, including the FDA’s considerations of MDMA as prescription drugs, will be the focus of much attention. Advocates have made it clear they won’t be giving up their local and state efforts to reform, and that California and Massachusetts are of particular interest.
Marijuana sales records, new legalization laws and other top state developments in 2023
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