Psychedelics policy came sharply into focus in 2023, with advocates chalking multiple wins as the drug policy reform movement’s momentum continued to expand beyond marijuana at the local, state and federal levels.
It was a year defined by firsts: historic federal legislation signed into law mandating psychedelics clinical trials, first-ever Food and Drug Administration (FDA) guidance on conducting research using entheogenic substances, a novel congressional hearing, psilocybin services opening in Oregon and a new opportunity to legalize MDMA as a prescribed medicine, to name a few examples.
What started as a local decriminalization project has quickly become one of the most significant and fast-moving sectors of the modern-day drug policy reform movement. And notably, it’s a renaissance that’s increasingly being shaped under a bipartisan framework, with Republicans frequently leading on the issue in Congress and state legislatures across the country.
For advocates, 2023 did see certain setbacks, such as California’s governor vetoing a psychedelics legalization bill that narrowly advanced through the legislature. But by and large, the year saw the reform coalition expand and mature, gaining steam that activists plan to leverage in the New Year.
Here are the top psychedelics moments of 2023:
Biden signs defense bill that requires psychedelics clinical trials for military
In late December, President Joe Biden signed the 2024 National Defense Authorization Act (NDAA), which contained provisions championed by GOP House lawmakers to fund mandatory Department of Defense (DOD) clinical trials exploring the therapeutic potential of certain psychedelics for active duty military service members.
The push to include the psychedelics language was led by Reps. Dan Crenshaw (R-TX) and Morgan Luttrell (R-TX), a military veteran who had disclosed earlier in the year that his advocacy around the issue is partly informed by his personal experience receiving ibogaine and 5-MeO-DMT treatment in another country.
While Biden didn’t weigh in on the psychedelics components of the NDAA, the bill’s enactment represents one of the most impactful reform achievements of the year, underscoring the bipartisan interest in tapping into the healing potential of entheogenic substances.
Under the legislation, DOD is required to establish a process by which service members with post-traumatic stress disorder (PTSD) or traumatic brain injury could participate in clinical trials involving psilocybin, MDMA, ibogaine and 5-MeO-DMT.
DOD will need to facilitate that process within 180 days of enactment. It can partner with eligible federal or state government agencies, as well as academic institutions to carry out the clinical trials, with $10 million in funding.
A psychedelics reform proposal was also attached to the House version of a large-scale defense spending bill this year, though it remains to be seen whether that will make it in the final deal sent to the president following bicameral negotiations early next year.
Meanwhile, Reps. Robert Garcia (D-CA) and Earl Blumenauer (D-OR) sponsored a bill this year titled the “Validating Independence for State Initiatives on Organic Natural Substances (VISIONS) Act,” which would prohibit federal intervention in jurisdictions that legalize psilocybin mushrooms.
In March, Blumenauer and Rep. Nancy Mace (R-SC) filed a bill to clarify that federal “Right to Try” (RTT) laws give seriously ill patients access to Schedule I drugs, including marijuana and psychedelics like psilocybin and MDMA.
Congressional lawmakers hold first-ever psychedelics hearing amid bill introductions
The House Veterans’ Affairs Subcommittee on Health held a historic hearing in November that centered on how substances like psilocybin and MDMA can aid therapy for military veterans’ facing mental health challenges.
Titled “Emerging Therapies: Breakthroughs in the Battle Against Suicide,” the hearing featured a series of witnesses from the advocacy and scientific community, as well as three VA officials who spoke to the department’s ongoing work on psychedelics research and its expectations for possible future clinical applications for veterans.
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 (R-MI), co-founding member of the Congressional Psychedelics Advancing Therapies (PATH) Caucus that relaunched this past March, said at the hearing that one of the goals of the committee is to “take the temperature down, get rid of the fear-mongering and get right into the realistic research and the outcomes that we know are potentially available.”
FDA releases psychedelics research guidance
In June, FDA released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.
The development came just two days after bipartisan congressional lawmakers filed a bill to direct the issuance of such guidance, indicating that the 14-page draft document’s release was responsive to that request.
“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges,” the agency said. “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
FDA’s draft guidance “describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements.”
Congressional lawmakers from across the aisle cheered the development, expressing optimism that it will help usher in a new era of psychedelics research that could inform future drug development.
Application for federal MDMA review submitted
Following extensive clinical trials, a psychedelics-focused drug development company formally asked FDA to review an application to approve MDMA as a prescription medication for the treatment of PTSD.
The MAPS Public Benefit Corporation announced in December that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.
If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.
MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”
FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.
First psilocybin service centers open in Oregon, as Colorado prepares for legalization rollout
Over the summer, Oregon regulators approved the nation’s first license for a psilocybin service center where people can use the psychedelic in a supervised and facilitated environment. Since then, hundreds have utilized the centers, attracting a long waitlist of prospective participants despite criticism of the services as prohibitively expensive.
The Oregon Health Authority (OHA) moved quickly in 2023 to implement that psilocybin program after voters approved its legalization at the ballot in 2020.
For example, they accepted the nation’s first state-licensed facilitators to administer psilocybin to adults at the regulated facilities, as well as a testing laboratory for the psychedelic. Regulators also approved the first-ever state-issued license for a psilocybin manufacturer in March.
But the implementation of the psilocybin initiative in Oregon hasn’t gone without hiccups.
There’s a major question about local access, for example, as more than 100 cities across the state have enacted two-year moratoriums or bans prohibiting the service centers from being established in their jurisdictions.
In Colorado, meanwhile, Gov. Jared Polis (D) signed a bill in May to create a regulatory framework for legal psychedelics under a 2022 voter-approved initiative. Basic legalization provisions for adults also took effect this year.
The legislation establishes policies on “healing centers” where adults 21 and older will be able to receive psychedelic treatment, tightens up rules on cultivation and facilitators, creates licensing requirements, dictates state agency regulatory responsibilities and imposes penalties for unsanctioned activities.
The proposal has received mixed reactions, with some advocates tentatively supporting the basic framework and others strongly opposing the proposal because of what they consider to be excessive regulations.
Colorado officials who will oversee the state’s legal psychedelics program also hosted a series of listening sessions earlier this year, one of the first steps toward implementing regulated access provisions of the voter-approved legalization law.
California governor vetoes psychedelics legalization bill
California Gov. Gavin Newsom (D) disappointed advocates this year after vetoing a bill from Sen. Scott Wiener (D) that would have legalized possession of limited amounts of certain psychedelics, while promoting the development of a regulated access framework.
In a veto message, the governor did caveat that he wants the legislature to send him a new bill next year establishing guidelines for regulated therapeutic access to psychedelics and also consider a “potential” framework for broader decriminalization in the future. But he said he was unwilling to let the reform as passed by the legislature be enacted with his signature.
“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,” he said. “Unfortunately, this bill would decriminalize possession prior to these guidelines going into place, and I cannot sign it.”
To that end, the Senate sponsor said in November that he will be filing a revised psychedelics bill next year alongside an Assembly Republican that will focus on providing regulated therapeutic access. Wiener said in December that California appears to be at an “inflection point” on psychedelics reform, expressing confidence that the modified legislation he’s drafting will fare differently if it gets to the governor next year.
States lawmakers and advocates advance psychedelics reform
Meanwhile, several other states saw additional psychedelics policy reform advance in 2023.
Arizona
In May, the governor of Arizona signed into law budget legislation that includes provisions to fund research into the medical potential of psilocybin mushrooms for a variety of conditions.
An Arizona Psilocybin Research Advisory Council that was established under the bill met for the first time in December to start the process of providing millions of dollars in grant funding to support the research.
Massachusetts
Massachusetts activists said in December that local election clerks across the state have certified that they turned in more than enough valid signatures to force legislative consideration of a psychedelics legalization initiative before potentially putting the issue on the state’s 2024 ballot.
The measure would create a regulatory framework for lawful and supervised access to psychedelics at licensed facilities. It would also legalize the possession and gifting of psychedelics such as psilocybin and ayahuasca, but it would not otherwise provide for commercial retail sales of the substances.
Meanwhile, Massachusetts Gov. Maura Healey (D) has separately introduced legislation that includes provisions to create a psychedelics working group to study and make recommendations about the potential therapeutic benefits of substances like psilocybin and MDMA for military veterans.
Minnesota
The governor of Minnesota signed a large-scale health policy bill this year that contained provisions to create a psychedelics task force meant to prepare the state for possible legalization.
That task force met for the first time in November. Members must return a final report to the state with findings and recommendations on psilocybin, MDMA and LSD by January 1, 2025, and at least one key lawmaker has said that he plans to file a reform bill shortly thereafter.
Nevada
In June, Nevada Gov. Joe Lombardo (R) signed a bill to create a new working group to study psychedelics and develop a plan to allow regulated access for therapeutic purposes.
As introduced, the measure would have legalized psilocybin and promoted research into the psychedelic, as well as encouraged studies of MDMA—but it was significantly scaled back in a Senate committee.
Members of the Psychedelic Medicines Working Group will examine the use of entheogens “in medicinal, therapeutic, and improved wellness.” Activists recently met with staff at the governor’s office to discuss the need to make timely appointments so that group can get started on its work with enough time to make recommendations by a December 31, 2024 deadline.
Washington State
In May, Washington State Gov. Jay Inslee (D) signed a measure into law to promote research into psilocybin and create a pilot program to provide therapeutic access to the psychedelic for mental health treatment.
As introduced earlier this session, the measure would have more broadly legalized psilocybin, allowing people 21 and older to access the psychedelic under the care of licensed facilitators. But it was significantly watered down at the Senate committee stage to only provide for a task force and advisory group to study the reform.
Rep. Nicole Macri (D) did modestly expand the now-enacted legislation with a committee amendment to add in the pilot program to allow the University of Washington (UW) to provide access to the psychedelic for military veterans and first responders in the treatment of post-traumatic stress disorder (PTSD) and mood and substance use disorders.
Legislators have also pushed for psychedelics reform legislation this year in several other states, including Connecticut, Illinois, Iowa, Missouri, New Hampshire, New Mexico, New York, North Carolina, Oklahoma, Texas, Vermont and Wisconsin.
Local decriminalization movement expands
At the local level, advocates and lawmakers enacted measures to decriminalize psychedelics in a number of cities across the country this year, expanding on the localized movement that started in earnest in Denver in 2018.
The jurisdictions that enacted psychedelics decriminalization in 2023 were: Eureka (CA), Ferndale (MI), Jefferson County (WA), Portland (ME) and Provincetown (MA).
Federal court rejects doctor’s push to force DEA psilocybin scheduling review, as agency again proposes ban on two psychedelics
In December, a federal appellate panel denied a motion by lawyers for a Washington State doctor trying to reschedule psilocybin under the federal Controlled Substances Act (CSA).
In an order, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected the doctor’s request for a rehearing of an earlier court decision that returned the matter to DEA.
While the earlier ruling, in October, technically went against DEA, the court did not send the rescheduling petition to FDA for review, as lawyers for the doctor had requested.
Meanwhile, DEA is taking another shot at banning two psychedelics after abandoning its original scheduling proposal last year, teeing up another fight with researchers and advocates who say the compounds hold 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).
At the same time, DEA is looking to substantially build up domestic production of delta-9 THC and other cannabinoids for research purposes next year, while also maintaining high levels of psychedelics production as scientific interest continues to grow.
Studies highlight therapeutic potential of psychedelics, as federal officials promote research
The year saw another wave of research published indicating that psychedelics hold significant therapeutic potential, particularly as it concerns mental health conditions such as depression and PTSD.
For example, the results of a clinical trial published by the American Medical Association (AMA) in December “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.
In September, meanwhile, researchers at Johns Hopkins University, Ohio State University and Unlimited Sciences published findings showing an association between psilocybin use and “persisting reductions” in depression, anxiety and alcohol misuse—as well as increases in emotional regulation, spiritual wellbeing and extraversion.
Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of that study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.”
A separate study from AMA came out in August showing that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
As for other entheogens, a peer-reviewed study published in the journal Nature recently found that treatment with MDMA reduced symptoms in patients with moderate to severe PTSD—results that position the substance for approval by the Food and Drug Administration (FDA) as soon as next year.
Another study published in August found that administering a small dose of MDMA along with psilocybin or LSD appears to reduce feelings of discomfort like guilt and fear that are sometimes side effects of consuming so-called magic mushrooms or LSD alone.
A first-of-its-kind analysis released in June, meanwhile, offered novel insights into the mechanisms through which psychedelic-assisted therapy appears to help people struggling with alcoholism.
At the federal level, the National Institute on Drug Abuse (NIDA) started soliciting proposals for a series of research initiatives meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.
At a Senate committee hearing in May, NIDA Director Nora Volkow told members that there’s emerging evidence that psychedelics carry “significant potential” as therapeutic treatments for certain mental health conditions, and it’s a topic of “great interest” for researchers.
In March, meanwhile, bipartisan and bicameral congressional lawmakers filed an updated version of a bill to streamline the federal rescheduling of “breakthrough therapies” like psilocybin and MDMA in order to promote research and drug development.
More psychedelics reform expected to come in 2024
With support for psychedelics reform growing meaningfully in 2023, and a wider bipartisan coalition committed to expanding on their progress, advocates are well-positioned to expand on their gains in the new year.
Much attention will focus on federal psychedelics policy, such as FDA’s consideration of MDMA as a prescription drug. But advocates have also made clear that they will not be letting up on local and state reform efforts, with California and Massachusetts being of particular interest to that end. (Full Story)