i2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the private sector, particularly for proponents of their potential medicinal and therapeutic uses.
The Food and Drug Administration issued its first-ever guidance providing considerations for those developing psychedelic drugs for the treatment of medical conditions. The guidance describes basic considerations for the drug development process, including trial conduct, data collection, subject safety and drug application requirements. When publishing the guidance the FDA said that,“[p]sychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders… By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these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 goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”
In December, President Joe Biden signed into law the 2024 National Defense Authorization Act (NDAA) directing the Department of Defense to begin clinical trials exploring the therapeutic potential of certain psychedelics for active-duty military service members. Obtaining federal funding for research with the support of bipartisan lawmakers is a positive indication of what may be to come.
The House Veterans Affairs Subcommittee on Health held a hearing in November that focused on how psychedelics – including psilocybin and MDMA – can aid therapy for veterans facing mental health challenges. This was the first-ever congressional hearing on psychedelics. In her opening remarks, Rep. Marianette Miller-Meeks, a Republican congresswoman for Iowa and chair of the Subcommittee, said “psychedelic-assisted therapy is a groundbreaking clinical procedure that has the potential to transform the way we look at mental health care.” Rep. Julia Brownley, a Democratic congresswoman for California and the panel’s ranking member, made similar statements, saying “we are at the brink of a new era in which [psychedelics]—once stigmatize [sic] and misunderstood-are being examined for their potential to address mental health and addiction challenges.”
Federal courts weighed in as well. The Ninth Circuit kept alive a physician’s petition to reschedule psilocybin from Schedule I to Schedule II.
Momentum also continued at the state and local levels. Oregon opened its “first-of-its-kind legal market” for psilocybin, more widely known as magic mushrooms. The first licensed center opened in Eugene, Oregon, in June and at least 16 more service centers have opened since that time. It’s been reported that hundreds of people have used psilocybin legally in Oregon during that time. Hawaii’s Office of Wellness and Resilience announced the establishment of the Breakthrough Therapies Task Force, aimed at expanding therapeutic access to MDMT and psilocybin. In Colorado, Gov. Jared Polis signed a bill in May to “create a regulatory framework for legal psychedelics” under an initiative approved by voters in 2022. More specifically, the bill sets up regulations for the legalization law that focuses largely on regulations for using psychedelics in licensed healing centers under the guidance of facilitators. There’s been movement in other states as well, including in Arizona, Connecticut, Illinois, Iowa, Missouri, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, New York, North Carolina, Oklahoma, Texas, Vermont, and Wisconsin.
The local jurisdictions of Eureka, California, Ferndale, Minnesota, Jefferson County, Washington, Portland, Maine, and Provincetown, Massachusetts all enacted psychedelic decriminalization laws this year.
It’s not just government that’s interested in psychedelics. We are seeing one of the first opportunities to legalize MDMA as a prescribed medicine. In December, the MAPS Public Benefit Corporation submitted a new drug application (NDA) to the Food and Drug Administration for the use of MDMA-assisted therapy for post-traumatic stress disorder. If the NDA is approved, the DEA would then need to reschedule MDMA accordingly. If that happens, MDMA would be the first true psychedelic to obtain FDA approval. Some sources say FDA approval could be obtained in late 2024.
And the MAPS Public Benefit Corporation isn’t the only group that pushed forward with research, believing that psychedelics hold significant therapeutic potential. The American Medical Association published the results of a clinical trial this year that “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder.” A separate study by the same group “showed that people with major depression experience clinically significant sustained reduction in their symptoms after just one dose.” Researchers from Johns Hopkins, Ohio State University and Unlimited Findings likewise published the results of a study that they say demonstrates “persisting reductions” in depression, anxiety, and alcohol misuse, as well as “increases in emotional regulation, spiritual wellbeing and extraversion” with the use of psilocybin. This is just a sampling of the many studies that published research this year.
It’s not all roses for industry advocates though. While proponents of the industry were excited about the bill passed by the California legislature to decriminalize possession of “naturally occurring psychedelics,” Gov. Gavin Newsom vetoed the bill in October. And there are certainly other detractors. As The New York Times reported, the American Psychiatric Association urged caution, saying that treatments should be limited to research studies for the time being. The DEA is trying again to ban two psychedelics — 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC). The next trip around the sun will certainly encounter similar roadblocks.
Public opinion continues to be in favor of the use of psychedelic therapy for therapeutic and medicinal uses, though. And the mental health crisis facing our country is not going anywhere. As reported by USA Today, “[n]early 50,000 people died by suicide in 2022 and 5.8 million emergency department visits were linked to mental, behavioral, and neurodevelopmental disorders in 2021.” While the data for 2023 has not been released, we doubt there will be much of a change. And we do know there is not enough funding or programming in place to combat the growing crisis. In the face of this landscape, we expect the momentum in favor of the psychedelic industry to continue – particularly as it relates to the push to use psychedelics for medicinal uses. We also think the industry will continue to see decriminalization at the local level and more widespread access in states that led the charge on cannabis, such as Colorado and California.
2023 has been somewhat of a “renaissance” for psychedelics – it’s been one “that’s increasingly being shaped under a bipartisan framework, with Republicans frequently leading on the issue in Congress and state legislatures across the country.” Last year was a good one for supporters of psychedelics, and we predict 2024 will be a good trip for the industry, too.
