Psychedelic Frontiers Series – Part 4 | FDA Says No, But the Future Looks Bright: Political Support for Psychedelic Medicine
In Psychedelic Frontiers: Diverse Perspectives on a Mental Health Revolution, FTI Consulting experts embark on a journey to explore the various ways in which psychedelic medicine is perceived across different stakeholder groups, including the research community, medical and mental health providers, and political stakeholders. The series aims to underscore the nuances of communicating about psychedelic medicines with vested parties, especially in regard to the therapeutic potential of these substances amid the growing mental health crisis.
Our first three installments of the series explored the public perception of these substances, perspectives from the scientific community, and provider experiences.[1] [2] [3] Our final installment of this series seeks to understand the rapidly evolving discourse surrounding psychedelics driven by shifting political landscapes. Our series has demonstrated that changing attitudes amongst the scientific, medical, and public spheres indicate a growing interest in the therapeutic potential of psychedelic medicine. Regardless of this interest, the recent FDA rejection of MDMA-based treatment for PTSD suggests that there is still much to be done to transition psychedelics from stigmatized substances to trusted therapy.[4] Nuanced communications strategies are central to a successful transition and are of critical importance in shaping perceptions of psychedelic medicine on Capitol Hill.
Old Policies with Lasting Impacts
Psychedelic substances have had a complex history, characterized by periods of both acceptance and prohibition. In the 40s and 50s, psychedelics like LSD and psilocybin were explored for their therapeutic potential, but by the late 1960s, a backlash driven by political and social factors resulting in their criminalization.[5] The Controlled Substances Act of 1970 in the United States classified psychedelics as Schedule I drugs, deeming them to have a high potential for abuse and no accepted medical use.[6] This legislation set the tone for global policies, effectively halting research and pushing these substances into the shadows for decades.
While there has been positive momentum toward acceptance and integration of psychedelic medicine into clinical practice, the FDA’s decision to reject MDMA-assisted therapy for PTSD suggests that while progress has been made, there is still much work to be done to improve clinical trial procedures and stakeholder engagement. Regardless of this setback, research into psychedelic therapies continues marching ahead, with lawmakers and scientists alike touting their therapeutic benefits, particularly for mental health conditions like PTSD, depression, and anxiety.[7] These champions are essential for the long-term success of emerging medicines and convincing regulators to look past historic stigmas and instead look towards the robust potential of these therapies to dramatically improve the lives of Americans struggling with mental health and neurodegenerative conditions.[8]
State Legislation: Trends in Psychedelic Policy Reform
Early movers and pioneers in this space, Oregon and Colorado, have made significant strides in the field of psychedelic legislation. In 2020, Oregon became the first state to legalize the therapeutic use of psilocybin, setting up a regulated framework for supervised sessions.[9] This landmark legislation reflects a broader trend toward public health approaches to psychedelic use, including harm prevention measures. Of note, Oregon has recently pulled back on its decriminalization effort in response to rising crime and rates of opioid use,[10] most notably by introducing legislation walking back broader decriminalization and barring the use of psychedelics for nonclinical purposes.[11] This decision, while impactful to recreational markets, has little impact on the wider use of psychedelics in clinical healthcare, given that clinical use is still permitted and the regulatory decisions governing emerging medicines are made at the federal level. This decision may even contribute to the expedited integration of alternative therapies into traditional healthcare by clearly staking out support for psychedelics as regulated medicine rather than recreational substances.
Colorado followed suit, legalizing the personal use of certain psychedelics, including psilocybin, DMT, and mescaline. This initiative also established a path for licensed healing centers where individuals can access psychedelic-assisted therapy. These states’ pioneering efforts have not only influenced local policy but have also served as models for other states considering similar reforms.
Beyond Oregon and Colorado, a wave of psychedelic-related legislation is sweeping across the nation. According to Psychedelic Alpha’s data,[12] more than a dozen states have introduced bills aimed at decriminalizing or legalizing psychedelics, particularly psilocybin. This includes states like California, where SB 58 sought to decriminalize the personal use of psychedelics, and New York, where A6065 proposed a legal framework for psilocybin therapy. [13] [14] While several of these legislative initiatives have been stalled or vetoed, the frequency and support behind this proposal demonstrates a keen interest to champion psychedelic therapies amongst certain state lawmakers.
The trend is not limited to the coasts; states like Texas, traditionally more skeptical of alternative therapies and emerging medicines, are also exploring the health benefits of psychedelics. Texas passed HB 1802 in 2021, which mandates a study on the use of psilocybin for veterans with PTSD, signaling a bipartisan interest in the therapeutic applications of these substances.[15]
Drivers of Reform
Several factors are driving this state-level legislative activity. First, there is growing public support for drug policy reform, influenced by increased awareness of the national mental health crisis and the limitations of existing treatments.[16] Psychedelics are increasingly seen as promising alternatives, particularly for conditions like PTSD, depression, and anxiety.
Second, the success of cannabis legalization has paved the way for broader drug policy discussions. Many of the states leading the charge on psychedelics have already seen the economic and social benefits of legalizing cannabis use, which has created a more favorable environment for psychedelic reforms.[17]
Finally, the influence of grassroots advocacy must be considered. Organizations like the Oregon Psilocybin Society and New Approach Colorado have successfully lobbied for state-level reforms, providing the financial backing, strategic guidance, and legislative support necessary to enact substantive policy changes related to psychedelic medicine.[18] [19]
Takeaways
Despite the progress, there are challenges ahead. State legislators must navigate a complex web of federal regulations, public safety concerns, and cultural sensitivities. The recent FDA decision to decline to approve MDMA-assisted therapy for PTSD and the related controversy surrounding psychedelic research necessitates additional engagement with political, regulatory, and scientific stakeholders. The FDA decision emphasizes the critical need for robust regulatory frameworks to guide the trials and research central to the broader adoption of emerging psychedelic medicines.
Moreover, as states move forward with reforms, the importance of communication becomes paramount. Policymakers, treatment developers, and advocates must work together to ensure that the public is informed, that risks are appropriately communicated and that cultural sensitivities are respected. This approach will help build and maintain public trust while advancing the psychedelic conversation toward a clinically integrated future.
Related Insights
Related Expertise
[1] Will Stone, “FDA gives thumbs down to MDMA for now, demanding further research”, NPR (August 9 ,2024), https://www.npr.org/sections/shots-health-news/2024/08/09/nx-s1-5068634/mdma-therapy-fda-decision-ptsd-psychedelic-treatment
[2] Kenneth W. Tupper, Evan Wood, Richard Yensen, and Matthew W. Johnson, “Psychedelic medicine: a re-emerging therapeutic paradigm,” Canadian Medical Association Journal (October 6, 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4592297/#:~:text=In%20clinical%20research%20settings%20around,posttraumatic%20stress%20disorder%20(PTSD)
[3] Julie Carney, Michael Adeyanju, Ethan Lutz, Annika Chauhan, “Psychedelic Frontiers Series – Part 1 | Rebellion to Remedy: The Changing Public Face of Psychedelic Medicine”, FTI Consulting (May 30, 2024), https://fticommunications.com/psychedelic-frontiers-diverse-perspectives-on-a-mental-health-revolution-part-1
[4] Julie Carney, Michael Adeyanju, Ethan Lutz, Annika Chauhan, “Psychedelic Frontiers Series – Part 2 | How Scientists Navigate Regulatory Storms to Advance Psychedelic Research,” FTI Consulting (June 25, 2024), https://fticommunications.com/psychedelic-frontiers-diverse-perspectives-on-a-mental-health-revolution-part-2
[5] Julie Carney, Michael Adeyanju, Ethan Lutz, Annika Chauhan, “Psychedelic Frontiers Series – Part 3 | Psychedelic Healers: The Importance of Provider Involvement for Psychedelic Clinical Integration,” FTI Consulting (August 1, 2024), https://fticommunications.com/psychedelic-frontiers-series-part-3-psychedelic-healers-the-importance-of-provider-involvement-for-psychedelic-clinical-integration/
[6] “Law and Politics,” UC Berkeley Center for the Science of Psychedelics (n.d.)
https://psychedelics.berkeley.edu/law/
[7] Andrew Jacobs, “Veterans and Lawmakers Lobby in Bipartisan Push for MDMA Therapy”, The New York Times (August 8, 2024), https://www.nytimes.com/2024/08/08/health/fda-mdma-therapy.html
[8] Eric Weiner, “Congress May Have a Vision for Psychedelic Regulation in the US,” Health Law Advisor (October 10, 2023)
https://www.healthlawadvisor.com/congress-may-have-a-vision-for-psychedelic-regulation-in-the-us
[9] Zoe Cormier, “Psilocybin Treatment for Mental Health Gets Legal Framework”, Scientific American (December 1, 2020), https://www.scientificamerican.com/article/psilocybin-treatment-for-mental-health-gets-legal-framework/
[10] Oshan Jarow, “Psychedelics are about to become a casualty of Oregon’s opioid crisis”, Vox (March 16, 2024), https://www.vox.com/future-perfect/24102102/psychedelics-oregon-opioid-crisis-decriminalization-war-drugs-fentanyl-house-bill-4002
[11] Ben Botkin, Julia Shumway, and Lynne Terry, “Gov. Kotek signing expansive drug addiction bill while reviewing other proposals”, Oregon Capital Chronicle (March 8, 2024), https://oregoncapitalchronicle.com/2024/03/08/gov-kotek-signing-expansive-drug-addiction-bill-while-reviewing-other-proposals/
[12] “Psychedelic Legalization & Decriminalization Tracker,” Psychedelic Alpha (March 14, 2024)
https://psychedelicalpha.com/data/psychedelic-laws
[13] Anabel Sosa, “Newsom vetoes bill to decriminalize ‘magic mushrooms’ and other psychedelics in California,” The Los Angeles Times (October 7, 2023), https://www.latimes.com/california/story/2023-10-07/gavin-newsom-psychedelics-magic-mushrooms-sb-58-veto-drugs-california
[14] “Bill A.6065A – 2021-2022 Regular Session,” The New York State Senate (March 8, 2021), https://legislation.nysenate.gov/pdf/bills/2021/A6065A
[15] Jessica Gonzalez, “Texas bill paves way for study of psychedelic drugs to treat conditions like PTSD”, KFOX14 (March 1, 2022), https://kfoxtv.com/news/local/texas-bill-paves-way-for-study-of-psychedelics-drugs-to-treat-conditions-like-ptsd
[16] Gianna Melillo, “Nearly half of U.S. adults support legalizing some psychedelics for mental health treatment”, The Hill (October 25, 2022), https://thehill.com/changing-america/well-being/mental-health/3703454-nearly-half-of-u-s-adults-support-legalizing-some-psychedelics-for-mental-health-treatment/
[17] Katherine Schaeffer, “9 facts about Americans and marijuana,” Pew Research Center (April 10, 2024), https://www.pewresearch.org/short-reads/2024/04/10/facts-about-marijuana/
[18] Lizzy Acker, “Timeline of Oregon’s legal psilocybin program”, The Oregonian (August 6, 2024), https://www.oregonlive.com/health/2023/12/timeline-of-oregons-legal-psilocybin-program.html
[19] Gregory Ferenstein, “A glimpse into Colorado’s emerging legal pyschedelics scene”, The Reason Foundation (July 10, 2024), https://reason.org/commentary/a-glimpse-into-colorados-emerging-legal-psychedelics-scene/#:~:text=In%20Colorado%2C%20New%20Approach’s%20psychedelics,legalizing%20the%20possession%20of%20psychedelics
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