August 31, 2023 – A coalition of psychedelic-assisted therapy and mental health advocacy organizations has united to provide collective insight on the psychedelic drug and clinical investigation guidance recently issued by the U.S. Food and Drug Administration (FDA). This coalition, led by Reason for Hope, the Veteran Mental Health Leadership Coalition, and BrainFutures, aims to ensure that the FDA’s guidance enables research in the field of psychedelic-assisted therapy to keep participants safe and continue making scientific breakthroughs in the treatment of a wide range of diseases.
The FDA’s draft guidance, Psychedelic Drugs: Considerations for Clinical Investigations, released in June 2023, provides general considerations for drug development programs considering the therapeutic potential of psychedelics for the treatment of psychiatric and substance use disorders. The guidance covers key elements involved in the drug development process, including data collection, trial conduct and design, practitioner qualifications, and subject safety. The release of this draft guidance signals the increasing mainstream recognition of human psychedelic research and demonstrates that the FDA is proactively considering its role in shaping the future of this promising new field.
At present, there are at least 25 recruiting or ongoing studies involving MDMA, 69 involving psilocybin, and 27 with LSD—three of the compounds that are covered by the FDA’s guidance. These numbers, on top of hundreds of other completed studies on these compounds, demonstrate the burgeoning scientific interest in psychedelics and psychedelic-assisted therapy. This interest is kindled by a number of blockbuster studies in recent years that have demonstrated impressive outcomes in the treatment of serious mental health conditions such as treatment-resistant depression, major depressive disorder, PTSD, and alcohol use disorder. At present, psychedelics and psychedelic-assisted therapy are showing promise for treating a wide range of psychiatric and nonpsychiatric disorders, from cluster headaches to eating disorders. However, there is still much work to be done at the frontiers of scientific knowledge about psychedelics, especially as potential treatments for these serious conditions.
The FDA received over 200 public comments from professional organizations, experts, and advocates in the psychedelic-assisted therapy field. Common themes from many of the comments included a desire to expand the list of qualified monitors (practitioners), emphasis on the importance of psychotherapy for both safety and efficacy, and recommendations that the FDA reconsider how it evaluates adverse events and abuse potential in the context of psychedelics by destigmatizing the expected and potentially therapeutic experiential effects that psychedelics occasion.
Amongst these commenters, Reason for Hope, the Veteran Mental Health Leadership Coalition, and BrainFutures, each known for their contributions to the advancement of psychedelic therapies, came together to consolidate recommendations to the FDA for updating their guidance. In addition to providing feedback on safety, efficacy, and public health regulation, the coalition’s comments address issues around the potential medical use of psychedelics outside of psychiatric disorders, as well as misconceptions about the abuse potential of psychedelic drugs.
Retired Marine LtGen Martin R. Steele, Founder and President of the Veteran Mental Health Leadership Coalition and Co-Founder and CEO of Reason for Hope, expressed the importance of this collaborative effort: “Given our nation’s worsening mental health and suicide crises, which disproportionately impact the Veteran community, continued expansion of psychedelic-assisted therapy research is critical for developing innovative treatments that help people in dire need of new options. We hope that the collective expertise of our broad coalition helps the FDA issue a final guidance that best enables safe and effective therapeutic outcomes in both clinical research and practice.”
The coalition’s comments include key signatories from eighteen organizations, including Sunstone Therapies and the Navy SEAL Foundation. The comments were also endorsed by fifteen individual psychedelic-assisted therapy experts, researchers, and practitioners.
“The multitude of organizations supporting our recommendations to the FDA underscores the significance of this cause. This support strengthens our call for regulatory framework that represents the collective expertise of the many people dedicated to advancing psychedelic-assisted therapy,” said David Esselman, Executive Director of BrainFutures.
The comments proposed by this coalition provide evidence-based considerations that may shape the future of psychedelic-assisted therapy research in the United States. By working together, the group aims to advocate for guidance that best reflects the general consensus of experts currently researching and conducting psychedelic-assisted therapies.
“Our comments to the FDA reflect our commitment to ensuring research that translates to safe, effective, and affordable real-world treatments for those suffering from a variety of behavioral health conditions,” said Brett Waters, Esq., Co-founder and Executive Director of Reason for Hope.
To read the coalition’s comments to the FDA and see the full list of signatories, please visit: https://www.regulations.gov/comment/FDA-2023-D-1987-0210
BrainFutures is a national nonprofit organization dedicated to assessing and advancing the practical application of neuroscience research to maximize human potential. Breakthroughs in our understanding of the brain have the potential to improve learning outcomes for children, maintain sharp thinking as we age, optimize functioning at work, and enhance treatment for a mental health or substance use disorders. Since 2015, BrainFutures has provided rigorous analyses of new brain health research to share how advances can positively affect all areas of life. To learn more about BrainFutures, please visit www.brainfutures.org.
BrainFutures Contact: David Esselman
Reason for Hope is a national non-profit organization focused on advancing safe and affordable access to psychedelic therapies to prevent deaths of despair (including suicide and substance overdose) and improve quality of life. Reason for Hope’s work includes educating government officials and various stakeholder groups on the scientific and legal landscape for psychedelic medicine, establishing pilot programs that focus on bridging the gap between research and access to treatment for those most in need, and collaborating with experts to develop and advocate for the policy and legal reforms needed to safely increase access to treatment. Reason for Hope’s co-founders and multi-disciplinary leadership team includes Lieutenant General Martin Steele, USMC (ret), Lynnette Averill, PhD, and Brett Waters, Esq. To learn more about Reason for Hope, please visit https://www.reason-for-hope.org/
Reason for Hope Contact: Brett Waters
The Veteran Mental Health Leadership Coalition (the “Coalition”) is a national member-based Veteran organization that advocates for increased research and safe, affordable access to psychedelic medicine and assisted therapies for Veterans and their family members. The Coalition’s founding members include (but are not limited to) the leadership of various Veteran Service Organizations, researchers, and mental health providers with expertise in psychedelic medicine. The Coalition, alongside its 40+ partner organizations, has successfully advocated for over $12 million in state funding for Veteran-focused research and implementation of psychedelic therapies in the healthcare system. The Coalition is led by retired Marine Lieutenant General Martin Steele, the Chief Executive Officer of Reason for Hope, who in 2015-2016 served on the VA Commission on Care exploring the future of VA healthcare. To learn more about the Veteran Mental Health Leadership Coalition, please visit https://vmhlc.org/
The Veteran Mental Health Leadership Coalition Contact: Lieutenant General Martin Steele