Report Responds to Congressional Request for Information on Regulatory, Ethical, and Cultural Considerations for Integrating Prescription Psychedelic Medicine into the United States
Washington, DC — The Congressional Psychedelics Advancing Therapies (PATH) Caucus released a report capturing responses to a 2024 Request for Information into how psychedelic-assisted therapy (PAT) could be safely and ethically integrated into the United States health care system.
The report found broad consensus among clinicians, researchers, veteran advocates, Tribal leaders, payors, regulators, and patients that PAT could offer safe, equitable, and evidence-based treatment for a wide array of treatment-resistant conditions – including generalized anxiety disorder, depression, PTSD, and substance use disorder. It also offered several federal policy recommendations for the U.S. Food and Drug Administration (FDA) and Congress to consider as they aim to improve health outcomes for patients across the country.
“Every day, more than 130 Americans die by suicide, including over 20 veterans,” said Congressman Lou Correa (D-CA-46). “Psychedelic-assisted therapy has shown promising results for treatment, but we need more information. This report is a serious step toward bringing it into our health care system safely and ethically, so that all Americans, especially those who served our country, can get care that works for them.”
“This report is exactly the kind of resource Congress needs to legislate responsibly,” ?said?Congressman Jack Bergman (R-MI-01).?“Our Veterans have waited long enough for successful treatments and breakthrough therapies to help mitigate PTSD and other service-related conditions. It’s time to advance real, actionable policies that meet the unmet mental and physical health needs of Americans in every community.”?
Key Findings
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Respondents agree that the U.S. faces a severe mental and behavioral health crisis – including treatment-resistant depression, PTSD, suicidality, substance use disorder, and high unmet needs among veterans, terminally ill patients, minorities, low-income families, seniors, and rural communities – requiring novel and efficacious treatments.
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Respondents highlight clinical trial evidence suggesting that PAT can produce meaningful and sometimes transformative improvements in PTSD, depression, end-of-life distress, addiction, and overall functioning and quality of life, though it is not considered a single solution and is seen as appropriate only in structured, supervised medical settings.
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Respondents encourage national guidance and credential verification systems to be developed before the first FDA approvals of prescription psychedelic medicines.
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Respondents highlight the need for evidence-based, standardized adverse event monitoring and robust ethical guidelines to protect patients and ensure trust.
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Respondents recommend federal guidance that supports multidisciplinary, culturally competent care teams.
Policy Recommendations
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The report suggests that federal agencies – including the FDA, U.S. National Institutes of Health, Substance Abuse and Mental Health Services Administration, Department of Homeland Security, Department of Veterans Affairs, Department of Defense, Drug Enforcement Administration, and Office of National Drug Control Policy –
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should work with state regulators and Tribal Nations/Territories to develop national guidelines for safe and ethical delivery of prescription psychedelic medicines
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The report recommends that federal agencies establish flexible, tiered credentialing pathways to balance safety with accessibility, and to standardize consent and screening protocols nationally.
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The report proposes a hybrid policy framework to guide Congress, federal agencies, Tribal Nations/Territories, states, and communities in a balanced, pragmatic rollout of PAT, supported by coordinated leadership, flexible regulation, investment in workforce and infrastructure, and robust long-term data systems.
See here for the full report.
About the Congressional PATH Caucus
The bipartisan Congressional Psychedelics Advancing Therapies (PATH) Caucus, co-chaired by Representatives Jack Bergman (R-MI) and Lou Correa (D-CA), aims to address the nation’s mental health crisis by promoting rigorous, FDA-aligned clinical research into the therapeutic potential of psychedelic-assisted treatments for mental health disorders and integrating these promising treatments into the U.S. health care system for millions of patients with unmet needs.