US federal agencies accelerate work on psychedelic therapies, as Europe considers the Biotech Act
A series of federal announcements in the United States yesterday illustrates the rapid pace of change in public policy surrounding psychedelic therapies and mental health innovation.
In a single wave of announcements, several US federal agencies, including the Food and Drug Administration (FDA), Department of Veterans Affairs (VA), Advanced Research Projects Agency for Health (ARPA-H), National Institute on Drug Abuse (NIDA), and Health Resources and Services Administration (HRSA), have publicly expressed support for psychedelics-related research, regulatory preparation, and healthcare system readiness.
The announcements include FDA final guidance for clinical investigations of psychedelic medicines, a public hearing on their potential future therapeutic use, a new collaboration between the VA, HHS, and FDA, federal support for psychedelic research, and a request for input on how healthcare infrastructure should prepare for the possible roll-out of psychedelic therapeutics, if approved (to be released today).
More specifically, US agencies are now exploring how to increase trial participation, train clinicians in preparation for possible approvals, collect and share real-world data on safety, effectiveness, and costs, coordinate research and evidence sharing, develop clinical guidance and educational resources, and support early clinical development and preparation for regulatory review.
This follows the April 2026 Presidential Executive Order accelerating the research, approval, and responsible access to promising mental health treatments, including psychedelics, as well as ARPA-H's recent $100 million mental health moonshot. In November 2025, PAREA called for a European mental health moonshot for precisely this reason: Europe also needs the scale, infrastructure, and regulatory tools to responsibly move promising mental health innovation from research into care.
Psychedelic therapies are no longer a distant scientific possibility; they are becoming a practical policy, regulatory, and health system question. Europe should not wait until therapies are approved elsewhere before asking how they will be evaluated, implemented, and accessed here. Responsible preparation means building regulatory learning, clinician readiness, health data infrastructure, reimbursement pathways, and safe care models in advance.
The European Biotech Act presents one opportunity to do this work. Although the Act is broader than psychedelic therapies, it can help ensure that mental health innovation is part of Europe's competitiveness and health innovation agenda. PAREA has called for mental health to be reflected across the Act's existing tools, including regulatory sandboxes, repurposing and off-patent innovation, strategic mapping, high-impact projects, investment mechanisms, support networks, and data infrastructure.
This could provide Europe with the tools to rigorously evaluate promising treatments for mental health disorders, support responsible innovation, and prepare health systems for safe and equitable access.
