A Call for System Readiness at the FDA Hearing on Sept. 14

As the future of psychedelic therapies approaches an inflection point, mental health leaders call for action on system readiness

National mental health leaders are pushing for evidence-based strategies that support patient safety and access. The hearing precedes an Oct. 5 deadline for comments on the future of psychedelic drugs

WASHINGTON, DC — The Food and Drug Administration held a public hearing on September 14, 2026, on considerations for the potential future therapeutic use of psychedelic drugs, gathering testimony on provider training, patient safety, access, and data standardization ahead of an Oct. 5 public comment deadline. In response, national nonprofit BrainFutures is releasing the following statement from Executive Director Sarah Norman, MPP.

“Today’s hearing confirmed what BrainFutures has long argued: psychedelic care belongs inside our existing health system, not beside it. We heard nurses, social workers, pharmacists, and physicians alike describe how existing licensure and training pathways, such as Columbia’s psychedelic curriculum built into its MSW program, can scale psychedelic therapy without inventing a parallel system. We applaud the FDA for giving a forum to speaker after speaker. They converged on the need for evidence-based training frameworks and clinical guidelines– exactly in line with the professional practice guidelines and core competencies that BrainFutures has been developing.”

The hearing’s goal was to gather public input on access and data standards, provider training, and patient safety, with written comments due Oct 5. The potential approval of the first psychedelic drug could arrive before year’s end, though timing remains uncertain. BrainFutures is highlighting the  need to support a properly trained workforce, evidence-based clinical guidelines, sustainable reimbursement pathways, and other infrastructure for a smooth and responsible rollout. 

“There’s no question as to whether or not psychedelic therapies might become available in clinical settings – we know they will. The question is ‘How do we get ready for them in a responsible, collaborative and patient-centered way?,” said Sarah Norman, MPP, the executive director of BrainFutures. “We need to shore up our systems so the treatments will be delivered safely and effectively and integrated into our broader health care system – not somewhere off to the side of it.” 

BrainFutures is building the scaffolding to integrate psychedelics into our healthcare system, including strategies for coding and reimbursement, professional practice guidelines, and interdisciplinary core competencies for training. The goal is a shared foundation that supports patients entering a system with well-established standards for ethical and competent health care, rather than a parallel system revolving around a single novel treatment. BrainFutures, Mental Health America, National Council for Mental Wellbeing, and Meadows Mental Health Policy Institute previously submitted written comments to HRSA outlining system readiness strategies.

“Health system preparation is crucial. With FDA approval on the horizon, we need to prepare systems and standards that ensure care delivery is  patient-centered and anchored in rigorous science,” said Sarah Norman, MPP, the executive director of BrainFutures. “Every single patient needs and deserves a system built for them and centered on compassionate, safe, and ethical care. Every time, every patient – no exceptions.” 

Our Call to Action

BrainFutures recognizes that no one organization can prepare the health care system alone. That’s why BrainFutures brings together researchers, patients, policymakers, and payers to turn conversation into concrete, consensus-based resources, including practice guidelines and core competencies for provider care teams. A system that waits for approval before preparing risks falling behind, and too many patients can’t afford to wait.

BrainFutures is a national nonprofit that advances adoption of evidence-based innovations in brain health. We translate research into practice, including extensive work on system readiness for psychedelic therapies and other emerging mental health treatments. 

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