At World Patient Safety Congress Americas 2026, Melissa Landers led a panel exploring how REMS for psychedelic therapies can balance safety, patient access, and operational feasibility.
Risk evaluation and mitigation strategies (REMS) are anticipated across psychedelic products if approved, although FDA will determine each product’s requirements individually. Effective REMS require more than appropriate safety controls. Those controls need to reflect the individual therapy, be supported by evidence and work within real-world care delivery.
Five key considerations emerged from the discussion.
Five insights from “Navigating REMS for Psychedelic Therapies— Balancing Access, Safety, & Operational Feasibility,” a panel held at World Patient Safety Congress Americas 2026
Psychedelics are not a one-size-fits-all category
Risk profiles, treatment models, duration of effect, and anticipated sites of care vary across psychedelic therapies. REMS design should reflect the individual therapy—not impose a single model on an increasingly diverse category.
Training matters more than credentials
People responsible for patient monitoring must be appropriately trained. Where supported by the therapy’s risk profile and evidence, well-designed REMS training can provide a practical foundation for monitoring responsibilities without unnecessarily restrictive credential requirements.
Healthcare setting economics must be considered
Staffing, monitoring duration, and personnel requirements affect the operational and financial viability of treatment delivery, especially when extended monitoring is needed. Clearly defined requirements should reflect real-world care delivery and help establish the resources needed to support it.
Similar requirements should follow similar operational pathways
Healthcare settings should not need materially different processes to achieve essentially the same risk-mitigation objective. Where appropriate, consistent REMS workflows can reduce unnecessary complexity and help settings integrate new therapies into practice.
Forward-looking clinical trials can inform future REMS design
When a REMS is reasonably anticipated, sponsors can consider potential risk-management questions during clinical development. Generating relevant evidence can inform regulatory discussions and support evidence-based positions on managing risks in clinical practice.
The takeaway: The safest REMS is not necessarily the most restrictive. It is the one that achieves the safety objective while working in real-world clinical practice.
About the panel
In October 2026, Melissa Landers led “Navigating REMS for Psychedelic Therapies— Balancing Access, Safety, & Operational Feasibility” with representatives from a manufacturer with an active REMS in mental health, a psychedelic manufacturer with a product in late Phase 3 development, and a healthcare setting offering Spravato treatment and implementing its REMS requirements in real-world practice. Melissa is Vice President of Two Labs Safety Services, where she helps manufacturers navigate REMS strategy, regulatory engagement, and program implementation and operations.
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