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History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?
Session Chair(s)
Elaine H Morrato, DrPH, MPH
Founding Dean, Parkinson School of Health Sciences and Public Health
Loyola University Chicago, United States
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks when used in real-world settings. Today, there are approximately 75 active REMS programs. This forum will discuss the evolution of risk management in the U.S. culminating with the inception and implementation of REMS. Presentations by speakers from FDA, industry, and academia will discuss FDA Guidance to Industry; how REMS are being operationalized and integrated into the healthcare system; FDA’s framework for benefit-risk counseling to patients about drug’s with a REMS; and pragmatic approaches from implementation science for informing REMS design and assessment. Interactive audience engagement will occur throughout the forum to stimulate dialogue on implications for advancing risk management science and practice. Discussion questions will include: What areas for further risk management guidance development are you most interested in? and why? What opportunities do you see for further integrating REMS into the healthcare system? What challenges, or barriers, have you experienced when implementing patient-counseling frameworks? How have you overcome them? What ideas do you have for further advancing the science of REMS?
Learning Objective : Describe the evolution of FDA risk management guidance and implementation of REMS over the past decade; Discuss challenges and solutions for operationalizing risk management frameworks and guidance and integrating REMS into the healthcare system; Identify pragmatic scientific approaches for ensuring pre- and post-market continuity in safety management planning and execution.
Speaker(s)
Evolution of Risk Management and FDA’s Regulatory Guidance
Cynthia LaCivita, PharmD
FDA, United States
Director, Division of Risk Management, OMEPRM, OSE, CDER
Opportunities for Integrating REMS into the Healthcare System
Gita Toyserkani, PharmD, MBA
FDA, United States
Associate Director, Research & Strategic Initiatives
The FDA’s New Benefit-Risk Counseling Framework: How Do Manufacturers Operationalize It?
Hilda Wiryawan Chan, MD, PhD, MPH
Amgen, United States
Benefit Risk Management Scientist
Application of Implementation Science for REMS Design and Assessment
Elaine H Morrato, DrPH, MPH
Loyola University Chicago, United States
Founding Dean, Parkinson School of Health Sciences and Public Health
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