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Past Event

Risk evaluation and mitigation strategies (REMS): Building a framework for effective patient counseling on medication risks and benefits

Under the Food and Drug Administration Amendments Act (FDAAA) of 2007, the FDA has the authority to require pharmaceutical manufacturers to develop Risk Evaluation and Mitigation Strategies (REMS) for drugs or biologics that carry serious potential or known risks. Since that time, the REMS program has become an important tool in ensuring that riskier drugs are used safely, and it has allowed FDA to facilitate access to a host of drugs that may not otherwise have been approved. However, concerns have arisen regarding the effects of REMS programs on patient access to products, as well as the undue burden that the requirements place on the health care system. In response to these concerns, FDA has initiated reform efforts aimed at improving the standardization, assessment, and integration of REMS within the health care system. As part of this broader initiative, the agency is pursuing four priority projects, one of which focuses on improving provider-patient benefit-risk counseling for drugs that have a REMS attached.

Under a cooperative agreement with FDA, the Center for Health Policy at Brookings held an expert workshop on July 24 titled, “Risk Evaluation and Mitigation Strategies (REMS): Building a Framework for Effective Patient Counseling on Medication Risks and Benefits”. This workshop was the first in a series of convening activities that will seek input from stakeholders across academia, industry, health systems, and patient advocacy groups, among others. Through these activities, Brookings and FDA will further develop and refine an evidence-based framework of best practices and principles that can be used to inform the development and effective use of REMS tools and processes.

Agenda

Welcome and introduction

Introduction to the REMS integration initiative

C

Claudia Manzo

Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration

Patient benefit-risk counseling in REMS

R

Reema Mehta

Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration

G

Gary Slatko

Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration

Session I: Principles and best practices for effective patient benefit-risk counseling and shared decision-making

N

Nananda Col

Principal - Shared Decision Making Resources

B

Betsy Sleath

Distinguished Professor and Chair of the Division of Pharmaceutical Outcomes and Policy - UNC Eshelman School of Pharmacy

H

Holly Witteman

Assistant Professor, Faculty of Medicine - Université Laval

M

Michael Wolf

Professor of Medicine, Feinberg School of Medicine - Northwestern University

Session II: Translating best practices into a benefit-risk counseling framework: Key challenges and facilitators

P

Paul Han

Director of the Center for Outcomes Research and Evaluation - Maine Medical Center Research Institute

R

Reema Mehta

Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration

T

Theo Raynor

Professor of Pharmacy Practice - University of Leeds

G

Gary Slatko

Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration

P

Pamela Williamson

Senior Vice President of Global Regulatory Affairs and Patient Safety - Alexion Pharmaceuticals

Session III: Translating best practices into a benefit-risk counseling framework (Cont.)

P

Paul Han

Director of the Center for Outcomes Research and Evaluation - Maine Medical Center Research Institute

R

Reema Mehta

Acting Deputy Director, Division of Risk Management - U.S. Food and Drug Administration

T

Theo Raynor

Professor of Pharmacy Practice - University of Leeds

G

Gary Slatko

Associate Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration

P

Pamela Williamson

Senior Vice President of Global Regulatory Affairs and Patient Safety - Alexion Pharmaceuticals

Session IV: Applying best practices to the design and implementation of a benefit-risk counseling support tool(s) in REMS

G

Gary Appio

Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation

G

Geri Baumblatt

Executive Director of Patient Engagement - Emmi Solutions

N

Nilay Shah

Associate Professor of Health Services Research - Mayo Clinic

Next Steps

G

Gary Appio

Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation

G

Geri Baumblatt

Executive Director of Patient Engagement - Emmi Solutions

N

Nilay Shah

Associate Professor of Health Services Research - Mayo Clinic

Closing remarks

G

Gary Appio

Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation

G

Geri Baumblatt

Executive Director of Patient Engagement - Emmi Solutions

N

Nilay Shah

Associate Professor of Health Services Research - Mayo Clinic

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