Sep 25

Past Event

Expert Workshop: Strengthening Risk Evaluation and Mitigation Strategies (REMS) Through Systematic Analysis, Standardized Design, and Evidence-Based Assessment

Summary

On Wednesday, September 25, 2013, the Engelberg Center for Health Care Reform at Brookings convened a diverse group of regulated industry, regulators, content area experts, health care providers, and other key stakeholders to explore systems-based approaches to standardizing REMS design, standardized frameworks for REMS tool development and selection, and strategies to assess the effectiveness of REMS. Following the passage of the Food and Drug Administration Amendments Act of 2007, the U.S. Food and Drug Administration (FDA) was authorized to require Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug outweigh its risks. Since the development of the REMS program, concerns have arisen regarding the impact on patient access and undue burden on the health care system. In response, FDA has sought stakeholder feedback and launched initiatives to improve the standardization, assessment, and integration of REMS within the existing and evolving health care system. This workshop presented an opportunity to augment these ongoing efforts by moving towards the adoption of systematic methods to increase the effectiveness of REMS programs and reducing much of the uncertainty and burden on the health care system.

Event Agenda

  • 9:00

    Welcome, Introduction, and Expert Workshop Objectives

  • 9:15

    Broad Goals for Standardizing REMS Design, Tools, and Assessments

    • Gary Slatko

      U.S. Food and Drug Administration

    • Adam Kroetsch

      U.S. Food and Drug Administration

  • Session I: Systematic Approaches for Standardizing REMS Design

    • Moderator

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • James Bagian

      University of Michigan

    • Jeff Fetterman

      ParagonRx LLC

    • Elisabeth Paté-Cornell

      Stanford University

    • Meredith Smith

      AbbVie Pharmaceuticals

  • 11:45

    Lunch

  • 12:45

    Session II: Practical Considerations for Applying Systematic Approaches to the Development of Standardized REMS Tools

    • Moderator

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Ayse Gurses

      Johns Hopkins University

    • Michael Kalsher

      Rensselaer Polytechnic Institute

    • Florence Houn

      Celgene Corporation

    • Raymond Coghlan

      Bristol-Myers Squibb

    • Thomas Menighan

      American Pharmacists Association

  • 2:30

    Break

  • 2:45

    Session III: Potential Mechanisms for Standardizing the Assessment of REMS

    • Moderator

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Elaine Morrato

      University of Colorado

    • Julie Aker

      Concentrics Research

    • Joseph DeRosier

      University of Michigan

  • 3:45

    Closing Remarks and Next Steps

Details

September 25, 2013

9:00 AM - 4:00 PM EDT

The Brookings Institution

1775 Massachusetts Ave., NW

Map

For More Information

Brookings Office of Communications

202.797.6105