Building a Common Risk Evaluation and Mitigation Strategies (REMS) Platform Public Meeting


Public Workshop

Building a Common Risk Evaluation and Mitigation Strategies (REMS) Platform Public Meeting

June 7, 2016 — 8:30AM–12:15PM


Gregory Daniel, PhD, MPH
Michele V. Davidson, RPh
Andrew Gettinger, MD
Adam Kroetsch
Marie Link, RPh, PharmD
Mark McClellan, MD, PhD
Gerald McEvoy, PharmD
J.Marc Overhage, MD, PhD
Roger Pinsonneault, RPh
Scott M. Robertson, PharmD, RPh, FHL7
Paul Sheehan
Shelly Spiro, RPh, FASCP
Katie Stabi, PharmD, BCPS
Annette Stemhagen, DrPH, FISPE
Theresa (Terry) Toigo, RPh, MBA
Kelly Wygal


Over the last several years the U.S. Food and Drug Administration (FDA) has pursued a number of initiatives aimed at improving the design, operation, and assessment of REMS programs with the common aim of standardizing and integrating Risk Evaluation and Mitigation Strategies (REMS) into the health care system. The platform will comprise a set of electronic health data standards that REMS may use to operate within the health care system and communicate with participants in a standardized way. This will help facilitate the integration of REMS tools and processes into provider and health system workflows assuring timely patient access to REMS drugs while also reducing the complexity of complying with REMS requirements.

In support of next steps in this effort, and under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy hosted a half-day public event to: 1) present FDA’s vision for a common REMS platform and obtain feedback on those aspects of the platform that are ready for further development, 2) identify existing data standards and partnerships that may be leveraged in order facilitate the development and broader uptake of REMS common data standards, and 3) explore innovative new tools and systems that may be developed under the common REMS platform.

Funding for this conference was made possible in part by a cooperative agreement from the Food and Drug Administration, Center for Drug Evaluation Research. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.