Building a Common Risk Evaluation and Mitigation Strategies (REMS) Platform Expert Workshop

June 7, 2016 - 1:00 pm to 4:45 pm

Speakers

Mark McClellan, MD, PhD
Adam Kroetsch, U.S. Food and Drug Administration
Steven Berman, U.S. Food and Drug Administration

Description

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.

On June 7th, the Duke-Margolis Center for Health Policy hosted a half-day expert workshop in support of next steps in this initiative. Stakeholders from across government agencies, standards development organizations, health information technology vendors, health care providers, industry, and pharmacies gathered to consider the necessary data elements and system needs to support information exchange for a specific REMS use case developed by the Agency: Health Care Prescriber Certification. The development and refinement of this use case is intended as the first of many stakeholder collaborations that will inform the platform’s development.

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.