REMS Integration Initiative

In 2011, FDA created the REMS Integration Initiative, designed to evaluate and improve our implementation of Risk Evaluation and Mitigation Strategies (REMS) authorities. The goals of the REMS Integration Initiative include:

developing guidance on how to apply the statutory criteria to determine when a REMS is required
improved standardization and assessment of REMS
improved integration of REMS into the existing and evolving healthcare system

This initiative will incorporate input from stakeholders on issues and challenges associated with the development, implementation and assessment of REMS.

To support the REMS Integration Initiative, the FDA Center for Drug Evaluation and Research REMS Integration Steering Committee (RISC) oversees the activities of three subordinate work groups whose deliverables will fulfill commitments FDA has made under the reauthorized Prescription Drug User Fee Act (PDUFA V).

The Policy Work Group is currently developing a draft guidance to provide more information about how FDA applies the statutory criteria to determine whether a REMS is necessary.
The Design and Standardization Work Group is leading FDA’s efforts to identify best practices to incorporate into REMS design, as well as appropriate ways to standardize REMS tools and integrate REMS into the healthcare delivery system. This group will solicit stakeholder input within the next year and expects to develop a report of its findings.
The Evaluation Work Group is leading FDA’s efforts to develop an evidence-based approach to assessing the effectiveness and burden of REMS. In addition to a June 2012 public workshop on survey methodologies, the Evaluation Work Group will obtain additional stakeholder input and expects to publish a draft guidance on evaluation methodologies.

Guidances

FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary (PDF - 129KB)

Meeting Information

April 14, 2016 Duke Expert Workshop: REMS Patient Counseling - Meeting Information
July 24, 2015 Brookings Expert Workshop: REMS Patient Counseling – Meeting Information
May 18, 2015 Brookings Expert Workshop: REMS Continuing Education – Meeting Information
July 25-26, 2013 Standardizing and Evaluating REMS – Meeting Information [ARCHIVED]
The purpose of this meeting is to obtain input on issues and challenges associated with the standardization and assessment of REMS for drug and biological products.
March 8, 2013 REMS Update for PDUFA Stakeholders - Meeting Minutes (PDF - 68KB)
FDA staff provided an update on the status of the REMS Integration Initiative and progress towards meeting FDA’s PDUFA V REMS commitments.
March 8, 2013 REMS Update for PDUFA Stakeholders - Slides (PDF - 2MB)

This report fulfills FDA’s PDUFA commitment to issue the Agency’s findings regarding REMS standardization and evaluation. The report describes stakeholder engagement achieved in FY 2013 and includes recommendations received from stakeholders through a variety of methods. Stakeholder feedback guided the Agency in selecting four priority projects within areas specified by PDUFA V; detailed project proposals are included in the report.