In 2011, the Food and Drug Administration (FDA) launched the REMS Integration Initiative with the goal of standardizing Risk Evaluation and Mitigation Strategy (REMS) programs and better integrating them into the healthcare delivery system. The REMS Integration Initiative was built on stakeholder feedback, and leveraged activities such as public meetings, workshops, listening sessions and a pilot program to ensure comprehensive stakeholder representation. We are very grateful to all those who contributed their time and perspectives to this project. FDA has issued various reports and guidances over the course of this initiative describing what we heard and how we responded. A comprehensive list of work completed can be found on our REMS Integration Initiative website.
However, there are a few recent REMS-related publications that we would like to highlight for stakeholders, including the:
- Guidance for Industry: Use of a Drug Master File (DMF) for Shared System REMS Submissions: Use of the DMF is an efficient method for sponsors to coordinate the submission of shared system REMS-related files to FDA.
- Revised Draft Guidance for Industry on Format and Content of a Risk Evaluation and Mitigation Strategy Document: This guidance establishes a new REMS document template, designed to make a REMS document easier to write, review and read.
- REMS and Continuing Education for Health Care Providers: FDA Feasibility Report: This assessment discusses potential scenarios for incorporation of continuing education into REMS programs.
- Framework for Benefit-Risk Counseling of Patients Taking Drugs with REMS: This report is designed to support health care providers who are counseling patients about drugs that require a REMS.
The REMS Integration Initiative ended on September 30th 2017 and is a major milestone in FDA’s drive to improve REMS. However, the end of the REMS Integration Initiative does not mean the end of FDA’s efforts to improve REMS. Feedback is welcomed. Stakeholders interested in providing feedback on the new REMS document template or the use of the DMF should provide comments to the related dockets. In addition, the REMS Platform Standards Initiative is just one example of a new project to continue improving REMS and is a key part of FDA’s mission to make safe and effective therapies available. The REMS Platform comment period will be open indefinitely.