By Andrew Yazwa, John West, Lindsay Crampton and Jemma Contreras
The U.S. Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program is relatively recent, dating back to passage of the Food and Drug Administration Amendments Act (FDAAA) in 2007. But it has been very active, and REMS programs have evolved substantially in both scope and complexity since then. Approximately 80 REMS (including shared REMS) programs were in place as of April 2019.
Implementing and managing a REMS program takes a distinct set of skills and expertise. Manufacturers often struggle, however, to find an organizational “home” for those responsible for administering these programs, whose roles are often spread across pharmacovigilance, drug safety and regulatory affairs functions. Furthermore, those charged with overseeing and administering REMS programs within sponsor companies often have limited direct REMS experience or REMS-specific training. When looking externally for talent, sponsors run into the same problem, encountering difficulty finding and hiring experienced REMS professionals, especially those with experience in overseeing the implementation of shared REMS programs.
Read how to better prepare associates for their REMS managerial and supporting roles, and ways to bring greater awareness to REMS program design, implementation and assessment as a specialized discipline.