REMS Modernization Can't Wait: A Call to Action

By Andrew Yazwa, Kristin Phelps, Lindsay Crampton and Jemma Contreras

It has been more than a decade since the Food and Drug Administration Amendments Act (FDAAA) was signed into law in September 2007. The Actenabled the FDA to mandate Risk Evaluation and Mitigation Strategy (REMS) programs for products that are approved but require specific steps be taken to assure safe use. Since then, REMS programs have evolved in both scope and complexity but the use of new technologies to relieve the burden a REMS can place on prescribers, pharmacists, other healthcare providers (HCPs) and/or patients has not kept pace.

Read more about the current state of REMS implementation today — what’s working and what’s not — and where to go from here to optimize the success of REMS by more effectively balancing risk mitigation with stakeholder burden.