Insights from the FDA’s Meeting on Standardizing and Evaluating REMS

This week the Food and Drug Administration (FDA) is holding a meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) to obtain input on issues and challenges associated with the standardization and assessment of REMS for drug and biologic products. UBC will have a strong presence at this meeting, providing key insights and experience. We believe that the REMS program significantly supports patient care and safety.  The additional safeguards involved have allowed for the approval of drugs that might otherwise have not been approved.  And, the program has undoubtedly prevented many patient adverse events. As we work with the FDA over the next few days, we’ll be driving influence and speaking from a position of unmatched experience.  UBC has supported more Risk Management programs than any other company.  UBC also has contributed to every Single Shared System REMS. The figure below highlights some of our experience in REMS Design and Evaluation. In addition, UBC partners with Express Scripts specialty pharmacy, Accredo, which dispenses 81 REMS drugs (of the 88 REMS drugs on the market.) At this week’s meeting, the FDA will be identifying high-quality projects that could offer the FDA and stakeholders the opportunity to develop, test, and implement new approaches to standardizing REMS and integrating them into the healthcare system.  We anticipate an informative meeting, and we look forward to engaging with the FDA and others, including prescribers, healthcare providers, patients, and manufacturers to ensure the highest levels of patient safety. Source :  http://www.ubc.com/blog/insights-fdas-meeting-standardizing-and-evaluating-rems