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When to Start Thinking About Risk Management and How to Prepare for a REMS

Tuesday, April 17, 2023

The reasons for Risk Evaluation and Mitigation Strategy (REMS) development vary based on many factors. Some companies proactively plan if they recognize the potential for a REMS either from experience or based on the similarity of the benefit-risk profile to another product on the market with a REMS. Other companies may develop a REMS in response to feedback from the FDA. This FDA feedback may be provided pre-filing, during application review, or post-product approval with the identification of new safety information.

Regardless of timing, it is important to align internally on proactive or reactive risk management/REMS planning, roles and responsibilities of team members or functional areas, and target milestones. Internal misalignment on these items will lead to wasted time, effort, and budget. For example, the misidentification of internal decision makers or contributors can lead to a rework of risk management strategy or REMS development, especially if the correct team members are not identified until late in the process.

Companies have different appetites for negotiating with the FDA. Some companies choose to propose a REMS that follows the most likely REMS scenario based on precedent, only making slight modifications to account for product-specific details. Other companies take into consideration how they may meet patient safety goals of the available precedents in a way that allows for better access to the product and less burden on stakeholders. This innovation, or challenging the status quo, is an important part of the evolution of REMS. Patient safety is the ultimate goal of any REMS design, but there is no one-size-fits-all approach for how to meet that goal. Through contingency planning, companies can explore options for a going-in position and also plan for the most likely REMS design based on precedents or clinical trial results.

Don’t know where to start? UBC leads workshops and facilitates roundtable discussions to assist companies in aligning on REMS organizational strategy and product-specific plans.

Don’t know when to start? UBC supports risk management strategy throughout the lifecycle of a product. This includes REMS and contingency planning toward the end of Phase III development prior to NDA/BLA filing, during application review, and after product approval; REMS modifications; and requests for REMS release.

UBC is a leading provider of risk management and REMS services. Our consultation, design, and implementation aim to reduce stakeholder burden, minimize barriers to access, and ensure product safety and value. You can learn more about our services here, or contact us here to discuss your safety and risk management needs with one of our experts.

About the Author

Rachel Bonfanti, MPH, is a Director, Risk Management & Scientific Consulting. In this role, she collaborates with UBC safety scientists and operational teams in risk management, is part of the REMS Assessment Team, and oversees the project management office services for shared system REMS. Rachel develops strategy and creates REMS, REMS Supporting Documents, REMS tools, and REMS Assessment Reports for both single product and shared system REMS. She supports sponsors in the preparation for and participation in FDA Advisory Committee meetings and other regulatory meetings, supports REMS negotiations, and drafts regulatory communications regarding risk management topics. Most recently Rachel delivered the UBC Partnered Keynote “When to Start REMS Development and How to Create a Contingency Plan” at the 2023 Fierce Pharma Drug Safety Summit.