A Multi-Modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

A systematic, multi-method study describes a framework for evaluating how FDA Risk Evaluation and Mitigation Strategy (REMS) programs have operated in practice, incorporating insurance claims analyses of drug use and patient outcomes, physician and patient surveys and interviews, and assessments of risk communication effectiveness. The research aims to address the current lack of evidence on REMS program impacts on informed decision-making, medication access, and patient outcomes, with the goal of generating actionable recommendations for program improvement.