What is the primary purpose of REMS programs?

The primary purpose of Risk Evaluation and Mitigation Strategies (REMS) programs is to ensure that the benefits of a drug outweigh its risks. REMS is a set of safety protocols that the FDA can require for certain medications, particularly those with significant safety concerns. These programs are designed to manage risks associated with the use of specific drugs and to ensure that patients are informed about the risks involved in taking them.

By implementing REMS, the FDA aims to optimize patient safety and promote the appropriate use of medications. This includes ensuring that healthcare providers are educated about the potential risks and proper procedures necessary to prescribe these medications safely, ultimately leading to better patient outcomes.

While it is true that classifying medications by their risk level and providing education about medication interactions can relate to broader safety and efficacy measures, these are not the sole focus of REMS. Furthermore, increasing sales is not a goal of REMS; rather, it is a strategy focused primarily on patient safety.