What is a primary focus of the Risk Evaluation and Mitigation Strategy (REMS)?

The primary focus of the Risk Evaluation and Mitigation Strategy (REMS) is to mitigate risks associated with certain medications. REMS is a drug safety program required by the FDA for specific medications that have significant safety issues. It aims to ensure that the benefits of a drug outweigh its risks, particularly for medications that have the potential for serious adverse effects or misuse.

By implementing REMS, such as patient monitoring requirements, medication guides, and communication plans, the program actively seeks to minimize risks and enhance patient safety. This may involve ensuring that patients receive proper education about the medications, but the overarching goal is specifically about reducing harm from these medications. The emphasis is less on enhancing drug sales, facilitating drug approvals, or solely focusing on patient education, although those aspects may play a role in the broader context of medication safety and efficacy.