What is the purpose of a risk evaluation and mitigation strategy (REMS)?

The primary purpose of a Risk Evaluation and Mitigation Strategy (REMS) is to ensure that the benefits of a drug outweigh its risks. This is particularly important for medications that have significant safety concerns or adverse effects that could potentially harm patients if not properly managed. A REMS is a required strategy that involves a risk management plan developed in conjunction with the FDA. It may include various elements such as medication guides, communication plans for healthcare providers, and restricted distribution or usage protocols.

By implementing a REMS, manufacturers and regulators aim to mitigate risks associated with certain drugs while allowing patients access to therapies that can provide beneficial effects. This process involves careful monitoring and evaluation to ensure ongoing safety and efficacy, balancing the need for innovation in treatment options with patient safety concerns.

Other options, such as increasing drug availability, replacing clinical trials, or enhancing drug marketing, do not align with the foundational goals of a REMS. Increasing drug availability focuses on access rather than risk management, while the REMS does not replace the need for clinical trials, which are essential for establishing safety and efficacy before any risk mitigation strategies are even considered. Lastly, enhancing drug marketing is a commercial objective that is separate from the safety management responsibility emphasized by a REMS.