Over the past couple of decades, pharmaceutical innovation has provided many new treatments for diseases that previously had limited therapeutic options.
However, some of these specialty treatments have well documented side effects (known as adverse events) that must be carefully managed to prevent potentially life-threatening complications.
To help minimize the risk of potentially dangerous side effects, Congress authorized the U.S. Food and Drug Administration (FDA) to develop the Risk Evaluation and Mitigation Strategies (REMS) program, which requires pharmaceutical companies to design steps to help patients, caregivers, providers, and other stakeholders mitigate risks.
Pharmaceutical companies often have discretion in designating REMS requirements and may implement REMS at their own initiative. While REMS can be a valuable tool to help enhance patient safety, some manufacturers have exploited the program to keep lower-cost generic versions of their products off the market. They have also used REMS to restrict distribution to certain specialty pharmacies under exclusive contract so that their pricing power is maintained.
Full paper: Drug policy 101: FDA risk evaluation and mitigation strategy