Designing a Safety Risk Management Strategy

All therapeutic drugs involve some element of discomfort, side effects or safety concerns. A drug's full safety profile is often not known at launch and can only be characterized after it has been used by large numbers of patients over an extended period of time in less-controlled settings. Increasingly, therefore, regulatory agencies are strengthening the provisions for ensuring safe use of drugs after they have been launched. The US Food and Drug Administration (FDA) is now requiring manufacturers of drugs with higher risk profiles to submit comprehensive Risk Evaluation and Mitigation Strategies. This article provides a historic perspective on drug safety risk management and offers a framework for how companies can implement an acceptable and effective risk management system.