Using a drug-safety tool to prevent competition.

I 2007, the Food and Drug Administration Amendments Act (FDAAA) created an important new tool for dealing with drugs that have potential safety problems: the Risk Evaluation and Mitigation Strategy (REMS). The aim was to encourage prescribers and patients to use those drugs in such a way that their benefits would outweigh their risks. Troubling cases have emerged, however, in which this tool has been used to hinder competition from generic drugs — an unintended consequence that suggests that Congress may need to revisit its design. A REMS is a program organized by the drug’s manufacturer to provide safeguards for the use of certain high-risk medications. It can vary in complexity from the issuing of medication guides or other means of educating prescribers, patients, or both about