The Controversial Recall of Vioxx

Introduction The Food and Drug Administration (FDA) has received mixed reviews for its regulation of prescription drugs. Is there a conflict of interest in having the same authority in charge of both approving and recalling drugs? A drug must go through an extensive...

Is the FDA's REMS Program Effective?

Introduction Risk Evaluation and Mitigation Strategies (REMS) is a type of safety report designed to monitor any drugs “with known or potential risks.” The report must provide comprehensive data that shows a drug’s benefits outweigh their risks. Each REMS must be...