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Underselling Risk and Black Boxes
Many drugs and procedures have warnings that the FDA requires. Some prescription drugs have so-called “black box” warnings and other rules related to how they should be marketed to make sure special safety concerns are disclosed to patients. Sometimes the FDA requires other procedures, including a Risk Evaluation and Mitigation Strategy (REMS). REMS are required management plans that use risk minimization strategies beyond labeling to ensure the benefits of certain prescription drugs outweigh their risks. Pharmaceutical companies are aware that accurate disclosures and strict compliance with FDA procedures could limit their sales. Any shortcuts to the prescribed warnings and procedures or any sales techniques that deemphasize the warnings and procedures are potentially fraudulent and pose a threat to public safety. Murphy Anderson lawyers are experienced in identifying such fraudulent practices and presenting these schemes to government authorities.