Using a Drug-Safety Tool to Prevent Competition.

The article offers information on the Risk Evaluation and Mitigation Strategy (REMS) created by the U.S. Food and Drug Administration Amendments Act (FDAAA). Topics include its aim to handle drugs with safety issues, the proliferation of REMS programs on generic drug manufacturers, and the Tracleer Access Program. It also discusses the patenting of the System for Thalidomide Education and Prescribing Safety that was developed by drug manufacturer Celgene.