Grassley Pushes Bipartisan Bill Letting Generic Drug Makers Sue To Stop REMS Abuse

Senate Judiciary Chair Chuck Grassley (R-IA) is pushing bipartisan legislation designed to stop brand drug makers from using restrictive safety designations, known as Risk Evaluation and Mitigation Strategies (REMS), to delay generic drug entry to market. The measure, introduced Tuesday (June 14), would allow generic manufacturers to sue for injunctive relief and damage against brand-name manufacturers who use REMS designations as an excuse to deny the generic makers samples of the branded product or keep them from joining a shared...