FDA Urged To Stop REMS Patents, Waive Shared REMS, Publish Letters To Brands

FDA faced pressure from a variety of stakeholders to take several specific steps to stop brand drug makers from using Risk Evaluation and Mitigation Strategies (REMS) to delay generic drug marketing -- but also faced push-back from the brand pharmaceutical and biologics lobbies to some of the ideas raised at a public meeting this week. Among the ideas floated to the agency were preventing brands from patenting REMS, expanding waivers for brands and generics to share REMS programs and publishing...