Both Generics, Brands Question Gottlieb Plan To Publish REMS Protocol Letters

Neither the brand nor the generic drug lobby appear keen on FDA Commissioner Scott Gottlieb’s idea to publish the letters it sends to brand companies explaining that a potential generic competitor has adequate safety protections in place to be sold brand drug samples for the bioequivalence testing required as a prerequisite of generic approval. Generics worry the letters could lead to competition problems, while brands worry the letters without the proper context could soil their reputation. Gottlieb announced during a...