Drug Makers Split Over Usefulness Of FDA Efforts To Curb REMS Abuses

Brand and generic drug companies disagree over the usefulness of FDA’s and the Federal Trade Commission’s efforts to address gaming of FDA’s risk mitigation strategies, according to a report published by the Government Accountability Office (GAO) Thursday (Nov. 14). Among other issues, generic drug companies lament that FDA’s safety determination letters to brand drug makers don’t actually require brand drug makers to provide generics with samples of reference drugs needed to test for bioequivalence. And though FDA has recently taken...