GPhA-Backed Study Estimates $5.4 Billion In Annual Lost Savings Due To REMS 'Misuse'

Alleged misuse of Risk Evaluation and Mitigation Strategies have delayed market entry for 40 small molecule generic drugs, causing $5.4 billion in annual lost savings for public and private payors, according to a recent study conducted by Matrix Global Advisors and backed by the Generic Pharmaceutical Association. The study, which the generic drug industry hopes will reinvigorate legislative efforts to stymie drug innovators' alleged use of REMS to delay generics, predicts the costs will eventually extend to biosimilars -- $140...