New MGA Study Estimates Lost Savings from Misuse of REMS and Restricted Access Programs

A new study from MGA examines the practice by brand drug manufacturers of using Risk Evaluation and Mitigation Strategies (REMS) and other forms of restricted access to keep generic manufacturers from obtaining samples needed to develop generic drugs. MGA estimates that this misuse blocks $13.4 billion in generic savings annually, an estimate that has grown nearly 250 percent since MGA’s 2014 analysis of this issue.