REMS: The Regulatory Shield Blocking Affordable Generics

Brand name drug manufacturers have been using the Risk Evaluation and Mitigation Strategy (REMS), an FDA-regulated safety program, to block generic competition and maintain market monopolies. These manufacturers withhold drug samples from generic makers, claiming REMS restrictions, thus preventing them from conducting required studies for FDA approval. This tactic has reportedly cost the US healthcare system around $5.4bn annually. Legislators are responding with legislation like the CREATES Act, which could enable generic manufacturers to legally compel brand names to provide samples.