Ensuring Timely Approval of Generic Drugs

Brand-name manufacturers are exploiting FDA risk evaluation and mitigation strategies (REMS) to block generic competition by refusing to provide drug samples needed for required bioequivalence testing, and in some cases patenting their REMS programs to artificially extend market exclusivity. The authors advocate for the FAST Generics Act, which would create an FDA-authorized pathway for generic manufacturers to obtain brand-name drug samples regardless of REMS status, and call on Congress to create a safe harbor protecting generic manufacturers from patent infringement claims when replicating a brand-name drug’s REMS for a bioequivalent product.