Senate Bill Aims To Stop Brands From Delaying Generics With REMS

By Gabrielle Wanneh / September 23, 2022 at 12:58 PM
Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) on Thursday (Sept. 22) introduced a bill aimed at stopping brand drug makers from using drug safety programs to delay generic competition. FDA may require Risk Evaluation and Mitigation Strategy (REMS) to address concerns about drug side effects, but drug companies often use patented REMS to delay the approval of generic competitors. The Increasing Prescription Drug Competition Act would allow FDA to approve generic drugs despite patented REMS, avoiding 30-month approval stays...

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