AAM To FDA: Be Harder On Brands Manipulating REMS, Waive Single-Shared Systems More Often

The Association for Accessible Medicines wants FDA to exert greater pressure on brands thought to be manipulating Risk Evaluation and Mitigation Strategies (REMS) to block generic competition. The group suggests the agency condition approval of REMS drugs on the sponsor agreeing to make samples available to all future competitors, state that a brand's failure to provide samples within a period of time will be deemed a violation of the REMS, and take enforcement action against brand companies that manipulate REMS...