FDA Issues Draft Guidance Documents On Shared System REMS

The documents issued by the US Food and Drug Administration on shared system risk evaluation and mitigation strategies signal the FDA's willingness to grant waivers from the shared program requirement, but that may complicate matters for the companies trying to negotiate them and the healthcare providers trying to navigate them.

The US Food and Drug Administration (FDA) issued two draft guidance documents on May 31 related to shared system risk evaluation and mitigation strategies (REMS). A REMS is a required risk management plan for drugs associated with serious risks. When a generic drug applicant seeks approval to copy a reference listed drug (RLD) that has a REMS associated with it, the generic and RLD drug manufacturers are required to develop a single shared system (SSS) REMS program. One guidance provides information on developing an SSS REMS, and the other provides information on how generic drug applicants can request a waiver from the shared program.