In an attempt to minimize perceived obstacles to generic drug market entry, the FDA issued two draft guidance documents on May 31, 2018, related to shared system risk evaluation and mitigation strategies (REMS), providing the industry with insight into a previously underdefined area of FDA regulation. A shared REMS is one that encompasses multiple prescription drug products and is implemented jointly by two or more applicants. One of the new draft guidance documents sets forth the circumstances when a shared REMS program is required. The other draft guidance explains how to request a waiver from a shared REMS, signaling FDA’s willingness to grant such waivers.
Unfortunately, FDA did not provide any concrete steps to assist drug manufacturers with the challenging task of working cooperatively with market competitors on these drug safety programs. Nevertheless, the two guidance documents are a must-read for both brand and generic drug applicants.