FDA Issues Draft Guidance to Reduce Blocking of Timely Generic Drug Entry

The Food and Drug Administration today released two draft guidance documents aimed at reducing the ability of brand drug makers to use the agency’s Risk Evaluation and Mitigation Strategy programs as a way to block timely generic drug entry. The first document provides guidance on the development of a shared system REMS and includes general principles and recommendations to assist sponsors with developing these programs. The second guidance document describes when and how the FDA will consider waiving the single, shared system requirement, and how generic applicants can request a waiver. “We believe that by making the process for developing a shared system REMS more efficient, we’ll discourage brand drug makers from using REMS as a way to block generic entry and help end some of the tactics that can delay access,” FDA Commissioner Scott Gottlieb, M.D., said. “We’re also going to be clearer about the circumstances when we’ll issue waivers to let the generic firms develop their own REMS program.” The draft guidance documents will be published in tomorrow’s Federal Register. FDA will accept comments for 60 days.