FDA unveils guidance aimed at curbing REMS abuse

FDA released new guidance documents Thursday that are intended to curtail the abuse of REMS to stall generic competition. The guidances clarify the requirements for REMS when they are to be shared by both branded and generic drugs, and outline the factors FDA will use to allow generic drugmakers to obtain a waiver from a shared REMS.

The new rules focus on the complexity of many REMS programs, which generic drugmakers typically must negotiate to share with the branded drugmakers. FDA said some drugmakers have exploited the system to stall market entry for a generic drug by dragging out negotiations...