The Impact of REMS on Generic Drug Approvals and Drug Competition

From the conception of the REMS in the FDAAA Act of 2007, Congress was concerned that giving FDA authority to impose new post-marketing controls could raise competitive issues about market access for generics. Congress was right to be concerned. Despite a specific admonition in FDAAA to prevent use of the most restrictive REMS programs to prevent new competition, strategies to extend product exclusivity have emerged and the competitive landscape has changed.