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The Impact of REMS on Generic Drug Approvals and Drug Competition

 
• By Ed Tabor

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.

Congress specifically added provisions in the Food and Drug Administration Amendments Act of 2007 (FDAAA) to prevent a new drug safety tool, the Risk Evaluation and Mitigation Strategy (REMS), from causing delays in the approval of applications for generic versions. FDAAA states, “No holder of an approved covered application shall use any element to assure safe use [ETASU]… to block or delay approval of an application under section 505(b)(2) or … a drug that is the subject of an abbreviated new drug application [ANDA, i.e., a generic drug].”

FDA has reiterated its enforcement of that direction from Congress numerous times in the four years since it received REMS...

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