Gottlieb: 'End the shenanigans' on slow-playing REMS to delay generic drug competition
FDA commissioner Scott Gottlieb yesterday called on brand name drug companies to “end the shenanigans” that restrict generic drug competition, specifically pointing to the tactic of slow-playing shared Risk Evaluation and Mitigation Strategies (REMS) terms intended to prevent generic manufacturers from purchasing drug products needed to run bioequivalence or bioavailability studies that FDA approval requires.
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