FDA: Agency's Tools Not Strong Enough To Stop Brands' Misuse Of REMS

A key FDA official said Thursday (Dec. 11) that tools Congress gave the agency are not strong enough to address innovator companies' increasingly aggressive use of Risk Evaluation and Mitigation Strategies (REMS) to block generic drugs and biosimilars from reaching the marketplace. The comments came less than a week after FDA issued a draft guidance aimed at stemming brand companies' use of REMS to slow generic drug development. The issue came up at an FDA/CMS Summit in Washington where FDA...

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