A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and outside experts, with some saying the poorly defined effort is taking key decisions away from career scientists and placing them in the hands of political leadership.
The initiative by FDA Commissioner Marty Makary promises ultra-fast reviews for drugs that align with “U.S. national priorities.” It’s at the center of Makary’s stated goal to “cut red tape” and “challenge assumptions” at the agency tasked with assuring the safety of food, medicines, medical devices and other consumer goods.
