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Outrage of the Month: FDA Senior Leader Ignores Science, Approves Ineffective Drug for a Rare Disease

Read more in Public Citizen's October Health Letter On Sept. 19, 2016, the Food and Drug Administration (FDA) approved eteplirsen (brand name Exondys 51) -- the first drug approved for treating Duchenne muscular dystrophy (DMD) -- despite a disturbing lack of evidence that the drug is actually effective. The approval decision ultimately was made by Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER) -- the center that reviews and approves drugs -- over the strong objections of scientific experts at the agency who had reviewed the new drug application for eteplirsen.
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