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FDA’s Aduhelm Approval Process was Problematic

Biogen was prepared to spend more than two-and-a-half times the cost of the drug’s development on marketing.

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According to a recent New York Times article, a congressional investigation into the FDA’s approval of Alzheimer’s drug Aduhelm was “rife with irregularities.” The 18-month investigation was initiated by two congressional committees after the drug was approved. The review determined that Biogen, the drug’s manufacturer, set “an unjustifiably high price” of $56k/year in an effort to make history and “establish Aduhelm as one of the top pharmaceutical launches of all time.” The investigation also revealed that Biogen budgeted several billion dollars to aggressively market and counter anticipated pushback against critics of its price. 

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