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.
The congressional report also highlighted the FDA’s decision to grant “accelerated approval” after months of insisting the drug would only be considered for traditional approval. A council of senior agency officials met to review the drug and agreed that there wasn’t enough evidence that it worked, and suggested another clinical trial be conducted. However, three minutes after that meeting, the FDA told Biogen it was considering Aduhelm for “accelerated approval.” The agency’s justification lay in the fact that the drug targets amyloid, a protein that forms plaques in the brains of Alzheimer’s patients. That said, Alzheimer’s experts said that years of data hadn’t proven reducing amyloid slowed cognitive decline.