The U.S. Food and Drug Administration’s approval process for the controversial Alzheimer’s drug Aduhelm was “rife with irregularities,” despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims. Actions the agency took with Biogen, maker of Aduhelm, “raise serious concerns about FDA’s lapses in protocol,” the report concluded. But the 18-month investigation launched by two congressional committees also took Biogen to task for setting too high a price on the medication. Company documents showed Biogen officials settled on an annual cost of $56,000 for Aduhelm because it wanted to “establish Aduhelm as one of the top pharmaceutical launches of all time,” even though it knew the high price would burden Medicare and patients, the report found. Not only that, Biogen planned to spend up to several billion dollars on an aggressive marketing campaign to target doctors, patients, advocacy groups, insurers, policymakers and communities of color, who were drastically underrepresented in the company’s clinical trials of the drug. The controversy over Aduhelm (aducanumab) stretches back to its June 2021 approval. The Cleveland Clinic and the U.S. Department of Veterans Affairs, among others, decided not to offer Aduhelm infusions following the approval because of the drug’s questionable efficacy and risks of brain swelling and bleeding. Once Medicare sharply limited its coverage of Aduhelm, still expensive after… read on > read on >







