January 09, 2023

House Investigation into Alzheimer’s Drug Places Blame on FDA, Biogen

The Food and Drug Administration’s process for approving the Alzheimer’s drug Aduhelm, despite great uncertainty about whether it worked, was “rife with irregularities,” according to a congressional investigation. The report also criticized Biogen, Aduhelm’s manufacturer, for setting an “unjustifiably high price.”

The 18-month investigation, initiated by the House Energy and Commerce Committee and House Committee on Oversight and Reform after the FDA approved the drug, strongly criticized Biogen for setting a price of $56,000 a year for the drug. The inquiry found that Biogen wanted a history-making “blockbuster” in order 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 included the FDA’s own internal inquiry into its Aduhelm review process, which found that FDA officials leading the Aduhelm evaluation did not pay enough attention to dissenting views from the agency’s own statistical team, which said there was inadequate evidence that Aduhelm worked.

“It is reprehensible that Medicare premiums increased by 14.55% due in large part to one overpriced and unproven drug,” said Joseph Peters, Jr., Secretary-Treasurer of the Alliance. “Fortunately the 2023 Medicare premiums no longer reflect a major Aduhelm surcharge.”

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