Probe: Alzheimer’s drug approval ‘full of irregularities’

WASHINGTON – The Food and Drug Administration’s controversial approval of a questionable Alzheimer’s drug suffered another blow on Thursday, when congressional investigators described the process as “riddled with irregularities.”

The 18-month investigation by two House committees details “atypical collaboration” between FDA regulators and a company they are tasked with overseeing — helmet maker Biogen. The investigation also cited Biogen documents showing that the company intended to “make history” when it set what investigators called “unjustifiably high” an initial price of $56,000 per year for the drug.

The criticism comes as the FDA is expected to decide in January whether to approve another new Alzheimer’s drug. Thursday’s report urged the agency to “act quickly” to ensure future Alzheimer’s approvals don’t meet “the same doubts about the integrity of the FDA review.”

The FDA and Biogen issued statements Thursday defending Aduhelm’s approval process.

In 2021, the FDA suspended its own independent scientific advisers approved Aduhelm, although research studies have not been able to prove that it really helped patients. Biogen had stopped two studies after disappointing results suggested the drug wasn’t slowing the inevitable worsening of Alzheimer’s — only to later claim that a new analysis of a study showed higher doses offered an additional benefit.

The FDA argued that the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggests it would likely slow down the disease. An immediate backlash ensued when three FDA advisers resigned in protest and the agency’s then-acting head resigned called for an internal investigation. Ultimately Medicare refused to pay for the drug — even after the annual price was reduced to $28,000 — unless patients entered clinical trials to prove whether it actually slowed cognitive decline.

Thursday’s report said the FDA and Biogen were involved in an unusually high volume of phone calls, meetings and emails, some of which were not properly documented. In addition, regulators and the company worked together for months to prepare a briefing document for FDA advisors that does not adequately reflect the significant disagreements within the FDA over how to handle Aduhelm, the report said.

Investigators recommended that the FDA take steps to restore confidence in the approval process, including properly documenting interactions with drug manufacturers. They also urged manufacturers to consider advice from patient groups and other outside experts on fair drug pricing.

In a statement Thursday, the FDA said that Aduhelm’s decision was “based on our scientific review of the data” and that the agency’s own internal review determined that its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer’s drug development and review the findings of the investigation.

In its own statement, Biogen said “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm” but that it “stands by the integrity of the actions we are taking.”

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