Investigation: Alzheimer drug approval ‘rife with irregularities’

The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January.

WASHINGTON — The controversial FDA approval of a controversial Alzheimer’s drug Thursday took another blow as congressional investigators called the process “rife with irregularities.”

An 18-month investigation by two committees of the House of Representatives detailed an “atypical collaboration” between FDA regulators and the company they are supposed to oversee, maker Aduhelm Biogen. The investigation also cited documents from Biogen saying the company intended to “make history” when it set what investigators said was an “unreasonably high” starting price of $56,000 a year for the drug.

The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. In a report released Thursday, the agency called for “quick action” to ensure that any future Alzheimer’s claims are not met with “the same doubts about the integrity of the FDA’s review.”

On Thursday, the FDA and Biogen released statements in defense of the Aduhelm approval process.

In 2021, the FDA overruled the opinion of its independent scientific advisors when it approved Aduhelm, although studies failed to prove that it actually helps patients. Biogen suspended two studies after disappointing results showed the drug did not slow the inevitable worsening of Alzheimer’s, only to later claim that a new analysis of one study showed that higher doses provided an additional benefit.

The Food and Drug Administration (FDA) has argued that the drug’s ability to reduce a hallmark of Alzheimer’s disease—plaque buildup in the brain—suggests it may slow the course of the disease. An immediate reaction came when three FDA advisers resigned in protest, and the then acting head of the agency called for an internal investigation. In the end, Medicare refused to pay for the drug—even after the annual price was cut to $28,000—unless patients entered clinical trials to prove whether it actually slowed cognitive decline.

A report released Thursday said the FDA and Biogen had an unusually high number of phone calls, meetings and emails, some of which were not properly documented. In addition, regulators and the company have spent months working together to produce a white paper for FDA consultants that does not adequately reflect significant disagreements within the FDA over how to handle Aduhelm, the report says.

The researchers recommended that the FDA take steps to restore confidence in the approval process, including proper documentation of interactions with drug manufacturers. They also urged manufacturers to take into account the advice of patient groups and other external experts on fair drug pricing.

In a statement Thursday, the FDA said Aduhelm’s decision “was based on our scientific evaluation of the data” and that the agency’s own internal review found its interaction with Biogen was appropriate. But the company said it plans to update guidance on drug development for Alzheimer’s and will review the results of the investigation.

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

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