FDA Failed In Alzheimer's Drug Approval, Congressional Report Says

CAMBRIDGE, MA — The U.S. Food and Drug Administration broke its own rules during the approval process for Cambridge-based company Biogen Inc.'s Alzheimer's drug Aduhelm, according to a congressional report released Thursday.

According to the staff report, which showed the findings of two committees under the House of Representatives, the approval process for Aduhelm was "rife with irregularities."

Most notably, the report revealed that the FDA went against recommendations and accelerated the drug's approval despite data suggesting its ineffectiveness.

The investigation, conducted by the Staffs of the Committee on Oversight and Reform and Committee on Energy and Commerce, ran over the course of 18 months and examined the drug's regulatory review and approval, pricing, and marketing.

The committees found that the FDA granted accelerated approval for Aduhelm on the basis that the drug reduces amyloid beta plaque in the brain. The issue, according to the report, is that the go-ahead came despite the fact that Biogen canceled clinical trials for the drug in March 2019 due to an independent report suggesting it was unlikely to effectively slow cognitive and functional impairment.

Later, in November 2020, the FDA and Biogen prepared a joint document for the FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee, of which no members voted to recommend traditional approval for Aduhelm, the committees said.

But the drug was approved by the FDA anyway on June 7, 2021 — to be sold for the "unjustifiably high" price of $56,000 per year, according to the report. Even the company itself projected that Adujelm would be a burden to Medicare and costly to patients, the committees said.

"The findings in this report raise serious concerns about FDA's lapses in protocol and Biogen's disregard of efficacy and access in the approval process for Aduhelm," the Staffs of the Committee on Oversight and Reform and Committee on Energy and Commerce wrote.

The report listed several suggestions for the FDA to "help restore the American people's trust in the agency's processes and assurance of drug safety and efficacy," urging the agency to take measures to ensure that interactions with drug sponsors are properly recorded and protocols for joint briefing documents are established and followed.

The committees also suggested that the FDA updates its industry guidance for the development and review of new Alzheimer's drugs.

"The American people rely on FDA for assurance on the safety and efficacy of the medications they take," the report said. "The number of patients and families impacted by Alzheimer’s disease will continue to increase, and it is crucial that FDA and drug companies adhere to established procedures and conduct themselves with the transparency necessary to earn public trust."

An FDA spokesperson defended the FDA's decision to approve the drug, adding that an internal review found its staff's interactions with Biogen appropriate.

However, the FDA has already begun implementing some of the report’s recommendations, according to the spokesperson.

In its own statement released Thursday, Biogen wrote that the drug company "stands by the integrity of the actions we have taken," pointing out that "As stated in the congressional report, an FDA review concluded that 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation.'"