FDA approval of Alzheimer's drug 'rife with irregularities,' probe concludes

The Food and Drug Administration in 2021 granted approval to a controversial treatment for Alzheimer's disease, but a congressional investigation has called into question whether the agency followed proper procedure in granting its seal of approval.

Aduhelm, which pharmaceutical company Biogen produces, secured FDA approval after the agency overruled its independent scientific advisers, according to the Associated Press. Numerous studies had questioned the product's efficacy.

Three FDA advisers resigned in protest over Aduhelm's approval and the acting chief demanded an internal investigation, per the outlet.

A congressional report has further shown the FDA's approval of Aduhelm to have been "rife with irregularities." The House Oversight Committee along with the Energy and Commerce Committee documented the process by which the FDA and Biogen worked together to secure approval for the drug over internal objections within the federal agency.

None of the advisers on an independent advisory committee voted in a November 2020 meeting to assert the drug's effectiveness in treating Alzheimer's. One attendee told CNN that the FDA and Biogen were "fully in line with each other in support of the drug."

The report further observed that the FDA granted approval to "people with Alzheimer's disease" but that the clinical trials had only studied the drug's effects on a narrower target group.

Ultimately, the FDA approved Aduhelm "despite internal reservations about the lack of evidence of clinical benefit for patients at disease stages outside of the clinical trials and an unknown safety profile," according to the report.

Both the FDA and Biogen have denied any wrongdoing.