House staff report on Aduhelm (2022)

Later that month, Chairs Maloney and Pallone announced the Committees' investigation into FDA's decision to grant accelerated approval to Aduhelm.

Following the presentation, none of the committee members voted to recommend traditional approval for Aduhelm.

Following the drug's approval, several members of the FDA advisory committee publicly resigned in protest.

FDA and Biogen inappropriately collaborated on a joint briefing document for a key advisory committee.

FDA considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period.

released a staff report following an 18-month investigation into the Food and Drug Administration's (FDA) regulatory review and approval process of Biogen's Alzheimer's disease drug Aduhelm, and Biogen's pricing of Aduhelm.

Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) and Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) released a staff report

A joint investigation released Thursday by House Democrats

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making,” the agency said in a statement.

Biogen refuted the report’s implications, saying it “stands by the integrity of the actions we have taken.”

accelerated approval pathway — an option that was not presented to committee members.