House committees claim concern at apparent anomalies in FDA's Aduhelm review

A stern letter has been written to the US Food and Drug Administration (FDA) by the chairs of two US congressional committees, demanding answers in relation to the approval of Biogen (Nasdaq: BIIB) and Eisai’s (TYO: 4523) Alzheimer’s drug, Aduhelm (aducanumab).

Energy and Commerce chairman Frank Pallone and Oversight and Reform chairwoman Carolyn Maloney sent a letter to the FDA’s Acting Commissioner Janet Woodcock seeking information regarding the review process and accelerated approval.

"We are also concerned by reports of unusual coordination between the FDA and Biogen throughout the drug’s approval process"This follows the sending of a previous letter to Biogen in July and is part of the committees’ ongoing investigation into the drug’s approval process, marketing, and pricing.