Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug
WASHINGTON — Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and pricing of its controversial new Alzheimer’s drug.
The letter is the latest move in a congressional investigation into Aduhelm’s approval and pricing spearheaded by House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.). The request prominently references a STAT investigation that revealed Biogen had an off-the-books meeting with a prominent FDA regulator ahead of the drug’s unprecedented approval, and that the back-channel relationship between the two started earlier and was far more extensive than disclosed.
