(Reuters) – Two U.S. House committees have requested data and documents from the Food and Drug Administration related to the agency’s accelerated approval of Biogen Inc’s recently approved Alzheimer’s drug, Aduhelm.
The approval on June 7 sparked controversy and concerns over the FDA’s process in approving the drug despite a panel of its outside advisers recommending against it.
The Committee on Oversight and Reform and the Committee on Energy and Commerce launched an investigation in June into the drug’s approval.
In a letter dated Sept. 1, lawmakers from the two committees asked FDA to provide the data the agency relied on when it made its decision and to offer more details about who was involved in the decision for accelerated approval.
“We are concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm,” chairs of the two committee wrote.
(Reporting by Manas Mishra in Bengaluru; Editing by Vinay Dwivedi)
