FDA calls for federal investigation into its controversial Alzheimer’s drug approval
The head of the Food and Drug Administration has called for a wide-ranging federal investigation into the approval of Biogen’s treatment for Alzheimer’s disease just one month after a decision that sparked the ire of lawmakers, doctors, and public health advocates.
In a letter posted Friday, Acting Commissioner Janet Woodcock asked the independent Office of the Inspector General to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of Aduhelm. This follows STAT’s reporting that FDA officials worked hand in hand with Biogen executives to get the drug on the market, including an off-the-books meeting and an unprecedented decision to approve Aduhelm through a regulatory shortcut.
