FDA calls for federal investigation into its controversial Alzheimer’s drug approval

From STAT:

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 Inspector General to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of Aduhelm. The agency cited 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.

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“It would be really important to understand what went on and what sort of relationships might have influenced the decision,” said Steven Joffe, professor of medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine. “It seems like an independent investigation, which the OIG could do, would be good for the public and stakeholders to understand the background behind the decision.”