STAT reports:

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.

“There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock wrote in a letter to acting Inspector General Christi Grimm. “To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe it is critical that the events at issue be reviewed by an independent body such as the Office of Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures.”

Woodcock added that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making.”

STAT’s reporting has prompted calls for an OIG investigation from advocacy groups, former federal health officials, and members of Congress. [Continue reading…]