FDA calls for a federal investigation into Aduhelm approval

The FDA called for a federal investigation into the approval of Aduhelm for the treatment of patients with Alzheimer’s disease, as reported by STAT.

The expedited approval of Aduhelm (aducanumab, Biogen/Eisai), indicated for the treatment of patients with mild cognitive impairment or dementia, has called into question how closely FDA officials worked with Biogen executives to get the drug on the market; STAT reported off-the-books meetings led to an ‘unprecedented decision’ to approve the therapeutic 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,” Janet Woodcock, acting commissioner of the FDA, wrote in a letter to Christi Grimm, acting inspector general in the Department of Health and Human Services, STAT wrote. “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.”