The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).

In a Friday letter acknowledging the “significant attention and controversy” surrounding the drug’s approval last month, FDA Acting Commissioner Janet Woodcock, M.D., asked the Office of the Inspector General to quickly review the agency’s actions prior to its controversial decision. 

Woodcock expressed concern that reports of unofficial contact between Biogen and FDA reviewers outside of the formal drug trial review process would undermine the public’s confidence in the agency. 

“I believe it is critical that the events at issue be reviewed by an independent body … in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with any FDA policies and procedures,” Woodcock wrote.

Off-the-books meeting, shortcut involved

Medical news outlet STAT in late June reported 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,” as STAT reporters wrote in a news story regarding Woodcock’s letter.

In the meantime, a leading long-term care physicians organization has refused to endorse the prescription of Aduhelm to post-acute care patients or to long-term care residents. 

AMDA —The Society for Post-Acute and Long-Term Care Medicine cited a list of reasons for its decision not to endorse the drug: lack of evidence of benefit in Biogen’s clinical trials, a significant potential for dangerous side effects, the need for sophisticated neuroimaging follow-up care, and the drug’s high cost. 

The Food and Drug Administration has been criticized for greenlighting Aduhelm under an accelerated approval process, despite conflicting clinical trial results. Three of the agency’s own advisory committee members have since resigned in protest, saying that the approval was “foreordained” and didn’t take their concerns into account. 

FDA ultimately concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy. As a contingency of the accelerated approval, Biogen must conduct a new clinical trial of the drug. Results may not be available for years. 

Aduhelm is administered via monthly infusions, and safe treatment protocol may require regular brain scans to guard against side effects that may include bleeding and swelling in the brain. It works by removing amyloid beta, according to Biogen.

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