FDA asks for federal investigation of Alzheimer’s drug approval

The acting head of the Food and Drug Administration on Friday requested a federal investigation into her own agency’s controversial approval of an Alzheimer’s drug last month.

In a letter to the independent Office of Inspector General, acting FDA Commissioner Janet Woodcock asked the watchdog to investigate the interactions between representatives of Biogen and FDA during the process that led to the approval of the company’s Alzheimer’s drug Aduhelm.

“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 the letter posted and dated Friday to acting Inspector General Christi Grimm.

Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm. pic.twitter.com/iWJNxdZ5Cs

— Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021 

According to reports by Stat News, regulators worked directly with Biogen representatives to get the drug approved and onto the market. Aduhelm was the first Alzheimer’s drug approved in nearly 20 years, and the agency was facing intense pressure from patients’ family members and advocates.

The agency decided to approve the drug under its accelerated approval pathway, essentially a regulatory shortcut typically used for rare diseases or drugs with much smaller patient populations.

“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 wrote. 

The letter does not guarantee an investigation, as the Office of Inspector General is an independent watchdog agency.

FDA has been under fire since it first announced approval of Biogen’s drug late last month. 

The approval came over the near-unanimous objections of the FDA’s expert advisory committee. Three of the agency’s outside advisers resigned over the decision.

Aduhelm is not a cure for Alzheimer’s, and the FDA made its decision without clear evidence that the drug can even slow the progression of the disease. Instead, the agency based its approval on how well it reduces the amount of plaque in the brains of Alzheimer’s patients. Brain plaques are thought to be a contributor to Alzheimer’s disease, but it has not been proven.