The US Food and Drug Administration (FDA) approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s on June 7, making it the first new treatment approved for the disease since 2003. But the agency has faced criticism from many quarters over the approval.
In a letter posted Friday, and announced via Twitter, Woodcock asked the US government oversight body, the Office of Inspector General, to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of 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,” reads Woodcock’s 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.”
The acting FDA chief said she believes this “review and assessment will help ensure continued confidence in the integrity of FDA’s regulatory processes and decision-making.”
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
FDA releases internal memos
Internal FDA memos published last month showed that the US regulatory body’s drug statistics office concluded that there was a lack of sufficient clinical trial data to put Biogen’s product on the market.
However, the released communications showed more senior officials decided that the evidence indicating that the drug worked, while inconclusive, supported accelerated approval (AA) of aducanumab for the treatment of patients with Alzheimer’s disease (AD).
Peter Stein, director of the FDA’s office of new drugs, in a memo detailing his support for the AA approach for Aduhelm, said he agreed with the agency’s Office of Neuroscience that the data was “not sufficiently compelling or persuasive to meet the substantial evidence standard for standard approval.”
Nonetheless, he said studies strongly suggest that treatment with aducanumab may result in clinical benefit.
Last month also saw three members of a US FDA advisory committee resign in protest after the agency went ahead and approved the Biogen drug despite their reservations about its efficacy.
In November 2020, that group of external experts, the Peripheral and Central Nervous System Drugs Advisory Committee, voted against recommending the drug.
A BMJ story revealed that one of those who resigned, Harvard professor of medicine, Aaron Kesselheim, wrote in a letter to Woodcock, that the approval of Biogen’s drug was “probably the worst drug approval decision in recent US history.”
Also resigning over the FDA move were Mayo Clinic neurologist, David Knopman, and Washington University neurologist, Joel Perlmutter.