Activist group Public Citizen is crying foul on an “inappropriate close collaboration” between the FDA and Biogen surrounding the pharma’s controversial Alzheimer’s disease drug aducanumab and the related FDA advisory committee documents.
The scathing letter to the U.S. Department of Health and Human Services demands an Office of Inspector General investigation of the U.S. regulator’s “inappropriate close collaboration with Biogen before and after the submission of the biologics license application” for the drug.
The Alzheimer’s hopeful, which was on the verge of being dumped earlier this year before some data mining convinced Biogen to apply for an FDA approval, went up before a review last month.
The review, from a group of outside experts, panned the drug, saying it didn’t pass muster for an approval. But the official FDA documents, released several days before the review, told a different story: These backed the drug, which had failed previous trials, as “highly persuasive” and led many to believe it will indeed be approved next year.
The documents were a major surprise for most and read more like a Biogen press release than a formal FDA document, and Public Citizen says this is because the documents were jointly written by Biogen and the FDA.
Sifting through Biogen’s presentations, Public Citizen, certainly no fan of pharma in general, said it found this collaboration via press releases and presentation documents issued by Biogen as well as an “unprecedented” joint briefing document prepared by the FDA and Biogen for the Nov. 6 AdComm.
Public Citizen said this “has dangerously compromised the independence and objectivity of senior staff and clinical reviewers in the agency’s Office of Neuroscience (ON) in the Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs during the agency’s review of Biogen’s BLA for aducanumab and key data from two identical pivotal phase 3 clinical trials of the drug.”
The group said the FDA’s “unbridled enthusiasm” for aducanumab was “not supported” by the data, and the group believes the close ties between the company and the regulator are the real reason for this enthusiasm.
In an emailed statement, Biogen said: “Alzheimer’s disease remains one of the greatest public health challenges of our time. It robs memories, independence and eventually the ability to perform basic tasks from the people who live with the disease.
“The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the pathology of the disease and reduces the clinical decline associated with this devastating condition. We are committed to driving progress for the Alzheimer’s disease community, and we stand by the integrity of the review process as FDA continues its review of our filing.”
The PDUFA data for the drug is March 7.