Advocacy group accuses FDA of ‘inappropriate’ collaboration with Biogen

Dec. 9, 2020

An advocacy group called Public Citizen is calling on federal investigators to probe the FDA’s ongoing review of Biogen’s questionable Alzheimer’s treatment. 

In a letter addressed to the U.S. Department of Health and Human Services, Public Citizen, a long-time critic of pharma, has asked that the Office of Inspector General (OIG) to investigate the FDA’s “inappropriate close collaboration” with Biogen.   

The drug, aducanumab, has been on a controversial journey through regulatory channels for months. After stopping two large phase 3 trials of the drug in March 2019, Biogen stunned analysts in October by reporting that a reanalysis of the data showed it could be effective at a higher dose, and said it would be submitting it for review. According to Public Citizen, “the FDA and Biogen worked collaboratively to salvage the drug” and “jointly relied on dubious analyses that over-emphasized the results of one phase 3 trial. 

In November, an FDA advisory committee overwhelmingly panned the drug, with 10 out of 11 voting against approval. But an FDA briefing document released days before the advisory committee meeting offered a glowing review of aducanumab because, Public Citizen alleges, it was co-written with Biogen. 

In addition to an OIG investigation, Public Citizen is calling for the removal of the FDA’s neuro chief, Billy Dunn, until the probe is complete.

“By engaging in this collaboration with Biogen, the FDA dangerously compromised its objectivity and independence during the review process for aducanumab,” Public Citizen wrote.

The FDA is expected to render a final decision about the drug by March 2021.