SAN FRANCISCO — U.S. Food and Drug Administration Commissioner Robert Califf doesn’t disagree with the basic findings of a congressional investigation into the agency’s role in the controversial approval of Aduhelm, Biogen’s first Alzheimer’s drug. He just wishes the report’s tone had been different.
“There were no surprises in the report,” Califf told STAT’s Matthew Herper during a Monday night event hosted by STAT during the J.P. Morgan Healthcare Conference. “The language is inflammatory, I think, on purpose, because that’s what oversight committees do.”
The conversation, a recording of which can be watched online, marked Califf’s first public comments after a congressional investigation released in late December delivered an in-depth critique of both the FDA and Biogen’s handling of Aduhelm’s approval in 2021 and subsequent rollout, citing 500,000 pages of documents from both the federal agency and pharma giant.
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