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STAT: Calls for an Aduhelm investigation get that much louder

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Calls for an Aduhelm investigation get that much louder

Joining the chorus of lawmakers and advocates demanding a federal investigation into the FDA’s approval of Aduhelm is Rep. Katie Porter, a California Democrat whose theatrical interrogations of corporate executives have spawned widely shared clips.

In a letter to the Office of the Inspector General, Porter called for an independent look at the role the drug industry plays in the process of approving new medicines, citing STAT’s reporting about the extremely close relationship between Biogen and the FDA during the review of Aduhelm. “It appears very clear that Biogen had an inside route to FDA officials and had undue influence over their decision making and the evidence presented in various settings,” Porter wrote.

Porter’s appeal to OIG echoes statements from former health secretary Donna Shalala and Public Citizen, the progressive advocacy group founded by Ralph Nader. Last month, two members of Congress announced an investigation of their own into the FDA’s approval of the drug and Biogen’s decision to set a list price of $56,000 a year.