FDA Approval of Alzheimer's Drug to Be Reviewed

Agency chief fears damage to public confidence in process
By Bob Cronin,  Newser Staff
Posted Jul 9, 2021 2:50 PM CDT

(Newser) – The acting head of the Food and Drug Administration wants the agency's inspector general to conduct an independent review of the agency's approval of a new drug to treat Alzheimer's. The approval process, which one outside adviser had called a "sham" as he resigned, has been strenuously criticized over a lack of overwhelming evidence that the treatment works. Janet Woodcock, the acting commissioner, said she wants to know "whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures," CNBC reports. An FDA official informally met with a top official of Biogen, the drug's maker, at a conference in 2019, Stat has reported.

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In her letter requesting the review, Woodcock wrote that questions have been raised about such contacts, per the Washington Post. She made the request of the inspector general's office in the Department of Health and Human Services, expressing concern that the approval process "could undermine the public's confidence in FDA's decision," per CNN. The Wall Street Journal describes Woodcock's request to investigate doctors within her own agency as "highly unusual." Biogen shares, which had climbed sharply after Aduhelm was approved a month ago, dropped more than 3%. On Thursday, as the FDA dealt with the fallout over its decision, it narrowed its recommended use guidelines, saying that Aduhelm should be used only for patients with mild symptoms. (Two House committees also are looking into the drug's approval.)

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