FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug
Laurie McGinley 1 hr agoJanet Woodcock, acting commissioner of the Food and Drug Administration, on Friday asked for the inspector general to conduct an “independent review and assessment” of the agency’s interactions with the maker of a controversial new Alzheimer’s drug, whose approval has set off a torrent of criticism.
Woodcock said on Twitter she was requesting the review because of the “ongoing interest and questions” about the approval of the drug, called Aduhelm, on June 7. She said the review would focus on interactions between representatives of Biogen and the FDA during the process that led to the approval.
In a letter to the Office of Inspector General at the Department of Health and Human Services, Woodcock said there has been “significant attention and controversy surrounding the process” for Aduhelm.
She said she had “tremendous confidence in the integrity of the staff and leadership” of the agency involved in the approval but added that questions continue to be raised about contacts between Biogen and the FDA, “including some that may have occurred outside of the formal correspondence process.”
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