
Woodcock Seeks Outside Investigation to Restore FDA Credibility
FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.
Facing continued criticism of FDA approval for Biogen’s Alzheimer’s disease treatment, Aduhelm, acting commissioner Janet Woodcock took the unusual step of calling on the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) to examine the review process for that drug. In a letter to acting inspector general Christi Grimm last week that was posted on Twitter July 9, 2021,
This surprising move reflects Woodcock’s aim to protect FDA’s reputation for maintaining the gold standard for objective and science-based assessment of all new medical products. The action also seeks to distance Woodcock from the Aduhelm approval decision, as she struggles to gain support for leading FDA permanently.
Among the loudest critics were members of FDA’s Peripheral and Central Nervous System advisory committee, which had soundly rejected approval of the drug at a meeting in November 2020 due to the sponsor’s failure to provide convincing evidence of the drug effectiveness. Three members of that panel resigned in protest and called for the removal of top officials at the Center for Drug Evaluation and Research (CDER) and relevant new drug review offices.
As members of Congress demanded an investigation into the agency’s review process, FDA sought to stem the attack by releasing documents indicating a thorough analysis of clinical data for the drug.
Yet, in a surprise move last week, FDA supported a move by Biogen to revise the label for Aduhelm to limit prescribing to patients with milder forms of Alzheimer’s disease [see
Meanwhile, the House Energy & Commerce Committee and others plan to hold hearings on the issue and Woodcock’s role in the decision. Sen. Joe Manchin (D-WV) called on President Biden to fire Woodcock for permitting the Aduhelm approval, while Democrats are looking to add drug pricing provisions to current budget legislation. It remains to be seen if Woodcock’s request for an OIG investigation will calm the opposition and prevent heads from rolling at FDA.
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