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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, Woodcock requested an “independent reviewand assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.”
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.
FDA granted accelerated approval for Aduhelm on June 7, 2021 based on slim evidence that it may provide benefit for some Alzheimer’s patients, gains to be confirmed in post-approval studies [see ]. However, the approval decision ignited an eruption of criticism, largely due to a very broad label supporting prescribing for both early and late Alzheimer’s conditions. Biogen’s $56,000 price tag on the drug, moreover, generated outrage that it would bankrupt Medicare, which provides care for most patients likely to use the drug.
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. CDER officials used the press to further explain their actions. However, the criticism escalated further with the revelation by the STAT website of efforts by high-level FDA staffers to find a pathway for approving the Biogen drug despite the advisory committee rejection, largely to meet patient demands for any promising treatment [see ]. That internal discussion led the agency to decide that the possibility of some potential benefit supported accelerated (but not final) approval of 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 https://investors.biogen.com/news-releases/news-release-details/fda-approves-updated-aduhelmtm-prescribing-information-emphasize. Such action is highly unusual so soon after product approval and was seen as a way to reduce potential spending on the drug and thus deflect criticism. However, the revision is not expected to limit prescribing noticeably, although it may provide insurers with some flexibility to negotiate reimbursement.
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.