Woodcock Requests Independent Review Of Biogen-FDA Aduhelm Interaction … Not Approval Decision
US FDA Acting Commissioner’s request for an HHS OIG review related to the Alzherimer’s drug approval is fairly narrow and continues to frustrate critics who believe the drug should not be approved. Woodcock expressed confidence in the CDER team in the letter to OIG, framing the investigation request as a move to help ensure public trust in the FDA.
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A Congressional report on the US FDA approval of Biogen/Eisai’s Aduhelm generated another round of negative headlines for the agency – and rubbed salt in the wounds of a commercial disaster for the sponsors. But it probably could not have turned out better for FDA and the drug review climate overall.
US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings
Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.