Leaders of the US Food and Drug Administration (FDA) and members of the advisory panel that recommended against approval of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) have gone head to head in two perspectives published today in the New England Journal of Medicine.
In the first editorial, G. Caleb Alexander, MD, and seven past and current FDA Peripheral and Central Nervous System Drugs Advisory Committee members describe the drug’s approval as a “regulatory failure.”
“The FDA’s decision is at odds with the evidence and with the agency’s biostatistical review. The overwhelming unmet need in this common and devastating disease should drive research investments, not lowering of regulatory standards that Americans rely on for safe and effective medicines,” they write.
In response, Billy Dunn, MD, and other FDA leaders, including the director of the organization’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, MD, write that they believe “current knowledge was appropriately reflected” in aducanumab’s approval.
“Alexander et al. characterize the FDA’s decision as a “regulatory failure”; we could not disagree more strongly,” they write. “The decision fits squarely in the accelerated approval pathway, which was created to allow patients with a serious or life-threatening disease earlier access to a potentially important treatment.”
Since the June 7 approval of the drug, which was contrary to the nearly unanimous thumbs-down vote from the advisory panel, the debate among investigators, clinicians, and regulators has been contentious, with three of the advisory panel members resigning in the days following aducanumab’s approval.
Since then, the FDA has updated updated the label for the drug to focus only on the specific patient group that should be treated, while also calling on the Office of the Inspector General to launch a federal investigation into its own approval proceedings for the drug.
In a third paper, also published today in the New England Journal of Medicine, Gil D. Rabinovici, MD, from the University of California San Francisco, notes that practicing “clinicians and payers must now set responsible guidelines for clinical use of aducanumab,” even in the absence of certain evidence about the medicine.
This follows expert guidance on appropriate use released earlier this week and presented at the annual Alzheimer’s Association International Conference in Denver, Colorado.
N Engl J Med. Published online July 28, 2021.
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