In response to criticism, a top Food and Drug Administration official maintained that creating a firewall between agency staff during the process for reviewing medicines “would cause significant negative repercussions for public health.”
The notion was broached two months ago by the Public Citizen advocacy group shortly after an FDA advisory committee voted nearly unanimously not to recommend a controversial Alzheimer’s drug for approval. At the same time, however, the expert panel also took the unusual step of rebuking agency reviewers for glowing appraisal of the medicine, which was developed by Biogen (BIIB). Public Citizen argued the drug maker and agency collaborated so closely that the independence and integrity of the FDA was compromised.
The episode comes amid intense scrutiny of the medicine, aducanumab, because the clinical trial data that Biogen has promoted suggested the drug is the first to reduce cognitive decline. For this reason, there has been growing anticipation over its fate. Yet the path Biogen pursued — a slice-and-dice approach toward the data — divided the medical community and sparked uncertainty.
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