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Worked Closely

A group of senior officials at the US Food and Drug Administration concluded two months before the agency approved a controversial Alzheimer's disease drug that there was not enough evidence that the drug was effective, the New York Times reports.

It adds that the council of 15 officials thought that another clinical trial of aducanumab was needed prior to any approval. That conclusion echoes what an outside advisory panel told the agency last November. However, despite usually following the recommendation of its outside panels, FDA approved aducanumab, Biogen's Aduhelm, last month. The approval announcement triggered panel members to resign, with Harvard Medical School's Aaron Kesselheim calling the approval a "debacle." Acting FDA Commissioner Janet Woodcock has further called for an independent investigation of the approval following reports that there may have been "off-the-books" meetings between Biogen and FDA officials.

In a new report, the Times says that the "process leading to approval took several unusual turns, including a decision for the FDA to work far more closely with Biogen than is typical in a regulatory review." It notes, for instance, that the company and agency frequently met in summer 2019 to develop a path forward for approval and made a joint presentation to the outside group of experts. Additionally, the Times reports that an FDA official and Biogen official made joint presentations and appeared on panels together during the aducanumab trials.