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FDA Seeks Review of Approval

Janet Woodcock, the acting commissioner of the US Food and Drug Administration, is seeking an independent investigation into the agency's approval of a controversial Alzheimer's disease drug, the Financial Times reports.

The agency approved aducanumab, Biogen's Aduhelm, last month under its accelerated approval pathway despite an advisory panel determination that there was not enough data showing that the drug worked. The approval sparked resignations among advisory panel members, with Harvard Medical School's Aaron Kesselheim calling the approval a "debacle" in his resignation letter, as the Wall Street Journal reported. Stat News additionally reported there appeared to have been "off-the-books" meetings between Biogen and FDA officials.

Citing this, Woodcock called on the inspector general of the Department for Health and Human Services to review interactions between FDA staff and Biogen, FT says. "We believe an independent assessment is the best manner in which to determine whether any interactions that occurred between the manufacturer and the agency's review staff were inconsistent with FDA's policies and procedures," she says in a tweet.

Biogen told Stat News it "respect[s] and followed the FDA's guidance, regulations, and processes" during the review of Aduhelm and further tells CNN that it will "cooperate with any inquiry in connection with a possible review of the regulatory process."