Amid criticism, FDA narrows use of $56K Alzheimer’s drug, calls for probe [Updated]

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

Update 7/9/2021, 2:35 pm ET: The Acting Commissioner of the Food and Drug Administration sent a letter to the Office of the Inspector General Friday calling for an independent review of the agency's controversial approval of the Alzheimer's drug Aduhelm.

"I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures," Acting Commissioner Janet Woodcock wrote in the letter, which was addressed to acting Inspector General Christi Grimm.

In explaining the call for the investigation, Woodcock cited the "significant attention" and concerns raised by the agency's decision to approve the drug. It is "inevitable" that some FDA decisions lead to controversy, she wrote, and "I have tremendous confidence in the integrity of the staff and leadership" involved in the decision. But, a review is necessary, she added, because the mounting concerns could "undermine the public's confidence in the FDA's decision."

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