The acting commissioner of the Food and Drug Administration on Friday asked an independent watchdog to review the process that led to the controversial approval of drugmaker Biogen’s new Alzheimer’s treatment, Aduhelm.
In a letter to the Office of Inspector General at the Department of Health and Human Services, the FDA’s Dr. Janet Woodcock asked for “an independent review and assessment of interactions between representatives of Biogen and the FDA” during the approval process.
The request follows a report from STAT News late last month that detailed an unusual back-channel collaboration between Biogen and the FDA during the approval process, including an “off-the-books” meeting with the agency’s top regulator of Alzheimer’s drugs. “FDA played an extraordinarily proactive role, even drafting a road map on how the company could win approval,” the STAT report said. “Several experts said that relationship was not typical and raised serious concerns.”
In her letter Friday, Woodcock wrote that she has “tremendous confidence” in the integrity of the FDA officials involved in the approval process “and their commitment to unbiased and science-based decision-making.” But she added that, given the concerns raised about the contacts between the FDA and Biogen during the review process, an independent review was necessary. “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,” Woodcock said on Twitter.
