(CNN) US Food and Drug Administration Acting Commissioner Dr. Janet Woodcock on Friday requested an investigation by the US Department of Health and Human Services Office of Inspector General into the controversial approval of the Alzheimer's disease drug Aduhelm. In a letter posted on Twitter, Woodcock said an independent review and assessment should consider interactions between Biogen, the company that makes Aduhelm, and the FDA during the process that led to the June approval of the drug. Woodcock wrote she has "tremendous confidence in the integrity of the staff and leadership" in the FDA's Center for Drug Evaluation and Research involved in the review of the drug, aducanumab, and sold as Aduhelm. "There continue to be concerns raised, however, regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the form correspondence process," Woodcock wrote to to OIG Acting Inspector Christi Grimm. "To the extent these concerns could undermine the public's confidence in FDA's decision, 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."

Source: CNN July 09, 2021 17:36 UTC