Acting FDA Commissioner Dr. Janet Woodcock is responding to criticism about the agency’s controversial decision a month ago to approve aducanumab, Biogen’s and Eisai’s Alzheimer’s drug.
In a letter to Principal Deputy Inspector General Christi Grimm, Woodcock called for an independent investigation into the contacts between Biogen and FDA during the approval process. Biden has nominated Grimm to be inspector general. Grimm has served as the acting HHS inspector general since early 2020.
Woodcock stressed in the letter to Grimm that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making.”
Yesterday, Biogen announced that the agency had limited its prescribing recommendations for the drug to a subset of Alzheimer’s patients. The agency had initially indicated it for all Alzheimer’s pa…