FDA calls for federal investigation into approval of Alzheimer’s drug

The Food and Drug Administration’s acting commissioner on Friday called for a federal investigation into officials within her own agency who reportedly met with the makers of an Alzheimer’s drug ahead of its controversial approval last month by the FDA.

Acting Commissioner Janet Woodcock called on the independent Office of the Inspector General to investigate whether executives from Biogen, the company that makes Aduhelm, the drug in question, met with FDA staff outside of formal correspondence. “There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock wrote in a letter posted Friday to acting Inspector General Christi Grimm.