FDA calls for investigation into industry influence during Alzheimer’s drug approvalBMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1778 (Published 12 July 2021) Cite this as: BMJ 2021;374:n1778
- Owen Dyer
The acting commissioner of the US Food and Drug Administration (FDA) has asked the health department’s inspector general to investigate allegations of improper contact between FDA regulators and a company whose Alzheimer’s disease treatment won a controversial approval last month.
“Given the ongoing interest and questions,” Janet Woodcock wrote on Twitter, “today I requested that the inspector general conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm.”1
The request came hours after the agency restricted the potential market of aducanumab (Aduhelm), retreating from a June approval2 that would have made it available to all US patients with Alzheimer’s disease, estimated at over six million people. Instead, the drug’s labelling will indicate its use only in those who have not progressed beyond mild cognitive impairment or early …