US Review of Biogen Alzheimer’s Drug Could Have Been Handled Differently: FDA Chief

By Reuters
Reuters
Reuters
July 15, 2021 Updated: July 15, 2021

The U.S. Food and Drug Administration could potentially have done more to avoid the current controversies around its accelerated approval of Biogen’s Alzheimer’s drug, Aduhelm, FDA acting Commissioner Janet Woodcock said during a Wednesday summit hosted by Stat.

The FDA last week called for an independent federal probe into its representatives’ interactions with Biogen ahead of the regulator’s approval of Aduhelm last month.

“The accelerated approval was based on very solid grounds,” Woodcock said during Stat’s Breakthrough Science Summit. However, she said, “It is possible the process could have been handled in a way that would have decreased the amount of controversy involved.”

By Carl O’Donnell

Reuters
Reuters