Posted by Michael Wonder on 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes.
Yet, as Jeanne Lenzer and Shannon Brownlee report, they increasingly provide the basis for drug approvals.
In November 2020, not one of the US FDA’s 11 member advisory committee voted to approve Biogen’s aducanumab for the treatment of Alzheimer’s disease.
When FDA administrators nevertheless went ahead with the approval on 7 June 2021, three members of the committee quit in protest, sparking a national outcry.
