ICER President Discusses How Iffy Biogen Decision May Bring Down FDA’s Accelerated Approval Program

Steve Pearson of the Institute for Clinical and Economic Review (ICER) weighed in on how the Food and Drug Administration’s decision to approve Biogen’s Aduhelm may lead to the end of accelerated approval designation.

ICER President Steve Pearson remarks, “Aducanumab is, in a sense, a poster child for some of the issues around accelerated approval that people have been talking about. You take these general [problems], and you can basically pin the tail on the donkey with every one of them with aducanumab.” Read more here.

(Source: Nicholas Florko, STAT News, 8/10/21)