Bloomberg Law
Free Newsletter Sign Up
Bloomberg Law
Welcome
Go
Free Newsletter Sign Up

FDA Head Defends Speedy Process Used to OK Biogen Alzheimer Drug

Nov. 23, 2021, 7:08 PM

High drug costs are driving much of the criticism over the FDA’s decisions to speed up certain approvals by using data that predicts patient benefit instead of demonstrating it, the agency’s acting head said.

Janet Woodcock, a Food and Drug Administration veteran who’s been serving as acting commissioner since January, defended the agency’s use of accelerated approval in a video released Tuesday as part of the Biopharma Congress’s virtual series. That pathway comes with flaws, but it’s “saved a huge amount of lives” in the nearly 30 years it’s been available, she said.

“Much of the debate though ...