Drug companies need to “step up and take their drugs off the market as rapidly as possible” if a follow-up study shows their fast-tracked product doesn’t work, FDA’s oncology chief said.
Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, made his remarks in addressing criticisms of the accelerated approval program, which has come under fire after the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm. He has long supported ways to speed up access to potentially lifesaving medicines but acknowledged the need for changes to the program.
“This is a topic that’s near and dear ...