“Much of the debate,” around the US Food and Drug Administration’s accelerated approval program is not driven by the questions surrounding treatments’ risks and benefits but is instead spurred by “the larger societal trade off of the high prices for these agents,” FDA Acting Commissioner Janet Woodcock said in response to complaints around accelerated approval and whether she believes the program is ripe for reform or working as intended.
“Those perceived price tags don't just raise eyebrows, they create opposition to the entire program,” Woodcock said in a late...
