FDA Accelerated Approval Reforms Makes the Cut on US Congress Government Spending Bill

The US Food and Drug Administration (FDA) got a win in the just-passed $1.7 trillion government spending bill. The bill includes provisions that would allow the agency to ask applicants start confirmatory studies before they are granted accelerated approval. In addition, companies receiving accelerated approval would need to provide data from confirmatory studies every six months.

According to Max Bayer, “The reforms are intended to shore up an often-relied-on mechanism for companies to take potentially beneficial drugs and get them into the hands of patients with little to no treatment options. Accelerated approval allows therapies to be approved based on evidence that they are reasonably likely to predict clinical benefit, rather than more straightforward efficacy data. Companies must then perform confirmatory studies to prove benefits. The pathway was opened in the 90s to spur the development of HIV treatments, but in the last decade has been primarily used to advance cancer therapies.”

To read more, click here.

(Source: Fierce Healthcare, December 20^th, 2022)