USA – FDA’s accelerated approval program: Is change on the way?

The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?

At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has already acted to codify and grant enforcement authority to the FDA through the original act and subsequent reauthorizations, he explained.

“The question is, what will happen in 2022?” asked Dorsey, who is also a former FDA staffer. “I think the real lesson from this brief history is that Congress is well aware of what FDA is doing in this space, has given it consideration and essentially codified and agrees with FDA’s approach to accelerated approval, and has done so over an extended period of time.”…