FDA Accelerated Approval ‘Painfully Slow’ to Show Drug Benefits

Shortening the time it takes to determine whether a new drug offers its predicted benefit is the main way to improve an FDA approval process facing criticism, the agency’s commissioner said.

“Right now we have a system which is painfully slow to get the answers,” Robert M. Califf said Thursday. “Essentially, we need to get good studies done after the approval in a very efficient way as quickly as we possibly can.”

Califf’s remarks at the STAT Breakthrough Science Summit marked one of his first major public appearances since confirmation in February of his second tour as commissioner of the ...