White House sends mixed message on FDA user fees

On Thursday, the Trump Administration sent mixed messages on reauthorization of FDA user fees, reiterating its view that industry should fully fund product reviews and also saying it "supports the goals” of reauthorization legislation. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs,” according to a White House statement. “In an era of renewed fiscal restraint, industries that benefit directly from FDA's work should pay for it."

Congress has rejected the White House request. In testimony to congressional committees, FDA Commissioner Scott Gottlieb said the proposal was drafted before he joined the administration and he declined to discuss it. It would be impossible to renegotiate user fees on prescription drugs, generic drugs, biosimilars and medical devices before the current fees sunset on Oct. 1 (see BioCentury Extra, May 17)...