Pennsylvania Rep. Joe Pitts (R) lambasted the FDA in a recent editorial, calling the watchdog agency an impediment to continued U.S. leadership in the global medical device field.
Pitts is chairman of the Health sub-committee of the House Energy & Commerce Committee, which has budget authority over the watchdog agency.
"We need the FDA to make sure that devices are safe, but we don’t need them to stand in the way of cures or jobs," Pitts wrote. "New inventions and cures will only come if inventors have a clear path to bring their product to market."
He added that, while competition among nations is healthy, "some of the foreign gains have been made not because of ingenuity, but because U.S. companies are being held back by the Food and Drug Administration."
Pitts told the tale of a device from his home state, a non-invasive brain scanner by InfraScan of Philadelphia. The scanner has languished in FDA limbo since 2008, he wrote, while European regulators approved it in 30 days.
"U.S. allies are using the Infrascanner on the battlefield right now, yet U.S. soldiers serving next to them do not have access to this lifesaving device."
Some companies are giving up on the U.S. regulatory process, Pitts added, and moving operations and jobs overseas.
"In recent years, the FDA’s approval process has become a bottleneck," he wrote. "It has become less transparent, less predictable, and less efficient."
This is not Pitts’ first foray against the FDA.
In February, Pitts launched an inquiry into why the FDA’s medical device approval process takes longer than the European system. In May he joined forces with fellow Pennsylvania Rep. Frank Pallone (R) to defend medical imaging spending in a letter to the Medicare Payment Advisory Commission.