A congressional panel is set to hold hearings on the re-authorization of the Medical Device User Fee Act, in what could be a rough outing for FDA officials.
On February 15, the Health sub-committee of the House’s Energy & Commerce Committee will call Dr. Jeffrey Shuren, director of the Center for Devices & Radiological Health as its witness. The committee has budget authority over the FDA and CMS.
The GOP-led panel is chaired by Rep. Joe Pitts (R-PA), an outspoken critic of the FDA, who has called the watchdog agency an impediment to continued U.S. leadership in the global medical device field.
"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 in a November, 2011 editorial in The Phildelphia Inquirer. "New inventions and cures will only come if inventors have a clear path to bring their product to market…In recent years, the FDA’s approval process has become a bottleneck," he wrote. "It has become less transparent, less predictable, and less efficient."
It was not the first time Pitts set his sights on the regulatory process. In February of last year, he launched an inquiry into why the FDA’s medical device approval process takes longer than the European system. And 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.
The current medical device user fee amendement expires at the end of September.
FDA and representatives from industry have held several negotiation meetings over the past year in an effort to come to an agreement over new fees.