“I'm still concerned that we haven't resolved what the fundamental problem is,” Mazzo said at a media event today during the AdvaMed annual meeting. “Until we get that, I don't think any of our member companies will want to take action” on other outstanding issues.
The current legislative authority for MDUFMA, reauthorized in 2007, will expire in September 2012. The discussions are on track to produce a recommended approach by early 2012, he said.
Among the other issues the discussions seek to resolve is whether device companies will support increases in medical device user fees to fund more FDA personnel and additional training for them. Such steps will increase the speed of the device review process only if the existing problems already slowing down the process are addressed first, Mazzo said.
Tripling the FDA's user fees and doubling of its budget in recent years has not helped speed up the approval process, Stephen Ubl, president and CEO of AdvaMed, said at the media event.
“So it's not a simple matter of adding additional resources,” Ubl said.