In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.
"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.
Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.
I may have been born at night â€“ but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.