Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me.
I went to see my doctor a few weeks ago for a physical. Since I just turned 40, he recommended that I have a CT scan to check for calcification in my heart valves. Maybe I would have said "no," when he mentioned that the cost would not be covered by insurance, but his cautionary tale about a person he knew who had collapsed and died of a heart attack at the age of 42 persuaded me that maybe this was a good idea after all.
Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year.
The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up because Steve Grossman of the Alliance for a Stronger FDA (Washington) raised the issue recently at the Gooznews blog. So let's take a quick look at this issue and examine the question of not just whether FDA is sourced to do this, but whether it should even consider such a task.
A prolific inventor who died last week in upstate New York at the age of 92, Wilson Greatbatch is credited with more than 325 patents, including coming up with the first practical implantable pacemaker.