It doesn’t take 365 days to do useful things or to stink up the joint, but a year gives us plenty to work with, doesn’t it? Following is a list of a few things that were very interesting about 2014 to put it mildly.
To start, there’s the March 25 FDA notice in the Federal Register about medical device classification rules. I’ve blogged about this before, so there’s not much else to say other than that the agency seems to have bit off far more than it can chew on this one, given that the proposal seems to have fallen off the face of the Earth. One suspects its not over yet, though.
Congress got into the act, too – albeit inadvertently – where the Menaflex case is concerned. One interpretation (mine, anyway) is that the passage of the Food and Drug Safety and Innovation Act, which was itself not a 2014 event, allows FDA to up-classify a device without going through the rulemaking process. The upshot may be that Congress gave the agency a get-out-of-court-free card despite that FDA lost the Menaflex lawsuit at the end of September 2014.
Unapproved literature more to your liking? You would love the February 2014 revised draft guidance FDA dealt for the distribution of peer-reviewed articles dealing with off-label uses of medical devices. This has been in the works since 2008, and the latest effort prompted nearly 160 responses, which says a lot. As best as I can tell, this is another stalled FDA effort.
Maybe the biggest news from the CMS side is the new paradigm for coverage with evidence development (CED) program, a remarkably brief document given the fuss and bother that preceded it. Here’s a passage I find odd:
“CED will lead to the production of evidence complementary to existing medical evidence.”
If the device in question has to have been approved by FDA …
2014 was also the year that brought an end to the reign of Harry Reid over the U.S. Senate. Reid was one of the most Machiavellian Senate majority leaders in recent memory, blocking legislation – including dozens of spending bills – so routinely that the Senate became the ultimate do-nothing legislative body.
As for the health IT crowd, the Office of the National Coordinator became the HHS orphan with the announcement that the freshly-minted director, Karen De Salvo, would take the job of Ebola czar. Some now see ONC as a paper tiger, so…
And finally, one of the more interesting developments in the world of health research was that NIH finally pulled the plug on the National Children’s Study, an overly-ambitious undertaking that commenced when Bill Clinton was in the White House. Common sense mercifully prevailed where this gigantic life-science boondoggle is concerned, but not before $1.3 billion was siphoned off by the glitterati of the world of epidemiology.
So 2014 was certainly a scintillating year, but there’s tremendous potential for controversy waiting for us in the coming year!