For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002.
This is not the only example of a request for a device down-classification that lingered at the agency for close to or all of 10 years. The agency's Center for Devices and Radiological Health needed 10 years to reclassify a couple of catheter types last year after a request was filed in 2000 by Cook Medical (Bloomington, Indiana).
These are conspicuous delays, but I have to admit I have no recall of hearing anyone in industry complain about laggardly device re-classification requests, so I'm assuming they're none too numerous.
I asked around at FDA to find out what the explanation might be for the delay in the reclassification of Yersinia diagnostics. Here's what I heard:
CDRH's Office of In Vitro Diagnostics has been continuously working on this for some time and has at all times remained committed to the reclassification's completion. During this process a series of other issues have emerged, such as SARS, H1N1, HIV waiver, setting up a structure to deal with CMC emergency use preparedness, issues with laboratory developed tests and others that have needed to be made Office priorities. Many of these priorities have required the use of the same subject matter experts that were working on the reclassification.
Additionally, we have experienced significant personnel changes (which are natural for any small-to-mid size organization) during the reclassification effort and have been working within the usual clearance processes for these actions, which include many steps.
Whether that's good enough for anyone in industry I don't know, but it fits in with my (admittedly preconceived) notion that the resource crunch at FDA has created a lot of headaches for industry and agency alike. It'll be interesting to see how FDA fares in fiscal 2013, but I get it if some are pessimistic.
FDA, industry, docs all in cahoots?
The second tale has to do with a dinner my wife and I had recently with some friends, who'd invited several other friends over. My wife and I were not that familiar with the general views of many of the other guests, but that made for a great opportunity for opinion gathering.
I asked everyone at the table what they thought of FDA, and the answers were uniformly less than flattering … a lot less. They ranged from remarks to the effect that FDA is in bed with industry to the view that FDA is utterly incompetent and not to be trusted with anything. For what it's worth, some of the opinions were that doctors are also in bed with industry, making for an eerie healthcare ménage à trois.
Much of the suspicion regarding FDA and device makers had to do with the implications of user fees, but my dinner mates who felt the user fees were the problem were also unaware of how long the user fee program has been in place and hence could not say whether their suspicions pre-dated the onset of that program.
Whatever the case, there apparently is a strain of thinking which holds that FDA, industry and doctors are some sort of unholy trinity seeking to hoodwink patients into bad devices. I have no idea how widespread that kind of thinking is, but there may be tens of millions of Americans who see it that way. FDA, docs and device makers perhaps ought to ask themselves whether it's particularly smart to allow that kind of thinking to go unaddressed.
But we'll talk more about that later this week.