Well, Hi Wes. Good to see you around, you old curmudgeon. I have stuck mostly to the medical device threads this time on the Cove, but this is not my first time through, and I always enjoyed your posts on Quality matters. My favorite, which over the years I have periodically quoted in the "real world," was "Because management doesn't give a rat's patootie about Quality."
I did consider a formal complaint to FDA, but I wasn't sure if there was really anything to complain about. FDA has long been tolerant of companies claiming a medical device was "approved" when it was only "cleared." IMO, that contradicts the language in the press release, but perhaps FDA sees it differently. Plus "authorized" is a new ballgame, brought to the fore by the pandemic.
I also replied to many of the LI posts, saying that the product was NOT approved by FDA, but was an UNAPPROVED product authorized for emergency use only. That was in late April, when they received authorization. Before I started putting this together, I checked back to see if any had been deleted, but no.
Also before starting on this, I emailed someone at FDA for a bit of clarification, and they replied with just about that much. But they know me well enough to know that I might well be working on something like this, so this also served as a heads up. Realistically, however, this is probably the least of their worries, If a worry at all. Another reason not to submit a formal complaint. They have much bigger fish they should be frying. And also a frying pan or two they should be trying like crazy to stay out of themselves right about now.
I don't follow the media, but apparently 60 minutes did a bit on the EUAs the day after I posted this around LinkedIn and also in the forum of of the Regulatory Affairs Professional Society. I still haven't watched the 60 minutes piece, might never watch it, but my impression is that it was mostly bemoaning the lack of prior review of these products. Congress has also started rattling its chains. Funny how none of these players expressed any "concern" until now, after FDA had already rubberstamped well over 200 antibody tests into the market with virtually no review.
I don't consider this whistleblowing. I'm not a company insider reporting some secret misdeed that no one on the outside knew about. On the contrary, my concern was that the two companies and numerous employees had posted it publicly themselves.
The fact that it was these two companies made it "interesting" for me. I am in NC. One is headquartered here, and the other has a significant presence. I have connections to both companies and with people who work and have worked there. I used to work at one of them myself, but long enough ago for "disgruntled former employee" to be a tough sell. I even own a little stock in one, which has done pretty well over time.
One thing I now regret that I didn't point out in the post is that both of these are fundamentally service companies, not medical device manufacturers regulated by FDA. As far as I can tell, one has one test listed with FDA, a Class I 510(k) exempt device, the lowest risk and least regulated class of device. I personally would not expect either company to have deep knowledge of FDA regulations.
Plus they are both big snarly behemoths. Both were big snarly behemoths before the one acquired the other. Now, I can only imagine. Plenty of opportunity for many left hands not knowing what many right hands are up to.
I tried not to make this about the companies, but, first and foremost, about the question of whether or not this type of "advertising" met FDA's definition of "false and misleading." Then, if so, should FDA enforce it or exercise its enforcement discretion...and further, and more broadly, what is FDA to do about this type of social media advertising? What can it do, realistically?
