FDA will not tolerate fraud…meaning what, exactly?

Watchcat

Trusted Information Resource
#1
In April I decided I would follow up on claims of FDA approval for products that were authorized only for emergency use. It didn't take long for the initial trickle to become a tidal wave. When I realized that Reuters was touting pretty much every EUA product as having been approved by FDA, I let it go.

But there was one example that I just couldn’t shake. I still hadn’t shaken it when FDA’s press release came out last week:

“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk. Such conduct will not be tolerated by the FDA..." FDA Press Release, June 17, 2020
 
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Wes Bucey

Quite Involved in Discussions
#2
In April I decided I would follow up on claims of FDA approval for products that were authorized only for emergency use. It didn't take long for the initial trickle to become a tidal wave. When I realized that Reuters was touting pretty much every EUA product as having been approved by FDA, I let it go.

But there was one example that I just couldn’t shake. I still hadn’t shaken it when FDA’s press release came out last week:

“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk. Such conduct will not be tolerated by the FDA..." FDA Press Release, June 17, 2020

So I decided, okay, I will take up this one, at least…
So, by "take up this one, at least" do you mean that you will make a formal complaint to the FDA? Will you post corrective language as comments to LinkedIn posts touting the product? Will you want to enlist the members of the Cove in your campaign for true transparency? For more than 40 years, I have been consulting individuals and organizations on evaluating and implementing (OR NOT IMPLEMENTING) an idea (for a product, a course of action, a new market, etc.)

In the Quality business, we put a lot of stock into the concept of FMEA (Failure Mode Effect and Analysis), but in my consulting practice, I also have to help some clients consider the consequences of being a whistleblower. So, before embarking on your Crusade, please read through this long thread Ethics - Moral law vs. Criminal law
 

Watchcat

Trusted Information Resource
#3
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." :LOL:

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?
 
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Wes Bucey

Quite Involved in Discussions
#4
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." :LOL:

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?
When it comes to Agency enforcement of their rules, almost every federal agency has major "slips twixt cup and lip." One look no further than the woeful record of preventing spam calls and texts. Thank goodness, my current cell phone service has unlimited voice and text or I would go broke paying for all the wasted time and space engendered by spam calls and messages. VOIP has been a key to the kingdom for these spammers who spoof new phone numbers faster than I can blacklist them. I have over 200 numbers blacklisted, but each week brings more calls, many with blocked IDs.

Consider that the wording in most "Thou shalt NOT" rules are vague and wishy washy exactly because there has been participation in the wording by the very actors who either are, or lobby for, the miscreants. In the case of federal agencies, change is rarely instigated by lone wolves, but by organized groups who/which derive a benefit from the change. Seeking change requires researching to identify such groups and influence THEM to join the Crusade as if it were THEIR idea and instigation. When I would do my introductory presentation on Change Management, I would use a magic trick involving the audience to induce the question, "How did he do that?" The answer of course is "Very well, if you ask the question." then I'd go on to make the point, "Every magician knows what the outcome of the trick is going to be and how it was or will be accomplished. The effort is in leading the audience to participate in the journey. If you want change in an organization, you need to get employees, suppliers, customers, and regulators to join in the journey. Change does not happen in a vacuum."
 

Watchcat

Trusted Information Resource
#5
Every journey begins with but a single step.

I agree that groups can be good at effecting change. I must disagree about instigating, though. I think groups tend to be reactive, waiting for a good issue to fall in their lap...and often needing someone to push them into taking it up. I think lone wolves (or watchcats) are better at actual instigating.

In this case, there is "enforcement," "enforcement discretion," and interpretation. EUA is new. Step one is for the Agency to be made aware that this is happening. It might have already known, but given everything else going on, quite possibly not. (It definitely knows now, so that is one small change instigated by one lone watchcat.) Second, the Agency needs to decide if it thinks this is enforceable. If so, then whether or not to enforce it, or to exercise its enforcement discretion. Until that happens, there is nothing to change.
 

Wes Bucey

Quite Involved in Discussions
#6
Every journey begins with but a single step.

I agree that groups can be good at effecting change. I must disagree about instigating, though. I think groups tend to be reactive, waiting for a good issue to fall in their lap...and often needing someone to push them into taking it up. I think lone wolves (or watchcats) are better at actual instigating.

In this case, there is "enforcement," "enforcement discretion," and interpretation. EUA is new. Step one is for the Agency to be made aware that this is happening. It might have already known, but given everything else going on, quite possibly not. (It definitely knows now, so that is one small change instigated by one lone watchcat.) Second, the Agency needs to decide if it thinks this is enforceable. If so, then whether or not to enforce it, or to exercise its enforcement discretion. Until that happens, there is nothing to change.
Of course, the lone wolf instigates - the wolf just massages the ego of the mugwumps in the group to take ownership of the idea. The tried and true path is to determine the mugwump's WIIFM trigger (WIIFM = What's In It For Me)) and "let" him think the idea is his. (some mugwumps just like the attention of notoriety, others like the glory of fighting and winning against a faceless agency and maybe getting a higher office in his organization.) NEVER offer a cash emolument!
 

Watchcat

Trusted Information Resource
#7
There are a few other ways, but this one is reliable and I think the road most traveled by. As some Covers can undoubtedly attest, ego-stroking is not my strong suit, so I usually have to find another way. Or at least an ally who is better at that part than I am. Which is not exactly a high bar. :giggle:
 

McNeal

Registered
#8
The true meaning of the FDA's statement is that they will not tolerate any alternatives to the already existing products. Mr. Shuren says that alternative products "put the health of Americans at risk," but in fact, it's the FDA that slows down the approvement of almost every product. Several years ago, I suffered from their bureaucracy when I tried to approve one of the Chinese products to sell.
 

Watchcat

Trusted Information Resource
#9
I'm in no position to know why FDA declined to approve your product, but FDA clears or approves some 20,000 alternatives to already existing medical devices every year, so it seems unlikely that this was the reason.

I think the only person who can speak to the true meaning of any statement is the person who said it.
 
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