Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s discussion with guest, Mike Drues.

Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.

Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now. 

Listen now:

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Some of the highlights of this episode include:

• What an EUA is, and when it’s used

• An EUA as a pathway to market

• What the COVID experience has taught us about EUA

• Whether FDA reviews are back to normal

• The poor quality of some EUA submissions

• Quality requirements for EUA vs. non-EUA devices

• What’s new in EUAs beyond COVID

• Monkeypox EUA developments

• Improvements in EUA qualities as submissions continue

• Top takeaways from today’s discussion

Links:

Mike Drues LinkedIn

Article: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)

Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) Report

CDRH Website: Monkeypox Emergency Use Authorizations for Medical Devices

Article: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

FDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Webinar: How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic?

Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 here

Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 here

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know (GreenLight.Guru, April, 2020)

Podcast: Tips For Being Prepared Post-EUA (January, 2022)

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Mike Drues:

“Most every medical device can have some sort of digital layer to it.”

“The future’s already here, just not evenly distributed.”

“Lateral thinking means also just… trying new things and staying curious, but also sharing that with others.”

“You don’t want a separate device or app for every medical condition, you kind of want one ring to rule them all and to make holistic sense out of this.”

Transcript

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Jon Speer: Hello, and welcome to the Global Medical Device Podcast. This is the founder at Greenlight Guru, Jon Speer, and joining me today is president of Vascular Sciences, Mike Drues. Mike, welcome back to the Global Medical Device Podcast.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience.

Jon Speer: Absolutely. So you and I have talked about EUA, or emergency use authorization, maybe at least a time or two in the past on the Global Medical Device Podcast, and we'll dive into that here in a moment, but obviously the EUA topic, when we spoke about that before, was largely related or driven by COVID-19 and those sorts of things. But I'd like to dive into this a little bit more because I think we're at a point where obviously the pandemic seems to be coming to an end, and a lot of these products that went through the EUA pathway, there's probably some things that those companies need to be doing if they want to keep those products on the market and that sort of thing, so we might dive into some of that. But maybe a great place to start really is remind folks, give them a brief recap of what EUA is and when to use it and those sorts of things.

Mike Drues: Well, great question, Jon. And as always, thanks for the opportunity to have this discussion with you and your audience about a very important and still very timely topic. And by the way, Jon, I would make a little stronger comment of what you just said. We just haven't talked about EUAs from time to time in the past. We've talked about EUAs in significant detail in the past, and I'm also very proud to say that you and I were among the very first people in this industry to be talking about it. As a matter of fact, Jon, you may remember we did our first podcast on the EUA, and I did my first in- depth webinar on the EUA for Greenlight Guru in very early 2020, at the beginning of the pandemic, long before most other people in this industry, including the FDA, were talking about this. And the only reason why I point that out, Jon, not to be self- serving here, but I'm proud of the fact that many of the topics that we talk about are very much ahead of the rest of the herd. A lot of people, when they give a webinar, it's basically after somebody else has already talked about this 10 or 20 or 100 times. So anyway, that said, more importantly, a quick recap of the emergency use authorization for those in our audience that are not familiar with it, or maybe those that haven't heard some of our previous discussions. First and foremost, it's an alternative pathway to market. It's not in lieu of a 510K or a De Novo or a PMA. It's an opportunity for a company to get a device onto the market in an accelerated fashion, and I put that word accelerated in air quotes. I'll talk more about that in a moment. That's the theory. And one of the requirements of the EUA, on the labeling side, is we must make a COVID specific label claim. In other words, if you have a diagnostic device, an IVD, in vitro diagnostic, that can be used for, say, many different diseases, if you want an EUA on it, you have to make a COVID specific claim. If you have a ventilator or something like that, that might already be on the market for many different things. If you want an EUA on it, you need to make a COVID specific claim that the ventilator should be used for people specifically with COVID, or symptoms of COVID, or what have you. So one of the regulatory requirements is on the labeling side. Couple of other things just to note that I think are important for people to understand about the EUA, Jon, is in spite of what some of the politicians on the TV and what some of the folks at FDA will have people believe, there is definitely a lower regulatory burden for devices coming onto the market under the EUA as opposed to any other pathway to market. And there's no better way to demonstrate that, Jon, than to take FDA's words and throw it right back in their face. One of the statements that you see in a typical EUA authorization letter, and by the way, Jon, an EUA, as the name implies, it's an authorization. It's not a clearance or approval. But in the authorization letter it says, and this is a direct quote, " The device, when labeled consistently with the labeling authorized by the FDA, is authorized to be distributed under this EUA," and this is the important part, Jon, " Despite the fact that it does not meet requirements otherwise required by applicable federal law." Read that last part again, " Despite the fact that it does not meet requirements otherwise required by applicable federal law." And a similar sentence in typical EUA letters is, " Based on the totality of the scientific evidence available to FDA," direct quote, " That it is reasonable to believe that the device may be effective for emergency use in treating patients with whatever disease." In this particular case, COVID. "It is reasonable to believe that the device may be effective for emergency use for treating patients with COVID." And the reason why I bring that up, Jon, is because I think it's deceptive, or possibly even flat out lying, when people get onto the TV and say when it comes to medical devices, or even vaccines, that these products are held to the same standard, that they are just as safe and effective as other products, when that is, in my opinion, Jon, a factually incorrect statement.

Jon Speer: Yeah, that's true. I've heard similar things. I'm sure folks listening have heard these sorts of things, but as Mike has shared, and if you dive in deeper to the details, or if you're a company that actually went through and got an EUA for your product, it is a much, much simpler process than a more traditional 510K or De Novo or PMA, for that matter. So the" accelerated", but not just the" accelerated", the regulatory expectations are significantly relaxed as well, right?

Mike Drues: Yeah. And I don't want the audience to miss my message. I'm not saying that that's necessarily a bad thing because in a healthcare emergency, in a pandemic, taking certain, shall we say, shortcuts might be justified. But to illustrate perfectly, Jon, from my experience, I have a couple of customers who got UEAs on existing devices, and then they've gone back to the FDA for a 510K or a De Novo to keep the device on the market, and they are now totally overwhelmed, totally blown away at the additional work that they have to do. And they basically say to me, " Mike, we already got this through the FDA as an EUA. Why do we have to jump through a whole bunch of additional hoops for a 510K or a De Novo?" And I said, " Well, read FDA's verbiage." And just a couple of other things to close the review discussion, Jon, as I mentioned a moment ago, the EUA is a authorization, but it's a temporary authorization. Again, in the EUA letter, it says, " This EUA will cease to be effective when the HHS," Health and Human Services, " Declares that the circumstances exist to justify the EUA is terminated." And that's a political decision. And you may remember, Jon, back in January of this year, January of 2020, you and I did an EUA update. This is an EUA update update that we're doing today. But the previous EUA update was titled, " Tips for Being Prepared Post- EUA". And at that time, FDA announced they're probably going to be giving companies about six months to submit a 510K or a De Novo or a PMA if they want to plan to continue to have that EUA device at market. So once again, Jon, you and I have been ahead of the curve on this one multiple steps along the way.

Jon Speer: And I hope folks listened to that when we recorded that back in January, and took action. I don't believe the HHS has terminated the EUA as of yet, correct?

Mike Drues: They have not terminated it. In fact, they are still taking EUA submissions. Although, admittedly, Jon, they have really scaled back on which submissions they are taking. For example, in many areas, whether I agree with them or not is a different story, but FDA believes that we already have enough of these kinds of devices on the market, so they are actually now not accepting new EUAs in certain areas. But you can still do a 510K or De Novo or a PMA on anything you want. And as we're going to talk about it towards the end of today's discussion, Jon, in other areas beyond COVID, the EUA program is actually expanding. So within COVID, the EUA program is shrinking a little bit, but beyond COVID, it's actually getting bigger.

Jon Speer: Yeah, and I know EUA wasn't new or invented or created as a reaction to COVID. It was something that has been around for quite some time. Granted, not used probably all that often, or definitely not quite to the extent as we saw with COVID. But I know you've been on the front lines. You've mentioned at least one company that you've been working with on EUA. I'm sure you've worked with plenty of others. But what do you think we have learned about the COVID experience so far? I guess specifically with respect to EUA?

Mike Drues: Yeah, great question, Jon. I think we've learned a lot. And one of the resources that I was just reviewing recently, and we'll put this up on the website with the podcast for people to look at, this was about a 50 page report that was just issued last month, September of 2022, from the Office of the Inspector General, part of the Health and Human Services Department, so a parallel assistor to the FDA. And the title of this report was, " FDA Repeatedly Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 Testing". And interestingly enough, Jon, there was very little press about this report when it came out. I don't know why, because quite frankly, I think some of the findings in this report, well, they were not surprising to me, they might be surprising to some of us in this audience. So if it's okay with you, Jon, I'd like to just quickly highlight some of what I thought were the more poignant takeaways from that report, and then we can talk about them. And I got to preface this by saying that none of this was a surprise to me, Jon. Most of the problems that they talked about were not only preventable, but predictable. And it reminds me so many times when companies come to me, they're having a problem with the FDA, and they're in a hole and they want me to help them get out of the hole, and I say to them, " I'm happy to help you get out of this hole, but it would've been so much faster and easier and cheaper if you would've brought me in six months ago or a year ago to prevent you from getting into this hole to begin with." Because regrettably, Jon, one of the things that I've learned at playing this game now for about 30 years is virtually all problems that I see companies get into, not only are they preventable, but they're predictable. So with that said, here's some statistics for you. So at the beginning of COVID, FDA reviewed a record number of EUA requests, but many of these requests, they were a very poor quality. So let me just share with you some statistics, putting things into perspective. On average, before COVID, FDA typically would review about 100 in vitro diagnostic devices, or IVDs in a typical year, about 100. During the beginning of COVID, so we're talking the first couple months of 2020, at the beginning of the pandemic, FDA received on average more than 100 EUA requests per month, per month, as opposed to 100 per year before that, on top of what they were already reviewing already, right? And a year into COVID, so now we're fast forwarding into the beginning of 2021, FDA was still averaging more than 100 EUA requests per month for IVDs alone. Comparison to the previous pandemic, you may remember, Jon, back in 2009, the H1N1 influenza pandemic, which was the last pandemic prior to COVID, FDA issued in total 17 emergency use authorizations in the entire year. In comparison to the first year of COVID alone, FDA issued 320 EUAs specifically for COVID indications. And as a result, Jon, you may remember one of the things we talked about, certain branches within FDAs, specifically the IVD branch and the respiratory branch, they were so slammed that for over a year, I think almost a year and a half, they completely stopped accepting requests for pre- submissions. Not for COVID products, but for all products across the board. And several of my customers were affected by this. So clearly FDA has been inundated in terms of the workload. That's all publicly available information, Jon. The statistics that I just shared with you are from this report from just last month. But what is not publicly available, this is my Mike Drues' commentary on top of this, is that this reallocation of resources within FDA, and I have to be a little careful what I say here in a public podcast, has led to some folks in FDA being asked to review submissions that clearly they are not qualified to review. And I have had multiple senior folks at FDA tell me this personally. Of course, they would never say that publicly. But because they've just been totally slammed, they've got people reviewing submissions that, quite frankly, they're not qualified to review. That's some statistics for you. I want to go on, Jon, and talk about the bigger concern to me is that so many of these submissions were of, in FDA's words, poor quality. But before we go onto that, Jon, any comments about the statistics that I just shared?

Jon Speer: Well, I mean, a comment you made a little bit ago, FDA is still accepting new EUA applications, granted it's significantly less, and the other comment that you shared about basically FDA was resource constrained, so much so that they're pulling in people from here and there or what have you to help do reviews. Do you still feel as though FDA resources are strained? I mean, for example, IVD branch or division, have they stopped pre- subs yet even today, or have they resumed receiving pre- subs? Do we see life back to normal from an FDA review perspective?

Mike Drues: Well, what I would say, Jon, is life is going back to normal. I would not say that we're completely back to normal, but going back to normal. And once again, Jon, I don't like to talk, as so many people do, in just generalities and platitudes. I like to try to provide specific examples, direct evidence of what I'm talking about here. And again, I have to be very, very careful what I say. But I can tell you that recently I did a pre- sub with the FDA for a in vitro diagnostic. It was not for COVID, but it was a different type of IVD. FDA admitted in the pre- sub that they made a wrong decision on a previous submission of ours that happened during COVID, quite frankly because they were resource. In other words, basically they said, " We didn't have the proper time to evaluate this, therefore we made the wrong decision." And this was supposed to be a binding decision, Jon. But I was a little miffed. On one hand, I said, " Well, I appreciate you admitting, not publicly, but admitting privately to the company that you made the wrong decision, but with all due respect, what does your definition of binding meaning?" Because they're not sticking with this binding decision. So again, COVID is still having impact on many, many levels. So we're getting back to normal, but we're not quite there yet.

Jon Speer: Yeah. All right. Anything else that you think is important to point out of things that we've learned from the COVID experience?

Mike Drues: Yeah. So let me go on. This is something that I think is particularly problematic to me, the poor quality of these submissions. So here's a direct quote from an FDA reviewer, who said a lot of submissions, he or she is referring to EUA submissions, that FDA received were of" very poor quality." Very poor quality. That is not my words, that's this FDA reviewers'. And all that ate up our time. This is another reason why FDA was so slammed. Because not only did they get a ton of EUAs, but let's be honest, a lot of them were just total crap. And I've seen some of them. And I'm sorry if this sounds harsh to some people, Jon, but they were total crap. Examples of what low quality EUA submissions means includes things like they were missing necessary data or contained data that failed to determine if the test met authorized standards. As a matter of fact, FDA estimates that 80% of EUA submissions needed revisions, needed additional information. That means that only 20% of them were successful first time through the gate. And you and I have talked about statistics for the five 510K and the PMA and the De Novo, the EUA statistics are even worse than all of those others. So now the question is why? Well, this is interesting, and it's also talked about in the report, which is no surprise to me. They say that it's the smaller manufacturers and laboratories who have not interacted with the regulatory environment, i. e. the FDA, much before who struggle most in meeting this criteria. Here's another interesting statistic for you, Jon. Only 13% of companies who had requested an EUA for a non- COVID related product in the past. In other words, only 13% of companies that requested an EUA for COVID, only 13% of them did an EUA for something else prior to COVID, which means that, if I don't embarrass myself as a PhD in engineering child with my arithmetic, 87% of companies that pursued an EUA for COVID never did an EUA before. That's statistics number one. Statistics number two, only about 28% of them had gone through any FDA approval or clearance process at all, which means that over 70% of companies never went through any 510K, any De Novo, any PMA-

Jon Speer: This is a first time all-

Mike Drues: This is the first time you do brain surgery and you're cutting right into the guy's brain. No practice. No training. No nothing. And so as a result, experience helps. The experienced developers, the ones that had products on the market already, and the ones that had done EASs before, 91% of those developers who had previous experience with the FDA, either with an EUA or at least something else, went through the process successfully, 91%. Compared to 40% that had no experience, 40% went through the process without any major problems. In fact, and then if you want to chime in on any of this lack of experience, Jon, feel free, one FDA reviewer said that with less experience, they had no idea how things should be done, and required a significantly higher level of support. In other words, they relied on FDA to help them through this process. And as a regulatory consultant, Jon, and again, it might sound harsh to some people, that is not, underlining not, FDA's job to do. In spite of what the politicians will say, it is not FDA's job to help the company get their product onto the market. That's the company's responsibility. The FDA's job is to make sure that it's safe and effective, that it demonstrates the supports the label claims, and so on. In my opinion, Jon, it's like in a criminal trial where you have a prosecution and the defense. Are you going to expect the prosecuting attorney to give suggestions to the defense attorney on how to get their client off, right? They're probably not going to do that. That's not their job, right? So bottom line, Jon, if you have experience doing these things, you're going to be more successful. If you don't have experience doing these things, that's not a problem. You can't be an expert in everything, but get somebody to help you who is.

Jon Speer: Exactly. Thank you for sharing some of those statistics, because I have a lot of experience in talking with companies not in the medical device industry prior to, who have products or services or what have you that they felt would lend themselves well to help during the pandemic. Some examples, there were a lot of automotive companies that got into the mix and other non- medical device manufacturing companies that were involved in various EUA products and submissions and what have you. So I think the statistics that you just shared, that 28% of companies going through this for the first time, includes those companies who might not have been medical device companies before this EUA process as well.

Mike Drues: Correct. And Jon, that reminds me of one of the other differences in an EUA compared to other things that I didn't mention before, and I know that this is near and dear to your heart, so feel free to chime in, is the lower quality requirements for EUA devices as opposed to right non- EUA devices. And as perhaps some in our audience may remember from my webinar in the very early days of the pandemic, in I think March or April of 2020, when I did that webinar on the EUA and I took a deep dive into the EUA, and one of the examples that I used was ventilators. And one of the questions that I raised at the time, it was a rhetorical question, but today it's a very apropos question, what's better, to have a bunch of ventilators on the market sooner, or to have ones on the market that don't work? And that's exactly what's happened, and that's a result of the lower quality requirements, and it's also a result of, let's be honest, people doing things... They might have the best of intentions, but if you have a car company who now all of a sudden gets into the ventilator business, obviously there's going to be some similar skills, no question about it, but there's going to be some important differences.

Jon Speer: Absolutely. Well, that's a good, I think, synopsis of EUA in the COVID era, so to speak. I mean, I don't see EUA going away, but are there things on the horizon or things that are happening in this world that could have an impact on future EUA, I don't want to say opportunities, but situations or circumstances? I'm fumbling with words a little bit, but what's new in the world of EUAs beyond COVID?

Mike Drues: Yeah, great question, Jon. So just to recap, thus far I gave what I think are some of the important differences between the EUA versus some of the other pathway to market options. And then we did, using that inspector general report, a critical analysis of our COVID EUA experience thus far, and some of the lessons to be learned, including the poor quality of the submissions and so on. Now, let's take a look at the future, because that's most important to the companies that I work with is where are we going? Well, as you may remember, Jon, back in early 2020, that's when Health and Human Services first authorized the EUA for COVID. And now, two and a half years into that process, we're still doing it. The question is, where are we going from here? Well, COVID still remains at the top of the news a lot, but there's another thing that's been in the news a little bit recently, Jon, something called monkeypox. Have you heard of that?

Jon Speer: Yes, I've heard of it. So what's going on with monkeypox EUAs? Is this a thing now?

Mike Drues: Yeah, well, so this is starting to be a thing, Jon. A couple of things to keep in mind here. First of all, in August of this year, just two months before doing our recording today, in August, HHS, first they determined that monkeypox is now a healthcare emergency similar to COVID, not quite as much of an emergency here in the United States, but certainly an emergency in other places in the world. And so as a result, as of August and September of this year, again, just one or two months before when we're talking right now, HHS authorized companies to get an EUA for a monkeypox product, it could be a monkeypox device like a diagnostic or a monkeypox vaccine. And in point of fact, Jon, the FDA issued a monkeypox EUA template in September of last year for monkeypox EUAs. I would say, Jon, that the monkeypox EUA template is substantially equivalent, pun intended, to the COVID EUA templates that FDA has put out. And just last month, just about a month ago today, FDA issued first monkeypox EUA for a company with a realtime PCR, polymerase chain reaction, in vitro diagnostic. So we now have one successful EUA for a non- COVID, in this case, a monkeypox, diagnostic. The question is that going to be a trend that continues? Are we going to see more and more monkeypox related EUA submissions? Well, first of all, Jon, there's got to be a compelling business reason for companies to want to do this. And at the moment, I don't see a real strong compelling business reason for several reasons, not the least of which is, as I said a moment ago, monkeypox, at least right now, doesn't seem to be as much of a problem here in the US as it is elsewhere. And actually, Jon, there was a report that came out just three or four days ago from the CDC, and again, we can provide a reference to this report as part of the resources, but the title of the CDC report is, " Monkeypox Eradication Unlikely in the US as Virus Could Spread Indefinitely". But here's the important part that's not in the title. CDC says that monkeypox could continue to spread indefinitely, but at a very low level in the United States. In other words, not to the same extent as COVID. CDC says that monkeypox is unlikely to be eliminated from the US in the near future, and outbreaks are slowing as availability of vaccines have increased and people have become more aware of how to avoid infections, similar to COVID. So bottom line, Jon, is there a need for monkeypox products, and will we see more monkeypox related EUAs? I would say probably a few, but not nearly to the extent that we've seen with COVID. So here's my advice for companies in this area, Jon, and then feel free to chime in here. And what I'm talking about here is primarily for diagnostics, not for ventilators, not for personal protective equipment, not for imaging, but specifically for diagnostics. If you have a diagnostic that you can modify, maybe you have an EUA for COVID and you can modify it to be used for monkeypox, maybe it's an immuno based diagnostic where you take the antibody for COVID out and you swap it with an antibody for monkeypox, or if it's a molecular diagnostic, PCR, polymerase chain reaction, and you take a gene probe for COVID out of it and you replace it with a gene probe for monkeypox, then, to me, it's a no- brainer. I would definitely encourage the company to submit an EUA for that. It's going to be a pretty easy thing for them to do if they think that they can make a contribution in the monkeypox area. But for most other companies, Jon, unless something changes drastically, and again, we're talking about predicting the future here so nobody knows 100% certain, I don't see a real strong compelling reason, certainly not a business reason, for a lot of companies to get into the space for monkeypox. But most importantly to me, Jon, and this will be the last point in this area, then if you want to chime in, please feel free, prior to COVID, pretty much nobody in the medical device industry knew about the EUA or even heard of the EUA prior to COVID. Yeah, there were a few diagnostics for H1N1 and for a few things before that, but very much... When I used to teach medical school, Jon, I was fond of the adage, " When you hear hoof beats think horses not zebras." So the EUA, prior to COVID, has been very much a zebra, not a horse. With COVID, it has become a horse. I think by HHS now acknowledging monkeypox as a healthcare emergency, as a pandemic, and now allowing EUAs to be given for diagnostics, and we had, Jon, the first EUA for a vaccine for a monkeypox just a month or two ago as well, they've opened that door. So beyond monkeypox, who knows what's going to happen next? So I think now there's an interesting precedent that's being said here. In other words, in the past there have been very, very few declared healthcare emergencies with COVID and now monkeypox. Does that mean that we could potentially have more healthcare emergencies declared in the future? Of course, Jon, time will tell, but if we do, I want you and our audience to remember where did you hear it first. Thoughts on any of that, Jon?

Jon Speer: Yeah, I mean, it just doesn't feel like monkeypox meets the definition of a healthcare emergency, but I guess that's an ambiguous term that doesn't have necessarily a black and white criteria defined.

Mike Drues: Well, it's an interesting question, Jon. Admittedly, I'm not an expert in healthcare policy, and what you're talking about here are political decisions as much as scientific decisions. And I think it's probably beyond the scope of our particular discussion, whether monkeypox meets the definition of a healthcare emergency, but the point for our audience to remember is whether we think it is emergency or not, it has been declared a healthcare emergency, and therefore, for companies that this is applicable for, it now opens up the possibility for them of doing an EUA for a monkeypox diagnostic, or for any other product that you think might be valuable for a patient with monkeypox, including those personal protective equipment and ventilators and all that other stuff. But the same criteria, the same limitations that we've talked about today, as well as in our past discussions, that apply to COVID EUAs in terms of its a temporary author authorization and so on, that all applies to EUAs across the board, including a potential monkeypox. So my recommendation to our audience, Jon, especially to the regulatory folks in this audience, is you should definitely keep the emergency use authorization on your list of possible plays in your playbook, along with the 510k, along with the De Novo, along with the PMA, and all the other litany of possibilities, so that you're prepared to consider it if and when the time arises.

Jon Speer: No, I think that's good advice, because obviously from COVID healthcare emergency, now monkeypox being defined as a healthcare emergency, there's probably going to be something else in the not too distant future. I mean, that's not a bold prediction by any stretch. But I guess the hope is that as these additional EUA situations arise, and the EUA vehicle, if you will, continues to be an option, hopefully, fingers crossed, we see an improvement in the quality of those submissions for these future use cases. So we'll see.

Mike Drues: I could not agree more, Jon. As a matter of fact, I would say that that's probably one of the most important takeaways from our discussion is take these lessons to be learned that I shared from the Office of the Inspector General report not as criticisms, but rather as lessons to be learned. So my point here is not to blame, not to bash FDA or companies or anybody else. Instead, try to take this information and prevent these problems from happening again in the future. And I think it goes without staying, if you're going to submit something to the FDA, it's got to be of sufficient quality. This is not true for just the EUA, but this is true for all documents across the board. I think Jon, as you know, and as probably many in our audience know, I work not just as a consultant for companies, but I also work as a consultant for the FDA. I do get a chance to see some of the submissions coming into the FDA. Some of them are terrific, very well written, very well explained, very well argued. But some of them, quite frankly, Jon, are absolutely pieces of crap. I mean, they are painful to read, literally painful. Begs the question, Jon, do they even teach kids in elementary school anymore to construct a complete sentence? I'm not sure about that. Even when I read the assignments from some of my graduate students, an Ivy League institution, I say, did you have to go to elementary school first before coming to graduate school? So again, none of this is a surprise to me. These are all preventable. These are all predictable. And I've tried to give some specific examples on how to try to minimize some of those problems.

Jon Speer: Yeah, sure. Anything else that you think is important on this topic of EUA in October of 2022, based on our current knowledge and understanding of where things have been, where they are, and where they might be going? Anything else that you want to bring to discussion?

Mike Drues: Yeah, I think what you just said a moment ago, Jon, is a great way to paraphrase my intent of having today's discussion. Talk a little bit about where we were, in other words, what the EUA is and how it's to be used and so on, where we are now, and some of the lessons to be learned from the past, and most importantly, where we're going in the future. Next step is monkeypox, but beyond that, who the heck knows? My intent here was not just simply to rehash what you and I have talked about before with the EUA, and what other people have talked about, but to go beyond that. So I think we accomplished that objective. I think that was a good discussion.

Jon Speer: Okay. Maybe what do you think is the top takeaway that you want people to leave with today?

Mike Drues: Well, it's going to sound like something that we've talked about in the context of a lot of our discussions, Jon, and that is don't treat FDA as our elementary school teacher, " Here's my homework assignment. Will you mark it up and give it back to me?" When you look at some of those statistics coming right out of the investigator's report that said that 80% of these submissions were not complete, they were missing information. In some cases, critical information. That, to me, means that, quite frankly, and I'm going to be blunt here on purpose, Jon, many people... And again, I'm stereotyping. I admit that. I'm generalizing. There are exceptions. But many people in this game, in spite of their best of intentions, they don't know what the heck they're doing and they're expecting FDA to hold their hand and say, " Well, you've done a pretty good job thus far, but now you need to do X, Y, and Z." With all due respect, Jon, at least in my opinion, and you or perhaps other people in this field might disagree, that is not FDA's job to do.

Jon Speer: No, I agree. My takeaway from our discussion today is related to what you just shared, but when Mike shared those statistics regarding the COVID EUA experience, if you will, it's pretty clear based on some of those statistics that those so many companies went into this, this was their first real meaningful regulatory experience in dealing with FDA. And I think it showed that based on the quality issues and the number that were sent back with flaws and what have you, and incomplete information, it just makes sense. If you're going to go down this path, and you've never done it before, get ahold of somebody who has.

Mike Drues: To use a medical metaphor, Jon, because as a biomedical engineer working in the medical device industry and used to teach medical school back in the day, I do use a lot of medical metaphors, god forbid you need surgery. Imagine you're lying on the gurney about to be wheeled into the OR, and just before they put you under, your surgeon says, " Oh, by the way, Jon, this is the first time I'm doing the surgery." Well, if that's the case, I want to see the person standing next to them, the man or the woman who has done this 100 or 1, 000 times before. I have no problem with somebody doing something for the first time. After all, all of us, myself included, we have to do something for the first time once. If you're doing it for the first time, don't do it by yourself. And just one last example, Jon, and then we can wrap this up, because again, this is a real world example. I had taken a device to the FDA for a COVID indication. It was a COVID diagnostic. But long story short, it was a totally different mechanism of action. It was not an immuno diagnostic test. It was not a molecular diagnostic test. It was something completely different. And as a result, long story short, Jon, FDA refused to accept it as an EUA. FDA said, " You can do this as a De Novo. And I said, " Yeah, fine. We're going to do that, but we want to do it as an EUA first." And they said" No, because it's just too different." Well, I said to them, " Where in the EUA regulation does it say that your mechanism of action has to be substantially equivalent to something that already exists?" What they admitted to me privately was that because of some of the statistics that I shared today, that they've been slammed with so many submissions, and most of them being of, in their words, very per quality, they did not have the resources, shall we say, to apply to this as an EUA, and they would have to do it as a De Novo. I was miffed. I was absolutely miffed. And I had encouraged the company, and the company is looking at pursuing this in legal channels, but the problem is, Jon, one thing I've learned in this process is one side lawyers up, then the other side has to lawyer up. And when lawyers get involved, at the end of the day, nobody wins.

Jon Speer: Except for the attorneys, yeah.

Mike Drues: Except for the attorneys. Fair point. But this is another ramification that we're finding from this COVID experience, if you will. And that is that we do have some, in my opinion, very legitimate products that are being held up, or in some cases, not being allowed to get onto the market at all, because of some of the other actors. And what do they say, Jon? Every barrel's going to have a few bad apples. Regrettably, the bad apples are spoiling the brine for some of the others. But anyway, enough on that.

Jon Speer: All right. Well, Mike, I appreciate this dive into EUA and a Q4 2022 perspective on where things are currently sit with respect to EUA. So thank you for sharing some of those insights. And folks, I appreciate as always, you listening to the Global Medical Device Podcast. Certainly if you have questions about EUA, whether you already have products that went through that pathway or you're considering pursuing products for that pathway, it's good to ask and reach out to someone who has a lot of experience. And certainly, as I'm sure you've picked up from today, Mike Drues has a ton of experience in this area. So reach out to Mike with Vascular Sciences. He'll steer you in the way that strategically makes the most sense for your company and your products and all those sorts of things, so be sure to reach out to him. Again, thank you so much. And until next time, this is Jon Speer, the founder at Greenlight Guru, and you have been listening to the Global Medical Device Podcast.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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