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Promotional Compliance and Lab Testing with COVID-19: An Interview with Stephanie Noblit and Dale Cook

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Due to COVID-19, laboratory workers are either being overworked or are being furloughed. Why has the pandemic affected laboratories in this way? Join Darshan Kulkarni as he talks with attorneys Stephanie Noblit and Dale Cooke about the impact of the pandemic on lab testing. We’ll also discuss some of the primary issues with promotional compliance.

Narrator: This is the DarshanTalks Podcast, before this week's interview with Stephanie Noblit and Dale Cooke on promotional compliance and lab testing with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, May 7th 2020.

Darshan: So here are some interesting bits of information that have occurred in the last week that might be relevant. Number one, Health and Human Services issued a notification about enforcement discretion for provision of telehealth services during the COVID-19 pandemic. What does that really mean? It means that, number one, a lot of companies have come out and said, oh, they've legalized telehealth using FaceTime and they're like, "That's not what they've done." What they've done is they've simply said, we will use enforcement discretion which means, we will choose not to enforce at least during this one period of time. There are significant limitations.

Darshan: They actually said that they will not impose fines for non compliance with the regulatory requirements like not having the appropriate business associate agreement in place, but certain steps do need to be taken. That includes, enabling all available encryption and privacy modes, notifying the patient that third party applications, pose a potential privacy risk. So keep that in mind as you continue. The second bit of information that's popped up is that a lot of individuals and companies believe that the FDA has stopped doing audits during this time. It seemed that that's not true.

Darshan: The FDA just warned an Indian testing company, two device makers and a university lab for running a non clinical trial for a medical device. If you need more information, feel free to reach out about that. Do you believe that the FDA should be doing this testing? If you disagree with that, feel free to reach out. Feel free to comment on Twitter. You can reach me on twitter @DarshanTalks. The other bits of information is that, the PPP loans just came into play. And people have been wondering what this means, because PPP loans, what happens if the employee doesn't want to come back?

Darshan: Do you have to give those PPP loans back? So the EEOC provided some interesting information about that, and so did the Treasury. And off that, the question that was asked was, will a borrower's PPP loan forgiveness amount, be reduced if the borrower laid off an employee, and offer to rehire the same employee, but the employee declined the offer? And the short answer is no. That would not be the case. If you need more details, feel free to reach out about that as well. There is another interesting bit of information happening. Specifically, the question of clinical trials versus the right to try, and people are wondering what does this mean? What is the difference?

Darshan: So clinical trial is working on the proposition that both arms of a clinical study are equivalent, and the right to try works with the proposition that you have a preferred option. So with clinical trials, if you look at it, the subject enters into the clinical study with what's known as equipoise. And that means that they do not believe that there is any difference between the two arms of the randomized trial, for the randomization to be ethical. However, that analysis does not consider if while the individual patient may be indifferent, the researchers themselves may not be, so they may be actually aiming for a specific result.

Darshan: So, that becomes more complicated in the context of a pandemic, where patients just want to get better, while the actual individual researchers are hoping for one line of treatment, so that they can help other people. So, where a patient has a rational preference for the treatment, and the researcher are legitimately indifferent, there's a conflict, the best way is to start thinking about what are the clinical implications of this? Another bit of information is just what is the ethical responsibility in publishing clinical research results? That happens on analyses, especially in the context of hydroxychloroquine.

Darshan: And the idea is that, should you put out data if it's based on inadequately powered subject numbers if you will, or because there's inadequate power, so premature publication of definitive recommendation based on inappropriate conclusions, grounded in scant, hastily acquired data serve only at best to confuse and at worst to mislead, and this is often problematic is what this one position takes. The argument is that investigation will say only 20 treated patients, is significantly underpowered and greatly subject to sample size error.

Darshan: So that is again something to consider. The true ethical responsibility of researchers is to produce and publish data, and subsequent recommendations based on robust methodology and stringent review. Some investigators may be altruistically motivated and hope to rapidly disseminate multiple conclusions. However, we need to hold ourselves to a higher standard. So if you have questions about what this means and where things are going, feel free to reach out. If you disagree with some of the comments being made, feel free to reach out, you can find me on Twitter @darshantalks. Thanks for listening in.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, your regular podcast with host Darshan Kulkarni. You can find the show on twitter @darshantalks or the show's website at darshantalks.com

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have two special guests joining us, both of them are attorneys. Both of them have very, very unique backgrounds. We've actually met Dale before, Dale Cooke. And we also have Stephanie Noblit. Well, actually Stephanie, ladies first, would you like to introduce yourself?

Stephanie: Sure. First, I just want to say thank you for having me today. It's great to be here. So I'm Stephanie Noblit. I am an attorney and I also have a background in medical laboratory science. So I'm actually a certified medical laboratory professional. Prior to going to law school, I was actually working full time as a medical laboratory scientist. I worked here in Philadelphia at the Hospital of the University of Pennsylvania doing work in the toxicology lab there. But I am fully trained in all aspects of the medical laboratory and I'm now able to combine both my clinical knowledge and legal knowledge in my everyday practice.

Darshan: I can tell you Stephanie, no one cares about labs right now. It's a very non-

Stephanie: Yes, I know. Nobody cares.

Darshan: Dale, your turn.

Dale: Sure. Thank you, Darshan. So glad to be back with you again. I'm a regulatory attorney here in Philadelphia, my law firm's FDA and law and my FDA regulatory practice PhillyCooke. Consulting is focused on ad promo issues related to the advertising and promotion of all sorts of prescription products. And as you and I and Stephanie have been chatting outside of this podcast over the past few days and leaks, there's just a lot going on and a lot of confusion about what's okay and a lot of new, very important enforcement activity going on from the FDA and FTC related to this issue.

Darshan: I have no idea what you're talking about Dale, because no one is talking about anything bad right now, it's completely on the up and up. There has been no off-label promotion. So, this is really a podcast that's going to be very short, just so you know. But, let's pick on Stephanie and today is going to be like a ... It's a free flowing conversation. The goal is not to have any one of us be the speaker or the audience or anything of that, we're just going to have a conversation. So Stephanie, let me start us off with just talking about COVID-19. First of all, in your role, are you seeing any uptake in work because of this or has been slowed down because you've come at it from a very different angle?

Stephanie: So yeah, I've actually noticed an increase of work with what I'm doing now. So I'm actually working for a policy organization called the Legislative Analysis and Public Policy Association, LAPPA, and we are a policy and advocacy organization that does work on the topics of public health and safety, substance use and criminal justice and the intersections between the three. We're actually doing a lot of work right now concerning the COVID's impact on the already existing public health epidemic in America, which was the opioid crisis. So we're doing a lot of work talking about how the DEA and SAMSA regulations are changing.

Stephanie: Trying to make sure we don't exacerbate the underlying issue beyond COVID. So making sure we don't have people who arise in overdoses and relapses because people aren't able to access care as they normally would prior to COVID.

Darshan: Philadelphia for example is mostly on lockdown. Not as bad as some of the other countries for example, but are you seeing it impacting actual health and healthcare?

Stephanie: It's definitely impacting health care. I'm not working in the laboratory anymore, but I still have a lot of colleagues and friends that are still working there. And it's definitely impacting healthcare. Any hospital where they are doing the actual COVID testing, these hospitals are just going crazy doing the testing. The staff there are working more than 40 hours a week definitely. Going over time, definitely doing as much testing as they can. But then we're also seeing this unique phenomenon, specifically in the lab, where hospitals where they aren't doing the testing and they have decided to postpone all elective or unnecessary surgeries at the time.

Stephanie: A lot of laboratorians are now being furloughed, because there isn't as much laboratory testing going in those areas. So we're seeing the two extremes in health care when it comes to laboratory. Either professionals are working over time, being forced to stay long hours and do lots of testing where there's lots of backlogs and then facing the other end where there's not enough testing and staff are actually being asked to stay home.

Darshan: It's funny you talk about the lab testing, because to me, one of the big things that I'm trying to deal with in my own role as a FDA attorney, I should probably ... Well, you guys know my introduction, that I'm dealing with is the idea of, can those tests actually be trusted? Because, I'm seeing everything from, "I'm a Chinese manufacturer, I have a lab test, I want to sell you." To, "I'm a lab developed test in a hospital and I want to go out and basically I want to use it for my patients." I saw a notification yesterday I believe from the FDA saying that only one COVID-19 test has gotten an emergency use authorization from the FDA, which is the one from [inaudible 00:12:27] I believe.

Darshan: And there are I think 70 pending. So what is your take on that, using both your experience as a lab person ... I forget the term and a lawyer? And I just want to be clear before we continue for all of our sakes, nothing we're saying here is the opinion off our employers. It's just a conversation between the three people so it may not necessarily represent the opinion of anyone else. So, Stephanie.

Stephanie:
You had mentioned the one emergency-use authorizations for the [Cellex 00:00:05]. That is correct, that it's the only FDA emergency-use authorized antibody test. That's an important distinction to make. Right now, the Cellex is the only emergency authorized antibody test. The antibody tests are actually used post infection when we wanted to determine if somebody has been infected after they're done showing symptoms or if they were infected at some point and they developed an immune response to the virus. The antibody response testing is going to be really important as the epidemic starts to wind down and we're looking to see in how many people actually were infected for this virus. It's also really important because studies or people are predicting that the plasma of people who have had COVID and now have those antibodies built up in their system that their plasma may be able to be used as a potential treatment for those that are currently suffering from COVID-19. The only way to determine if the person has plasma that is going to be worthwhile in donating and treating somebody with is to have these antibody tests.

Stephanie:
So yes, the Cellex is the only current antibody FDA emergency-use authorized tests on the market right now, but more are coming. Dale actually sent me an article just this morning that the FDA is actually telling developers, just reminding them, "Hey, we only have this one Cellex antibody tests currently authorized. Please do not falsely claim your tests are authorized." But hopefully, more will start to come later on. I want to also point out that these antibody tests are separate from the RNA test to detect the actual virus itself in the person. Those are different set of testing that's performed at different times in the person's illness in state of infection and tell us two different things. When it comes to those RNA, and more recently, the antigen rapid tests for COVID-19, most of those have received emergency-use authorization. Actually, as of April, the FDA has issued 28 emergency-use authorizations for diagnostic products related to COVID-19, so just want to make it clear that there are a lot of diagnostic tests out there for COVID and they are receiving the proper authorization to be used.

Darshan: So Dale, that really Stephanie's comments bring us back directly into what you're seeing, which is promotional activity compliance around the advertising of these tests. What are you seeing? What is your take on this so far?

Dale: Well, the FDA is doing a lot of enforcement, around testing and around treatment options, and they're certainly partnering with FTC, it's a sad, recurring phenomenon that every time there is an epidemic or an outbreak, or even just a concern around a possible epidemic or an outbreak, there are always a group of people who see these health scares as an opportunity to make a buck. They are quite willing to violate FDA and FTC rules about advertising unapproved treatments and that unapproved treatment unapproved testing, in the treatment case, in some cases, we're talking about simply selling placebos and claiming they work.

Dale: In other cases, we're talking about selling dangerous ingredients, and telling people that they should take them, and in the context where you have a lot of mistrust right now just in general with the authorities and you have an entire epidemic going on in the country, Stephanie was talking about the opioid crisis, which has certainly hurt the industry. But also you've got the Anti-Vax Movement, which has developed a lot of skepticism around pharmaceutical companies and their trustworthiness.

Dale: So into that a context, you have then a group of people who are willing to hawk unapproved treatments and say, "Somebody is trying to hold this from you. You can't trust those people in positions of authority." And that's dangerous. That leads to very, very sad consequences.

Darshan: Which to me is really interesting because, I think two things popped up for me. One was I think I saw, someone was advertising, was it silver or mercury, as a potential treatment for COVID-19? Did you see that?

Dale: Yeah, there, Quicksilver ... I saw several products with the name Silver in them and I assume there's silver in the product as a supplement, so yeah, absolutely.

Darshan: That raises this new phenomenon that I feel like I've seen it a little bit in the last ... I don't know ... two years or so. But it's really taking on more prominence right now, which is, the joint FDA FTC enforcement. Is this just my imagination or was that always there and I just wasn't seeing it?

Dale: Well, I think the FTC and the FDA have always going back to the '60s been working together cooperatively. I think what you probably have seen, especially just in the past few weeks, is them being much more vocal and prominent about trying to make it a full government effort. And that actually, just earlier this year, completely independent of the COVID-19 outbreak, they did a very large announcement around biosimilar advertising. This was going to be a full government effort to make sure that everybody understood that this is a really important thing. So I do think we've seen very vocal, very prominent cooperation, and them being very public about it.

Dale: I don't think you're misunderstanding it or miss perceiving it but, they have actually been working together forever.

Darshan: Right.

Dale: Yeah, the cooperation itself is not new. Perhaps the prominence and the publicity around it has been elevated.

Darshan: Because that's really what I'm trying to figure out what caused the change in prominence. Like you said, so they've been working together forever, but why do you think that they're going ... Right now for COVID, The United Front is useful. But why before them?

Dale: Yep.

Darshan: I'd love to hear [inaudible 00:20:11] perspective both for my ad promo perspective and from a legislative perspective.

Dale: Yeah, I don't know the answer in terms of why we're seeing that. I think the FTC in general has been stepping up enforcement across the board. And so it could be some of that. The overall trend out of FTC has been, reduced enforcement and ad promo. So this is a much more prominent amount of enforcement, just with regard to COVID-19 than we've seen in ... I think we got more letters out of the FDA about COVID-19 than we've seen for all ad promo in the past two or three years. So they're clearly stepping up enforcement, which is entirely appropriate, right? They need to be doing what they're doing. T

Darshan: I'm sorry, Stephanie, I don't mean to cut you off. Do you want to add anything to that before I jump in?

Stephanie: No, go ahead.

Darshan: Okay, so what I was wondering, though was, you're 100% right, that the FDA is more aggressive shall we say? And they send out more letters. But are they letters, or are they more notices? Because I've seen more notices for the most part. I'm seeing a couple of letters for sure. But I also saw those same letters around pharmacogenomics. I saw those same letters around stem cells. I saw those same letters around ... What do you call it? Compounding pharmacies. So are you counting those in that analysis? Are you thinking more of this like your typical ad promo on title letters?

Dale: No, I wasn't. That's a really good point is that there's been a lot of enforcement in those areas as well. I haven't done a formal analysis of the total letter count.

Darshan: We weren't testing that part of it right now, you didn't know that was part of the analysis. Fair enough. No but, it's an interesting change to me as we continue. But Stephanie do you see legislatively, what are the changing leavers as you see it, that are moving, that COVID's pushing out for you?

Stephanie: Well, I see-

Darshan: Can I repeat the question? Yeah.

Stephanie: Well, I think COVID it's definitely changing a lot of the ways that we look at health care. I know specifically, when it comes to the laboratory, we're starting to realize the importance of the laboratory where we might as not have before, those in the laboratory profession we used to think of ourselves as the water company, as an analogy. So you never really think of the water company till you turn on the faucet and nothing comes out.

Darshan: Right.

Stephanie: And now that we're seeing the importance of laboratory testing, we're realizing how important those professionals are within the whole healthcare team. So, I know there has been a lot of push from a lot of laboratory organizations to do, within Congress to try to avoid issues like this in the future that we make sure that we have properly trained laboratory staff out there. So actually, there has been some bills that have been put out, so one is actually the Allied Health Professional Shortage Act, which is H.R.6302, which was put out earlier this month by Representative David Cicilline from Rhode Island.

Stephanie: And this is an act that would establish scholarships and loan repayment programs for people that are pursuing a degree within the allied health field. So this would include the medical laboratory profession, also other areas of allied health like PT, OT, respiratory therapy, in order to try to get more people into these professions. So that's something that's out there right now. And we hope that as Congress continues to push out these additional large COVID bills, that hopefully this will be included in them as well. There's also been some other movement regarding laboratory developed tests.

Stephanie: So going back to them to making sure that we have these testing available and that they're able to be put to use when they're most needed. So there's one act that was actually put out called the VALID Act, Verifying Accurate Leading-edge IVCT Development Act, which was put out by Representative Diana DeGette and Senator Richard Burr. So this legislation would actually create a new test product category within the FDA, which would include in vitro diagnostics. So that would include both the commercial laboratory test kits and laboratory developed tests, and it would give FDA the authority to review and approve these in vitro diagnostic tests, which right now, laboratory tests are actually governed by CLIA.

Stephanie: The Clinical Laboratory Improvement Act which is under CMS and FDA. Those that really have much to do with laboratory development test. So that's proposing and changing the landscape of how these lab test are regulated potentially.

Darshan: Do you think doing some [inaudible 00:26:15] that would slow responses in a situation like COVID though?

Stephanie: There is a worry definitely that getting the FDA involves that there could slow responses with getting things out. How that would actually work in practice yet, I guess ... I don't know. I don't know if there would be special consideration or a special track given when there's emergency public health issues or novel tests that are needed right away. But there are concerns from the laboratory community that getting the FDA involved, could slow down the process.

Darshan: So, I guess one of the things that that pops up for me, and I'm trying to figure out how to phrase this. So, Stephanie, I'm also a pharmacist, I also have a doctorate in pharmacy. And as part of that, one of the things that did pop up is, CMS came out yesterday I believe, and said, they want all the professionals of practice at the top of their license. I don't even know what those words actually mean. But those were the words that were used. And one of those things includes pharmacists administering COVID-19 tests. As someone who's a lab professional, as someone who's done this type of work, do you think that's a good idea or a bad idea?

Darshan: And again, you don't represent anyone outside yourself at this moment?

Stephanie: I think it's a good idea depending on the situation.

Darshan: Okay.

Stephanie: So laboratory test and laboratory professionals, are highly trained to run these complex tests. And not only do we understand how to run the tests, but we also understand the science behind them. And while anybody could claim that they could load the sample onto an instrument and wait for the printout to come out, do they then fully understand what the results mean? And are they able to troubleshoot the result, if they don't think the result is what it should be? Are they able to have that level of critical thinking that a trans laboratory professional would have to know if the result is accurate or not?

Darshan: Right.

Stephanie: There are things though called wave tests. So these tests can be performed by people that are not laboratory professionals outside the lab. So you'll often see wave test up on the floors in hospital, these are known as point of care testing. You might also find them in physician's offices, and also in pharmacies like you were stating. I think that these wave tests have a lot of benefit to them, I think there's good that can come out of having a test right at the point of care, where they can be done relatively rapidly and have the result for the patient. So I do think that they're good that way.

Stephanie: I do think though, that in order for these tests to be used to their highest benefit that we need to make sure that the people running them, whether they be a nurse, a pharmacist, or some other health professional that's not a medical laboratory scientist, that they do understand, I know what the testing involves that they're properly trained on what the results mean, how to run the test and also running quality control. So I do think that having a way of test, point of care test, test done by non medical laboratories when appropriate, is something good that is needed for patient care.

Stephanie: But we need to just make sure that all the steps are in place that we are able to train these people properly to make sure that they're running the test appropriately. Because then at the end of the day, it won't matter if the patient is able to get the result in 5, 15 minutes if the test is not properly run.

Darshan: So, you talk about the complexity of these tests, and you talk about how they can sometimes go wrong, and how you need the appropriate person reviewing this stuff. In that sense, does it make sense for the FDA to use what they're referring to as emergency use authorizations, to get approval for these products or these tests, using different target type markers and the like. Do you think the FDA is doing a disservice to patients, or is the need so great that this is exactly the right step?

Stephanie: No, I think the FDA is doing the right thing by offering the emergency use authorizations. While these tests might not be going through the rigorous regulatory process that they would in a non emergency situation, these tests are still going through a validation process, to make sure that they are actually doing what they're supposed to be doing. So for example, for a laboratory developed test, the laboratory that has created the test is required to do a validation, even with the emergency use authorization.

Stephanie: So they're required to do a series of testing to prove that the test actually works to determine what the level of false positives and false negatives could potentially be, as well as any other issues that could arise.

Stephanie: So, while we're doing things maybe a little bit quicker than we normally would, there are still steps in place to make sure that these laboratory tests are safe and are actually producing valid results.

Darshan: So Dale, have you ever seen promotional activity around lab developed tests?

Dale: The primary area that has come up has been with regard to this gray area that Stephanie was alluding to, where there are tests that are clearly falling outside of FDAs jurisdiction and tests that are clearly falling inside FDAs jurisdiction. And then there are a whole bunch of ad promo efforts where it's really not clear where that test belongs, and it's possible that the promotional activity itself, is putting the test into FDAs jurisdiction and taking it outside of the exemption. And so that's the type of thing that I've seen. That's been my experience.

Darshan: So as the ad from my expert, right? What is your three second recommendation for companies? I'm seeing a lot of startups that are coming out of nowhere. I have the product, I have the testing, I want to bring it onto the market. Let me market it to everyone I know. I've literally had people go [inaudible 00:33:34] market. And for me, I'm going, "No, that's not what I do." But, what do you offer? As the idea, as the recommendation that these people should be looking out for as they promote either the lab developed tests, or potential treatment protocols? I recognize a lot two very different discussions, but I forget, just throw that [crosstalk 00:33:57].

Dale: Yeah, sure. [inaudible 00:33:59] testing and things and where you're seeing FDAs enforcement activities, really understand the scenario where precise language is absolutely vital. When you were talking to Stephanie earlier about the emergency use authorizations, and really being clear what that means and what it doesn't mean. You don't have an FDA approved product, if you're going into the marketplace on the basis of an emergency use authorization. It's a much lower standard that the FDA is applying to grant you this exemption to limited time, during which you can market the product, and you don't want to mislead people any statements that inappropriately ...

Dale: To somebody who doesn't live and breathe this stuff on a daily basis, the statements can look very similar. Talking about an FDA authorized task versus an FDA approved test and that type of thing. But those distinctions matter. And the FDA is absolutely making sure that people are not misleading the public. The major activity right now is not so much the people who are trying to go through the appropriate routes and getting tripped up on these tiny things, most of the enforcement activity that I've seen, is people who are just blatantly lying about the status of their product.

Dale: Who are claiming that the FDA has approved their test when the FDA says, "We don't even know who this company is."

Darshan: Right. And I'm seeing a lot of those companies reach out to me, so I know exactly what you mean. They're always like, "I expect the approval tomorrow." Well, that's not how this works at all. It reminds me of that Facebook ad. I don't know if you've seen it. It's two old women talking to each other, and one of them [inaudible 00:36:00] I have friend you. She goes, "That's not how this works. That's not how any of this works." So.

Dale: Yeah.

Darshan: It's that same thing for me. But move that to the next step, which is treatment. And we talked about hydroxychloroquine. And there's been a lot of talk around the efficacy of hydroxychloroquine, and the implication and the importance of having a treatment. And the President of the United States comes out and this is not a political discussion. This is a straight up scientific discussion, regulatory discussion. From that perspective, what is your take on the President of the United States balancing the need to help calm down the populace by saying, "We have a treatment on hand." With the balance of, there's very little evidence, if any, to support that.

Dale: Yeah, so with regard to hydroxychloroquine, there just is no evidence. We don't know. The anecdotes seem to suggest that it's worth investigating. And so where we are with regard to that emergency use authorization that came down from the FDA, that was granted to BARDA, right? It was not granted to the products manufacturer, which is really important to understand. BARDA is a group, the Biomedical Advanced Research and Development Authority within HHS, and they're the group that requested it. And what they received from the agency, was an emergency use authorization, that really was a way of getting a form of expanded access.

Dale: A form of, "If you can't get into a clinical trial, because you don't qualify for it, then BARDA now under this emergency use authorization has the ability to distribute the product to the physicians to be able to prescribe it to a certain group of patients." And that then is helpful because, it doesn't discourage people from lying to get into the clinical trial, and it helps to keep the clinical trials that are ongoing to see whether this product really does work good. So anyone in a position of authority, whether that's an elected official or public health official has to be really cautious about their statements, and you don't want to ever suggest that something is a miracle cure, or that it's going to work without the evidence because, this is a dangerous product.

Dale: There are very serious side effects associated with it. And in the context of a condition where you're expecting a large portion of the patients who are getting treatment to die anyway, regardless of the whether they get treatment, then it's absolutely essential that you have very good data and tracking as part of a well established clinical trial protocol, so that you don't accidentally wind up giving these people a product that greatly increases their likelihood of dying. You might not notice that, unless you've got them going through a formal clinical trial. So, once we get data on whether this works, then we'll be in a position to talk more.

Dale: Everybody is scrambling to enroll people, patients in clinical trials and get the data to see what's working for patients. I just saw this morning a new article came out about a new clinical trial protocol being ran out of the University of Pittsburgh Medical Center, to evaluate multiple products at the same time, and everyone is doing everything they can to see what's going to work because, we're a long ways off from getting a vaccine. And in the interim, we need treatments. But giving patients treatments that we don't know whether they work outside of a clinical trial setting won't do us any good. We need the data.

Darshan: But now here's the interesting question. I just saw a generic company that came out and said, "You know what, I'm not going to make any promotional claims about my drug." However, the fact is now hydroxychloroquine, which was practically a known drug three weeks ago, is part of the common parlance at this point. And the company came out and said, "We have x million tablets ready to go if anyone wants them." The-

Dale: Yeah, that was-

Darshan: [crosstalk 00:40:55] discussion. Go ahead.

Dale: Mm-hmm (affirmative).

Darshan: Go ahead.

Dale: [crosstalk 00:40:57] donation to the federal government that then BARDA is the agency that is now distributing those tablets.

Darshan: Potentially. I guess my question is, is that technically promotional for an off-label promotion? Because if you say things like, "We have X number of tablets ready." And we all know what that tablet is supposed to be used for, and it's going to be used by X, Y, Z ... Either we're going to donate it to these people or donate it to the government. Is that a type of promotion? If so, do you need to worry about it or not right now. None of that stuff matters?

Dale: No, I don't think anybody interprets that type of an announcement from a company as being promoting the off label use. And through the emergency authorization, one of the things that happens there is that then when the tablets are actually being distributed into the marketplace they're going with, one of the things that happens under the emergency's authorization is that FDA has the ability to put requirements around the advertising and promotion. And so that we don't have labeling for the use of this product, because we don't know whether it works. But FDA has created a fact sheet that must be distributed with the products, and so it enables this route to getting whatever information we have out there, and that's a good thing.

Dale: Because otherwise you getting a ton of discussion in the mainstream press about this product. But I certainly hope that no physician is making a decision about using the product or how to use the product, based upon the articles that they're reading in the mainstream press or what they hear at a 4:00 PM news conference from Some elected officials standing behind a lectern, right? They need real information. And that's one of the nice things about this emergency use authorization is that even in the absence of true labeling, you can nonetheless put requirements around the advertising and promotion to get some good information out there.

Darshan: We usually aim for these to be about 15 to 17 minutes. I'm pretty sure we're well past that at this point. Any last words Stephanie?

Stephanie: No, I think Dale really summed it up and ... as far as the FDA regulatory side goes, but I think we're just in a very strange times right now for healthcare in general, for regulatory issues and I think it's definitely showing us where the holes and the gaps are definitely in some of our systems. So hopefully we can learn from this and try to improve. Because unfortunately when it comes to viruses and microbes, this isn't going to be the last time something like this is going to happen. So just being able to be prepared for the future and taking what we're learning now, and being able to apply that again for the next one hopefully, it won't be soon but just always being prepared I think is something we need to try to find the silver lining in this and that's knowing that we'll be better prepared for the next pandemic when it happens.

Darshan: Let's hope that's not anytime soon. Dale, any last words?

Dale: Yeah, stay safe. Stay home, wash your hands.

Darshan: You know what was really interesting to me. I learned how to wash my hands. I feel like during this epidemic, I've been washing my hands my whole life. But I was like, "'Wait, I'm not washing behind my thumbs." And I did not know that was important, which was fascinating to me. Thank you both of you for being on the call, for being on the podcast. And I hope we can do this again soon.

Stephanie: Yeah, thank you again.

Dale: Yeah, thank you. Stay safe.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, your regular podcast with host Darshan Kulkarni. You can find the show on twitter @darshantalks or the show's website at darshantalks.com

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