Capital Conversations: COVID-19 and FDA; Medical, Legal, and Regulatory Perspectives

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During the COVID-19 pandemic, the United States Food and Drug Administration (FDA) has sought to exercise regulatory flexibilities where possible to expedite the development of timely medical products and ensure the safety of consumers. As the pandemic has evolved and new scientific evidence has emerged, the FDA has needed to adapt its policies and develop new programs to support the public health response. In this teleforum, senior agency officials will share their perspectives on the key medical, legal, and regulatory considerations during the pandemic. Examples of discussion topics will include (1) the application of emergency use authorizations to expedite the development of COVID-19 tests, (2) regulatory lessons from the Coronavirus Treatment Acceleration Program, and (3) legal actions to protect consumers from fraudulent medical products during the pandemic as part of the agency’s Operation Quack Hack.


Stacy Amin, Chief Counsel, U.S. Food and Drug Administration; Deputy General Counsel, Department of Health and Human Services

Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, U.S. Food and Drug Administration

Moderator: Stephen J. Cox, 39th United States Attorney for the Eastern District of Texas


This teleforum is open to the public - please dial 888-752-3232 to access the call. Do note that this teleforum is off the record. 


Event Transcript



Dean Reuter:  Welcome to Teleforum, a podcast of The Federalist Society's practice groups. I’m Dean Reuter, Vice President, General Counsel, and Director of Practice Groups at The Federalist Society. For exclusive access to live recordings of practice group teleforum calls, become a Federalist Society member today at



Dean Reuter:   Welcome to a special Capital Conversations addition of The Federalist Society’s Practice Group Teleforum conference call as today, July 30, 2020, we discuss “COVID-19 and the FDA: Medical, Legal, and Regulatory Perspectives.” I’m Dean Reuter, Vice President, General Counsel, and Director of Practice Groups at The Federalist Society.


As always, please note that all expressions of opinion are those of the experts on today’s call. Also, this call is being recorded for use as a podcast.


Our call today is off the record. It’s open to the public but no press. We’re very pleased to welcome three guests to Teleforum conference call today, including a moderator. Our moderator is Stephen J. Cox. He’s the 39th United States Attorney for the Eastern District of Texas. I thank you all in advance. And with that, Stephen Cox, the floor is yours.


Stephen J. Cox:  Well, thanks, Dean, and thanks so much for having us and thanks to everyone for dialing in. I think we’ll have an interesting conversation. I’m privileged to moderate this with a couple of top officials from the Food and Drug Administration, and I’ll start with a couple of introductions. And then we’ll get into a good discussion.


First, let me introduce my good friend Stacy Amin. She is the Chief Counsel of the FDA, and she’s also the Deputy General Counsel of HHS, where she manages an office that provides regulatory advice and handles litigation for the FDA, and serves as a senior advisor to both the FDA Commissioner and the HHS Secretary. She previously served as a senior associate counsel to the President in the White House Counsel’s office, where she advised on issues arising under HHS’s jurisdiction. Before joining the Trump administration January 2017, she was Chief Counsel of the Senate Health, Education, Labor, and Pensions committee. And before that, she served as counsel on the House Energy and Commerce committee. She began her law in the corporate practice of Sullivan and Cromwell, and she graduated from Harvard Law School.


We also have Anand Shah. Dr. Shah is the Deputy commissioner for Medical and Scientific Affairs. He leads the FDA’s operations as it relates to medical and scientific affairs. He’s responsible for developing and leading high priority FDA policy initiatives and oversees cross-agency teams in support of their public health mission. He recently served as senior medical advisor for innovation at CMS and as chief medical officer of the Center for Medicare and Medicaid Innovation.


Prior to his government service, Dr. Shah served as an advisor to a venture capital firm. He was chief resident during his radiation oncology residency at Columbia. He earned an MD from the University of Pennsylvania, an MPH in healthcare management and policy from Harvard. He graduated with honors from Duke University with a degree in economics, and he also served as a Canada/U.S. Fulbright Scholar.


So let me make a couple of introductory remarks that really get to our panelists. Before I was in my current role, I worked in the Associate Attorney General’s office at the Department of Justice, and I had the pleasure to work with Stacy on a number of things relating to the administration’s top priorities of regulatory reform. And we worked even closer together during the pandemic because we were doing sort of reg reform on steroids in that we were trying to provide regulatory relief and enforcement relief to the private sector so that it could respond quickly to the pandemic.


And so she and I and others at DOJ and at HHS tried to work hand in glove to make sure that we were providing good advice to them and also being aligned with their regulatory and enforcement posture because we have a role to play at the Department of Justice, as well. But let me turn it over to Stacy for a couple of minutes of introductory remarks. And then Stacy, if you could turn it over to Anand for a couple minutes of introductory remarks. And then I’ll take it from there with some good questions for discussion.


Stacy Amin:  Thank you, Steve. Excuse me. My office is making a loud noise. Anand, maybe I could turn to you first?


Dr. Anand Shah:  Sure thing. Dean and Steve, first of all, thank you very much for the opportunity to join today’s conversation. From a medical perspective and scientific perspective, what we’ve learned about COVID-19 is that it is very deadly and highly transmissible. But our medical system, probably more so than any other, is far better equipped to help patients and develop therapies and vaccine at an unprecedented time scale.


Just to give folks some context, in January of this year we were at a point where there were less than 10 cases by the end of that month and zero deaths. And you fast forward to today, we’re closer to 4 million cases and nearly 150,000 deaths. And so what makes SARS-CoV-2, the pathogen that causes COVID-19, different from different pathogens is that it’s brand new. It’s respiratory borne, viral illness, and it has a significant degree of transmissibility and mortality. So it really checks all four critical boxes.


When you contextualize this to the pandemic of 1918, just for some history, also a very deadly virus -- in this case influenza. And at that time just a dire shortage of nurses and health professionals across the country. And this really went on for over a year with three waves.


But what did we learn that’s most relevant now? We learned that social distancing works. St. Louis, at the time, implemented social distancing early and had half the excess deaths as Pittsburgh, which implemented such policies late. And at that time there was no vaccine. We, in America, had to wait until the virus burnt out, so to speak.


Coming back to FDA, our medical and scientific professionals at the Agency -- we continue to adapt and remain nimble as we learn more about the virus. What I will say, that said, we remain steadfast in our commitment to science and data as it guides all of our decision making.


Stephen J. Cox:  Stacy, are you --


Stacy Amin:  Yeah. I’m good. That was a fire alarm, I think. It was very loud but short lived. Thank you for stepping in and going first, Anand. I just wanted to start my remarks by thanking The Federalist Society and Dean for inviting us to speak on this teleconference. It’s a great opportunity six months in now to the pandemic to talk about the intersection of law and medicine that we face every day at FDA.


And I wanted to thank my colleague Anand for being a brave doctor who’s willing to speak to a group of lawyers. I don’t know too many who are willing to raise a hand to do that. And also I wanted to give a special thanks to you, Steve, for moderating the panel. It’s a great honor to us that you had offered to do this.


And as you said, we’ve worked closely together before the pandemic, but especially during the pandemic I’ve really enjoyed that opportunity to work with you. And we’ve had some great collaboration between FDA and the Department of Justice, particularly on enforcement matters. And Steve has always been a great partner to me and to FDA.


So I’ll just give -- Anand, you gave a great overview of this coronavirus and this pandemic. And I just want to say a little bit before we dive into questions about the Food and Drug Administration for folks on the line who aren’t familiar with us. We’re about an 18,000-person agency with a headquarters out in White Oak, Maryland. But we have staff and offices all around the world. And FDA regulates about a fifth of the U.S. economy.


It’s really a huge regulatory jurisdiction -- everything from the food that we eat to prescription drugs and medical devices, even animal drugs and food and many other consumer products. And just every aspect of FDA’s work and every center and office at the Agency has been impacted by the pandemic, both fully engaged in responding to the pandemic, as well as taking steps to adjust the Agency’s regular work so, for example, drug approvals don’t lag behind and that sort of thing. So I think we’ll have an opportunity to get into more detail through the Q&A, so I’ll just turn it back to you, Steve.


Stephen J. Cox:  Okay. Great. Thanks. Well, maybe I’ll just pick up where you left off. And first of all, I’ll turn it to Anand with a question. Just telling us a little bit at a high level how the FDA’s work really has changed during the pandemic. And then maybe after you give your perspective, we’ll turn it back to Stacy to give her perspective on how the Agency’s work has changed because I know it’s been fairly dramatic.


Dr. Anand Shah:  Steve, we as an agency have sought to be as responsive and active as possible. Just to provide folks with some perspective to where we are today, the Agency has launched more than 200 de novo clinical trials for COVID-19 therapy. We’ve authorized more than 150 diagnostics, or I should say tests more broadly, for emergency use. We removed nearly 200 fraudulent medical products from the marketplace, and we’ve put out close to 60 guidance documents, public facing, for industry and consumers.


And all of this has happened as we’ve transitioned over 18,000 staff to telework and folks are continuing to work on statutory priorities like user fee goals. I would say that kind of the four key areas of focus during the pandemic have been testing, therapy, vaccines, and then PPE. But it’s also worth mentioning that the Agency has had a few substantial pivots along the way.


Running clinical trials is always very hard, and it’s even harder in a pandemic. We issued guidance early in the spring to provide flexibilities around the use of telehealth, remote data collection, making sure that clinical trial investigators have all the flexibility that they need to continue to conduct clinical trials, whether those are for COVID-19 or for other chronic diseases, such as cancer or heart disease. I mean, another lesson that we’ve learned is that virtual care isn’t just about Skyping your doctor. It’s about rethinking the home as a clinical site.


Digital health plays a huge part in this, and we’ve issued guidance early in the pandemic to expand access to remote patient monitoring devices to help with disease management. We’ve also expanded access to digital therapeutics for psychiatric disorders, really acknowledging that mental health is such a big part of this pandemic and the impact that it has on everyday people. We’ve created a number of fit-for-purpose programs for COVID-19 medical products, from the Coronavirus Treatment Acceleration Program, or CTAP, which we’ll talk about a little bit later – that’s to accelerate therapeutic development.


We’ve also launched evidence accelerators to monitor real world performance of medical products, also Operation Quack Hack to catch health fraud. So in all of this we’ve seen an emergence of traditional stakeholders, FDA stakeholders, as well as smaller players who are interfacing with the FDA for the first time. And so the Agency’s really tried to be responsive.


We’ve tried to handhold as much as we can, walk folks through our processes. We’re working closely with a number of state and local governments. We’ve run a number of townhalls and webinars on topics ranging from food safety to testing protocols. And we’re very closely interfacing with Congress, keeping them apprised of the Agency’s actions very regularly.


Stephen J. Cox:  Great. Stacy, can you tell me from your perspective in the Chief Counsel’s Office, how have you seen the FDA’s work really change during COVID?


Stacy Amin:  Yes, and it’s a great question to ask for the Office of Chief Counsel because we’re in a really interesting position here at the Agency were, aside from the Commissioner or the Commissioner’s immediate office, we really see -- we’re the only other office that really sees everything at the Agency because, of course, all of the Agency’s work has to touch the lawyers. So we have a nice bird’s eye view of all of the Agency’s work.


And Anand gave a great overview of the work we’ve done in the pandemic and how it’s impacted all of the Agency. Where I’ve seen a lot of the work in my office and where I can really talk about where I think the Agency’s work has changed, well, one of the things we’ve really tried to do is introduce regulatory flexibility wherever we need to in order to address sort of a dire need in the marketplace, whether it’s for testing or for ventilators and respiratory devices, hand sanitizer, face masks, sterilizers, and disinfectants, gowns, gloves, viral transport media. I mean, we’ve even seen it in nutrition labeling and food packaging and labeling and drug compounding and repackaging, just all of these different tools that we’ve used to try to address potential food shortages or drug and device shortages.


In the marketplace, we’ve just been putting out, as Anand mentioned, 60 guidances now. We’ve just been putting out policy after policy articulating regulatory flexibility in order to address the urgent needs of the pandemic. And that’s been particularly -- my office has been a central part of that because one of the things that we had to face very early on in the pandemic was the situation where we’ve got an urgent need to make an adjustment to a policy so that we can, for example, let’s say -- I know we’re going to talk about testing, so I won’t get into too much the testing example.


But if we’ve got an urgent need to make an adjustment in a policy and FDA wants to communicate that we don’t -- and we’re not going to take enforcement action against a company if, for example, they’re providing a face mask that doesn’t have approval from the Agency because there’s a shortage of face masks for critical workers. So the Agency, we’re governed by a part of a statute really unlike, I think, any other agency in the government. We have a requirement in our statute that, when we issue guidances, we have to go through a process that’s prescribed in the statute and in our regulations. We have publish notice in the Federal Register, and there are other sort of formalities that we comply with, as well as some really important procedural protections that are built in there to ensure that the Agency is adopting good policy and getting public feedback.


So I can recall early on in the pandemic where the Agency wants to and needs to quickly and urgently communicate to the public about a change in policy and the groans and the clenched jaws when I mentioned early on that, as of right now, there’s no change in law that allows us to skip this part of our statute because we’re in a pandemic. But we’ve worked really carefully and closely with the rest of the Agency. And we did it extremely quickly where we created a process so that we can still comply with our statute and what’s called our good guidance practices regulations. We can still comply with all of that but do it in a really efficient way.


And I think we’ll talk about this more when we get to testing, but we’ve been able to get guidances out of the Agency in less than a day’s time, which is a remarkable timeline for FDA. And I know if there’s anybody on the call that practices in the food and drug space, I think they’ll recognize really how amazingly fast the Agency has issued these policies but managed to still do it in compliance with those procedural requirements in our statute and regs. And maybe I’ll stop there, but there’s certainly more I could say.


Stephen J. Cox:  Sure. Having been over at the Department of Justice reviewing these guidances that come over from FDA and some of the other agencies and only having a limited amount of time to look at it and provide any comments, I know firsthand how quickly you are able to respond. And it was pretty tremendous. Well, let me ask a specific question about testing, since you mentioned that.


In the beginning, there was an urgent need for people to get tested, but there really wasn’t an abundance of—to put mildly—the FDA approved tests that people could readily access. So maybe, Stacy, you could give an example of some guidance or regulatory flexibility or enforcement forbearance that you had to do early to allow for non-approved or non-FDA approved tests. And then I’ll ask Anand to tell us about how -- what was the scientific and medical perspective or experience with respect to providing that kind of guidance? Because you had to use a different set of skills but also just as speedily to provide that kind of guidance. So Stacy, why don’t you go first, and then we’ll go to Anand?


Stacy Amin:  Great. Thank you. Yeah. This is a great one for us both to tackle, and certainly this pandemic has created a demand for new tests that is completely unprecedented both in the volume of tests needed and the urgency. And I think it’s important to note at the outset that --what FDA’s role is in testing, and we don’t create the tests or provide the tests. Our role is determining whether tests developed are sufficiently accurate and reliable and helping to provide timely access to such tests and balancing those two competing objectives.


And FDA -- I think for a lot of folks the pandemic really started in March, impacting your daily lives. But for FDA, it started in January. And we started really working around the clock in January. And our device center started working back in January with over 500 developers, and they were working really closely with CDC as well to make sure that, when CDC was ready to get authorization for their tests, that we had done all of the legwork so that we could quickly authorize it.


And I can leave the medical discussion of that to Anand. But what I will say about testing is that—and consistent with the public discussion as well—that it is clear that towards the end of February and early March that there weren’t enough tests available in the United States. So FDA took a very quick but hard look at whether there was more that we could be doing to facilitate access to testing in the marketplace. And we had, as I said, been working with over 500 developers and had an open-door policy from the beginning.


We had put out templates that could be used and were really ready and willing and wanting to hand-hold anyone through the process to get it done quickly. And I personally have seen our device center working overnight reviewing data and authorizing in a matter of days or less. So we were working very hard and very fast. But still, there was more that we wanted to do to facilitate testing.


So this is an early example of flexibility that FDA provided and, actually, I think, a great example of once the decision was made to provide that flexibility, drafting and getting it out to the public in 24 hours. So what we did early on was say -- in previous pandemics, the Agency had taken the position that laboratory developed tests needed to come to the Agency for emergency use authorization before they could be marketed to the public. And that was based on the very legitimate concern of the Agency that, in a pandemic especially, it’s important that tests not -- that there not be a problem with false negatives because that can further the spread in a public health emergency.


And what the Agency realized heading into the end of February is that we needed to provide more flexibility in order to just get more tests to the market. So we put out a policy to the public clarifying that for FDA we would not enforce any of the pre-market requirements against laboratory developed test developers and sort of described the circumstances in which we would not intend to use our enforcement authorities and encouraging developers to come to us after ten days of use with their validated tests and really laid out a process by which we would make that really efficient and painless. And that testing policy has continued -- it’s a great example of how the Agency has been nimble because that policy has continued to change and evolve during the last five months.


And it’s changed as different tests become available. At one point in time, we had a policy for serology tests, and those are tests that can’t diagnose whether you have the virus but can be used to tell you whether you have the antibodies. So maybe at one time whether you had the virus -- so we had a policy at one point that said they could be marketed. But developers need to notify us, and we would put up the list of tests that have notified us. But the developers still need to validate their tests.


And then as we learned that the validation wasn’t as reliable for a lot of those tests as we would have liked -- and other changing marketplace circumstances have lead us to change that policy. And as we’ve had authorized serology tests and we’ve, again, changed it even more. So it’s been very fluid and evolving to the marketplace needs. And I think that would be a good point for me to pause and let Anand talk about some of the science there.


Dr. Anand Shah:  Just to add to a lot of the excellent points that Stacy made, just from the very beginning we’ve been in direct communication with test developers, industry trade groups, academic labs, the states individually and their public health labs, and, most importantly, frontline providers. We’ve really been trying to sound out from these various stakeholders and constituencies what works, what doesn’t work. We’ve been closely coordinating with the White House, the department for us -- which is HHS, including our sister agencies, and then FEMA.


And what this has really lead to is I would say a very diverse ecosystem and universe of tests. Stacy mentioned some of the unique regulatory considerations related to commercial tests versus those that are laboratory developed. We’ve been working through with our federal agencies. CMS is an example on the CLIA side -- really working through the unique considerations for point-of-care testing versus that which is conducted in a laboratory and more instrument-based tests. We’ve launched, I would say, tests that really are fit for purpose, whether those are molecular diagnostic tests, such as PCR-based tests, antigen next generation sequencing, serology testing or antibody testing, as you may be hearing in the media.


So we’ve populated just through our processes, we think, the American marketplace with a variety of tests, not just shear number of volume of test kits but also tests that are different with different performance characteristics suited for different settings and really giving providers and patients different choices. In addition to the self-validation that Stacy mentioned, we launched a critical partnership with the NIH, specifically the National Cancer Institute there, on serology testing to independently verify test performance. And that’s yielded some interesting results.


We’ve put those findings public facing on our website. We were able to verify independently performance of many tests. There were others that we have found to be poor performers, and we’ve taken appropriate action. We as an Agency continue to provide direct technical assistance to stakeholders. We’re trying to connect the dots between tests, swabs, reagents, trying to be matchmaker and making sure that state health officials, other laboratories have all the necessary ingredients that they need for testing. And this is especially important because shortage reporting requirements to the FDA for medical devices are different than those that exist for drugs.


So what has this all led to? We’ve created streamlined emergency use authorization templates. Really our processes, by some estimates, are 90 percent shorter than a traditional device submission. We’ve created reference panels for molecular tests, which help to standardize the validation and enable comparisons for performance. And even most recently, there was some big news last week out of the administration around testing in all nursing homes.


We worked very closely with our sister agencies to ensure that regulatory considerations were worked through. We’re working very actively with state governments and universities around pooling for tests and how we pool tests as a strategy to have more efficient, higher throughput testing and also help to conserve testing supplies. We issued our first emergency use authorization to that effect last week. We’re also focused on encouraging and incentivizing the development of home testing strategies. And we’re prioritizing those internally as we receive related to emergency use authorization requests.


Stephen J. Cox:  That’s great. Let me pick up on a term that you just used but shift gears a little bit to therapy from testing. Stacy, can you tell us a little bit about kind of the difference between FDA approved treatment versus emergency use authorizations. Anand was just talking about those authorizations in the testing space, but I know there were at least some EUAs in the therapy space. But I think to the public we just hear FDA approval or FDA non-approved, but it’s a little bit more of a gray area. Can you talk a little bit about that?


Stacy Amin:  Yes. And it’s a great time to do that as, Anand, you were using the term EUA, an emergency use authorization. And I figured this is something that folks on the call might read about or hear about in the news. And it’s a tool that is different than our approval or clearance tools under normal circumstances.


So if we weren’t in a public health emergency, FDA would only have our approval and clearance authorities, which are just a different process and, frankly, one that takes a longer time. So a drug approval, that requires a determination of safety and efficacy. And it requires adequate and well-controlled clinical trials. And similarly, in the testing landscape for an approval or a clearance, it typically requires validation using -- testing using patient samples.


But we have a provision of our statute, the emergency use authority, that allows us in certain circumstances -- it doesn’t have to be a public health emergency, but it typically is a public health emergency where the Agency can -- the secretary can invoke this authority for the Agency to use. And then we can issue what’s called an emergency use authorization. And it’s in order to respond to a public health emergency-type situation. And the authority is very different.


It says “Based on the totality of scientific evidence available”—which can include adequate and well-controlled clinical trials, but doesn’t have to—“the Agency determines it’s reasonable to believe that a product may be effective in diagnosing, treating, or preventing the disease or condition, and,” excuse me, “the known and potential benefits of the product when used to diagnose, prevent, or treat such disease or condition outweigh the known and potential risks of the product and there’s no adequate approved and available alternative.”


So it’s an authority that allows us to -- it’s essentially a cost-benefit analysis that the known and potential benefits outweigh the known and potential risks of the product and allows us to assess with a different level of evidence, whether we think given the emergency circumstances in this case, is it reasonable for the Agency to authorize the use of this product. And the authority also allows us to impose conditions on that EUA—it’s called emergency use authorization—and requires adverse event reporting so that we can revisit the EUA if appropriate.


So it’s a tool that we got from Congress in, I think, 2004 or after September 11th. And it has allowed the Agency to much more nimbly respond to this pandemic and past pandemics as well. We’ve mostly used it in the testing and the space in our Center for Devices. We’ve issued over 180 EUAs from that center. But we have also issued a few from our drug center.


And I would love to turn to Anand to talk about what we’re doing to incentivize therapeutics and discussion of the EUAs in the therapeutic space.


Dr. Anand Shah:  Thanks, Stacy. And, Stacy, as you mentioned, we’re exercising an unprecedented degree of flexibility. Very quickly in this pandemic we realized the need for a coordinating hub at the Agency. This is admittedly a complex agency to navigate from the outside, and I think that’s even true for some of us on the inside.


So in March, we stood up a Coronavirus Treatment Acceleration Program, or CTAP, to help accelerate COVID-19 therapy. So we heard from innovators from across the spectrum, including some of whom who are probably convened here today on the call, about the need for a coordinated sub-regulatory process that was agile and responsive to the needs of industry and developers where there was streamlined communication. So we now have a one-stop portal, whether that’s for industry or academia or others, to work together with the FDA on drug development.


In just a few months, there have been more than 230 clinical trials that have been initiated through the CTAP program, over 500 trials that are now in planning stages. And really I’ll spare everyone from going into the science, but there’s really a wide variety of therapies that are being partnered on with the FDA and launched in clinical trial format. So more than 20 antivirals, 70 plus immunomodulators, 30 plus neutralizing antibodies, 60 trials that fit not neatly within those categories but convalescent plasma, hyperimmune globulin. And this work has yielded, I think, some encouraging results for the America public.


Remdesivir, which is an investigational therapy -- there was a large NIH study. And really based on some of the data that we saw coming out of the NIH, the FDA was able to issue an emergency use authorization. And then subsequently, we partnered with HHS and FEMA on allocation and distribution of that drug product to the states and onwards to hospitals and, ultimately, to patients. Dexamethasone is another example of an existing therapy, a corticosteroid, which dampens the immune response. We’ve been working very closely with the NIH just based on some of the encouraging data that we see. That treatment has been added to NIH guidelines. We continue to look at other corticosteroids that may have an analogous function as dexamethasone.


Another example I think that’s worth mentioning that people hear about in the news lately is convalescent plasma. So what exactly is that? So patients who’ve successfully recovered from COVID-19 have antibodies to the virus present in the blood. And so the liquid portion of the blood, known as plasma, contains these antibodies. And that can be separated from the red blood cells and platelets and other material in the blood following donation. And so why this is promising is that this can potentially be used, those antibodies that are harvested from someone who’s previously had COVID-19, to treat someone who might be hospitalized and seriously ill with COVID-19.


And we’ve seen the convalescent plasma has been used successfully in previous outbreaks, and that includes the Spanish Flu, more recently in SARS. And we’ve seen very encouraging data there. So there are active clinical trials that are enrolling patients throughout the country. We’re looking at the safety and effectiveness of convalescent plasma as a therapeutic for patients with COVID-19. And really, this research could provide insights for other antibody-based therapies as well.


As so we continue to work with industry and academia very closely. And we are, as Stacy mentioned, trying to eliminate as many regulatory roadblocks as possible to make sure that clinical trials are able to be launched and that we’re also being able to review that data as an agency in real time.


Stephen J. Cox:  That’s great. Well, I for one am very happy that you guys are being so nimble. And it isn’t really reported how many clinical trials and tests and how much innovation you guys are really pursuing in this environment. So kudos to the good work that you guys are doing.


Anand, at the same time that FDA is really allowing for this regulatory flexibility for this innovation, let’s talk a little bit about how FDA is protecting consumers and patients from counterfeit respirators, from fake personal protective equipment. And what measures are you taking? And then I can turn it over to Stacy and maybe I’ll ask Stacy some questions about how DOJ and FDA can kind of be aligned on that same front.


Dr. Anand Shah:  Sure thing. And I’ll try to tackle this one just from the consumer and patient perspective and maybe turn it over to Stacy to share some insights from the legal and regulatory end. I think one thing that is very clear is that flexibility should never really be thought of as a license for fraud. And crises -- and this agency has seen this time and time again. You see crisis is always accompanied by a rise in counterfeit products from bad actors that are trying to take advantage of consumer anxieties.


So we’ve seen this during SARS, H1N1 influenza, Ebola. We know this, and we’ve been prepared. We’ve partnered with retailers like Amazon and Walmart to monitor their online marketplaces for fraudulent products. Stacy can maybe speak to just some of the actions that we have taken there. But everything from colloidal silver, herbal products, essential oils, and even websites -- there’s a I’m just bringing up as an example that sold a nasal spray for prevention of COVID-19 infection.


So we as an agency detected the website, identified evidence that it sold products with false or misleading COVID-19 claims, and then issued a warning letter to the vendor requesting corrective action and then ultimately leading for the website to be taken down. We’ve also seen bad test kits, whether those are diagnostic tests or serology tests, with various claims made to patients that are either not up to the high bar of the FDA. And Stacy and team have taken action there.


Steve, you mentioned PPE. We’ve taken a very stepwise approach to personal protective equipment. People often colloquially refer to it as a mask or a face mask. We refer to it as respirator. And we’ve just, from the beginning of the pandemic going back to January, we’ve exercised kind of successive flexibilities to allow more and more personal protective equipment into the hands of patients and consumers. There were shortages.


Along the way, we’ve also given flexibilities for decontamination of respirators so that they can be used again and used again safely. In doing so, we found that especially a lot of the products that are coming out of China have had subpar performance and quality. We’ve taken swift action there.


And as Stacy mentioned, our policies and guidances continue to flex as we learn more about good performers and bad performers. We’re constantly at the drawing board as an agency working together in a multidisciplinary way across the FDA to make sure that our policies are kept contemporary and that poor- and low-quality products are kept out of the hands of patients and consumers.


Stephen J. Cox:  Great. Stacy, do you want to talk a little bit about some of the enforcement actions that you’ve taken? And then this area is a top priority for us in our district, and I know it’s a top priority for the Attorney General. But maybe we can also talk about how DOJ and FDA work together in enforcement.


Stacy Amin:  Yeah. That’d be great. Let me just make a few quick remarks, too, because I know we’re running short on time. So I would just add that we’ve really seen two different areas here. So one is just obvious fraud where someone’s selling a bleach product as a coronavirus cure or treatment or selling a colloidal silver product as a cure or a treatment. And those actions are just trying to take advantage of people’s anxiety and sense of helplessness and panic during the pandemic. And they’re really egregious cases.


And FDA has worked really closely with the Department of Justice to be very quick and robust in bringing actions in those cases. We try to start a lot with warning letters because sometimes that’s the fastest way to remove a fraudulent product from the market because a court action, obviously, takes a while. But we’ve kind of addressed it on both fronts where, if the warning letter doesn’t result in clearing the fraudulent product from the market, then we have had a great partnership with the Department of Justice and been able to bring -- for the first time in decades, we’ve brought PROs, and then had preliminary injunctions entered against fraudulent products. And that has been the result of, like I said, just a great partnership with the Department of Justice and really working hand and hand between the Agency and DOJ to be able to bring those actions quickly.


We’ve also seen a lot of interest, as you’ve said -- and I know in your own office, Steve, that I believe you guys even recently brought an action. But we’ve seen interest from the Attorney General and all across the U.S. attorney offices all over the country. And we’ve worked out a great system where we’re all working together. It’s a great triangle between DOJ main and the U.S. attorney offices and FDA all sharing information in real time and working together to bring actions as fast as we can and also balancing those actions against the flexibilities that FDA is offering because, while we have a lot of interest in clearing the market of fraudulent products or products that aren’t approved, there isn’t always a great understanding among the public or any particular prosecutor of what exactly is the regulatory status of some products.


So we’ve seen this occur with PPE, for example, or in some of the other areas we’ve mentioned before like even testing, for example, where a product may not be approved. And it may not even be under an EUA, but it might be subject to one of the policies of regulatory flexibility that FDA has put out. So that partnership between the U.S. attorney offices and main Justice and FDA has been really critical to constantly be sharing information.


And much kudos to Steve for helping to set up the collaboration that we’ve had. And we have kind of set up SWAT teams in all of our offices and are all collaborating in real time with each other.


Stephen J. Cox:  Great. I know that I had many conversations with different offices at the Department of Justice and also with you, Stacy, about how we could work together to sort of prevent a worst-case scenario where you’ve got kind of a good corporate citizen developing tests or treatments for the public, relying on the regulatory relief and enforcement discretion policy that FDA’s put out there, and avoiding sort of a premature enforcement action against that company for failing to meet what would ordinarily be the regulatory restrictions that apply. But I think we have developed a really good partnership and a really good balance, so I’m very proud of that.


Well, I know that we could turn to one or two other topics but let me pause here and turn it back over to Dean in case we have questions from the audience.


Dean Reuter:  Very good. Thank you, all three of you. Turn to our first caller.


Caller 1:  So I’m from You mentioned a panic. I’m a conservative who’s in a panic, not over getting the virus but over getting mandatory vaccination. So I’d like to ask if any of you could point to a clause in the Constitution that supports a federal health plan. I am aware of the 1905 Supreme Court decision in Jacobson vs. Massachusetts, and I agree with that tradition that the state of Massachusetts does have the health power to mandate a vax. But is there anything to support the sudden strain?


Dean Reuter:  Any of our guests want to take a shot at that?


Stephen J. Cox:  This is Steve. We might not just have the right folks on this call to field that. Let’s focus -- see if we can focus some of the questions on kind of the regulatory relief and enforcement discretion that we’ve been talking about to enable the private sector to really respond.


Dean Reuter:  We’ve got two questions pending. With that caution, let’s go to our next caller.


Caller 2:  Yes, I appreciate your presentations. I have two questions. One, to what extent was the Chinese purchase of PPE a factor in our having extreme shortages, which both of you have alluded to. And second, what is the truth, if there is any, about hydroxychloroquine, whether it kills or cures or if we know anything about it? Thank you.


Stephen J. Cox:  This is Steve. I’ll ask Anand and Stacy if they have anything to add to the first question. I know from my time at the Department of Justice any topic that touches on litigation is probably a topic that we probably shouldn’t discuss, just because we don’t want to prejudice our interest in that litigation. So I think the second topic, if you would agree, might be out of bounds for this call. But if you want to talk about the first question about what, if anything, you could say about the Chinese and PPE.


Stacy Amin:  This is Stacy. Anand, I don’t think I have the right expertise to answer the first question. I don’t know if you have anything to say on that one.


Dr. Anand Shah:  What I will say just on the PPE that’s coming in from China, we have just through independent testing from NIOSH, which is the National Institute for Occupational Safety and Health, and then also with our colleagues at the CDC, the Center for Disease Control and Prevention -- have found that some of the respirators that are coming in from China don’t meet kind of our standards here in the United States. And we’ve also seen this in the setting of decontamination of those respirators, that they tend to -- or there’s been some tendency to have a degradation or even a decrement in quality and performance.


What I will say is that the shortage -- and to your point on the shortage of PPE, just initially we saw such a remarkable surge in demand for personal protective equipment. And a lot of the PPE that was provisioned during non-pandemic times for healthcare settings -- much of that, whether that was coming out of hospitals and out of physician offices or also just coming out of the supply chain wholesalers, was now being used outside of healthcare settings in more kind of the general public setting. So just over time, we’ve been able to -- I think as a country been able to adjust.


There have been some excellent American companies that have stepped up to the plate to help provide and meet that demand for PPE. There’s also been kind of an evolution in continual updating of guidelines from the CDC. So we’re making sure that any spot shortages of PPE that may exist around the United States -- we’re giving the public alternatives. We’re recommending a whole variety of alternative face coverings that people can use.


So basic principles there: face covering, keeping social distance of six feet, frequent handwashing. We find that that goes a long way with respect to mitigating some of the disease burden.


Dean Reuter:  If we have time for a final question before we adjourn?


Stephen J. Cox:  Sure.


Caller 3:  Hi, thank you for your presentation. I was wondering if it’s possible -- like some of the assistant grades of flexibility of the FDA and using the emergency provisions and issuing really fast guidance to companies has been fantastic, especially on hand sanitizers and allowing a lot more companies to produce hand sanitizers that were not doing so before. Will any of those have the possibility of becoming permanent guidance by the FDA? And will that trend continue, the flexibility trend, into 2021?


Stephen J. Cox:  Stacy, I may send this your way. I know there’s an executive order that may touch on this subject where the President has asked the agencies that have provided regulatory flexibility to consider whether or not to make any of that permanent going forward. Anything to add on this topic?


Stacy Amin:  I exactly was going to mention the executive order. And we are in the process of evaluating the guidances we’ve issued. And actually, Anand is leading that for the Agency. So do you want to add anything? I don’t know if we’re ready to make any statements about that right now.


Dr. Anand Shah:  Yeah. As Stacy mentioned, we’re taking a comprehensive look at all of the actions that the Agency has taken to date as part of the pandemic. You could interchangeably refer to this as kind of a recovery or a review effort or mid-action review but really in the spirit of understanding which flexibilities that we have exercised can be made more durable or permanent and also how some of the policies that may be time limited can be extended to assist in our ongoing efforts around the pandemic. So it’s an area of great interest to us as an agency, one that we’re looking at very seriously.


And I think that just some examples that come to mind of -- and just looking more broadly even across outside the FDA and across the government, a lot of the flexibilities around clinical trials, telehealth. We’ve seen some innovations there that have come to fruition, that have really benefited patients and consumers. And so we’re looking at all the above.


Dean Reuter:  Well, Steve, we’re out of audience questions. I don’t know if you have a final question or you want to give each of our guests a minute or two to wrap up?


Stephen J. Cox:  I think I’ll take you up on the later offer. Stacy, Anand, you want to give a minute or two to wrap up?


Stacy Amin:  Well, I just want to thank everyone for the time and, Steve, your great questions, and I enjoyed talking with both of you.


Dr. Anand Shah:  And this is Anand. I want to first just thank all of our guests today on the call. Thank you very much for the thoughtful questions here at the end. Steve, Dean, thank you very much for moderating today’s discussion. It’s really great to do this with my esteemed colleague, Stacy Amin, and we’re happy to answer any follow up questions just going forward. We’re fairly easy to reach here at the Agency. Thank you.


Dean Reuter:  Very good. Well, this is Dean. My thanks as well to the three of you, Stephen Cox for moderating, and to our two guests from the FDA. We certainly appreciate your time and your insights. We’re very pleased to have you on. I want to thank the audience as well for dialing in and for your thoughtful questions. A reminder to check the website and check your emails for notices for upcoming teleforum conference calls. But until that next call, we are adjourned. Thank you very much, everyone.




Dean Reuter:  Thank you for listening to this episode of Teleforum, a podcast of The Federalist Society’s practice groups. For more information about The Federalist Society, the practice groups, and to become a Federalist Society member, please visit our website at