Deep Dive Episode 136 – It Can Be Done Live: The Future of Our Health

The creators of the award-winning documentary, They Say It Can’t Be Done, in partnership with the Federalist Society’s Regulatory Transparency Project, present It Can Be Done Live – a conversation between entrepreneurs, regulatory experts, and noted academics around creative and bipartisan solutions to global challenges to our shared future. The second of four panel events, It Can Be Done Live: The Future of Our Health, took place on September 17th, 2020.

We are in the throes of a global pandemic that threatens the lives of millions and the way of life for billions more. Our healthcare systems are stretched to their limits. At the same time, innovations are being developed that could move us from treatments to outright cures. How do we ensure that these advancements are safe and effective, but not needlessly delayed when we need them most? The panelists explored the potential of human ingenuity to solve these problems and the conditions necessary to make those solutions a reality. We say it can be done.


Although this transcript is largely accurate, in some cases it could be incomplete or inaccurate due to inaudible passages or transcription errors.

Nate Kaczmarek:  Hi, everyone. We are so pleased to welcome you all to “It Can Be Done Live.” My name is Nate Kaczmarek. I am Vice President and Director of the Regulatory Transparency Project for The Federalist Society. This is our second virtual panel for the new film They Say It Can’t Be Done. We hope the movie inspired you and made you think more about medical developments, healthcare, regulatory policy, and the wonderful possibilities that innovation can create. 


Tonight, RPT and Just Add Firewater are thrilled to be hosting this timely and important discussion on the future of our health with truly an all-star panel. I’m please to introduce our moderator. Her name is Christina Sandefur. Christina is an Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights. Christina is a graduate of Michigan State University College of Law and Hillsdale College. Go Chargers. 


We’re also happy to have Christina’s help on RTP’s FDA and Health working group. In a moment, I’ll turn it over to Christina, who will guide tonight’s discussion. Once the panel has had ample opportunity to converse, we’ll go to our audience for questions. So please think of the difficult questions you’d like to ask of our panel and send it to us via the chat on the right side of your screen. Thank you very much to our panel for joining us. Christina, the floor is yours. 


Christina Sandefur:  Great. Well, thanks so much, Nate, and thanks to everyone for joining us. And I have to say I’ve been introduced many times before, but I’ve never actually had someone say, “Go Chargers.” So that’s great Hillsdale pride. 


I’m so excited to moderate this panel. We have such distinguished guests with us tonight. And what I really love about this film — and hopefully you share my enthusiasm if you’ve seen it already. If not, you’re in for a treat when you do — is that these are really difficult times for our country — for the world. This film gives me hope. 


It gives me optimism about our future because it really shows how human ingenuity can address really complex problems, especially in the space of healthcare, which of course is our topic tonight. And of course, the film also explains that we can really fully unleash the power of human ingenuity to address these problems if regulators allow us to do so. And that’s really what we’ll be talking about on the panel tonight. So I want to introduce to you are distinguished guests to talk about these topics. 


First up, we have Dr. Julie Allickson. Dr. Allickson is the Chief Manufacturing Development Center Officer at Wake Forest Institute for Regenerative Medicine. Julie has more than 25 years of experience in clinical translation of cellular therapies and regenerative medicine products, and she’s an experienced scientist who excels at delivering innovation, driving milestones, strategic planning, and regulatory expertise. So basically, everything that you want to know about, she’s going to be able to answer those questions pertinent to this discussion. 


Next up will be Dr. Betsy McCaughey. Dr. McCaughey is a patient advocate and a former Lieutenant Governor of New York State. She’s a founder and chairman of the Committee to Reduce Infection Deaths. This is a national campaign to stop hospital acquired infection. And she’s also a New York Post columnist and the author of a brand-new book that just came out this summer called The Next Pandemic, available from Encounter Books. My copy actually could be being delivered as we speak because Amazon told me it was out for delivery. So I look forward to reading that. 


Next up we’ll have Dr. Joshua Sharfstein. Dr. Sharfstein’s Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health. He served as the Secretary of Maryland Department of Health and Mental Hygiene, the Principle Deputy Commissioner at the FDA, Commissioner of Health of Baltimore City, and is a health policy advisor for Congressman Henry Waxman. He’s an elected member of the National Academy of Medicine and the National Academy of Public Administration. 


And finally, last by not least, we have Dan Troy. Dan is Valo’s Chief Business and Administration Officer and General Counsel. He served as General Counsel at the FDA. He served in the Office of Legal Counsel at the U.S. Department of Justice. He’s clerked for the D.C. Circuit judge Robert Bork. And he’s also been a partner at two nationally known law firms and currently chairs the U.S. Chambers Litigation Center. 


My favorite part of your bio, though, Dan, is that in 2013 the Burton Awards named him a “Legend in the Law.” And so this is actually my new goal now in life is that I would like to be called a “Legend in the Law.” Anyway, welcome to you all. Thanks so much for being here. All right. Great. Well, let’s dive right in. We’re going to have each of our speakers give brief opening statements, and then we’re going to open it up for discussion. So let’s start with you, Julie. 


Julie Allickson:  Thank you. Thank you, Christina, and thank you for the organizers. I’m really excited to be here tonight. And as we’re talking about the future of health, the title of this session, regenerative medicine is the future of health. It’s really the capacity to regenerate, repair bodies, or rejuvenate. And there’s a lot of emerging therapies that are shifting really the paradigm from treatment to being able to cure patients. 


So at the Institute — Wake Forest Institute for Regenerative Medicine, we’re doing product development on different types of cells, genetically engineered cells, tissue engineered organs, biomaterials, and devices. Our mission is really to help improve patients’ lives with regenerative medicine and leading a global transformation from treatments to cures. So we’re hoping that we can see the potential of revolutionizing healthcare through engineering organs and bodies or stimulating the body to repair themselves. 


And as you all know, there’s a huge organ shortage. There’s greater than 100,000 patients that are on a waiting list. And we see 20 patients that are dying each day because they can’t get an organ. So what can we do for that? There’s also $3.6 trillion in healthcare costs annually, so this is super high. And how can we look at being able to bring that down? 


We really think that regenerative medicine has that capacity, if we can cure, that there’s opportunities to bring that down but first of all bring quality of life to the patients. I lead the clinical translation, as Christina said, for regenerative medicine. And we have a unique model where we have everything under one umbrella, all the way from the basic discovery work through early phases of clinical trials, Phase 1 and 2. 


And this really starts out with a dedicated faculty. We have world renowned faculty. Dr. Tony Atala founded the Institute in 2004, and he was the first — and his team — to be able to engineer a laboratory grown organ, a bladder, that was implanted into a patient. There’s a lot of technology that’s been developed since then. We have about 13 projects in the manufacturing development center that are moving forward. And we have several that are already in clinical trials that we’re quite excited about. 


We work closely with FDA. FDA has been able to help us to move things forward. There’s several different exciting pathways that they offer, such as the RMAT, where you get a lot of facetime. And they’re able to help give you advice to move things forwards. Besides that, there’s several others as well. 


And FDA has really evolved over the years. I’ve been in the field for a long time, and I’ve worked with them for a long time. But I feel like they’ve done a great job at being able to educate us, bring guidance documents for us, webinars, and all kinds of things, even emailing someone and they’re responding within a short period of time. So I feel like it’s really a different — it’s a different organization the way they’re trying to work side by side with people to move things forward. I feel like regenerative medicine is a game changer in healthcare, and Wake Forest Institute for Regenerative Medicine is really excited to be able to help move that forward. Thank you. 


Christina Sandefur:  Excellent. Well, thank you so much. I look forward to asking you some questions. Such a fascinating field to be in. Let’s move on to Betsy. 


Betsy McCaughey:  Thank you. Well, I am delighted — really very honored to be part of this eminent panel. And I thought to myself what would stimulate the most exciting discussion? So I thought I’d give you three examples from the regulatory world: an example of profound regulatory failure, an example of regulatory overkill, and then an example where less regulation will save more lives than more regulation. So let’s start with regulatory failure because that’s where I’ve been particularly concerned. 


My organization, the Committee to Reduce Infection Deaths, their goal is to educate the public and hospitals and regulators and state law makers about the perils of hospital infection. It’s one of the biggest causes of death in the United States. Amazing, something that hospitals give you. A conservative estimate is 75,000 deaths a year, but in fact, it’s far more than that. 


And hospital infection is the major impediment to allowing seriously ill patients, such as cancer patients, to take advantage of all the medical breakthroughs that science has to offer. Because if you can’t go into the hospital because it’s simply too dangerous, you can’t take advantage of those breakthroughs. And we saw that in a small example recently with COVID-19. 


Many hospitals stopped treating patients for other matters, not simply because of the surge in demand, but also because they were so concerned they would not be able to stop the spread of COVID-19 to patients who didn’t come in with it. And in fact, thousands of patients, as well as healthcare workers, did contract COVID-19 in hospitals. What is the cause? 


Well, it’s mostly inadequate cleaning, inadequately cleaned equipment, rooms, and operating rooms. And the sad story is that we have the technology. We have the knowledge to prevent this, but what has been lacking is the will and particularly the regulatory support from federal agencies, as well as state governments — a lot of suspicion of what the for-profit sector has to offer, combined with something I would call these regulatory agencies being co-opted by the hospital industry so they keep saying they’re reluctant to ask hospitals to do more when, in fact, these infections add about 35 billion a year to our nation’s health tab in addition to costing so many lives. 


So this is an example where regulation could do far more. When I founded RID, not one state required hospitals to disclose their infection rate. Now, 38 do. But that’s only once a year. Even now, the CDC and state governments do no require hospitals to tell you when there’s an outbreak. So if you’re a pregnant woman going into the hospital, you’re not going to know if the hospital you’ve chosen has an outbreak of MSRA in the neonatal intensive care unit. So that’s a problem of lack of adequate regulation and support for progress that we could be making based on the technology we already have. 


The other two I’ll go through very quickly. Overkill, we’re living through it right now. And that is the overkill of closing down the nation because of COVID-19. We now realize that that was a very blunt instrument and not appropriate for all parts of the nation. And we should have targeted our assistance, rushed assistance, for example, to nursing homes where half the deaths in the nation have occurred. That’s an area where my organization’s particularly focused. And instead, we closed down restaurants and businesses where younger, far less vulnerable people work. 


Now, as we see a second wave of COVID-19 taking over much of Europe, even the top leaders in those countries are saying, “The one thing we’re not going to do is shutdown entirely again.” And most of you who are legal experts probably noticed the Pennsylvania decision, the decision by a federal court in Pennsylvania earlier this week knocking down Pennsylvania’s very rigorous, really draconian lockdown rules. So I would say in ending that part of it that what we probably need in the near future is for each state to pass an anti-petty tyrant law to limit the duration and scope of what governors can do in the next pandemic. There will be a next one. 


And finally, let me just say in two sentences that probably the best example of when more regulation or more lengthy regulation is not necessarily better is the debate the nation is engaged in right now over emergency authorization of a vaccine. Listening to all the politicians, you’d think that somehow the FDA intended to cut corners and rush this vaccine out regardless of the safety and efficacy data. But in fact, this emergency use authorization was devised by Congress in 2013 after the failure of a previous administration to come up with an H1N1 flu vaccine in time for the peak of that disease threat. 


And what this does, this emergency authorization, is simply look at the data as it rolls out and make a decision, rather than waiting until all the data from the clinical trials are in. The standards of efficacy and safety are still there, and most importantly, the same expert panel will still be making the decision. So I hope we have lots of discussion on those three topics and many others. And again, thank you for including me in this really interesting evening. 


Christina Sandefur:  Great. Well, thank you so much, and I am for an anti-tyrant law under all circumstances. I’m going to add that one to my colleagues’ list of legislation. All right. Next up is Josh. 


Joshua Sharfstein:  Thanks so much for having me. It’s good to be here. So I wanted to take as a jumping off point the documentary, which I was pleased to be able to look at and hopefully a lot of the people who are watching were able to see as well. And coming from my own background working for Henry Waxman, political appointee for Barack Obama, I wasn’t quite sure what I was going to see, whether I would agree with it or not. And I was pleasantly surprised that there were some significant areas of agreement. 


And the first area of agreement I’d point out is that the premise of the film is the public health. We have these major challenges, challenges threatening the planet, like climate changes, the enormous challenge faced by patients with failing organs. These are public health problems, and I teach at a school of public health. My career has been in public health. And I think the basic orientation to asking what is the direction that improves health that the documentary had is exactly correct. 


And frankly, these days, if I can find somebody who says, “Let’s improve public health outcomes and let’s use science to get there,” we’re basically agreeing on all the major things. I used to take that for granted, but not so much anymore. But I felt that the documentary did have that starting place. 


I would just point out just briefly that innovation is an important path, I completely agree, to advancing public health to address these big challenges. It’s not the only path. In the field of public health, we look at innovation. We also look at what the evidence is that works that’s in place now. We think about the barriers to doing things that could actually make a difference in the short term. But for the purposes of this discussion, I’m in agreement. I want innovation that advances public health. 


I’m also in agreement with many of the speakers that there is a very important need for regulation. And I don’t just mean by saying that Julie who said that FDA really is helping more forward with this health technologies or Betsy who said it’s time for regulators to ask hospitals to do more — but the speakers in the documentary, someone who said, “I don’t want to die from drinking milk.” We don’t want another thalidomide. 


And it really matters when there’s good regulation, not just to prevent horrible things from happening, but to facilitate innovation. And Dr. Atala from Wake Forest, I saw a good article where he said, “We need to make sure these technologies are reliable and reproducible time and again before you put them into patients.” It is people’s confidence in innovation that it’s safe and it’s understanding of how it’s safe and effect that regulation can bring. 


And certainly, we see that now for COVID therapies and COVID vaccines. We want safe and effective products. And while I didn’t totally agree with all the details of what Betsy said, the general idea that we have an agency that is going to do a good job — and I do have confidence in the career staff at the FDA to do a good job figuring out which vaccines are the ones for me and my family to take — that’s essential. We need that. I think the idea that there is regulation that supports public health is firmly in that movie. 


But we also want — don’t want regulation that doesn’t support public health, and I agreed with a lot of the points made in the documentary there, too. Where does regulation go wrong? It goes wrong when special interest, vested interest manipulate the regulatory process. And there was some examples of the meat industry. I have had some run ins with the meat industry myself — professional societies using regulation just to block entrance. I’m actually sympathetic with some of the work that the Cato Institute does there. 


There is — are examples of outdated regulations that don’t apply well to new technologies. And those regulations need to be modernized. I’d add a couple other examples that aren’t in the movie for regulations that don’t support public health. Stigma-based regulation — and I am very involved in efforts to address the opioid epidemic. And unfortunately, very effective treatments, methadone and buprenorphine, face very high regulatory barriers at the federal and state level without evidence to support them based in large part on the stigma of treating opioid use disorder with those medicines. 


I also think that there’s a problem in this country with ideology-based regulation where it’s not really about science or the public health. It’s about achieving an ideological end by another means, whether that’s on the left or the right. So from my perspective, the question is not is all regulation bad? It obviously is not. It’s how do we get more good regulation and less bad regulation? 


How do we get the regulation that supports the public health and not the regulation that undermines the public health? And so I think part of that is recognizing that blanket statements that regulation is fundamentally averse to progress or innovation are just not true and not helpful. You wind up with policies like freezing all regulation when, in fact, you need regulations for things like cell therapies to move forward. 


What is helpful? Three things to mention — maybe four things. Number one, transparency. I think transparency about the regulatory process so people can understand that is very important. When I was at FDA, I started and lead the Transparency Task Force. We listened to a lot of businesses about what they wanted from FDA. And some of those things we were able to do but some we weren’t. And I wish we had, particularly to tell people when guidances would be coming out that would help them — but other types of transparency. 


Aligned economic incentives, we can talk about that more, but I think in the movie that was clear on the climate example that a carbon tax would be quite helpful to align economic incentives for a healthier planet. Resources for scientific agencies, for regulatory science to be able to adapt regulations to changing technology just like Julie mentioned for cell therapies and our regenerative technologies. And finally, integrity in the regulatory process. We need protections against interference by vested interest, by politics, by narrow political considerations, whether Democratic or Republic, and by ideology, whether left or right. We should have science-based regulation that advance the public health. Thank you. 


Christina Sandefur:  Great. Thanks so much, Josh. You know, one of the things I really like — one of the points that you made that I really like is that there is so much that brings us together. I think in these times that seem very hyper-partisan and very divided it’s important to remember that a lot of us come from the same place: wanting to advance healthcare innovation and do what’s best. So I think this is going to be a really great discussion knowing that we’re starting with that baseline. Finally, Dan? 


Dan Troy:  So first of all, happy Constitution Day, everybody. The Constitution was signed today in 1787. As the co-chair of the FDA and Health Committee of the Regulatory Transparency Project, I want to welcome everybody. And I’m particularly grateful to our excellent, outstanding panelists. 


I especially want to give a shoutout to Josh. So this is the second time you’ve reminded me and, indeed, this is the second time we’re meeting. But from the perspective of I was chief counsel during Bush 43, and actually under the Obama administration FDA was thwarted scientific self-confidence, which it lost after Vioxx. So if you look at the number of approvals, approvals in the late 2000s fell to like the 20s. And they got up to 40 during the Obama administration. 


So anybody who thinks simplistically that, well, under Republicans there are lots of approvals and under Democrats there’re not, it is so much more complicated and nuanced than that. And I’m actually in violent agreement with Josh. He stole a lot of my thunder. On reviewing the movie, I was struck by how much it highlights the need for regulation to support and enable innovation, smart, appropriate, transparent regulation. It was great to hear, Julie, what you said about FDA. 


So I work for a new company called Valo Health, which we’re trying to use compute to reduce the cost and size of clinical trials. We’re trying to discover and develop drugs faster, cheaper, better. And we’re going to try and do things like simulated clinical trials. We’re going to need FDA. There’s no way we’re going to be able to do that without being really hand in glove with FDA. And we’re going to need FDA to be well-funded. Josh made the point about resources. 


We have, at my company, brilliant, incredibly intimidating, but not intentionally, PhDs/MDs, computational biologists. And they need to be able to have people at FDA who can actually understand what they’re trying to do and actually, as Julie says, sort of guide them. So here are the kinds of questions that FDA is going to need to opine upon. 


So machine learning, there’s a brand of artificial intelligence, machine learning, that it’s actually a black box. The machine comes out with answers, and we don’t actually know why. Other brands of artificial intelligence we do know why. But the question is what if something works but we don’t actually understand why? Right now, FDA’s like no, you have to be able to understand why. 


But what if we have a really high degree of reliability from a compute process, from an algorithm, but we don’t actually really understand as humans how it came to that outcome? But that outcomes seems to work a lot? That’s going to be a really hard question for FDA to wrestle with. And the question’s like what degree of reliability will FDA or other regulators require? A good example is telehealth, right? 


So we tolerate a degree of mistakes from doctors. We don’t need to get into medical malpractice, but nobody expects that doctors are going to be right 100 percent of the time. Real regulators allow telehealth or actually digital health where it’s not right all the time. Right? That’s going to be really, really tricky question. 


By the way, one of the things on the telehealth point, I really hope that it is an example of the type of regulatory change that comes out of COVID-19 that we will stick with. I also hope that the sort of urgency that we have seen with respect to therapies and vaccines — I mean, I hope we keep some of that because that’s actually — we shouldn’t actually only have to be in a pandemic to pay attention to the needs of patients — if you’re a sick patient, whether you have COVID or you have cancer, there’s a degree of urgency for you. That said, as Josh says, this has to be safe and effective and repeatable and reproducible and based on science. And we do have to have faith, as I do, in the career professionals at FDA. 


I also hope one of the things we’ll remember — and it’s something that I happened to be at FDA — I got there three weeks before 9/11. One of the things we did is we partnered with the private sector. We understood that at FDA we test, we regulate, but we don’t actually do. And I feel as if the government has kind of gotten that right with respect to the COVID-19 vaccine. I think we got that sort of right post-9/11 at FDA. I don’t think that the CDC got that right with respect to testing, right? So whatever the mistakes were, but the mistake of saying “We’re going to do it on our own, and we’re going to be the ones to supply the tests,” and not waiting to partner with the private sector until much later, I feel like that was a really big mistake. 


The last point, it’s not covered in the movie, but I think it does get, to a certain extent, to Josh’s point about aligned economic incentives. We are, today, relying, hoping, praying that the pharmaceutical and the biopharmaceutical sector will come to our aid with vaccines, with therapies. We literally are relying on that sector to safe our lives. And yet, at the same time on a bipartisan basis — it’s not a partisan point — we are proposing price controls. 


I can tell you I was the — one thing that wasn’t mentioned in my bio. I was the General Counsel of GlaxoSmithKline, which is, by the way, the largest vaccine manufacturer in the world by volume, for ten years. Drug companies need to be able to earn an adequate return on interest. What GSK had the first what seemed to be workable Ebola vaccine. Moncef Slaoui, he was the head of our vaccine business. He’s now the head of Operation Warp Speed. He was sitting at the table with the WHO and Gavi and NHRA and CDC and guiding the world, literally, through the Ebola vaccine. 


Now, the GSK one turned out not to really be the one that won, if you will. But what happened was the world lost interest in the Ebola vaccine, and GSK got stuck with literally $150 million loss. So the next time that a vaccine crisis came up, you know what GSK said? And GSK was incredibly altruistic company as companies go on the Access to Medicine Index award under Andrew Wheeler five times. But the next time a vaccine crisis came up, we said, “Let’s let Sanofi do it.” 


So you have to actually compensate companies for the things that they do. I have been in the room when the board of directors asked the CEO and head of R&D, “Well, should we just give that money back to the shareholders in the form of dividends or bare buybacks? Or should we spend it on R&D?” If there’s no adequate return on investment, the investment is simply not going to be made. 


So the last point I’ll make is cutting drug prices 40 to 50 percent would reduce R&D projects by about 60 percent according to the National Bureau of Economic Research. There’s a University of Connecticut economist who basically showed that if the EUA price controls had been in effect from 1986 to 2004 we would have 117 fewer medications — fewer medicines available. So as we actually rely on the pharma sector, let’s not slay the goose that we hope will lay and has laid the golden eggs. So again, thank you to the panel and thank you for the opportunity to be here. Appreciate it. 


Christina Sandefur:  Great. Thank you, Dan, for those remarks. I want to aim the first question at you, Josh, but I hope that others will chime in after you’ve answered. You’ve been talking about — assuming that we’re all coming from the same baseline that some regulation is desirable or that we have to have some regulation out there, the next question then becomes, okay, well, how do we design appropriate regulation? And in your remarks you talked a little bit about how we want to make sure that regulation is based in science rather than maybe based — or biased in favor of special interests or based on politics or ideology. 


And I think it’s true that you see this both on the left and the right. There are stories out there about how various forms of birth control, for example, or pregnancy tests were delayed in being approved because of politics on the right. And of course, you hear the same accusations made against the left. 


So my question to you is I think we can all get behind — or at least I think everyone on this panel can get behind the fact that that stuff should be taken out of the equation. We need to move forward. And if we’re going to have regulation, it should be science based. The question is how do we get there? Because that’s a lot easier than it sounds. 


And that’s especially true, I think, when we talk about some of the points that both you and Dan had made, and others, about the interest in having a partnership with the private sector. So how do you do that in a way that actually benefits the public at large and that doesn’t become such a cozy relationship that now you’ve got special interests sort of capturing the regulatory process. 


Joshua Sharfstein:  That is a great question. And it was partly the question that I faced when I started at FDA as the Acting Commissioner because, at the time, there was a series of articles in the Wall Street Journal that made the allegation that there was a device that had been approved over the objection — or cleared over the objections of FDA scientists after some congressman had intervened and the Commissioner had gotten involved. It was kind of a big mess. 


And the question was was FDA just going to pretend that that didn’t happen? Were we going to do anything about it? And what I did as the Acting Commissioner is I asked the Agency’s chief attorney Mike Landa, chief scientist Jesse Goodman, and chief policy person who all were there before I got there — and that was Jeff Shuren — to look into what happened. And the very first question about this was how do you define integrity in regulatory decision making? And that was the first thing that they had to do. 


And they came up with a definition that had three parts. And I’ll just briefly say them. Number one, it should be based on a rigorous evaluation of the best available science. And part of that was the appropriate expertise, including the use of advisory committees, is brought to bear. So you get great, smart people from the outside to advice the Agency. You don’t assume you know it all, but that’s one way that you also can clear up whether there’s something that is really based in science or some other agenda if you can get a really strong advisory committee. 


Number two, it’s reached and documented through a process that promotes open mindedness. And that includes transparency. They wrote the basis of decisions and processes should be adequately documented and explained to internal and external stakeholders. So I think advisory committees, transparency — and finally made without inappropriate internal or external interference. So you have to be able to say what that looks like and what shouldn’t happen. And people should be empowered. There should be whistleblower protections. There should be ways to stop a regulatory process from getting invaded in different ways by biased parties that don’t have ultimately the public health as their main priority. 


So I think those are the kinds of things — I think that definition reasonably stands the test of time. And it points in the direction of some of the things that maybe we could agree to would be very important — that these decisions should be, for example, about the COVID vaccine should not be made in the White House. They should be made at FDA. 


Christina Sandefur:  Great. Do others have any thoughts on that? 


Betsy McCaughey:  I do. Not pertaining to the vaccine. I think I made my point that the emergency approval is actually laid out very clearly in statutory language to ensure that it will be made by the experts on the independent panel, selected by the FDA, the very same ones who will make the decision on the final authorization or approval of the drug. But I’d like to look at this a little differently. 


It seems that in my 20-year battle to reduce hospital infections one of the things I’ve seen is that many regulatory bodies on the state and federal level are too closed off from the innovation occurring in the commercial world. I’ll just give you two examples, one at the New York State level — that’s what I’m most familiar with having spent many years in Albany — and that is that in Albany they had a rule at the Department of Health that somebody who works in the Department of Health regulating hospitals, for example, or handling something like hospital infections — well, they could talk to a university person or another government person any day of the week. 


But if somebody from the for-profit sector, an innovator, wanted to come talk to them, they had to wait for vendor day. It was like somebody who works for a company would have a big scarlet letter on their forehead. And the result is that many of the people in that state regulatory agency had no clue about the newest innovations, the most effective technologies, in my case, to battle hospital infection, something that is caused mostly by bacteria and, in some cases, viruses or fungus and mold on inanimate objects, in operating rooms, on bedrails, on pulse oximeters, things that we can eradicate. 


So my second example happened rather recently. This summer, the Centers for Disease Control and Prevention put out a 17-page guide on how to reopen society after COVID — how to reopen schools, churches, offices, restaurants, and other venues. And when I read it, I was struck. It could have been written 50 years ago — in fact, almost 100 years ago. It said put the desks six feet apart and open the windows. 


It didn’t talk about antimicrobial keyboards for offices, antimicrobial coatings, using copper doorknobs the way we know can stop the spread of bacteria or viruses from the many people who open or close the door. It didn’t talk about the many ways we now have of deactivating viruses in the air, insertions into the HVAC systems to continuously, non-toxically, automatically improve air quality, including from these viruses. I was so struck that this 17-page guide was literally devoid of technology at a time when we really need it and, in some cases, it’s costly technology, but not as costly as shutting down our entire economy. 


So I would say that, in some instances, in an effort to prevent too much influence from the commercial world regulators are insulating themselves from the good news and the new science and the capabilities of improving health. 


Christina Sandefur:  All right. Well, Dan, did you want to say something to that? 


Dan Troy:  So I’ve experienced both. I have experienced times at FDA and people at FDA who just would not meet with someone from the private sector. They thought they were verboten. On the other hand, I have on occasion had to defend FDA calling in people who were trying really cool new things, in one case cloning technology. And FDA wasn’t actually interested in it because they actually — because cloning is illegal. But the technology, PhD/MD scientists — by the way, FDA has more PhD/MDs per capita than any government agency, including NIH. And these people are really interested in developments in the science. 


So I think we should encourage that. I think the better regulators are the ones who are open to hearing from the private sector. Obviously, there’s the issue of capture. I’m not going to say that that’s not an issue. But by and large, people who go into a place like FDA, they could make way more money somewhere else, and they’re doing it because they’re public spirited and they really believe in the mission and the agency. 


And I’m not saying mistakes aren’t made. I’m not saying sometimes people don’t get a little too close to industry. But I felt as if it was a pretty good healthy tension between the private sector and the regulators. And they each knew that they needed each other, which they do, and that by and large people were all trying to, from different perspectives — trying to kind of do the right thing. 


Christina Sandefur:  Julie, I want to switch gears a little bit and turn to you. I have to say the part of the film that focused on the organs and the tissue development was just fascinating to me. And I believe — and I think, Dan, maybe it was you that used the term “bespoke” in the film, which I’m going to borrow now and use when I talk about it. 


I’m actually a beneficiary of a 3D printed device. I have rheumatoid arthritis, and I had to have double jaw joint replacement. And back in the day, they would select one, two, three — you got like four sizes. And basically, the doctor found the one that was closest to your face. And then they just put it in, and you just dealt with it. And those who have had one size fits most clothing, you could imagine what that would feel like in your jaw. But I was the beneficiary of this amazing technology. 


So what they did is I got an MRI, and they 3D printed these joints that were made specifically for my face and my head. And it’s just incredible. The down time, I was out of work for a week, and then I was just back. And I didn’t have to have — to my husband’s dismay, I didn’t have to have my jaw sewn shut or anything like that. So I was just fascinated to hear about sort of what that next step is where we can take tissue engineered organs or you can make organs that involve people’s own — that are individualized for people that involve their own DNA, just fascinating. 


So what I want to ask you is what are the roadblocks? Because that’s interesting to all of us on this. It’s interesting to somebody like me who has seen the benefit of these innovations. What are the roadblocks that prevent these technologies from being brought to mass commercialization and being widely made available to patients? 


Julie Allickson:  Yeah. Thank you for that. So it’s kind of interesting because yesterday all day I was at a public policy meeting for regenerative medicine. And this is pretty much what we were focused on is like what are the roadblocks. And one of the huge roadblocks is, when you look at regenerative medicine and the number of clinical trials, there’s about 1,000 right now. But if you look at tissue engineered organs, it’s a small amount. And then compared to all the clinical trials, the regenerative medicine is a fairly small amount. 


So when there’s funding available, especially during COVID where there was a lot of funding available, barred head funding available for the vaccines and so forth, a lot of the cell therapy regenerative medicine funding got pulled back. So funding for the clinical trials and being able to move these products forward is key. That’s one of the things that’s really challenging, even if it’s a small company. If it’s a larger pharmaceutical company it’s going to be much easier. 


But where we’re innovating things at the Institute, it’s hard to keep it going unless you have funding. We had a lot of funding from Department of Defense. We have philanthropy and other state type of funding, but that’s one of the huge challenges. 


The other challenge is manufacturing these products. You saw a little bit on the film of a tissue engineered urethra. But those are all pretty much handmade. The scaffold that we use is produced by a company, and then it comes in and we have to work with it from there. We have to get a biopsy from a patient, get the cells, expand those, seed them on, and then they’re maturing in what’s called a bioreactor, a little oven device for several weeks. That whole manufacturing process is very rigorous. 


So that’s something that is a bit of a roadblock because what we need is reagents and supplies to be able to move forward easily. When I say that, it’s of a certain grade GMP that allows us to use those and make the product with it. We don’t necessarily always have that. There’s not enough money yet in regenerative medicine. As it becomes more commonplace, we’re going to get more money. And that’ll bring the cost down, which would be amazing. 


But that, I would say manufacturing, the cost of goods, just being able to fund the clinical trials are really some of the most important roadblocks that we see right now. But I will say that listening to the comments about FDA, one good thing about the U.S. and FDA is that we don’t have to prove potency right out of the gate. And people might say, “You know, well, you’re infusing these things, and you don’t really know whether it’s potent or not if it’s a cell therapy?” 


But they see it’s working, but they don’t necessarily know what growth factor it is or what’s going on because some of these cells home to the site of injury, produce the growth factors, and stimulate the repair. The FDA gives us time until the end of Phase 2 to be able to determine exactly what that is. If you’re in the EU, you need to know that out the gate. So I think they’ve been really accommodating with a lot of the innovative therapies that we look at. As long as it’s safe, it can move into Phase 1. 


Christina Sandefur:  Dan, I want to see if maybe you can build on this a little bit. One of the things that you mentioned in the film was that the Federal Food, Drug, and Cosmetic Act was really geared towards mass market, right, bringing products to mass market for many people? And that really doesn’t seem to always jive with the types of products that, say, Julie’s talking about or things that technology makes very bespoke or very directed toward one particular individual. So do you see that as a roadblock to innovation, the fact that maybe our regulations, maybe congressional laws are really aimed toward a thing of the past and not necessarily toward the way — or where medicine is going, the wave of the future? 


Dan Troy:  Yeah. So hold on. I do think that FDA, going back to the time of compounding, which is a product that is made for a particular person at a particular time, FDA struggled with compounding. We used to joke that if it’s on the corner, it’s okay. But if it’s in the middle of the block, it’s not. I mean, FDA’s really struggled with compounding. And it has struggled with things like cell and gene therapy. 


That doesn’t mean there aren’t — there are any better places in the government to regulate it. But we do have statutes that — the Food, Drug, and Cosmetic Act was initially enacted in ’38, obviously substantially amended in ’62 and many times since then. The device statute I actually like better because it’s much more modern. It actually allows for much more titrated regulation with classes one, two, three. Because a device is everything from a Q-tip to a heart implant. But statutory tools are always going to be behind the times. They just are. 


And even regulation and guidance is always going to be behind the times. The question is getting the balance right of moving quickly enough, being transparent enough, but also not being too much of a break on innovation. It’s not easy. It’s not easy. 


One of the things that Peggy Hamburg, I think, talked about in the film is regulatory science, and that’s something that absolutely needs to be supported. Like I said, from our perspective, FDA can’t have enough MD/PhDs, computational biologists, smart people who are interested in innovation, interested in the science, and who are trying to get that right because the industry can’t really move forward without the guidance of the Agency. But it’s not easy adapting regulatory and statutory tools that — the first Food Drug Act was 1906 — that have so many barnacles, if you will, on them from a legal perspective to modern day. But that’s the challenge. 


Julie Allickson:  Can I just comment on that? 


Dan Troy:  Go ahead. 


Julie Allickson:  He’s right. It took a long time to get CBER to understand the regulations for cell and gene therapy and biologics. It did. It took a long time. But I feel like they’re there now. We’ve got regulations, and they’re trying to improve it. But you’re right. When something new starts up, they’re talking about in the movie the food science or what have you — it’s challenging. It’s challenging to get to that point. That’s where you need to bring people together in partnerships and speak to Congress and so forth to be able to move it forward. We need to all be really active. If it’s just one or two of us or small groups, it’s not going to move. So I agree. 


Christina Sandefur:  So Josh, one of the things that you said in your introductory remarks was about aligning incentives. And I want to ask you about that, thinking about, okay, how can we make regulations more effective? Well, there are different ways to regulate, right? Rather than maybe just having a “thou shall and thou shall not,” how do we maybe align economic incentives in a way that gets the private sector — that frees the private sector to be able to do what they do best while still making sure that we have some kind of regulation? 


Joshua Sharfstein:  That is a great question which I totally want to answer. But before I do, I want to ask you a question, Christina, if that’s okay, based on your last question and the answers that we heard. The major roadblocks to the regenerative technology that Julie mentioned were not regulation. And Dan mentioned regulatory science, which I think was kind of mocked a little bit in the movie the way that they presented it. 


And I wondered, given the importance that you’ve heard from Julie for an FDA that is able to understand the science and what Dan is hoping for his technologies — that The Federalist Society, the Goldwater Institute should endorse a strong FDA with science-based regulation protected from interference and not take the position that regulation, per se, is averse to innovation. Do you think that’s unfair to ask, given the conversation that we’re having today? 


Christina Sandefur:  Well, I think absolutely you’re right that regulation should be science-based. And without stepping too far outside of my moderator role — because, as Nate knows, I will do that, and then I’ll never come back — I will just say that I agree with what you said. I think some of these things, as all of you have admitted and as Dan said, are easier said than done. Or sometimes we may all agree that science-based standards are a good thing, and then the question is, well, what does that mean? 


We’ve seen all sides — both sides of the political aisle argue that they are doing things based on science. And then the question becomes, well, who’s science? As an attorney that is often in courtrooms with experts, you can have an expert on the government side. You can have an expert on the other side. And both experts can argue that they’re the right ones. So I do appreciate the sentiment. I would very much endorse a system that is more based on science and that embraces innovation than one that is going to be —


Joshua Sharfstein:  Yeah. And I just think we should stop the language of permission free innovation — that by its nature regulation is a problem. It’s not true. You heard Betsy calling for more regulation. You heard Julie saying that it helped her technology. So I just want to emphasis that point because I think there’s a lot that we agree on. But it’s sort of sometimes wrapped up in rhetoric that just doesn’t help. 


So I wanted to make that point because I actually think that there’s an awful lot that we agree on, and I could give examples of when I was at FDA. I walked down to the review agency. I heard from industry, and we were able to get great people together around the table to rethink the way that things were being regulated for the advancement of innovation. But that’s what we want. And I just hope that we’re able to see the commonality as these discussions go forward. 


Christina Sandefur:  Before you answer my other question, Josh —


Joshua Sharfstein:  Sure. Which I will, yes. 


Christina Sandefur:  — something in response to you. So let’s go to her first. And then we’ll go back to the new question. 


Betsy McCaughey:  Well, I was just going to point out that, in an era of a pandemic — or maybe I’ll say it this way. There’s a silver lining to this pandemic, believe it or not. One silver lining is that we are advancing innovative technologies that have already been available but were being ignored. I’m going to give you another example from my world: hospitals. 


We have been pushing — the Committee to Reduce Infection Deaths has been pushing hospitals for years to use point of care testing. That is, instead of taking a culture and sending it out to a lab and waiting 48, 72 hours to find out what kind of infection that patient has, using a technology that’s 100 years old — growing it in a petri dish — we’ve had for many years now point of care testing using genomics that could tell you in 45 minutes or an hour using a little toaster size or small device at the nurses’ station does that patient have strep — type B strep, for example, if you’re giving birth to a baby. We want to know those things, right? 


Now, fortunately because of the pandemic, the need for point of care testing has finally been recognized. Point of care decks from Cepheid and Abbot, all these other manufacturers, are flooding the market. Goodness, it’s a great thing. And I’m hoping that as a result when I walk into a hospital in the future I will see point of care tests at the nurses’ station for the kind of common hospital infections — staph, strep, CDIP — that are costing so many lives every year, and we didn’t have answers to them. So that’s one thing. 


The other side of that is that, in a pandemic, it’s not just regulation; it’s delay that can cost so many lives. That’s why I brought up very briefly the issue of the emergency authorization for a vaccine. Of course, we don’t want lower standards. But the idea of improving the timeliness of at least a narrow approval process, as Congress suggested in 2013, would be important because now we’re looking at September. And the predictions that either another 200,000 Americans will die by December or, according to one of Vice President Biden’s advisors, Irwin Redlener, it could be as many as 400,000 more. 


So of course delaying that approval you can actually weigh the delay against the cost of the lives that could be saved by a more rigorous and timely vaccination process. So I just wanted to come in with that and say, in a pandemic, we see the cost of delay and we also see the silver lining, more innovation pushed through more rapidly. 


Joshua Sharfstein:  Great. Thank you. I actually think Dan’s point about telemedicine I couldn’t agree with more. It’s similarly that the adoption of telemedicine extremely important for patients, and it really is reflecting some barriers that really didn’t need to be there. Addiction is a great example and all the requirement around addiction treatment. One quick thing, Betsy, I’ll tell you is that the EUAs were around before 2013. I signed them when I was at FDA in 2009 — some of which we did over the weekend for H1N1.


Betsy McCaughey:  Good for you. 


Joshua Sharfstein:  So to your question about economic incentives — which you were very, very nice to take my other question. So I appreciate that. But I will answer your question on economic incentives. I think it’s important. I think it’s very hard for a regulator to kind of push the tide back into the ocean. 


If there’s enormous economic incentive going the other way from what the regulator is trying to do, by and large I don’t think that’s an issue with drugs and devices. I think generally speaking the drug and device industry they’re long term economic interest — even their short-term economic industry is in having their products be safe and effective and having FDA bless them as safe and effective. I think that there’s a pretty good alignment. 


But in some times there isn’t. And a good example of that might be tobacco products. And I’ll just give a specific example on electronic cigarettes, which as you may now were and have been an enormous problem for youth. I don’t want to get into all the challenges of electronic cigarettes. But let’s say we were to agree, hypothetically, that we don’t want 16-year-olds getting addicted to nicotine through electronic cigarettes. 


The FDA has a number of tools to try to regulate that. They could — and some of them I think they should be using more, but they took some flavors out. They did certain things. That’s one way to do it. 


Another approach that would be complementary and possibly more effective would be an economic incentive where you could have a survey of those types of electronic cigarettes that are used by youth and have a tax that is proportionate to the youth use of electronic cigarettes. And if you did something like that, which that concept has had bipartisan support before for tobacco products — if you did that, then you would suddenly have an incentive for the companies not to have young people use it. And that could really much more clearly align the interest of the companies with the concept behind regulation. 


And you don’t have this cat and mouse game that’s going on now where the FDA bans one type of electronic. Then you get disposables that kids are using. So to avoid that kind of adversarial situation, if there are ways to use economic incentives like that, I think that might be a way where you get the goal of products that could help smokers quit without having 16-year-olds become addicted. 


Betsy McCaughey:  I knew we’d agree on things. 


Christina Sandefur:  Julie, I want to go back to you briefly. So we talk sometimes about this thing called the knowledge problem when we talk about regulation, right? The idea that even though we have, say, an FDA or other government agencies that are staffed by really, really smart, well-credentialed people, they can’t always — no person can always foresee what the future’s going to bring or what technological advances might come. So of course, this, again, can be problematic when you have a system where regulation is supposed to deal with technology and our regulators just can’t possibly foresee all the technological advances that are going to come, especially, again, in the field of healthcare. 


So how do regulators either poorly or well address innovation in your field, in the field of regenerative medicine without — to achieve the goals that you all agree are important, safety, efficacy, and what have you, but without needlessly delaying or stalling, as Betsy mentioned, or even completely stifling innovation? 


Julie Allickson:  Yeah. That’s a great question. And the FDA actually knows me by first name basis all the way up to the top, Peter Marks, because I’m always asking questions. I’m the one that’s working with tissue engineered organs or organoids or strange things that usually don’t come to their desk. 


One of the things that we talked about on the movie was the bioprinting. And nobody’s gone to clinic yet with a bioprinted with human cells in it. So you talked about the bioprinted structure scaffold. Yes, that’s already being used. But where we can produce, say, a urethra that’s bioprinted, that’s something that’s not there yet — or a nose that actually has the patient’s cells. Those are things that are being worked on. So as you share these things at meetings with the FDA — and the FDA accepts all invitations lately. It’s amazing. I’ve done a lot of different panels with FDA. And yesterday, we had all the way from Peter Marks to years and years back of the FDA Commissioners were participating in this meeting. But we do have their ear. 


So I’ll use the example of bioprinting in that they came out with regulations, guidance document with what they thought was important for advanced manufacturing, as they called it — bioprinting. And they also allowed a special pathway called CAT, which is for these complex products that you can go to them with a few pages of a document, and they’ll come back and answer your questions in a short period of time. So I think once they understand that it’s something that’s possibly going to move forward to clinic, they try to get everything in order so that they’re looking at how they can help you. 


I’ve been in the field for 30 years, and I remember the beginning was very different. And it wasn’t really for biologics. It was blood. I was in a blood center. And everybody was afraid when they walked in the door. But it’s very different now because they want to help. They have these documents, or they produce these pathways. 


The RMAT is a pathway that helps regenerative medicine move forward that was funded through the 21st Century Cures Act. But if you know it’s a medical need and you’ve treated already with it, they can fast track your technology. So there might be an opportunity if you have efficiency and safety that you get approval at Phase II, similar to some of the immunotherapies that you see, which is amazing. So I do feel like they’re responding. 


But they have to understand what the consideration is. I went to them not too long ago with organoids. We’re doing drug testing with organoids, but maybe in the future we’d like to see how to use those in therapies or potentially for preclinical studies instead of that. So they listen to that. We don’t have the answers for it yet. But they definitely take us seriously to try and get feedback. So I appreciate them. 


Christina Sandefur:  Anyone else want to comment on that question? All right. Well, Betsy, you just wrote this book, and it’s got a very provocative, interesting timely topic, the next pandemic. And in it you look at sort of what agency response was like to this pandemic. And there’s been a lot going on in the chat box — chatter about COVID and about how various agencies have responded. So my question to you is give us a little preview. What regulatory agencies get the highest marks and which ones get the lowest marks (Inaudible 01:03:37) on those? 


Betsy McCaughey:  It’s fun to be able to mark, right? The reason I wrote this book is that this isn’t the last pandemic. We’re in a global society. We know that there will be more emerging pathogens. 


And so the book is really about two things. One is the untold story of how much progress we’ve made in the last six months — it’s really quite remarkable — at getting ready for the next one, whether it’s supplying the national strategic stockpile or starting a made in America supply chain or the thing that interested me the very most, which is finally there’s now a huge push to improve rigor in hospitals and other healthcare facilities, rigor in infection prevention. And I’ll just say as an aside for those who probably have never read this story, this is not the first coronavirus. And one reached the Western Hemisphere in 2003, SARS. 


And it’s a very interesting story what happened because, on the same day, two men unknowingly infected with SARS went to hospitals in two different Canadian cities. And in Vancouver, which has a very rigorous culture of infection prevention, he went to the emergency room. He was immediately whisked into an isolation facility. Everyone wore the proper PPE, and no one else in that hospital got SARS. 


But in Toronto, the man who went to the emergency room unknowingly infected with SARS sat in the ER for 16 hours. The man three beds down on the right who was there for a heart attack got SARS. The man two beds to the left who was there for — I can’t remember now — got SARS. And 77 percent of the people who contracted SARS in Toronto got it in a hospital — in a hospital. Either they were patients, healthcare workers, or visitors. 


So that was our first warning that improving rigor of infection prevention is a really important thing, and it’s a major issue in this next pandemic because our safety even this time around largely depended on what the first healthcare workers did when the first patients came down with it. We saw it rage through nursing homes, and it wasn’t identified immediately when somebody went into the ER with it. And that is a major reason it was allowed to spread. 


So I think that improving use of — improving the rigor of infection prevention in hospitals and improving the use of technologies that are already available — already available to deactivate viruses in the air, to ensure that bedrails and pulse oximeters and blood pressure cuffs and wheelchairs are free of super bugs, we could be doing this and saving tens of thousands of lives, even in the years when we have no pandemic. So please come to and read more about it. And if you are going to the hospital yourself, one pitch, we have a lot of information. 


In fact, let me just pick this up. We have brochures like this: “15 Steps You Can Take to Protect Yourself from a Hospital Infection.” And I would love it if you would ask us for this information. That’s a big part of the next pandemic, what we’re already doing to get ready for the next pandemic and what we still need to do. 


In terms of grades, I think that FEMA got an A+. Surge in hospital capacity to cities when they needed it. I would say in response to one of the other panelists, the CDC gets a pretty bad grade because they didn’t realize that by partnering with the private sector the way the President did to make ventilators and masks and other things — they could have had tests out there really fast, including rapid tests. We lost a lot of valuable ground because of that fundamental mistake by the CDC. 


So it’s a mixed bag. But I think that, in general, technology really offers great promise to getting ready for the next pandemic in workplaces, in schools. If we installed the kind — let me say it this way. We all need to become indoor environmentalists. Dan will like that. We need to become indoor environmentalists. And if we do, if we use now the impressive technologies we have — diluted hydrogen peroxide, UV light — technologies that can make all of those spaces stay safe day after day, when the next pandemic strikes, we won’t have to close things down. 


Julie Allickson:  Here, here. I’m excited about that. And that’s what we’re doing. I see that happening. We’re cleaning with UV and doing a lot more things that we’ve never done. So it’s amazing. I want to read the book. 


Betsy McCaughey:  Thank you. Page 51 has a big list of things we can do. 


Joshua Sharfstein:  Can I jump in for a quick second? 


Christina Sandefur:  Sure. 


Joshua Sharfstein:  So I think in addition to the important work of hospital infection control — extremely important — there are other technologies that are going to be necessary as we think about preparing. We want to shorten the development of a vaccine even further. We want to get testing to be able to be stood up even quicker. All those things, there’s going to have to be a major investment in the science and innovation. 


And a critical piece of that investment — it’s not enough just to fund the basic scientists — is going to be to support regulation so that people can really understand which are the good and promising technologies and which are the ones — and what do they need to be able to do to demonstrate that they’re worthwhile for the American people. So I hope and trust that as the legislation eventually moves forward to really think about that kind of investment that people realize that it’s not let’s just give money to people and hope they come up with stuff and then we’ll sort it out when the next pandemic comes but that we actually have regulators who are helping, just like Julie said — helping with the innovation to figure out what are the key goals, what is a sign of something that’s not going to be safe, how you steer these different technologies. That’s going to be really important as we make that investment. 


I would also just put in the two quick other things from a public health perspective that we have to think about for the next pandemic, one of which is really investing in our public health infrastructure. We’ve had tens of thousands of health officials and public health employees have left over the last decade because of massive budget cuts. And we’re paying the price. 


Innovation has to actually get to people to work. There’s a saying in public health that vaccines don’t save lives; vaccination saves lives. So you actually have to be able to deliver it. And if you’re just focused on that basic science investment and you don’t think about the infrastructure to deliver the trust that you need in communities, the ability to communicate, the IT systems, all of that, it’s going to be hard. And that is really a weakness that we have as a country going into the COVID vaccination era. 


And the last thing I’d say is that we have been exposed as a country because of the deep racial and ethnic disparities that we have, the shocking increases — two, three, four times in rates of infection, hospitalizations and death for African Americans and Latinos is really shameful, and we should be thinking about why that happened and what we can do as a society to make sure that we’re not facing a pandemic and throwing some of the most at risk communities into harms’ way first. 


Julie Allickson:  Josh is making a lot of good points. I just want to follow up to say — to be able to support everybody, I think that the FDA also needs funding because what I’m seeing with the pandemic and COVID when I’m submitting these emergency INDs is that they’re calling within an hour. They’ve got people around the clock. You’re working on the phone with them at 3:00 in the morning. The resources that they need to be able to move this stuff forward has to be increased. So I feel like that’s a big issue. As you talk about everybody down the line, it needs to get the funding. 


Christina Sandefur:  Dan, you wanted to comment? 


Dan Troy:  So I want to echo what — I agree on the resources point. I think I’ve made that a few times, as did Josh. But I want to echo his point on the disproportionate impact of many of these health — impact of these health things on disparate communities and on minority communities. It is shocking. It is something we need to deal with. 


And that’s why — by the way, the fact that Moderna paused its trial enrollment in its vaccine trial to get more minorities in the trial was so important because this vaccine is going to need to — because the disease disproportionately impacts minority communities, it’s going to be really important for those communities to actually believe in this vaccine. And they’re not going to believe in the vaccine if the trial does not really sort of represent all of the people who are most impacted by this disease. So I thought that was a really, really good decision on the private sector’s part, and that’s the kind of thing that we should stand up and applaud and support when it happens because that is so important. 


Christina Sandefur:  So we have time for one last quick question, and I want to actually build on that, Dan, and also something that you said, Josh. Everyone’s sort of talking about it’s more than just government, right? There has to be infrastructure in place. There has to be a belief in the system. And you’ve also spoken a little bit about the politicization of things in government. 


I would argue that we’re pretty polarized in some ways in our nation right now, as well, on things like wearing a mask or getting vaccinated, whether it be for a major COVID vaccine or even something else, like the flu. It’s become very divisive, very political. So how do we address that? And the answer might not be with regulation. The answer may be something else. 


But how do we address that? Because I think in order to recover from something like COVID and things like that, you do really need buy in from the public at large. And I’m not sure we seem to have that. So do you think I’m wrong. And if not, how do we address that? Go ahead, Dan. 


Dan Troy:  I’ll take that. I actually think events like this. When you actually sit down and talk to people and ignore Twitter and social media — you actually sit down and talk to people, we find much, much, much more agreement. Josh and I come from very different perspectives, but I think we probably agree in this area on 60, 70, 80 percent of things. I’m sure we could find areas to disagree on. 


But the key thing — and that’s why I’m really glad for The Federalist Society doing this. I’m glad for the Regulatory Transparency Project doing this. I’m really glad that Josh came on among everybody else because it’s when you sit down and just really have human to human contact and have dialogue that you actually realize we’re not as polarized as the mainstream media and social media makes us out to be because that’s in their economic interest to do. 


But I happen to be a conservative who lives in Montgomery County, Maryland. So most of the people I encounter don’t necessarily agree with me. That doesn’t mean you can’t be friends and we can’t talk about things on which we agree and seek agreement rather than disagreement. 


Christina Sandefur:  Well, thank you for that. 


Betsy McCaughey:  Something that we all really appreciate and celebrate, innovation is the answer to so many of the problems we want to solve. 


Christina Sandefur:  Excellent. Well, with that, thank you all, to our panelists. And I just want to say that I’m so thrilled that there was so much we are able to agree on tonight. I’m not sure, Josh, that you’re going to get me to stop using the term “permission-less” much, but beyond that, I think that —


Joshua Sharfstein:  I think that we should call a truce on the war on regulation. I think we should be talking about improving regulation, not the war on regulation, not regulation isn’t necessarily antithetical to progress. And I think this conversation is a great starting point for that. And I want to just say thank you for having me. Thank you for doing this. I really appreciate being here. 


Christina Sandefur:  Absolutely. Well, we’ll turn it over to Nate now. 

Nate Kaczmarek:  Well, great concluding remarks, a wonderful discussion. We’re grateful to Christina, Julie, Betsy, Josh, and Dan. You’ve all given us a lot to think about. Certainly to our audience, we welcome your feedback on tonight’s program by email at [email protected]. That’s [email protected]


One quick announcement before we go, be sure to join us next Thursday night at 7:00 — same time, 7:00 p.m. Eastern. We’ll be hosting our next panel, which is on the future of our Earth. That panel will feature EPA Administrator Andrew Wheeler, David Doniger from the Natural Resources Defense Council, Susan Dudley from George Washington University Regulatory Studies Center, and Charles Hernick of Citizens for Responsible Energy Solutions. So we’ll see if they can top this great panel tonight. But anyway, thank you all for joining us. Have a wonderful evening.

Julie Allickson

Chief Manufacturing Development Center Officer

Wake Forest Institute for Regenerative Medicine

Betsy McCaughey


Committee to Reduce Infection Deaths

Joshua Sharfstein

Vice Dean for Public Health Practice and Community Engagement

Bloomberg School of Public Health, Johns Hopkins University

Dan Troy

Managing Director

Berkeley Research Group

Christina Sandefur

Executive Vice President

Goldwater Institute

FDA & Health

They Say It Can’t Be Done

It Can Be Done Live

The Federalist Society and Regulatory Transparency Project take no position on particular legal or public policy matters. All expressions of opinion are those of the speaker(s). To join the debate, please email us at [email protected].

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