Podcast: COVID-19 Vaccines and HHS Updates

Michael Werner: My name is Michael Werner. I am a partner at Holland & Knight. I'm based in our Washington, D.C. office. I am a specialist in government relations and regulatory work, and I represent companies that manufacture, distribute, develop and dispense products that are regulated by the U.S. Food and Drug Administration. I also co-chair our firm's national Healthcare and Life Sciences Practice Group. I'm joined by my colleague today, Ethan Jorgensen-Earp, and I'll let him introduce himself.

Ethan Jorgensen-Earp: Thanks, Michael. Hi, I'm Ethan Jorgensen-Earp, I'm a senior public affairs advisor in the Washington, D.C. office of Holland & Knight. I do a lot of government affairs work with health care entities, including those regulated by the Food and Drug Administration. I also represent a number of those entities on Capitol Hill and before federal agencies and look forward to the discussion today with you, Michael.

The Vaccine Rollout and Pandemic Preparedness Infrastructure

Michael Werner: So, Ethan, I think what we wanted to talk about during this podcast really was focusing on the vaccine rollout and related issues relevant to the response to the COVID-19 pandemic. I guess the big news around vaccines these days is the pause in the administration of the Johnson & Johnson vaccine. I'm curious what you think about how that impacts President Biden's goal of trying to get all Americans vaccinated by this summer.

Ethan Jorgensen-Earp: Well, that's a great question. Certainly the news coming in about the Johnson & Johnson vaccine having some side effects related to clotting were certainly concerning. It was one of those situations where the U.S. was looking at other countries that were utilizing the AstraZeneca vaccine, which generated some side effects as well that caused some consternation. In this case, when you first read it, you think that it's going to have a very significant impact on the vaccine rollout. However, when you really take a look at it, 95 percent of the shots that are given domestically are Moderna or Pfizer vaccines. So there's really a small sliver of the vaccine grouping that are Johnson & Johnson vaccines. So I think it's interesting that Anthony Fauci, who is helping to provide the scientific basis for the vaccine rollout, said this is a good thing, that they're halting. This is something that should create confidence, not concern. So we'll certainly see how that goes, but I think that the initial rollout of the vaccine will not be as terribly affected as people think it will be. I did want to ask you what you thought about CDC's advisory committee was supposed to meet yesterday and come to a conclusion about whether they should limit administering the shots based on age or sex, and then they seem to deadlock and push the decision off. I didn't know you had the opinions about sort of that signal and what it sends to the populace.

In this case, when you first read it, you think that it's going to have a very significant impact on the vaccine rollout. However, when you really take a look at it, 95 percent of the shots that are given domestically are Moderna or Pfizer vaccines. So there's really a small sliver of the vaccine grouping that are Johnson & Johnson vaccines.

Michael Werner: Well, it's certainly not good news, not only for Johnson & Johnson, but I don't think it's good news for the Biden Administration. I saw a Doctor Fauci's comments as well. I'm not quite sure that's the way a lot of other people would think of this. We already have a situation where around 20 percent of Americans have expressed some hesitance about getting the vaccine, and it's kind of hard to imagine that all the publicity around this won't either raise that number or make it harder for the administration to get that number to go down. I think your analysis is correct, right? I don't think as a practical matter it makes that much difference, but the perception isn't very good. I think that certainly there were a lot of folks hoping that the CDC could make its recommendations quickly, and if it meant limiting who should get the J&J vaccine, just implementing that limitation and then moving on. Then the vaccine is just available to everyone else. The fact that they delayed it and said they didn't have enough information is certainly not good news. But again, I think given the fact that mostly it's Moderna and Pfizer and by the way, both of those companies, as you know, have said that they've got the manufacturing capacity, that they'll be able to develop more vaccines. So I think in the end, Americans who want the vaccine are going to be able to get it. It'll be interesting kind of how this plays out. The other interesting thing, of course, is that the Moderna and Pfizer vaccines may get full approval from the FDA in the near term. That, I think, certainly is going to be a market differentiator for them over Johnson & Johnson or AstraZeneca, if AstraZeneca ever gets its product to the market.

Ethan Jorgensen-Earp: No, absolutely. That's a great point. I think not just for vaccines, but those that are producing other medical products that first came to market under Emergency Use Authorization (EUA), they're going to have to start thinking about what the next steps are as they try and move from the EUA to an actual full approval. One of the benefits of the vaccine is that they had so much data available that, while it's a complicated product to make, the transition could be a little bit easier because the data package is there to really help sponsors of those vaccines. There's been a lot of reporting on the variance of the COVID virus. A couple of them, one seen primarily in the UK and the other seen in South Africa, apparently are much more highly transmissible than the original field virus that was seen coming out of China. So I did want to touch on that a little bit. It seems that the Pfizer vaccine in particular is still effective against those variants, but I think that this does cause some concern for a lot of people just given how transmissible they are.

Michael Werner: Yeah, I mean, there's no question. I think what this really signals is that any hope or perception that, "Well, the COVID pandemic, we're going to get a vaccine and then it's just all going to go away and just be kind of something we all think about in the history books or read about five years from now." I think that the fact that there are these variants that are coming around that, as you said, seem to be more easy to transmit, demonstrates that what we might be looking at is that COVID becomes almost like the flu and that there might be new variants every season. It might be that we need booster vaccines or it might be that some of these vaccines work on the current variants, but then there will be another variant down the road. It's really hard to predict all of that, obviously, and viruses mutate, right? That's just what happens in nature and in biology. So really, the lesson from the pandemic is, once we get things a little more under control, how do we create a public health infrastructure so that we can manage when there are new variants of this virus or other viruses that come down the road? That actually leads me to a question for you, which is we know that Congress has started to do a little bit of thinking about this, what can you tell us about what some of the ideas are that are being kicked around on Capitol Hill and where you think that's going?

So really, the lesson from the pandemic is, once we get things a little more under control, how do we create a public health infrastructure so that we can manage when there are new variants of this virus or other viruses that come down the road? 

Ethan Jorgensen-Earp: That's a great question. Certainly, the near-term stimulus package has provided billions of dollars to combat COVID in the near term, and we can touch on that a little in a little bit. I think long term, certainly there are going to be discussions on Capitol Hill about how to organize the federal government so that it is more efficient when it's dealing with pandemics. Back in the mid-2000s, a lot of people will recall that there really wasn't a pandemic's office at HHS. There was nothing really permanent there. It took George W. Bush reading the book, The Great Influenza, when he was on holiday in Crawford, Texas. It scared him so badly that he ended up going to his advisors who ended up writing legislation and shopping it around Capitol Hill, and it led to the development of the Biomedical Advanced Research and Development Authority at HHS, also known as BARDA. That really started the government understanding, and trying to deal with, pandemics and related issues. At this point people are now trying to figure out, is that the best mechanism? Currently, they oversee the Strategic National Stockpile, which is located at various sites around the country, and it is a store of what you would think of as the most critical medical supplies that you would need during a pandemic or another emergency. I think people are going to ask, is the stockpile big enough? Is it organized properly? Can you send those supplies out across the country quickly enough to deal with different emergencies? In addition to that, people on Capitol Hill will be trying to figure out, well do we have enough permanent resources for the development of countermeasures? Are we looking at the current shortage of drugs and especially those drugs that are not prescription drugs, but generic drugs that are used all the time in dealing with emergencies? So I think there are a number of conversations that are going to happen in the next six months that will give us a better sense of what we're going to do in the future.

You deal a lot with the User Fee negotiations at FDA on various types of medical products. How do you think those efforts might affect that process? Again, it's a very regular process that happens every five years, but this is certainly a very interesting time, especially when you're dealing with the FDA and its leadership.

Michael Werner: What's interesting is this year, the authorization for prescription drugs, generic drugs and devices are all up. The legislation is up for reauthorization, which means there's negotiations between the FDA and the regulated industry in each of those areas. Those negotiations typically just focus on the User Fee program, which means that the FDA and the industry kind of decide what the User Fee amounts should be and how much industry should pay and kind of consequently what FDA should spend that money on. Industry has typically been very careful to say that that money needs to be spent on items within the review process. So FTEs in particular, review divisions perhaps, or performance goals that industry needs to see from the FDA in terms of how quickly they review applications or how quickly meetings take place, all of those things. So that'll, I'm sure, be all part of all these negotiations. They always are. But what will be interesting is the question you raise, which is we're having these conversations, and by the way, after the industry and FDA are done, Congress then gets its bite of the apple and reauthorizes the legislation. All of this is happening kind of in this context of the pandemic or perhaps on the tail end of it, if we're lucky. And so to me, that means that when the industry and the FDA are negotiating, they're probably going to be talking about things like what processes did FDA implement during the pandemic that can be extended even if we're not in the period of a pandemic. So great example of that is use of virtual inspections by FDA. I would anticipate that issues like that will be part. So the pandemic influencing the User Fee negotiations, because some issues that came up during the pandemic I think are now kind of fair game for discussion between the regulated industry and the agency. Another example might be you sort of alluded to the supply chain questions, and of course, especially in the early days, there were a lot of discussions about "we don't have the manufacturing capacity in this country," or "how can we get products from other countries to the United States or pharmaceutical ingredients," things like that. So to me, all of those issues are going to be part of now the reauthorization process, whether it's part of the industry negotiations with FDA or once Congress kind of jumps in and starts taking a look at these issues.

Speaking of FDA, Ethan, we still don't have a full-time commissioner. And to quote Yogi Berra, that great American politician, "it's getting late, early," and it's kind of getting late for a permanent FDA commissioner to be named. What are you hearing about that?

That means that when the industry and the FDA are negotiating, they're probably going to be talking about things like what processes did FDA implement during the pandemic that can be extended even if we're not in the period of a pandemic?

HHS Leadership Roles and the Search for an FDA Commissioner

Ethan Jorgensen-Earp: Yeah, it's certainly something at top of mind. As a lot of people have seen, there have been a number of nominees for other HHS posts that have that have moved through, including Surgeon General and some others in the Office of the Secretary, but the Commissioner of Food and Drugs remains vacant. There have been some interesting shifts in the leadership at FDA, one noteworthy issue is Amy Abernethy leaving. She was the Principal Deputy Commissioner and had been there for a long time and she had vacated her post. You also had Janet Woodcock, who had led the Center for Drug Evaluation and Research for a couple of decades, took an acting role, and as people may recall, she was one of the principal advisors to Operation Warp Speed earlier. So she had had a fluctuating role at the agency when they were developing a vaccine. It was assumed a couple of months ago that Janet Woodcock would be the top choice for the for the nomination, that she would move through pretty quickly. As we've seen over the past couple of weeks, there have been several individuals in Congress and the Senate, Democrats, who have expressed their concern over her nomination because of her activities during the opioid epidemic. Whether you consider those thoughts and opinions fair, given her record, regardless, it's created quite a lot of difficulty for President Biden and his advisors as they're trying to figure out who should fill that post. You all probably also saw that the Center for Drug Evaluation and Research filled Janet Woodcock's post with Patrizia Cavazzoni, who has been there for a long time. So now you have a situation where she will either be nominated, and potentially become the Commissioner of Food and Drugs, or she will vacate the agency. But it's certainly a very high profile position, especially when you're dealing with rolling out a vaccine and I think it's causing a lot of consternation.

What do you think the ripple effects are as we get further and further down the line and we still don't have a commissioner? Because, you know, obviously the review divisions and others can move forward with their daily work. But as you alluded to earlier, there are going to be a number of decisions that the agency is going to have to make, not only now, but in the User Fee negotiations and moving forward that takes a strong leadership role to make. So I wanted to ask you what you thought about sort of the long term effects of this delay.

Michael Werner: Yeah, you know, it's kind of fascinating in a lot of different ways. I've kind of been intrigued watching the situation with Dr. Woodcock, because, ironically, the things that made her a strong candidate and as you said, perhaps in many people's minds, kind of the presumptive candidate, either aren't helping or haven't quite worked out the way anyone thought. So, for example, one of the things that I think Dr. Woodcock always prided herself on, and with good reason, was her support in Congress, bipartisan support forever, really a lot of respect on both sides of the aisle from staff, from the members themselves. so here we have a situation where she might not get the role because folks in Congress are raising such red flags. I think in January we would have said, "Oh, well, the big advantage Dr. Woodcock has over other candidates is how much she's liked and admired by members of Congress." The other thing that's interesting is that she's beloved by the cancer community for all of her work with supporting new drugs for patients with cancer and the whole breakthrough designation was something that she was very, very supportive of. Certainly President Biden has, like many people, has personal experience with cancer and undoubtedly as vice president, had lots of interactions with Dr. Woodcock in her role as the head of Center for Drugs. But you're right, despite all of that, she seems to be kind of stuck over her role in the opioid crisis.

Normally, FDA watchers would say it's not good for the agency to not have a permanent commissioner, as you pointed out, I mean, you really want to have a strong leader. The agency gets involved in so many difficult issues and they get pulled in so many different directions and a strong leader really, really is important to kind of keep things moving ahead. Dr. Woodcock is a little bit of a unique case as an acting because of what we're talking about, because she's been at the agency for so long and has the respect of the senior staff at the agency and does, despite evidence to the contrary, I guess, has political support in a lot of circles. So, look, I don't think it's a good thing. It's not as bad as other times when there's been either no commissioner or an acting commissioner, and I think she is behaving as if she is the commissioner and not just filling a seat, but I think there's no question that things would be a lot better and a lot more stable ultimately if well, certainly from the agency's perspective, if she became the commissioner. But even if not, if there was a commissioner that was named. I don't know, and I'd be curious to know what you think, I don't know if that Biden Administration is just kind of letting this play out more. It's not easy to find a good candidate, but you would think if they really wanted one, they would have found one by now.

Normally, FDA watchers would say it's not good for the agency to not have a permanent commissioner, as you pointed out, I mean, you really want to have a strong leader. The agency gets involved in so many difficult issues and they get pulled in so many different directions and a strong leader really, really is important to kind of keep things moving ahead.

Ethan Jorgensen-Earp: I agree with you. I think it's interesting. There are probably a number of candidates out there, obviously those with some political experience, there are fewer of those, and that doesn't necessarily preclude you from being selected for the position, but I think it certainly helps if you have a track record of some sort of being able to deal not only with the scientific issues, but also with the political issues. It also sort of brings me to the next item I wanted to talk about.

Obviously, there was a stimulus bill, the American Rescue Plan, and it provided billions and billions of dollars’ worth of funding to various agencies to predominantly deal with the COVID pandemic. Certainly, the FDA was a recipient of some of those resources. I would assume that not having a leader at the agency would also make that a difficult process if you're trying to take that money in and transfer it and develop some breakthrough therapies and some other medical products that can deal with the COVID pandemic and the symptoms of COVID. So I did want to bring that up and get a sense of what you thought about that.

Appropriations for the CDC and the Agency's Role Moving Forward

Michael Werner: Yes. So that's a great example of where not having a permanent leader is potentially problematic. I think it will also be problematic when, and not if, but when there's a really controversial topic that the FDA has to manage. You know, in previous administrations that could be issues around vaping or regulation of tobacco or the NIH is talking about fetal tissue research. I mean, those kinds of issues that the politics gets really hot, hot, hot. I think that's when you really need the strong commissioner who can reassure everybody, all the political factions internally and externally, that the agency's got a plan, it's solid, it's science based and it's going to be credible. Now, again, Dr. Woodcock has a lot of that credibility, so she might be able to pull it off, but I think that's really when we're going to see the test of this. You're right, the appropriations and then something like that. And so we have the appropriations and the rescue plan, you know, just getting back to vaccines and contact tracing and the like. This is a huge windfall of money for the Centers for Disease Control, which I think in some ways over the last decade haven't had big increases when we look at appropriations. Certainly not like the NIH, for example, but they have clearly been on the front lines, they clearly are going to be on the front lines. Congress has recognized that in giving them a lot of funds. So talk a little bit about how you think that money is going to be spent, and there are probably opportunities for folks in the private sector to collaborate with the agency.

Ethan Jorgensen-Earp: Your point is a really good one. Everyone talks about the regular increase in discretionary appropriations for the NIH, but CDC and some other sub agencies at HHS have seen minimal increases in their funding over the years. The American Rescue Plan provided almost $50 billion to the CDC, which is an unfathomable amount of money, and it'll go towards, like you said, testing, contact tracing, COVID mitigation activities, certainly vaccine rollout activities. So I think to a large extent, some of that funding is going to be distributed to the states through preexisting formulas that have been used in other cooperative agreements, but I think that they're going to be a number of activities where the CDC is going to require assistance from outside companies. Whether you're trying to help with the vaccine rollout by identifying populations that haven't been vaccinated or if you are a company that develops sort of the equipment around the vaccine itself, whether you're developing the syringes or anything like that, there are going to be opportunities there for sure through the CDC. I agree with you, they've been viewed as the ideal agency to do something like the vaccine rollout and to deal with the pandemic. They're not located in D.C. They're in Atlanta, Georgia. So they're viewed as outside of sort of the political inside the Beltway sphere. They also specialize in epidemiology, so from a scientific perspective, they were logical when trying to do some of the population analysis that you would need if you were to roll out this many vaccines. I should mention, for those that are developing technologies that can either deal with it now or for future pandemics, certainly the Department of Defense is going to have a huge part to play in this. $10 billion was provided through the Defense Production Act to ramp up the production of various health countermeasures, equipment and the like. So that's something to definitely keep an eye on as we move forward, that HHS has been in the driver's seat for the most part, but the ability of the DOD on medical research and also moving equipment and personnel has really put them in a position to assist using the Defense Production Act.

The American Rescue Plan provided almost $50 billion to the CDC ... it'll go towards, like you said, testing, contact tracing, COVID mitigation activities, certainly vaccine rollout activities. So I think to a large extent, some of that funding is going to be distributed to the states through preexisting formulas that have been used in other cooperative agreements, but I think that they're going to be a number of activities where the CDC is going to require assistance from outside companies.

For more on Biden's First 100 Days in office, listen to our other podcasts in the series covering Healthcare Priorities and Landscape and the Digital Economy and Tax.