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Dr. Anthony Fauci, Admiral Brett Giroir, Dr. Robert Redfield Testify Before Senate Today; Fauci Says, We Run The Risk Of A Resurgence In Fall. Aired 1-1:30p ET

Aired May 12, 2020 - 13:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.

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SEN. LAMAR ALEXANDER (R-TN): Senator Braun.

SEN. MIKE BRAUN (R-IN): Thank you, Chairman.

There's so much discussion about testing, in general. Listen to Senator Romney earlier. I think Senator Kaine mentioned it. Everybody has. Dr. Hahn, if you remember when we first met, I said, is the FDA is going to be more entrepreneurial? Is the FDA going to kind of not be stodgy (ph), talking then about how we fix the healthcare system in general?

Now this is brought into clear focus. I got a timeline that I am going to submit from the record that shows from January 24th through March 5th and I want to emphasize what Senator Burr asked earlier, has the administration ever put an impediment in front of trying to get to testing.

And, Dr. Hahn, this will end up in a question in a moment. But there was a span of time from January 24th through March 5th that I hope the American public looks at. And it gets back to what's wrong with our healthcare system, in general.

Early testing, from what I'm seeing, was created by the fact that the CDC said it was going to do its own test. The South Korean test, it gets sided so often, was not going to be looked at, we had to do our own. I know the FDA works with the CDC. But the long and short of all of this is that for nearly a month, this was in that bureaucratic swirl.

The FDA prevented private and academic development of tests for weeks. The CDC denied access to functioning tests, as I cited in South Korea.

This created, through all the red tape and bureaucracy to where we had to come up with a one-size-fits-all approach due to the uncertainty of the virus and we are stuck with that now. I don't want to dwell on that necessarily because I think those are mistakes that we made. I am tired of having it heard that it's the administration's fault.

Dr. Hahn, I'd like to ask you this question. In that spirit of what we've talked about during your nomination process, here going forward, will we shed some of that stodginess? Will we look to get therapeutics and vaccines through the system in a quicker method because, I fear if we don't and if we treat through bureaucracy how we did the early period of testing, we can be labored into the distance future. And at that point, there is going to be not only the carnage from the disease itself but from the economy to deal with.

So I would like your comment on that one-month stretch, what accountability the FDA and the CDC have and then whether it looks better in terms of moving more quickly into the future?

DR. STEPHEN HAHN, FDA COMMISSIONER: Thank you, Senator Braun for the question.

Our timeline of that period demonstrates that we began working with test developers beyond CDC in January 24th and had double-digit number of test developers working with us. One of the issues that we identified was, in fact, availability of the virus and other supplies to actually to get that test development done in a timely fashion.

Senator, I complete agree with you that this is an opportunity for us to take a look and determine how we can do things better and I think that's a really important thing for all of us to do certainly the FDA can promise you we'll do that.

Looking forward, sir, I can commit to you that we will look at every one of our regulatory authorities, we have done so during this outbreak. We have provided significant flexibility and have tried to provide the right balance between regulatory flexibility and enabling of the great test developers and therapeutic developers in this country with the need to ensure that our goal standard of safety and efficacy is in place.

We have leaned in with manufacturers. We've learned a lot from them, as well as the other state brokers (ph). And we will continue to learn and we will, I commit to you, sir, implement the changes that are necessary to make sure we connect in a more nimble way but still protect the safety and efficacy of medical products.

BRAUN: Thank you. Dr. Fauci, taking a page from your anti-AIDS playbook that implemented a formal, clearly defined treatment review pathway, can we do that for COVID-19 in a similar parallel track that you put into place back then in the '90s? In fact, I have got a bill called the Promising Pathways Act, that is based upon that protocol you put into place.

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Can we do that more quickly, get through to therapeutics and vaccines here with COVID-19?

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES: Well, it's a different story but some similarities. If you're referring to the parallel track that I put into place back in the late 80s, which was when there was no availability of drugs at all for HIV and when we were testing drugs within a protocol that we would make it available outside of the protocol in what has ultimately turned out to be compassionate use. So what we did is we didn't want to interfere with the integrity of the protocol to determine the control way, what was safe and effective, but there was a dire need for some sort of accessibility to those drugs outside of the clinical trial for those who might even have some chance of having it. And, in fact, that was really, in many respects, the birth of the really firm concept of compassionate use.

And, in fact, there is a version of that which I will hand over to Commissioner Hahn that is when you have expanded excess and emergency use of authorizations with drugs that have not yet been fully proven in a clinical trial. So there is somewhat of an analogy and similarity between what I did in the 1980s and what is actually being done with the FDA now.

So, Steve, if you might want to comment on that?

HAHN: I think that's right, Dr. Fauci. The emergency use authorization process by statutes allows us to have flexibility and assess the risk/benefit ratio in a public health emergency, and we've done that on the therapeutic side in three separate occasions and continue to look at those requests as they come in.

BRAUN: Thank you, very much.

ALEXANDER: Thank you, Senator Braun.

Senator Rosen?

SEN. JACKY ROSEN (D-NV): Here I am. Thank you Mr. Chairman for bringing this hearing and I want to thank the dedicated doctors today for their lifetime of work and study and passion. We are a grateful nation for all of your lifelong commitment in fighting the disease and not just in the United States but around the world.

And as I talk to Nevadans about safely reopening the economy, one question that frequently comes of this, so when are we going to have a vaccine, like everyone has talked about. In Nevada, travel and tourism, of course, is the lifeblood for us and the jobs associated with those industries can only fully come back if we know it is safe to travel, visit or work in our hotels, casinos, restaurants and attractions.

Ultimately, to make it happen, we have to build confidence to our visitors that it is safe, we need a vaccine, and that research is extremely important.

However, understanding that this takes time to develop and ensure both safety and efficacy, I would like to hear more about what's research is happening regarding preventative medication research. It could be helpful in the timeframe before a vaccine and especially before one that's widely available.

So I would like to ask if this could be part of a pack to helping us begin to reopen our economy safely and bring visitors not only back to Nevada but across our country. So Dr. Fauci, what research is currently happening to identify potential monoclonal antibody preventative treatments or other therapeutics? If the right antibody is identified or can be identified, will this be used as a preventative medication to block COVID-19 virus from latching on to those host cells, much like the treatments from rheumatoid arthritis, severe asthma other diseases?

And secondly, would preventative medication options like this will complement the effectiveness of a vaccine once it's available?

FAUCI: Yes. So thank you for that question, Senator Rosen. That's an excellent question. And in all of the therapeutic interventions that we are developing, and you mentioned several of them. It could be direct antivirals along the line of remdesivir, but that's just one of the number of possibilities since there are several viral targets in the replication site.

Using convalescent plasma in preventive modality, as well as monoclonal antibodies in a preventive modality, are, in fact, all feasible and will be pursued in parallel to the development of a vaccine.

The model of using drugs and other interventions that are effective for treatment is really a great success story in the issue with HIV/AIDS, because many of the interventions that were developed for the full treatment of an infected person are exquisitely effective in preventing the infection of HIV.

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So that's the kind of model that we work out in parallel with treatment for disease, and so using as treatment as preventions. I believe that will be a part of our effort at the same time as we're putting a full court press on trying to get a vaccine. So it's an excellent question, very relevant (ph).

ROSEN: I know I have a short time left, so I'm just going to kind of abbreviate this. The second most important question that I get, not just from our first responders, and people are worried about work, but, generally, what does the next generation of PPE need to look like for all of us as we go about our lives, not just as workers?

Depending on your work, you may need something stronger, more specific, and as all of us as we want to go out and shop or out to eat or whatever those things are, get on an airplane. Should masks be made of a certain material, gloves, are handkerchiefs effective? Can you talk about PPE for the general public?

FAUCI: Well, the best PPE for the general public, if possible, right now, is to maintain social distancing. But as we've said, and I think all of us would agree, there are certain circumstances in which it is beyond your control when you need to do necessary things, like go to the drugstore and get your medication, go to the grocery store and get your food. That, in fact, you need some supplementation to just physical distancing. That's the reason why some time ago, the recommendation was made, I believe, it was Dr. Redfield at the CDC who first said that, about getting some sort of a covering. We don't want it to call it a mask, because back then, we were concerned we would be taking masks away from the healthcare providers, but some sort of mask, like facial covering, I think for the time being, should be a very regular part of how we prevent the spread of infection.

And, in fact, the more and more as you go outside right here and where I'm sitting in Washington, D.C., you can see many people out there with masks on, which gives me some degree of comfort that people are taking this very seriously.

ROSEN: Thank you.

ALEXANDER: (INAUDIBLE) Rosen.

Senator Loeffler.

SEN. KELLY LOEFFLER (R-GA): Thank you all for being here and for your service.

Admiral Giroir, before I start my questions, I want to recognize your new role as the U.S. representative to the World Health Organization.

Mitigating a resurgence of this pandemic will take global cooperation. In order to do that, we need accountability and transparency at the WHO. This organization was established to ensure the timely flow of accurate, unbiased information on global health emergencies just as this. Reforms must be made in order to restore the trust that we need here. I hope you will work with our allies to push for these reforms.

This question -- I have two questions. The first one is for Dr. Redfield. And, Dr. Redfield, Georgians are wondering how we got here today, 1,400 deaths, a third of Georgia's workforce out of work. I'm incredibly concerned about the cover up and the misinformation coming from China and their efforts to suppress lifesaving information at the outset of this outbreak.

As we continue to reopen our economy safely, we have to take steps to ensure that another outbreak cannot take whole of the world in this way. I understand CDC has worked with the Chinese, CDC on global health security for decades. Can you comment on the level and the timing of the information that you received and relied upon from your Chinese counterparts as this virus emerged?

DR. ROBERT REDFIELD, CDC DIRECTOR: Well, thank you very much, Senator, and I want to echo how important global health security is as a national security priority for this nation. And we're going to need to be able to respond to that as long as we are a nation.

CDC has had relationships with many countries around the world. We have offices in over 45 countries right now, people (ph) over 60. And one of those happens to be China, where we have a U.S. CDC that's with the Chinese CDC. We have worked together for decades particularly on influenza and emerging infectious diseases. And that has been a very productive, collaborative, scientific interaction.

When this original outbreak of pneumonia of an unknown ideology (ph) came from the original seafood market. They were obviously in discussions with the U.S. personnel were with the Chinese CDC.

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I personally had discussions as early, I think, CDC did as early in January and myself, January 3rd, with the counterpart to discuss this.

So at a scientific level, we had very good interaction. That's different than the broader Chinese government level.

LOEFFLER: Thank you, Dr. Redfield. I have a final question for each of our great witnesses today, and it's one that my constituents often ask me. The mainstream media and, indeed, some of my colleagues in the Senate seemed to want to paint each of your relationships with our president during this wartime as confrontational and lacking consensus.

Can you categorically say here to the American people today whether this is true or untrue from your testimony today? I have seen a very coordinated effort to address this with the administration to combat this pandemic. Can you give me a sense of whether this -- what the characterization is -- whether it's true or untrue? Thank you. I'd ask Dr. Fauci to answer that first.

FAUCI: Yes. No, there is certainly not a confrontation relationship between me and the president. As I mentioned many times, I give advice and opinion based on evidence-based scientific information, he hears that, he respects it, he gets opinions from a variety of other people. But in no way, in my experience over the last several months, has there been any confrontational relationship between us.

LOEFFLER: Thank you. Dr. Redfield? Dr. Hahn?

REDFIELD: Again, I would echo what Dr. Fauci said. We are there to give our best public health device, and that's what we do. It's grounded in data and science. And I've always felt free to give the best public health advise that I think needs to be given at the time. And it's always been done in a very professional way.

HAHN: Senator Loeffler, this is Stephen Hahn. I do not have a confrontational relationship, have not had a confrontational relationship with the president. He asks asked questions, I have given him my honest answers rooted in data and science. And he has listened respectfully to those, incorporated that into his decision-making.

ADMIRAL BRETT GIROIR, ASSISTANT SECRETARY FOR HEALTH, DEPARTMENT OF HHS: And Brett Giroir, I have nothing else but to echo my colleagues. We work closely together on all the, all the physicians and, of course, Ambassador Birx, other scientists within our group. We have a productive working relationship with each other and also with the president and vice president. It would not be confrontational and I certainly feel that we have the ability to honestly state our opinions and recommendations, and that's been that way since the beginning. ALEXANDER: Thank you, Senator Loeffler.

Senator Murray, do you have closing comments?

SEN. PATTY MURRAY (D-WA): I do. And it's all right, I have a couple of two quick questions.

ALEXANDER: Sure.

MURRAY: Well, thank you.

Dr. Fauci, while President Trump and (INAUDIBLE), there is no question that an essential part of reopening our economy safely and successfully developing and distributing a vaccine for COVID-19, we need a plan now to deploy a vaccine once it's proven safe and effective.

But it is absolutely crucial, this planning process, from a clinical trial to distribution in the administration, recognizes and addresses racial and ethnic disparities in our healthcare system that, as we all know, for too long, have been overlooked and unacknowledged in this country. And we have to ensure equitable access to this vaccine for everyone.

Dr. Fauci, let me start with you. What steps is NIH taking to make sure that clinical trials for COVID-19 vaccines and therapeutics account for racial and ethnic disparities?

FAUCI: Yes. Thank you very much. That's a very relevant question, Senator Murray. And, in fact, in the design of our clinical trials and the sites that we've chosen in our clinical trial network is going to be very representative of being able to get minority populations and populations at most risk to be part of the trial so that we know during the trial what the relative efficacy as well as potential adverse events.

It is something we start back in the days of HIV when tried to get good demographic representation and we're going to do that with these (INAUDIBLE). Thank you.

MURRAY: Thank you. And, Dr. Hahn, tell me what steps the FDA is taking out to make sure the United States is prepared to produce a sufficient number of vaccines, including the necessary manufactures, supply chain capacity for supplies, like vials and stoppers and syringes?

HAHN: Thank you, Senator. This is an effort that started as a partnership with the vaccine developers and the NIH and their efforts. So one of the most important things, Ma'am, has been the data transparency, sharing of data of both of the agency, NIH and with the manufactures so we can understand what the capacities are, what the needs are from the supply chain and then how to actually share that so that if one manufactures vaccine doesn't go forward, we can use the capacity of that manufacturer for another manufacturer's vaccine. I'm very happy to report that the work of Dr. Marks (ph) and Dr. Fauci has led to that sort of effort. We've developed, as I mentioned before, this Gant chart that describes all of the steps that go forward with vaccination, including those supplies you described. It is somewhat complicated, Ma'am, and that we may very well have hopefully five to seven different candidate vaccines that may need different supplies associated with them. But we have been upfront identifying those supplies where they are available and then working with the manufactures to make sure that they are available.

MURRAY: Okay. Thank you. Thank you very much.

And, Mr. Chairman, thank you and thank you for all of our witnesses who are joining us today. It is really clear to me that we have more work to do before we can safely get back to work and school and some semblance of normal life in our country. We need testing that can be fast, free and everywhere, and we need the White House to lay out a detailed national plan to make that happen.

We still need adequate personal protective equipment both for our healthcare workers and for workers in our businesses and schools when the time comes. We still need guidance from our experts so our communities have the information that they need to reopen schools and businesses safely, confidentially -- confidently and complete competently.

And so public health workers and healthcare providers have the information they need to keep their patients and communities safe. And while experts have been clear that the day we can safely reopen maybe ways off, there are plenty for us to do in the meantime, both to plan ahead, for example, to make sure that we once we have a safe and effective vaccine, we can produce and distribute it to everyone quickly, equitably and at no cost and to address the immediate challenges, for example, making sure there are appropriate mental health resources for everyone who's coping with the challenges that are presented by this virus, from the stress of physical isolation, loss of income, to the trauma and anxiety of patients and the workers who have been on the frontlines.

So I am going to keep pressing Congress and the White House to provide the action and leadership that our communities need. And I hope, Mr. Chairman, that we'll continue to have the opportunities like this to hear directly from the experts and ask pressing questions about how to get our country through this crisis. It's clear we've got a lot further to go and a lot more to do.

And so I hope that as our efforts continue, we'll be able to bring many of you back, our witnesses for another hearing, seeing you again. Thank you all of you for joining us today.

ALEXANDER: Thank you, Senator Murray.

I've got a clarification question and a couple of quick comments and then we'll thank the witnesses and wind up here.

And my clarification is, because I want to make sure I didn't create some confusion the way I asked the question of going back to school. I asked Dr. Fauci first about treatments and vaccines and Admiral Giroir second about testing. But I thought I heard was that Dr. Fauci said that vaccines are coming as fast as they ever have but it will be later in the year, at the earliest before we see that (ph).

But there are some treatments of -- that have -- that are modest, that are promising. There could be more. But that doesn't mean you shouldn't go back to school. That would be more for testing strategy, am I right Dr. Fauci? You didn't say we shouldn't go back to school because we don't have vaccines?

FAUCI: No, absolutely not, Mr. Chairman. What I was referring to is that going back to school would be more in the realm of knowing the landscape of infection with regard to testing. And as Admiral Giroir said, it would depend on the dynamics of the outbreak in the region where the school is. But I did not mean to imply at all any relationship between the availability of a vaccine and treatment and our ability to go back to school. You're quite correct.

ALEXANDER: Thank you.

And what I heard from Admiral Giroir was that you're ramping up current technologies. You are hopeful for Dr. Karl and Dr. Collins' shark tank in the National Institutes of Health.

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But in any event, you would expect to have the capacity in the fall of 40 or 50 million tests a month and that ought to be adequate for the principal of a middle school or even the chancellor of a campus to design a testing strategy that could provide, for example, of an antigen quick test to screen all the students in the school if necessary. Is that correct?

GIROIR: Yes, Sir, Mr. Chairman. And, again, we want to make as many tests available as absolutely possible.

What I said is what I feel comfortable knowing the production schedules being in the position of being able to work with the FDA and the CDC that we should have 40 to 50. We will have 40 to 50 million tests available per month that needed to be deployed in a smart, strategic way depending on the dynamics in that area and in that region.

Still, having testing even widely does not nullify the need that we're going to have to change our practices in terms of sanitation, personal cleanliness, distancing, face masks, things like that, given what the dynamics could be.

ALEXANDER: Well, thank you for those comments, because given that number of test that will be available in, say, three months, or as we ramp up to that number three months from now, that should giver every principal, every chancellor of every college campus. And, again, we have about 5,000 campuses and 100,000 schools some reassurance that testing as well as the common sense hygiene practices you've talked about could be used to develop a strategy for reopening schools in August. And then two quick comments. One is, Senator Murray talked about the national plan, which was in the legislation that we all voted for. There is a little bit of a push and tug between what's national and what's federal, what Washington should do and what the states should do. I've always thought it's a mistake to say, federal equals national. In other words, COVID-19 is clearly a national problem. But that doesn't mean the federal government is supposed to do everything, for example, testing.

The law actually requires states, to tell you, Admiral Giroir, of what their plans are, what their needs are. And then you said that during the month of May, you had a series of state plans that identified 12.5 million tests and you thought you could help beat that.

On the other hand, you've also noticed the efficiency of the marketplace for some supplies that the federal government is buying those and allocating them to the states. So we don't want to get in a situation where Admiral Giroir is telling all states what to do.

Governor Lee in Tennessee doesn't really want you to tell him what to do. He wants to tell you what he's doing and let you comment on it. I don't think Governor Cuomo wants President Trump to tell him what to do. So push and tug between what Washington does and what the states do.

I think we have a testing, contact tracing, isolating national strategy and plan led by the governors designed by the federal government as a national effort, and then national effort clearly is to do the research of the treatments and the vaccines, what we've heard today, as that's coming along on a faster track we have ever seen before.

Finally, I want to reiterate -- I thought this was a very helpful hearing. I thank the senators for their questions. I think anybody who took the time to watch would be impressed by the diversity of opinion and the honest answers we've got from four really remarkable experts who are in the midst of this every day.

I want to reemphasize what I said earlier that I intend to make sure that we focus, Senator Murray, suggested we need to have more hearings. I agree with her. And as we deal with this pandemic, we need to make sure we're ready for the next one and what can we learn about faster treatments and vaccines for the next one, what can we learn about the stockpile, what ought to be in it, who ought to be managing for the next one, and what can we learn, can we learn anything about having hospital beds so we don't have to shut down hospitals and bankrupt them and purge (ph) patients out in order to create beds for sick people from the pandemic, what about states and hospitals that sell off their PPE in between pandemics, how do we keep our focus in between pandemics when we have so many important things to be worried about in this country? How do we make sure that we in congress sustain and fund all the things that we need to do?

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And I want to make sure that we do that this year and we -- our collective memory is short.