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4 Top Trump Administration Health Officials Testify in House Hearing on Coronavirus Response. Aired 11:30a-12p ET

Aired June 23, 2020 - 11:30   ET

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

[11:30:00]

DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES: Speaking of the first, fundamental knowledge of the virus and what the virus is capable of doing. We've done a number of studies now that have informed how we're approaching therapeutics and vaccines.

For example, the precise molecular structure of the spike protein, which is that part of the virus which actually gives it its name, coronavirus, because of the spikes that stick out from the virus. That is the way the virus binds to cells in the body. This has been precisely delineated by NIH scientists and those that we fund.

Second, the demonstration of the precise receptor. whereby the virus binds to cells in the body, allowing it to enter and cause disease.

In addition, we develop animal models. We do natural history studies such as understanding the virus in different demographic groups.

Second, it's the development of diagnostics and assays. We need and we will get within a reasonable period of time, based on a basic investment in the RADx program, diagnostic, point of care, that are simple, precise, sensitive and specific. We hope by the end of the fall and into the early winter we will have these for wide distribution.

Third, the development and characterization of drugs. You've all heard of the first successful randomized placebo-controlled trial of a drug called Remdesivir. which was used in hospitalized patients with lung disease.

It showed a statistically significant but modest impact on decreasing the time to release from the hospital, namely faster recovery.

In addition, this drug is now being used in combination with another drug that blocks the inflammatory response.

We're also looking at a variety of others, convalescent plaza, hyperimmune globulin, other drugs, monoclonal antibodies, as well as other immune-based therapies.

Fourth, the development of safe and effective vaccines. The hallmark of all really defining responses that we have to virus diseases. If you look at the history of viral diseases, it is generally vaccines that put the nail in the coffin of these types.

We are now mounting a major effort in which we're collaborating with public and private partnerships to get vaccine trials that are developed, that harmonize with each other.

In other words, they have multiple trials in which we have common questions that are being asked, common laboratories that are being looked at, common data and safety monitoring board and common primary, secondary and tertiary end points so that the data can be compared from one to another.

You have probably heard that one of those vaccines -- and there are more than one, there are several that are moving along at various paces. One of them will enter phase three study in July.

This is one that has already shown in preliminary studies some very favorable response in the animal models that were developed. There will be others that will follow one month, two months, three months later.

Although, you can never guarantee at all the safety and efficacy of a vaccine until you actually test it in the field, we feel cautiously optimistic.

Based on the concerted effort and the fact that we are taking financial risks, not risks to safety, not risks to the integrity of the science, but financial risks to be able to be ahead of the game so that when -- and I believe it will be when, and not if -- we get favorable candidates with good results, we will be able to make them available to the American public.

As I said to this committee months ago, within a year from when we started, which would put us at the end of this calendar year and the beginning of 2021.

I'll stop there, Mr. Chair, and will be happy to answer questions later.

REP. FRANK PALLONE, (D-NJ): Thanks, Dr. Fauci. And thanks for all your contributions to fighting this pandemic.

And I'll say the same about Admiral Giroir, who I bother the most.

You're recognized for five minutes, Admiral.

ADM. BRETT GIROIR, ASSISTANT SECRETARY OF HEALTH, HHS: Thank you, Chairman Pallone. And I always enjoy our conversations. You can call me any time.

Thank you, Ranking Member Walden, distinguished members of the committee.

On March 12th, Secretary Azar requested that I lead the coordination of COVID testing efforts within the Department of Health and Human Services. And I would like to be clear that, though I'm no longer full-time deployed to FEMA, I'm maintaining my role as coordinating testing.

To date, the nation has performed over 27 million COVID-19 tests, now averaging about 500,000 tests per day. Even without any major technical advances, I estimate the nation will have the capacity to perform between 40 million to 50 million tests per month by fall.

[11:35:03]

To address the public health challenges over the past months, we implemented a phased approach to meet the testing needs at each stage of the pandemic, especially now during the reopening when the need for testing is the greatest.

In early March, HHS and FEMA developed and implemented 41 community- based drive-through testing sites in locations prioritized by the CDC in collaboration with our state and local partners.

These sites have tested nearly 300,000 high-risk individuals and served as prototypes that have been duplicated multi-fold.

Next, we leveraged trusted pharmacies to further implement community testing, especially for minorities and underserved.

This federal program is now providing testing at 611 locations in 47 states in the district, 70 percent of which are in communities with moderate to high social vulnerability. This program has tested over 688,000 individuals.

Federally qualified health centers serve over 29 million people across the nation. They provide care to one in five of those uninsured, one in five rural Americans, one in three living in poverty and 1.3 million homeless.

Again, to assure we reach these most vulnerable among us, 93 percent of FQHCs offer COVID-19 testing.

To further expand access, we authorized all licensed pharmacists to order and administer COVID-19 testing under the Public Readiness and Emergency Preparedness, or PREP, Act. Over 90 percent of Americans live within five miles of a pharmacy, again, assuring widespread availability.

On June 4th, using authorities provided to the secretary under CARES, HHS released new mandatory laboratory reporting guidance so that we can confirm that all groups are benefiting equitably from COVID-19 testing. Lab reports must include demographic information like race, ethnicity, age and gender.

And today, I am pleased to announce the selection of Morehouse School of Medicine as the awardee for a new $40 million initiative to fight COVID-19 among racial and ethnic minorities as well as rural and other socially vulnerable communities.

This cooperative agreement with the office of the assistant secretary for health, Office of Minority Health and Morehouse School of Medicine will develop and implement a strategic network of national, state, territorial and tribal and urban locations to deliver COVID-19 information to communities hardest hit by the pandemic.

In the first year of this agreement, Morehouse School of Medicine will receive $15 million.

This massive expansion of testing resulted in unprecedented demand for supplies, reagents and laboratory platforms.

To meet this demand, we secured the global supply chain through a military air bridge. We worked directly with manufacturers to increase domestic production. We collaborated with external partners to validate and create technologies. We secured and prioritized scarce point-of-care tests for Indian Health Services and other critical needs. Finally, we used Title III to further invest in domestic manufacturing.

These actions and others have enabled our current efforts with states, territories and tribes to implement evidence-based diagnostic and surveillance plans.

I would like to close by recognizing my fellow officers in the United States Public Health Service Commission Corps, the uniform service that I lead.

And 4,482 officers have deployed to support the pandemic response, including to the "Diamond Princess" cruise ship in Japan, to our military bases repatriating Americans, and to our community-based testing sites, three-man (ph) tasking forces directly inside nursing homes, and to field hospitals across our nation exemplifying the care and compassion that all of us feel for those who have suffered during this pandemic.

I thank each and every one of these officers and their families.

And on their behalf, I would like to thank all of you in Congress for supporting our training needs and the establishment of a ready reserve corps to supplement our ranks during inevitable future national emergencies.

Thank you, again, for the opportunity to provide these remarks.

PALLONE: Thank you, Admiral. And thank you for mentioning the both military and civilians who are out front in helping us during this crisis. We really appreciate all that they do. And we have to make sure that we help them as much as possible.

Last, but certainly not least, because the FDA is just as important, is Dr. Hahn or Commissioner Hahn.

STEPHEN HAHN, FDA COMMISSIONER: Chairman, Ranking Member Walden, and distinguished members of the committee, thanks for inviting me here today.

First, I would like to start by thank you all of the support of the agency and the U.S. government with the laws that you have passed in becoming law of the land. It's helped a great deal in our response.

[11:40:05]

FDA has a critical role in the federal government's response to the COVID-19 pandemic. We remain focused on our mission of protecting and promoting the health and safety of Americans.

President Trump has requested and we have provided appropriate regulatory flexibilities to ensure that the American public have access to critical medical products, safe foods, and the confidence that the government is it taking measures to address important public health issues.

FDA has used our emergency authorities since the beginning of this pandemic. We have issued more than 100 emergency use authorizations for diagnostics, personal protective equipment, ventilators and other devices as well as for drug products.

Since the public health emergency was declared, we issued more than 50 guidance documents to help ensure that continuity of health care and safe food supply. And we've put into place new initiatives to accelerate the development of needed products.

Additionally, we have kept the American public up to date on what they need to do to protect themselves and to contain the virus from spreading.

We are now preparing for the next phase of addressing this evolving crisis. It is mission critical that the agency continue to be diligent, assuring the safety of the products that we regulate, and that we also put in place processes needed to assure the protections that the public will need.

There are a number of experiences we have gained over the past few months that will inform our plans. We recognize that we must be bold in our decision-making, and advance effective solutions to achieve challenging public health objectives.

Therefore, we have begun a comprehensive real-time review and assessment of our actions to date to address the COVID-19 pandemic.

The objective is to identify and address potential organizational and programmatic changes that should be implemented without delay to advance the ongoing response to COVID-19.

We need to assure that we leverage what is working well, while at the same time review our framework and policies to be positioned to effectively identify and respond to quickly evolving public health situations.

A major focus of this effort will be to identify what regulatory policies should be continued and accelerated consistent with Executive Order 13294 signed by the president.

Durable policy, organizational and programmatic changes will be consistent with advancing the agency's public health mission and will inform our strategy priorities moving forward.

One of the challenges facing FDA during the COVID-19 pandemic is how to assure the timely review of medical product applications despite an incredible surge in volume and constraints on our ability to insight inspections.

I'm pleased to announce today that the FDA has maintained its same pace on meeting goals for the application of medical products in the last six months that it has maintained in recent years.

We're on target to meet the user-fee goals for our drugs this year by reviewing and taking timely action on at least 990 percent of brand, generic and biosimilar drug applications, even during the pandemic.

Additionally, this work has continued at a time when the number of applications received in some centers is substantially higher than the pre-COVID-19 times.

I want to thank the more than 17,000 employees of the FDA for their incredible efforts, one that reflects the remarkable dedication and commitment to the public health of all Americans.

Finally, I would like to discuss what is top of mind for all Americans, namely the work they have a day is doing to implement the development of safe vaccines and therapeutics.

FDA launched an emergency review and development program called the Coronavirus Treatment Accelerated Program, or CTAP. And we continue to work night and day to provide guidance and review proposals from companies, scientists and researchers who is are developing therapies.

Let me be clear. The data and science will dictate when we'll have safe and effective treatments and vaccines for COVID-19, as Dr. Fauci just mentioned. Toward that end, FDA is using every available authority and applying every appropriate regulatory flexibility to facilitate the development in testing.

We have not lost sight of our solemn responsibility to the American people to ensure our decisions related to all medical products are based on science and data. And that is a commitment that the American public can have confidence in.

Again, I assure you that the FDA will provide leadership, expertise, guidance and information and whatever else that is needed as we continue to address this unprecedented challenge.

Thank you, and I look forward to your questions.

PALLONE: Thank you, Commissioner Hahn.

That concludes our openings from the witnesses.

So now we'll move to member questions. Each member will have five minutes to ask questions of our witnesses.

And I'll start by recognizing myself for five minutes. [11:44:58]

Now, you know that I'm very critical of the president for a lack of leadership from the start of this pandemic, which I think continues. And, of course, it's difficult because you work, in theory, for the president, and I feel that many of you, on many occasions, actually wanted to take more leadership and be, as Dr. Hahn mentioned, or Commissioner Hahn, fully cognizant of the data and the science.

So it's difficult because I'm going to ask you questions about the president's lack of leadership. And I know it's hard for you to answer those. So we'll see.

But I do believe the president is encouraging behaviors that are not consistent with good public health, such as encouraging thousands to attend a rally and not mandate the wearing of masks. And I can't imagine that NIH or CDC would suggest that this is a best practice in the face of this pandemic.

So it's sort of like there's two version of reality here. One is the president's and one is hopefully yours based on data and science.

But I want to hear from the experts.

Let me start with Dr. Fauci.

You are a trusted voice and have always been candid with us and the American public. Give us an unvarnished view of where we are at our fight against COVID-19, quickly if you can.

FAUCI: Thank you very much for that question, Mr. Chairman.

It really is a mixed bag. We have a very large country, very heterogenous, major differences, for example, between the New York metropolitan area and Casper, Wyoming.

If you look at how we've been hit, we've been hit badly. I mean, anybody who looks at the numbers, we've had now over 120,000 deaths and we've had 2.5 million infections, so it's a serious situation.

In some respects, we've done very well. Right now, for example, the New York metropolitan area, which has been hit extraordinarily hard, has done very well in bringing the cases down and using the guidelines that we have very carefully put together in a step-wise fashion to try and carefully reopen their city and their state.

However, in other areas of the country, we're now seeing a disturbing surge of infections that looks like it's a combination. But one of the things is an increase in community spread. And that's something that I'm really quite concerned about that. And you know that. This has been something that's been in the press over the past couple of days.

Where we're going down from 30,000 to 25,000 to 20,000 and now we sort of stayed about flat, and now we're going up. A couple of days ago, there were 30,000 new infections. That's very troublesome to me. The way you address that -- and I've said this over and over again --

is you have to have the manpower, the system, the testing to identify, isolate and contact trace in an effective way so that, when you see those increases, you can understand where they are coming from, and you can do something about them.

Right now, the next couple of weeks are going to be critical in our ability to address those surges that we're seeing in Florida, in Texas and in Arizona and in other states. They are not the only ones that are having a difficulty.

Bottom line, Mr. Chairman, it's a mixed bag, some good and some now we have a problem with.

PALLONE: All right. Now, I'm going to have to ask about the president because you talked about testing and how important it is. And I, you know, I know how important it is.

At his rally over the weekend, the president said, and I quote, "When you do testing to that extent, you're going to find more people, you're going to find more cases. So I said to my people, slow the testing down, please," unquote. And this morning, he said he meant this.

So, Dr. Fauci, do you agree with that. Does it make sense that to safely open our economy we should be limiting the number of tests rather than ensuring that anyone who needs a test can get one. And you don't have to mention the president. I did. But tell us about the testing.

FAUCI: I, as a member of the task force --

(CROSSTALK)

PALLONE: Your microphone is on?

FAUCI: Sorry.

I as a member of the task force and my colleagues on the task force, to my knowledge, I know for sure, but to my knowledge, none of us have ever been told to slow down on testing. That just is a fact.

In fact, we will be doing more testing, as you've heard from Admiral Giroir. Not only testing to specifically identify people in the identify, isolate and contact trace, but also much more surveillance, if you want to get your arms around and understand exactly what's going on in community spread.

So it's the opposite. We're going to be doing more testing it, not less.

PALLONE: And then let me just ask the same question of Dr. Redfield.

Do you agree with the president on this? Do you think we should be testing more people? If you don't want to talk about the president, just tell us if you think we should be testing more people. REDFIELD: Yes. As Dr. Fauci said, all of us have been and continue to

be committed to increasing readily timely access to testing. We've made a marked improvement. We still have a ways to go.

[11:50:05]

One of the key things, as Tony mentioned, is surveillance, expanding surveillance because of the asymptomatic nature of this infection. And in doing so, we're looking at ways that can really substantially enhance testing by potentially pooling sample.

So right now, as Giroir said, we are doing 500,000, 600,000 tests a day. If we can pull samples, five to one, that will bring it to three million tests a day.

So we're continuing the try to enhance testing. It is a critical underpinning of our response.

PALLONE: Thank you, Dr. Redfield.

I recognize Mr. Waldon now for five minutes.

REP. GREG WALDEN (R-OR): Thank you, Mr. Chairman.

Let me go straight to the question that my colleague asked. I'll just ask each of you for a yes-or-no question.

Has President Trump ever directed you to slow down testing for COVID- 19 in the United States?

Dr. Redfield?

REDFIELD: No.

GIROIR: No, sir.

HAHN: No, congressman.

WALDEN: Thank you.

All right. Let's go to some other issues here.

Dr. Hahn, you created a Web site I believe on the FDA site dealing with convalescence plasma and antibody rich investigational therapies that may help fight the virus.

What's the status of the research into the effectiveness of convalescent plasma in fighting COVID-19? What do we know right now?

HAHN: Thank you, Congressman Walden.

A really important question from a therapeutics point of view.

As everyone here knows, convalescent plasma is where you take the natural immunity of a person who's recovered from COVID-19, those antibodies, and administer to a person who's sick. So we have partnered with BARDA and HHS and the Mayo Clinic to develop an expanded access program. We have safety data of over 20,000 patients that shows this is a very safe therapy. And our preliminary assessment of the effectiveness is encouraging.

We continue to look at the information. If those data hold, we will have potentially another weapon against COVID-19, pending those final results.

This will also allow us to have information to feed the development of monoclonal antibodies. And something else called a hyperimmune globulin, which we can pull that plasma and actually give it as an injection to people.

So I think it is a good-news story right now. We have to wait for the final data to come in. And we should know very shortly about that.

There are also several randomized trials looking at this, as well, that are ongoing across the country.

WALDEN: All right, thank you very much.

Dr. Redfield, CDC has developed a new test to simultaneously detect two strains of influenza and the COVID-19 and is seeking an emergency use authority. How does the CDC envision its combined test to be used?

REDFIELD: I think it's very important. As I mentioned, as we get to the fall, we will have influenza and COVID at the same time.

And CDC's developing that test that is right public health system but in parallel the private sector also now has advanced development. Maybe Dr. Hahn wants to comment -- on similar tests in the private sector, so to facilitate timely diagnosis of these two co-circulating pathogens.

WALDEN: Dr. Hahn, do you want to comment on that?

HAHN: Yes, sir. In cooperation with Admiral Giroir, we have been working with companies to actually look at that.

Admiral Giroir is at the forefront of this. He's been a great --

(CROSSTALK)

WALDEN: Admiral?

GIROIR: I would agree with my colleagues. We are all concerned about the possibility of co-circulation of influenza A and B as well as COVID-19 when it comes to flu season. So we want to do everything we can to simplify the diagnosis.

And you can have -- if you have a single test -- and we're working with multiple manufacturers. As is usual, the CDC is usually in the lead. But there are multiple manufacturers both at point of care and laboratory who will have this kind of test available.

WALDEN: All right. Excellent.

You all have been subject to a lot of criticism, as has the president. Often, that's leveled after we know facts we didn't know at the time when things started. It is really great if you have hindsight and 20/20 vision. You can look back and say should have done that then. I want to look forward.

What is it you need from Congress that you do not have now to have America ready for the fall? What should we be preparing for now for the fall?

I don't care who wants to start but I'm down to a minute to answer so, Dr. Redfield?

REDFIELD: I think, first, I want to just express appreciation to Congress for the supplemental funding. I think it's of note that CDC has been able already to disperse $12 billion to the states to help prepare their COVID responses. And really, that's an unprecedented amount of resources.

I would only ask that we look to how to make it a sustainable investment as opposed to a sporadic investment to this particular challenge we have right now.

WALDEN: All right.

Dr. Fauci? What do we need to worry about? What don't you have?

[11:55:00]

FAUCI: Well, I just reiterate what Dr. Redfield said. We are extraordinarily grateful for the unprecedented amount of supplementary funding which the Congress gave to use that made it totally possible for us to do the kinds of things we need to do on an emergency basis.

But, again, to mention what Dr. Redfield said, we have to establish some corporate memory. I've said to this committee literally many times over the many years, that we forget things when we get distant from them.

WALDEN: Yes.

FAUCI: We are going through a terrible ordeal right now. We need to have in place the stable type of support for preparedness for outbreaks.

We will get through this. This will end, hopefully sooner rather than later, but we need to establish a system so that we are prepared for future outbreaks.

WALDEN: Thank you.

Mr. Chair, could we have the other two just answer that question quickly?

Admiral? What do you need you don't have? What should we be worrying about?

GIROIR: I want to express my thanks, again, to the committee.

WALDEN: Right.

GIROIR: But let me get to the point. I think sustainability and commitment is very important. I was involved in Ebola in 2015 in Dallas trying to lead some of the policy options during that time. And you see, over a five-year period, we sort of forgot all the lessons we were trying to get implemented, including PPE and other stockpiles.

I would say some of the biggest limitations -- and I know everyone is working on this -- is the national data infrastructure we need.

When we started out, I'm calling up 100 hospitals a day trying to understand who's on an ICU bed, who's not, who has a ventilator, how much you got left. And we got through this not by systems but by people working 24/7.

The third thing is I'm just going to pound the vaccine infrastructure in this country, to promote vaccine confidence, to make sure that people have the right information about safety and efficacy, that we order enough flu vaccine because we really need to get everybody vaccinated this winter.

One thing to minimize our problems is, if we get everybody the flu vaccine, is one less virus that could kill 20,000, 30,000, 50,000, 70,000 and potentially even be a co-infection with COVID.

WALDEN: Dr. Hahn?

HAHN: Thank you. Again, thank you for the support.

One big point I want to make here is that what we have learned during this pandemic is that we had an access-to-information issue. We have learned that we need to collect real-world evidence in real time during an emergency just like a doctor would during an emergency to inform decisions and how we can change them moving forward.

So your support for real-world evidence generation would be incredibly helpful.

PALLONE: So now we move to our members based on seniority.

And I think our next few are virtual, so just remind you to unmute if you don't do so on your own. I'll keep reminding you.

Next, we have Mr. Rush, from Illinois.

REP. BOBBY RUTH (D-IL): I want to thank you, Mr. Chairman, for holding this important hearing.

Last week, the Health Subcommittee held an informative hearing on the racial and ethnic health disparities being highlighted by the coronavirus. While these disparities are very troubling, and even extremely outrageous. A "Scientific American" article published earlier this month found

that, quote, "If black people were dying at the same rate as white Americans, at least 13,000 mothers, fathers, brothers and sons and loved ones would still be alive. Even more shocking is that, among those 35 to 44 black men and women died from the coronavirus and at least nine times the rate of white Americans."

Dr. Fauci, when did it become apparent that institutional racism and discrimination played a part in why certain racial and ethnic communities are suffering more than white communities?

FAUCI: I think I know what the -- I didn't hear it quite as clear as I want but I think I know what the Congressman is referring to.

So when you look at the African-American community and the minority community, in general, as a demographic group, there are two elements that make it much more difficult for them and why they're suffering disproportionately.

[11:59:50]

One is the risk of infection. Because of economic and other considerations, the jobs that the majority of them would find themselves in does not allow them to protect themselves by looking into a computer and doing telework. Most of them are essential on outside having to mingle in a society in which the virus is circulating.