Mar 3, 2020

CDC Official Testimony Transcript to Senate on Coronavirus

CDC Officials Testify on Coronavirus to Senate
RevBlogTranscriptsCongressional Testimony & Hearing TranscriptsCDC Official Testimony Transcript to Senate on Coronavirus

CDC officials Anthony Fauci, director of the National Institute Of Allergy And Infectious Diseases, and Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention, testified before the Senate Committee on Health, Education Labor & Pensions on the coronavirus (COVID-19) outbreak on March 3, 2020. Read the full transcript of their testimony.

Speaker 1: (00:00)
So, we’re having a hearing today to address the coronavirus.

Senator Lamar Alexander: (00:04)
So I don’t have to say that? Okay.

Speaker 2: (00:05)
[crosstalk 00:00:05].

Senator Lamar Alexander: (00:10)
Good morning. The Committee on Health Education, Labor and Pensions will please come to order. I have one goal today, and that is accurate information. Accurate information that can help Americans understand what they should do about the coronavirus, and accurate information to help members of Congress decide what else we ought to be doing about the coronavirus. Around the world, the spread of the Novel Coronavirus is alarming. 90,000 cases in 65 countries, 3,000 deaths, according to the World Health Organization, but most people in the United States are at low risk.

Senator Lamar Alexander: (00:51)
Here’s what the New York Times said on its front page two days ago on Sunday in describing the situation in our country: Quote, ” Much about the coronavirus remains unclear, and it is far from certain that the outbreak will reach severe proportions in the United States or affect many regions at once. With its top notch scientists, modern hospitals, and sprawling public health infrastructure, most experts agree the United States is among the country’s best prepared to prevent or manage such an epidemic.” That’s from the front page of the New York Times two days ago in describing where we are in our country.

Senator Lamar Alexander: (01:35)
Today in our country, while there are 90,000 cases around the world, there are about 100 cases in the United States, maybe a few more, and about half of those contracted the disease overseas, and have been brought back here to be quarantined and monitored. There have been six deaths in the United States, and in addition to the human suffering the virus is causing, it’s disrupting the global economy. According to our trade representative, more than 20% of everything we import is from China. Medicines, car parts, cell phones, televisions. China’s shut down factories and locked down 16 cities where 760 million people live. Think about that for a moment. 760 million people is more than twice as many people as live in the United States, and they’ve been locked down in China as China tries to grapple with this. In the short term, this could disrupt American companies’ ability to buy and transport goods and materials. In the longterm, the production of these materials could shift and there would be implications on jobs and prices there.

Senator Lamar Alexander: (02:40)
So the first goal of the hearing is to provide the American people with accurate information. Today’s witnesses are respected professionals who have a lot of experience in what we’re talking about today and who know what they’re doing. And I want to take a moment to emphasize their backgrounds.

Senator Lamar Alexander: (02:59)
Dr. Anne Schuchat. She spent 30 years at the Center for Disease Control and Prevention. She’s the principal deputy director there. Her work has been with these kinds of epidemics through Democratic and Republican Presidents and health emergencies, including the 2001 anthrax attack, the 2003 SARS outbreak, 2009 flu pandemic.

Senator Lamar Alexander: (03:29)
Dr. Anthony Fauci. Dr. Fauci has held his position as the Chief of Infectious Diseases at the National Institutes of Health since President Reagan’s time. So he’s worked for Presidents Reagan, H.W. Bush, Clinton, Bush, Obama, and now President Trump. He’s led the agency’s response to HIV AIDS in the eighties and nineties, the emergence of the West Nile Virus in ’99, SARS in 2003, Ebola outbreaks in Africa in 2014 and 2018. For these professionals, this is not their first rodeo.

Senator Lamar Alexander: (04:06)
Third, 14 years ago, led by Senator Burr of this committee, Congress created the position of Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. Dr. Robert Kadlec was working for Senator Burr at the time. He helped draft the bill, he now holds the position that was reauthorized by Senator Casey and Senator Burr. Not long ago, Dr. Kadlec had previous work assisting the FBI and the United States Air Force in biological threats.

Senator Lamar Alexander: (04:37)
And finally, Dr. Stephen Hahn is the newest to the federal government of these respected professionals, but he’s had plenty of experience before becoming Commissioner of the United States Food and Drug Administration, the FDA. Most recently, he was Chief Executive of the University of Texas MD Anderson Cancer Center, a large organization, 21,000 employees.

Senator Lamar Alexander: (04:59)
So the reason I go through that is because if we’re looking for accurate information, these four ought to be able to provide it. Now, in addition to getting accurate information for the American people, we wanted ourselves to know what else we should be doing to limit the damage of the coronavirus to the American people and the American economy. And before we talk about what else needs to be done, I want to briefly summarize what we’ve already done.

Senator Lamar Alexander: (05:28)
Let’s start with Congress. It’s not the first public health threat we’ve faced. There are some senators and staff members who are here today who were here 20 years ago when the anthrax attack occurred. 2003, SARS, another coronavirus similar to the one we’re seeing today. 2009 flu pandemic killed an estimated 151,000 to 575,000 people worldwide. And then there was the Ebola outbreak in 2014 and ’18.

Senator Lamar Alexander: (05:57)
So following the anthrax attack in the Bush Administration, Congress created Project BioShield in 2004 to develop and stockpile new treatments and vaccines. After the SARS attack in 2006, also in the Bush Administration, Congress passed the Pandemic and All Hazards Preparedness Act that guides the federal government in how it prepares for and responds to public health emergencies. It gave the Department of Health and Human Services the authority, for example, to prioritize funding for the development of vaccines and treatments for infectious diseases. It improved our public health emergency fund.

Senator Lamar Alexander: (06:36)
The Senate, as I said earlier, passed the most recent update of the pandemic law, led by Senator Burr and Senator Casey. Senator Blunt and Senator Murray, in their work on the Appropriations Committee, fund public health preparedness programs. We all know that Presidents and their budgets, and this includes all the Presidents that I know about, sometimes underfund these programs. But last year, Congress provided more than $4.5 billion for public health and preparedness programs.

Senator Lamar Alexander: (07:07)
When a crisis occurs, we often need money quickly. That’s why Congress has created two funds, the Public Health Emergency Fund and the Infectious Disease Rapid Response Fund. For example, Secretary Azar’s already used $105 million from the Rapid Response Fund, and using authority Congress has given him, he’s transferring $136 from other programs in his department to respond to the coronavirus, and the Trump administration has requested an additional $2.5 billion dollars. Others in Congress have made suggestions and we’re likely to vote on that in the Senate this week.

Senator Lamar Alexander: (07:48)
In addition to what Congress has done to get ready for pandemics like this, both Democratic and Republican Presidents over the last 20 years have used their executive authority during public health emergencies. President Obama sent the military to West Africa during the Ebola outbreak. President Bush sent CDC experts around the world to investigate and respond to the SARS epidemic. President Trump similarly appointed a task force on January 29. He put the Vice President in charge. He moved Ambassador Birx from the State Department, who’s had years of experience in dealing with infectious diseases, to be a principal deputy in leading that effort.

Senator Lamar Alexander: (08:32)
On January 31, at a time when there were only six cases confirmed in the United States, the administration for the first time in 50 years announced they would quarantine Americans who have been exposed to the virus while in China, and impose travel restrictions on foreign nationals who traveled to China in the last 14 days. The same time, the State Department warned Americans not to travel to China, and the CDC recommends Americans reconsider cruises in Asia. A couple of days ago, the State Department added Italy and South Korea to the countries that Americans should reconsider traveling in.

Senator Lamar Alexander: (09:12)
Under the authority of the Immigration and Nationality Act, the administration said foreign nationals who have traveled to China in the last 14 days can’t enter the United States. On Saturday, the President updated this to include travelers from Iran. Dr. Fauci, who is testifying today, has said that if we hadn’t taken these steps, we would have had many more cases right now.

Senator Lamar Alexander: (09:34)
A third example of executive action is developing a test to diagnose the coronavirus. The FDA authorized that on February 4. It’s been made available to 46 labs in 38 states and Washington DC. Two days ago the FDA authorized a new test developed in New York, and is working with 65 other private sector developers, including academic medical centers and commercial labs, to increase the availability of these tests.

Senator Lamar Alexander: (10:05)
Fourth, Dr. Fauci has said that we’re developing a vaccine for coronavirus more rapidly than we’ve ever developed any other vaccine, and drug manufacturers met with the President yesterday to see if treatments and vaccines could be made available more rapidly. Finally, scientists at our national laboratories, Oak Ridge, Argonne, Livermore, are using their super-computing and imaging capacity to try to understand this virus better.

Senator Lamar Alexander: (10:33)
Of course, in addition to the impact on us and our individual lives, there’s the impact on the global economy. The trade representative says about 20% of what we import comes from China. As people get sick and can’t go to work, that slows down what’s sent here, and has an impact across the board. 13% of the facilities that make active ingredients for drugs are in China, according to the FDA. Some people have said that 80% of the ingredients for drugs are produced in China. We should evaluate that figure carefully. It appears to be based on a 1998 report that may not have a source, but I’ve discussed with a number of senators how we can inquire into whether we should explore the dependence we now have on other countries, not just China, for medicine and health supplies. Most businesses in the United States that need supplies have more than one source for what they do. Perhaps we need to take another look at that.

Senator Lamar Alexander: (11:41)
And it’s just not medicines that are affected. In Tennessee, we have Eastman Chemical. They have nine manufacturing plants. The CEO said that the recent phase one China trade deal caused orders to go up in his company, but the coronavirus problems in China have caused them to go down, and that has an effect on jobs in Tennessee, just as it does jobs in other places.

Senator Lamar Alexander: (12:07)
So today’s hearing is an opportunity to listen carefully to four respected professionals who have decades of experience and are the right people to give the American people and members of Congress accurate information about the coronavirus, both what individuals can do, and what else the federal government needs to do to respond. We’re going to finish by noon today so that Dr. Schuchat and Dr. Fauci can join the Vice President in briefing senators at our respective lunches. Senator Murray.

Senator Patty Murray: (12:42)
Thank you very much, Mr. Chairman. Thank you to all of our witnesses today. I just want to say at the top that I’m really grateful to all the women and men out there who are working now to keep our country safe, and I hope you pass it along to all of your teams as well. Chairman, this is really a frightening time. At least six people in my home state have already died from the virus. I am told we should expect more. We expect the number of infections to continue to grow, and the people across my state, and I’m sure across the nation, are really scared. I’m hearing from people who are sick, who want to get tested, are not being told where to go. I’m hearing that even when people do get tested, and it’s very few so far, the results are taking way longer to get back to them.

Senator Patty Murray: (13:28)
The administration has had months to prepare for this, and it is unacceptable that people in my state and nationwide can’t even get an answer as to whether or not they are infected. To put it simply, if someone at the White House or in this administration is actually in charge of responding to the coronavirus, it would be news to anybody in my state, and I’ve been on the phone with all of our local officials for days now. This is unacceptable.

Senator Patty Murray: (13:53)
We are now seeing community transmission of this virus. Families deserve to know, and fast, when testing will actually be ready to scale up, what they, the families, should be doing, and most importantly, what we are doing. And unfortunately I have to say that while I am profoundly grateful for the work public health officials are doing, I’m very frustrated at the steps the President has taken, from repeatedly contradicting experts’ advice to downplaying the seriousness of this threat, and to appointing a politician to lead the response.

Senator Patty Murray: (14:29)
So I’m really glad today, Mr. Chairman, that we have the opportunity to hear today directly from the experts and get answers to the questions that I am hearing at home, I know people want answered, and one of those is, “When are we going to scale up this testing?” Especially now that we are beginning to see community transition in the United States. After all, it’s only after a long, frustrating delay that we are finally able to start testing patients for this disease at state labs across this country, and the last few days seem to confirm what experts have been warning, that this is likely to continue spreading. We now have more than 100 cases of coronavirus that have been tested in this country, including repatriated cases.

Senator Patty Murray: (15:16)
While there’s a lot we are still learning, there are a few things that are abundantly clear about how we need to respond. First of all, we do need to be listening to the experts and making sure facts and science drive our response. In particular, the public needs to be able to trust the information they’re hearing from experts in the federal government is in no way influenced by political considerations or ideology, and that the policies being put in place are based on evidence about how to keep our families safe, not fear or prejudice.

Senator Patty Murray: (15:49)
I was very heartened to hear your assurances, Dr. Fauci, That contrary to reporting, you’ve not been muzzled by the administration. It is essential that that continue to be the case. We cannot have an effective response without accurate information and transparency from the administration, and I will continue to be very focused on this.

Senator Patty Murray: (16:09)
Secondly, we’ve got to provide adequate resources to meet the needs of our federal, state and local health officials, because we know resources that come through programs like CDC’s Public Health Emergency Preparedness Program are absolutely critical, but also were never envisioned to be sufficient to respond to a threat like this, so we have a lot more to do. Congress, as you know, is now working on a bipartisan emergency supplemental funding agreement that will reimburse our state and local public health officials for costs they’ve already incurred combating coronavirus, and provide additional resources to our communities. It will guarantee resources are available to respond to outbreak hotspots. It will support development of vaccines and therapeutics to prevent and treat this virus and invest in public and global health programs to keep us prepared to respond to future emergencies. I do want to thank and recognize all the Democrats and Republicans who came together to work quickly on this package, and I urge the Senate to pass it very quickly. I’m very glad we’re working on that agreement that goes well beyond what President Trump’s inadequate requests for $1.25 billion in new funding, and I really, again, urge the Senate to take this up as soon as the House does get it passed and get it to our local communities who are dealing with this.

Senator Patty Murray: (17:28)
I’m also very encouraged by this committee’s strong bipartisan record in responding to public health emergencies as well. Just last year, this committee strengthened and reauthorize the law underpinning so many of the federal efforts and resources we are seeing employed today, so I especially want to thank you, Mr. Chairman, for our work together, Senator Casey and Burr for their efforts on that.

Senator Patty Murray: (17:52)
Third, we have got to be sure we aren’t just responding to the latest developments but staying ahead of this crisis by planning ahead, because this is not likely going to end anytime soon. We are already seeing some of the challenges that will come next, like the strain this will put on our healthcare system. We’re seeing that in Washington State. We need to make sure our hospitals have the capacity to address this virus without overwhelming their ability to provide other care that people need.

Senator Patty Murray: (18:21)
We need to make sure that those healthcare workers caring for coronavirus patients are safe from infections themselves, including by making sure we have a sufficient supply of protective equipment. We need to manage our nation’s drug and medical device supply, especially considering we expect demand for some supplies and are already seeing that to skyrocket, and how many drugs and devices are manufactured in countries where an outbreak could interrupt production, something that we, again, are already seeing.

Senator Patty Murray: (18:51)
We also need to give adequate attention to our public health education. In an age where disinformation has been weaponized, and falsehoods and rumors gain traction, as we all know, faster than ever, we can’t let conspiracies stoke panic or spur ugly discrimination, or spread dangerous misinformation, or undermine our public health experts. We need to actively take steps to prevent and respond to bullying and harassment that is motivated by stereotypes and fear, and we also have to account now for the ways that some of the harmful health care policies have undermined our ability to respond to public health threats.

Senator Patty Murray: (19:32)
Our uninsured rate is going up again for the first time in years. Junk plans, which are not required to cover diagnostic tests or vaccines, are expanding, and those actions make it much harder for people to get the care they need to keep this crisis under control. So we have to make sure that everyone who needs it has access to diagnostic testing going forward. And while a vaccine is still likely over a year away, we need to make sure cost is not a barrier for that as well.

Senator Patty Murray: (20:06)
But it’s not just our healthcare system we need to be considering as we work to stay ahead of this disease. Communities and families right now are facing difficult decisions. What measures should our schools take to keep our students safe? What can parents do? When should schools close? Employers and workers in my state, and I’m sure others, are facing similar questions about whether their employees should go to work or whether they should stay open. I will be pressing Secretary Devos more later this week about how her department is helping to prepare for these issues, and I’ve written to Secretary Scalia about this as well.

Senator Patty Murray: (20:43)
And is as so often the case, this public threat will have hidden and higher costs for those who are low wage workers, who don’t have affordable childcare, who don’t have health insurance, and who are experiencing homelessness. In my home state, people are being told to stay home for two weeks if they are sick. There are not tests, so they can’t get tested. Guess who can’t stay home? If you don’t have childcare, if you’re a low wage worker, if you don’t have sick leave. When those people’s basic needs are not met, they cannot make choices to protect themselves, which means they can’t make choices that best protect others too, because one person getting sick has repercussions for all of those around them.

Senator Patty Murray: (21:27)
Situations like this remind us we are all a community in a very real sense. We all have a stake in one another’s wellbeing. So when we talk about the impacts of this health threat, I want to be clear this is not just about changes in the stock market, but we also need to develop plans responsive to the day to day experience families actually have, and that is something I plan to raise today, and will keep raising. I look forward today to hearing from all of our witnesses about how we can best prepare our communities, and I will continue to work with all of you and our health officials to keep families in my state and across the country informed about what they should be doing, what we are doing, and to keep them safe. And I’ll keep pushing to make sure that as this situation continues to develop, we keep listening to the experts, providing our health officials the resources they need, and planning for the longterm. Thank you, Mr. Chairman.

Senator Lamar Alexander: (22:22)
Thank you, Senator Murray, and thank you for your cooperation, which is typical of the way you work. In dealing with this issue, we’ve, Senator Murray and I have hosted four briefings for Senators, several briefings for staff. At Senator Burr’s suggestion, we had one of our Senate briefings in a classified setting, so Senators could be sure that there weren’t any secrets, that what we were saying in private is the same thing we’re saying in public, and nothing came up in that meeting that we aren’t able to say in public. And I agree with her that we should listen to our four professional, respected experts who are here today. Each one will have five minutes to give his or her testimony, then we’ll go to a round of questions.

Senator Lamar Alexander: (23:14)
I gave each of them a pretty good introduction earlier, so I’ll shorten it here except to say Dr. Schuchat is the Principal Deputy Director for the Centers for Disease Control and Prevention, and she’s had a variety of roles, dealing with responses to SARS, to anthrax, to pandemic influenza, over the last 30 years.

Senator Lamar Alexander: (23:43)
Dr. Tony Fauci is the top person at the National Institutes of Health in infectious diseases. He’s held his position since 1984. He’s worked with six Presidents and led the Institute’s efforts on HIV, AIDS, influenza, malaria, Ebola, and other infectious diseases.

Senator Lamar Alexander: (24:08)
Dr. Robert Kadlec is Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. As I mentioned earlier, he spent time as career officer and physician in the Air Force, special assistant to President George W. Bush. Working with Senator Burr, he helped write the legislation that makes our country better prepared for pandemics.

Senator Lamar Alexander: (24:34)
And finally, Dr. Stephen Hahn, who is the Commissioner of the US Food and Drug Administration. He was formerly the Chief Executive at the University of Texas MD Anderson Cancer Center in Houston.

Senator Lamar Alexander: (24:49)
All of you are not getting much sleep these days. We thank you for your willingness to serve the American people in the way that you do, and we look forward to your testimony. Dr. Schuchat.

Dr. Anne Schuchat: (25:00)
Thank you so much Chairman Alexander, Ranking Member Murray, and members of the committee. CDC’s role in this whole of government, whole of society response is built on decades of our infectious disease experience and pandemic influenza and other emergency preparedness planning. Our response is dependent on support for core public health capabilities at CDC, and at a network of dedicated front line public health workers at the state and local level living in your communities.

Dr. Anne Schuchat: (25:36)
Two months into this response to a novel virus, CDC has learned a lot. We have acted nimbly in the United States and around the world, but we do so with humility about the work ahead. There are many things that each of us can do as individuals, businesses, communities, and organizations, and we’re thrilled to see the website posted behind the senators.

Dr. Anne Schuchat: (26:02)
CDC is responding with the following strategy. Our goal has been to slow the spread of this virus through a multilayered, aggressive containment, and as needed, mitigation effort. We’re using evidence-based public health interventions that have included early case recognition, isolation, and contact tracing. We’ve issued travel advisories and dealt with targeted travel restrictions as well as the use of quarantine for individuals returning from transmission hot zones, including through funneling of flights from Hubei Province and mainland China to 11 airports. We’ve worked with the CBP to get data to ensure that appropriate followup could happen through the state and local public health departments, and we’ve supported the quarantine of repatriated Americans from Hubei Province and from the Diamond Princess cruise ship. We’ve been working with the World Health Organization and ministries of health around the world, underscoring our leadership in global public health, and the power of our investments in international influenza surveillance and global health security. More than 1,500 staff at the Centers for Disease Control and Prevention have been responding to this outbreak.

Dr. Anne Schuchat: (27:19)
The situation today is evolving and dynamic. In just two months, this outbreak has grown from a cluster of pneumonia in China in one city, to affecting over 70 countries and territories around the world, with more than 90,000 cases and about 3,000 deaths. We are now in the United States seeing, in addition to the very small number of travel associated cases or close contacts, we are seeing community transmission in a few areas, and a tragic outbreak in a healthcare facility or a longterm care facility in Washington State. Our hearts go out to the people affected by this virus directly or indirectly, and to everyone who’s working so hard to counter it.

Dr. Anne Schuchat: (28:03)
There are steps each of us can take. I want to recognize that people are concerned about this. As always, our number one priority is the health and safety of the American people, and we appreciate that Americans are taking this threat seriously and continuing to seek information about how they can prepare.

Dr. Anne Schuchat: (28:22)
While the immediate risk to the general American public remains low and the US government’s doing everything we can to keep it low, risk varies by exposure, and some areas of the country are now experiencing community spread. State and local jurisdictions where community spread of the virus is occurring are intensely investigating and assessing potential community interventions. CDC has got staff on the ground in Washington and California and elsewhere, to provide technical assistance. Our role in this type of community measures is to develop principles and tools based on our updated pandemic planning playbook, and based on what we’ve learned from other areas that have been experiencing the outbreak, including in Singapore, where they’ve done a very good job of managing it.

Dr. Anne Schuchat: (29:11)
A key planning principle is to protect the most vulnerable. I trust you, as senior leaders in your communities, to help us with our mission to provide clear information to you and your constituents by urging people to get the facts from, which you can see up there, and I want to say that I look forward to answering your questions.

Senator Lamar Alexander: (29:34)
Thank you, Dr. Schuchat. Dr. Fauci, welcome.

Dr. Anthony Fauci: (29:38)
Thank you very much, Mr. Chairman, Ranking Member Murray, members of the committee. I appreciate the opportunity to spend a few minutes talking to you about one of the aspects of the whole government response to this emerging outbreak, and that is in the realm of what we call interventions, both with regard to therapy, namely treatment of a person who was already infected, and the other is in the area of vaccine-

Dr. Anthony Fauci: (30:03)
And who was already infected. And the other is in the area of vaccines or prevention of infection for those who are not infected. And it’s important to point out that the timelines for each of these are fundamentally different. And I’d like to just take a moment to kind of explain why, when you talk about, in the American public and the global public, understandably want to know how quickly we can get interventions to them. So let’s start off first with therapy. As we know from the data that have come out predominantly from China, if you look at the now 90,000 people who’ve been infected and the number of deaths that have occurred, about 80% of individuals who get infected do really quite well without any specific intervention. Namely, they spontaneously recover.

Dr. Anthony Fauci: (30:56)
However, about 15% to up to 20% of individuals, usually those who are elderly and in risk groups wind up getting serious disease, requiring supportive care. That could be oxygen, that could be intensive care, that could be intubation or even more dramatic interventions. So we want desperately to have a therapy for these individuals.

Dr. Anthony Fauci: (31:20)
There are a number of candidate therapies that literally as I speak to you today, are being tested in randomized controlled trials. One of these is called Remdesivir, which was developed by the Gilead company. It is being tested in a large trial in China and it is also being tested here in the United States in an NIH-sponsored trial in collaboration with Gilead. We should know within a period of a few months, several months, whether or not this particular drug works. If it does, the implementation of that would be almost immediate. Now, I can’t guarantee that it’ll work or other drugs which are in the pipeline a little bit behind them. But the timetable for treatment is different than the timetable for a vaccine. And that’s why I want to see if we can clear up any misunderstandings that are sometimes out there.

Dr. Anthony Fauci: (32:18)
Right now, the technology that we have has allowed us to go from the time the sequence of the virus was put in a public database to the time we actually stick a candidate into the arm of someone, has gone down to literally be the fastest that we’ve ever done. I expect that at least one of those candidates, and it’s not the only one, will likely go into clinical trials in a phase-one study within about two months or maybe even six weeks. That would be a record.

Dr. Anthony Fauci: (32:53)
However, that is not a vaccine, because it will take about three months or more to show that it is safe. And then if you show that it’s safe, you’ve got to put it into what’s called a phase-two trial to show that it works. And the reason is there’s a medical, ethical, and other considerations is that we’d be giving this to normal people to prevent infection.

Dr. Anthony Fauci: (33:17)
So you must be sure. The edict of medicine: first, do no harm. So we need to make sure it’s safe and we make needs to make sure it works. That entire process will take at least a year or a year and a half. So when we hear talk about a vaccine is going to be ready in a couple of months, it won’t be ready for being deployed. It’s going to take a while.

Dr. Anthony Fauci: (33:42)
So we’re going to have a multistep process. We have the public health measures that you’ve heard about from Dr. Schuchat, you’ll hear about from Dr. Han and Dr … I’m sorry … Kadlec. Excuse me. But the issue is, in addition to those public health measures, interventions are going to be critical. So we hope that we’ll be able to get good news to you and that we’ll be able to say in the next X number of months that we have candidates. But there’ll be no guarantee of that. And the only way to know that will be to do the kind of clinical testings that I’m talking about. So hopefully we’ll have the opportunity to update you on a regular basis about where we are with that. Thank you.

Senator Lamar Alexander: (34:30)
Thank you, Dr. Fauci. Dr. Kadlec, welcome.

Dr. Kadlec: (34:33)
Thank you Chairman Alexander, ranking member Murray, and distinguished members of the committee. I really appreciate the opportunity to testify before you today on how ASPR is supporting the HHS and whole government response to the coronavirus situation. I think you heard from Dr. Schuchat very well and Dr. Fauci in terms of the rapidly evolving domestic situation. And this morning we’ll just take a couple of minutes to give you an idea about how we’re trying to address this problem from a point of strategic anticipation, to Senator Murray’s point.

Dr. Kadlec: (35:05)
ASPR has a four-pronged approach to basically manage and support the domestic preparedness and response, incident management, direct support to state and other entities, supporting the healthcare system of the United States, and also medical countermeasure development. In the era of medical countermeasure development, we’re working very closely with Dr. Fauci at NIH and our DOD colleagues, to see what kind of therapeutics and, specifically, diagnostics that we can rapidly bring to bear to this problem and see how quickly we can field the additional capabilities that CDC has already fielded with commercial activities.

Dr. Kadlec: (35:42)
Specifically, we’re looking at areas that would allow us to do point-of-care diagnostics, which I think Senator Murray has talked about. And we have some very potential promising candidates that will take several months to bring online. But we’re also identifying therapeutics. Dr. Fauci has talked about Remdesivir. We’re also working with a company on monoclonal antibodies and looking at two potential vaccine candidates, one that was a product of the investments that Congress made in pandemic influenza with a recombinant vaccine that is licensed by the FDA made by Sanofi. And another one that is a product, a candidate vaccine that was developed for the Ebola crisis made by Janssen. So those are very important and very active activities we’re moving on, first of all.

Dr. Kadlec: (36:28)
And second, we’re looking at how do we support America’s healthcare system through the hospital preparedness program, working in coordination with the public health emergency preparedness program that CDC ministers, we’ve been looking at how can we basically work better to improve collaboration and coordination amongst hospitals and the public health service sector and other entities like emergency medical services.

Dr. Kadlec: (36:51)
I just want to highlight one area that again that Congress was very crucial in developing and employing during the Ebola crisis, which is the National Ebola Treatment Network. That has proved to be vital in terms of our ability to manage this, not only through the repatriation of Americans who were taken from Wuhan, but also from the Diamond Princess. That capacity and that capability and that, if you will, education and training, were vital in how we managed it at the locations in those military bases as well as I think Spokane, Washington, actually housed a number of people through the Regional Ebola Treatment Network. And that was vital in terms of how we could do that.

Dr. Kadlec: (37:28)
The other issue is around how are we doing incident management? Since this had started, we’ve been working with FEMA to actually put in place and we have activated formerly as of yesterday an incident management network that really is based on a national response framework, is how can we bring the whole of government to respond? This is the first time we’ve done that formally. We’ve done it under exercises. But it’s a means by which we can leverage FEMA and all the emergency support functions that may be necessary by states, when asked, to basically employ responders to assist them in dealing with this crisis.

Dr. Kadlec: (38:03)
And the last area I’ll just highlight is really around the direct support to state and other entities. I mentioned our repatriation efforts. 1100 Americans brought back under very difficult circumstances from Wuhan and from the Diamond Princess. First time that was ever done. But we had been working two years in advance across HHS and with our Japanese colleagues to actually prepare for such an event. And we’re actually supposed to have an exercise in March of this year to actually employ this as a test case. But we actually got to do it for as a real thing. And so we executed that.

Dr. Kadlec: (38:39)
But more importantly, we’re now focused on how do we provide direct state aid. And so with the state of Washington, we’ve used a Strategic National Stockpile to deploy personal protective equipment to protect healthcare workers. To highlight what Dr. Schuchat has said, we are very concerned about how do we work proactively with healthcare entities like longterm care facilities, like elder care areas, where we know the most vulnerable populations reside. And how do we shield them from the effects of this potential virus? And lastly, we’re looking to actually employ and deploy some of our national disaster medical system personnel as well as other federal health care personnel to assist at the Evergreen Longterm Treatment Facility. So we’re doing all these things, really, together as a team, to respond to this.

Dr. Kadlec: (39:26)
So with that I’ll pause and yield back the rest of my time. Thank you, sir.

Senator Lamar Alexander: (39:30)
Thank you Dr. Kadlec. Dr. Hahn, welcome.

Dr. Hahn: (39:33)
Thank you Chairman Alexander, [inaudible 00:39:35] Murray and other members of the committee. Really appreciate the opportunity to speak to you today about FDA’s efforts. First of all, on behalf of the 15,000 FDA employees, our hearts go out to those who’ve been affected by the novel coronavirus and those who’ve lost their lives. That’s why we had deployed thousands of FDA career men and women to address this and to proactively look at aspects of diagnostics as well as the medical supply chain.

Dr. Hahn: (40:02)
I will focus today’s update on areas where FDA has recently communicated new information, supply chain impacts, and expediting the availability of certain laboratory-developed diagnostic tests. Please remember that some of this information that I can share now does change quickly. But it is my hope that this information will help members of this committee as well as the American people have better visibility into the emerging situation.

Dr. Hahn: (40:28)
Regarding the drug supply, we have been and continue to be proactive in contacting manufacturers, not only to remind them of the applicable reporting requirements, but also to ask them to assess their entire supply chain. And much of what we’re asking manufacturers, they are not required to tell us. But as you might expect, they’ve been very forthcoming in these discussions.

Dr. Hahn: (40:49)
Since January 24th FDA has been in touch with more than 180 manufacturers of human drugs to assess whether they face any drug shortages due to the outbreak. As a result of this outreach, last week, one manufacturer did tell us about a shortage related to the novel coronavirus. That was reported and immediately disclosed to the American public through our drug-shortage list. The good news about that is that we are working very closely with that manufacturer and we expect that to be resolved in a very short period of time. The other good news is that there are alternatives to that drug that are available to providers and patients. I know that there is interest in additional details surrounding this drug. But I can’t provide the name because it’s confidential commercial information. I think this also highlights what we’ve put in the budget proposals regarding the authorities that the FDA has here. We do not have the authorities to actually require manufacturers of devices to tell us about shortages. Again, they’ve been very cooperative with us, as have the drug companies, with respect to giving us the information that we need.

Dr. Hahn: (41:57)
Please be assured that if other potential shortages or disruptions of medical products are identified by the FDA, we will be very transparent about this. And we will quickly share that information with you. A fast breaking bit of information that we just found out this morning is that India has restricted the export of 26 active pharmaceutical ingredients for export, which represents about 10% of their export capacity. We’re working very closely to look at that list to assess how that will affect the medical supply chain. Regarding devices, we have been in touch with 63 manufacturers of essential medical devices. We’ve been aware of, known. We’ve been told of no shortages of those devices, although we understand on the demand side, particularly on personal protective equipment and masks, that there is significant pressure and demand, particularly domestically. But we’re working very closely with those manufacturers. What we have found is that some of the manufacturers in China have reported disruptions in the workforce, as you might expect, particularly in Wuhan province. In an effort to mitigate any potential shortage of anything. Respirators, any other personal protective agreement for healthcare, FDA, as you know, yesterday issued an emergency use authorization to allow the use of NIOSH-approved, disposable, filtering face-piece respirators, so masks basically, and to allow some flexibility for healthcare workers and to increase the supply within the nation.

Dr. Hahn: (43:26)
We have a lot of information that we’re communicating to hospitals and healthcare workers about that. But that should increase the capacity for the healthcare system. Regarding diagnostic tests on February 4th, as was mentioned by a chairman Alexander, the FDA issued an EUA to enable immediate use of a diagnostic test that was developed by CDC and facilitating the ability for this test to be used in CDC-qualified public health labs. On February 29th, we also issued an EUA to authorize testing for the COVID-19 at two public health labs in New York. And since that time, additional labs on the West Coast, Washington, California have also notified that they’ve begun testing using this emergency EUA approach.

Dr. Hahn: (44:08)
We’ve had a lot of contact with both private and public and academic centers with respect to the development of these tests. As I mentioned yesterday, we’ve seen it in cooperation with CDC and a significant expansion in the ability to perform those tests. We have one manufacturer who’s working closely with the CDC to expand that over this upcoming week. And we expect that to be available, those kits to providers, by the end of the week. And that expansion will continue.

Dr. Hahn: (44:37)
Thank you for the opportunity to update the committee on the FDA agency’s response to this crisis and I look forward to answering your questions.

Senator Lamar Alexander: (44:43)
Thank you Dr. Hahn. We have very good attendance by senators. We’re going to continue the hearing until 12:30 in hopes that every Senator will have a chance to ask questions. I know that the witnesses have been asked to go to Senator’s lunches with the Vice President, but that’s us. So we’d like you to stay here until you answer our questions and then go to lunch with us and answer our questions further. And I think we can complete that by 12:30. I’m going to ask senators to keep the total amount of time for each one, on questions and answers, to five minutes each, so every Senator has a chance to ask questions.

Senator Lamar Alexander: (45:28)
Dr Fauci, I’m going to ask you a series of questions within my five minutes. And these are the kinds of questions I get at home, or sometimes here. Senator Roberts asked me yesterday and I couldn’t give him the exact answer. What do we mean by community transmission?

Dr. Anthony Fauci: (45:43)
Right. Community transmission means when there are cases that are in the community, in which the original source is not known. If you get someone who travels, let’s say from Wuhan to the United States and you know they’re a travel case, and one of their contacts gets infected, you know the source. Whereas if all of a sudden-

Senator Lamar Alexander: (46:03)
You’re talking about person to person, that means we know who it is?

Dr. Anthony Fauci: (46:07)
Yeah. No, person to person, but you don’t know what the original source is. In the state of Washington-

Senator Lamar Alexander: (46:12)
No, that’s good. I thought there was a difference between person to person and community transmission.

Dr. Anthony Fauci: (46:16)
No. Any transmission of an infection is from a person to a person, except-

Senator Lamar Alexander: (46:22)
Well what if you do know who it is? What do you call that?

Dr. Anthony Fauci: (46:25)
Well, if you’re able to identify them, that is not so-called community. But if it’s community, you might have a cluster in the community.

Senator Lamar Alexander: (46:32)
I understand that, but what do you call it if Senator Murray has it and gives it to me, what do you call that?

Dr. Anthony Fauci: (46:38)
That’s person-to-person transmission.

Senator Lamar Alexander: (46:40)
All right. And community transmission means if I get it and we don’t know who caused it. Is that right?

Dr. Anthony Fauci: (46:43)
Right. Exactly. You don’t know what the original source is.

Senator Lamar Alexander: (46:46)
Well, are we at the peak of the flu season?

Dr. Anthony Fauci: (46:53)
Well, the answer is likely, and maybe even on the way down. If you look at the curves-

Senator Lamar Alexander: (46:58)
We’re just over the peak of-

Dr. Anthony Fauci: (46:59)
Well it went up, it went down, it went up. And then now it’s starting to come back again.

Senator Lamar Alexander: (47:02)
Talking about the ordinary flu, we have every year?

Dr. Anthony Fauci: (47:05)

Senator Lamar Alexander: (47:05)
About how many Americans, if you had to estimate, have the flu this year.

Dr. Anthony Fauci: (47:10)
There are probably around 30-plus million infections, a couple of hundred thousand hospitalizations.

Senator Lamar Alexander: (47:15)
In the United States?

Dr. Anthony Fauci: (47:16)
In the United States.

Senator Lamar Alexander: (47:17)
And how many Americans die every year from what we call the flu?

Dr. Anthony Fauci: (47:22)
You know, it ranges from a low year of 15 to 20,000, to the high year that we had in 2018, which was about 70-plus thousand people.

Senator Lamar Alexander: (47:31)
About 70,000 people.

Dr. Anthony Fauci: (47:34)
In one of the worst years. =.

Senator Lamar Alexander: (47:35)
In one of the worst years.

Dr. Anthony Fauci: (47:36)

Senator Lamar Alexander: (47:37)
The flu is a respiratory disease like coronavirus. Is that correct?

Dr. Anthony Fauci: (47:41)
That is correct.

Senator Lamar Alexander: (47:42)
Well, how do you know of you have the flu as opposed to the coronavirus?

Dr. Anthony Fauci: (47:49)
Well, the definitive test would be to get a test for the flu or a test for the coronavirus, so you’d need a test. There is overlap in symptoms. The situation with coronavirus is predominantly fever and a lower respiratory infection, as opposed to an upper respiratory infection starting off with … and then you might get a pulmonary involvement, which is flu.

Senator Lamar Alexander: (48:15)
What’s a lower respiratory?

Dr. Anthony Fauci: (48:16)
Your lung, as opposed to sore throat, sinusitis, sneezing. When you have lung involvement, you can get that with flu. But usually it’s upper respiratory and then lower.

Senator Lamar Alexander: (48:28)
So fever and a cough.

Dr. Anthony Fauci: (48:30)
Fever and a cough can be either of them.

Senator Lamar Alexander: (48:34)
Okay. What should you do if you have fever and a cough.

Dr. Anthony Fauci: (48:37)
Well it depends on the circumstance. I mean if you’re in the middle of a flu season right now and you have fever and a cough, obviously if you have a cough, it could be in pneumonia, you should see a physician. Certainly if you’re a person in a risk group, elderly or underlying condition during the flu season, you should see a physician, because we do have antivirals for flu and you can be helped by doing that.

Senator Lamar Alexander: (49:01)
Should we all be wearing masks?

Dr. Anthony Fauci: (49:03)

Senator Lamar Alexander: (49:03)

Dr. Anthony Fauci: (49:04)
Because right now there isn’t anything going around in the community, certainly not coronavirus, that is calling for the broad use of masks in the community.

Senator Lamar Alexander: (49:13)
Why do health care workers wear masks in the hospital then?

Dr. Anthony Fauci: (49:17)
Well, because a health care worker who is taking care of someone who was known infected with a transmissible virus, that’s different from walking around in the streets wearing a mask.

Senator Lamar Alexander: (49:27)
Are children getting the coronavirus?

Dr. Anthony Fauci: (49:30)
To a much lesser extent than adults, and for reasons that are still unclear. It may be that they are getting infected, but their symptoms are so low, they’re not being recognized. But in a number of reports that have come out from China, there are very few cases less than 15 years old. You’ll always find the exception. But most of the cases are a mean age of about 50.

Senator Lamar Alexander: (49:53)
What can we do or what can our families do to protect ourselves? What’s the most effective way?

Dr. Anthony Fauci: (49:59)
Right now, and I think the question you asked about flu is important. Right now we are still in the flu season. What you can do to protect yourself against the possibility of Coronavirus is the kinds of things you would do to protect yourself against flu. Now obviously you get a flu shot. You can at least protect yourself against flu. But also things like, we always say it, it sounds simplistic, but it’s true washing of hands, if possible, staying away from people who are coughing and sneezing. If you yourself are infected, stay out of work. Don’t send your children to school if they’re infected.

Senator Lamar Alexander: (50:36)
My time is up. Senator Murray.

Senator Murray: (50:39)
Thank you Mr. Chairman. And I’m going to yield the first questioning to Senator Jones who has to leave for a flight. I will take the second round. Thank you Senator Murray.

Senator Jones: (50:47)
Thank you Senator Murray. Dr. Fauci, I’d like to follow up on that real quickly. So if somebody right now in Alabama presents and they didn’t get their flu shot. And so all of a sudden they’ve got a fever and they’ve got a cough, they go get a flu test now. Will that test, if they don’t have the flu but have coronavirus, will that test come back negative?

Dr. Anthony Fauci: (51:05)
[inaudible 00:51:05] the test would come back negative.

Senator Jones: (51:06)
All right. So they should be concerned if they present some symptoms for the flu and that comes back negative. Follow up question on that is about testing. I didn’t hear a lot about the testing. We’ve had some concerns in this country about testing. It’s inadequate, to say the least right now, but I know there’s efforts. What capacity do we have to do the testing. As you sit here today and how are we working to expand that and when will that all happen?

Dr. Anne Schuchat: (51:42)
Yeah. Thank you. The CDC’s piece in this is to supply the public health labs with tests and we are rapidly doing so. We developed the test very quickly and then detected some problems after the quality control steps were measured. So by the end of this week, really all of the state labs, the public health labs, should be able to do testing.

Dr. Anne Schuchat: (52:04)
But I think for context, it’s important to understand what the clinical labs do in respiratory testing. Last week in the United States, clinical labs tested 42,000 respiratory specimens for influenza and 11,000 of those were positive for influenza. And so far this year, the clinical labs have tested almost a million respiratory specimens and about 200,000 were positive. Public health labs, as opposed to a million so far this year, tested about 62,000. Public health labs are a tiny piece of the testing world. That said, most people with influenza don’t actually get tested. We have about 30 million people with influenza so far this year and as I said, about a million tests. So I think the public health issue is to detect early when there is emergence of this virus, recognize it in travelers or in the community as we’ve said. And then right now we’re really keen with the FDA’s assistance, to get those clinical labs up and running and that’s really an FDA and a BARDA issue.

Senator Jones: (53:12)
So how will the testing, how much more capacity will we have by the end of this week versus two weeks, three weeks from now? Dr. Hahn?

Dr. Hahn: (53:23)
Sure, yes, Senator. We’ve worked with the CDC on their test. We’re using, they’re not, we’re not, but the outside manufacturers, private companies are using their platform right now to further develop the test. Our expectation in talking to the company that’s scaling this up is that we should have the capacity by the end of the week to have kits available to the laboratories to perform about a million tests.

Senator Jones: (53:46)
All right, great. One thing I would urge, to please continue as I think both Senator Alexander and Senator Murray said, please get information out there. We’re about to get head into the allergy season as well. And I just can tell you, people are so scared out there right now that the first time they sneeze with an allergy, they’re going to think that they’ve got this and we need to make sure that we try to educate folks so that those tests that we have, those limited ones, are for the right reasons.

Senator Jones: (54:10)
Second question I have and concerns rural areas. In my state alone, we’ve got hospitals that are … we have another rural hospital closing this week in the state of Alabama. Are there specific things that you guys are doing to make sure that rural hospitals who are living from paycheck to paycheck almost, have the resources that they need, the financial resources and the tools that they need to make sure their communities are protected as well? I’ll ask Dr. Kadlec.

Dr. Kadlec: (54:39)
Yes sir. Thank you for the question. And frankly, we’ve been monitoring that situation very carefully with our health healthcare coalitions that are funded by the hospital preparedness program. And we do recognize there is a paucity in some areas of resources as well as assets and staff. And so we’re looking at investigating about telemedicine and how we can basically make that available. As Dr. Fauci said, the majority of individuals with the coronavirus don’t need care. But the critical thing is identifying those people who can. And that is something that CDC has been working on messaging to kind of identify guidelines. One, individuals who may be at risk, particularly for severe disease, should seek hospital care. And if Dr. Schuchat would like to follow on that. But we’re looking at telemedicine options as one piece of the puzzle that would help us fill in the gap. But there needs to be a longterm solution to that challenge.

Senator Jones: (55:31)
In that regard, I appreciate that. I had a question on that. But I also would encourage you to get with CMS and have them allow for reimbursements for telemedicine. They don’t do that right now and that could be a really important factor.

Dr. Kadlec: (55:42)
Sir, we’re in conversations with them on that.

Senator Jones: (55:44)
Perfect. Thank you. All right, that’s all I have. Thank you.

Senator Lamar Alexander: (55:48)
Thank you senator Jones. Senator Burr?

Senator Burr: (55:51)
Chairman, before my five minutes starts, could I ask unanimous consent that I enter a statement into the record and that I ask on behalf of all members, that if they want to enter a statement into the record that they can. And just remind the members, in 2005 when Senator Kennedy and I passed [PAPA 00:26:10], it was with this day in mind, that we would be faced with a pandemic and we’re close to that determination. And I would only say the temptations to do legislation are great. Before you do it, read what the statute says. Read what the latitude is that our responders have. Let them do their jobs.

Senator Burr: (56:31)
Dr Hahn expressed that he just did to emergency-use authorization. That’s part of the work of this committee. So let’s not be too quick to go out and encumber them with micromanaging what they do. Thank you.

Senator Lamar Alexander: (56:44)
So we’ll go ahead and unanimous consent to put that in and look forward to reading it.

Senator Burr: (56:49)
Thank you Mr. Chairman. Dr. Schuchat, I heard you say that you’re rapidly trying to reach testing. Now as of March the first, CDC’s website had total tested up on their website. It was 472, even though Secretary Azar said last night, 3,600. I don’t know which one’s right. What I’m curious about is why on March the second did you take the total number tested off the CDC website?

Dr. Anne Schuchat: (57:16)
Thank you for that question. Let me clarify. There’s a lot of numbers out there. There’s a difference between persons under investigation who have been tested, and all of the tests that we have run. For instance, an individual case, the first 12 cases that we saw here, we did serial testing on them to understand how long the virus was present and when it was safe for them to leave the hospital, or when they no longer needed isolation. We collected multiple specimens, so we understood with this very new virus, is it the upper respiratory, the lower respiratory. We’ve also collected other specimens from them. So the over 3000 tests run is correct. We’ve tested way more than the 500-some persons under investigation. We’ve also tested some of the hot cohorts or the hot risk cohorts, like the repatriation individuals from the Diamond Princess.

Senator Burr: (58:10)
We’ve know about the potential threat since early January, if not in December, with what we’re looking back at now. Diagnostics had to have been one of the things that we were looking at saying we’ve got to be able to do this. And we devote through PAPA $150 million each year to strengthen the surveillance capabilities at the state level. How can we have a situation like Washington state, where we’ve known for up to six weeks, reaching possibly 1500 individuals. Yet we experienced what we have with this longterm care facility and clearly a cluster that we don’t know the magnitude of. How can that happen when we’ve invested so much in being there early on and understanding it and being prepared.

Dr. Anne Schuchat: (58:58)
CDC very rapidly developed a new PCR for a completely new virus. We posted the instructions for that PCR on the website, so other labs, academic labs, commercial labs, research labs could similarly develop tests. BARDA has the responsibility to work with the private sector to get commercial labs up and running. And the CDC has supplied the public health labs with the ability to do the testing.

Dr. Anne Schuchat: (59:27)
The situation in Washington state is tragic. An outbreak in a longterm care facility is one of the things we have been worried about from day one. We learned from the SARS experience, in 2003, that super events or super spreading individuals could cause very large amplification rapidly. And so the concern about healthcare settings has been foremost in our mind.

Senator Burr: (59:53)
Dr. Schuchat, I believe you, I’m only looking at were we better prepared for this happening? And it doesn’t seem to be that we were. Now PAPA also in the reauthorization-

Senator Burr: (01:00:03)
… to me that we were. Now PAPA also in the reauthorization provided direct hiring authority for 30 new employees at CDC dedicated to development of a bio-surveillance system at CDC. Of those 30 slots, how many have you filled?

Dr. Anne Schuchat: (01:00:15)
I don’t have that information, but I can tell you that the laboratory activities for the coronavirus are not one of the larger parts of our program. We have a really built our response around our influenza capacity, which has really grown with the generosity of the American people through Congress. Our coronavirus capacity is relatively small. We built it up a little bit after MERS, but were not able to sustain that, so we really appreciate the support from Congress to strengthen that public health infrastructure both at CDC and at the states.

Senator Burr: (01:00:48)
I personally was shocked, and I like to think that I’m fairly knowledgeable of everything that we instruct and provide for agencies. I was shocked to find out that in the normal appropriations, this $150 million that that can also be used for CDC facility construction. It’s a little misleading to say this went for surveillance when the flexibility exists for some of it to go for facility construction. Do you know what portion of 150 did not go directly to fund surveillance?

Dr. Anne Schuchat: (01:01:19)
I’m not sure what the 150 million line is. I think I’m going to need to get back to you on that. Our construction, renovation appropriations are separate, so I will need to get back to you on that.

Senator Burr: (01:01:32)
Yeah. I think if you’ll check the appropriations, in all the appropriations that go to CDC, there’s an ability to move money from that to construction facilities. I would encourage the appropriators on this committee, especially as we look at the emergency funding, for God’s sakes, let’s make sure it goes to response and not construction of a campus at this time. I yield back, Mr. Chairman.

Senator Lamar Alexander: (01:01:54)
Thank you, Senator Burr. Did you have something else? Senator Murray?

Dr. Anne Schuchat: (01:01:58)
No, just we’ll follow up for the record with the accurate information.

Senator Lamar Alexander: (01:02:01)
Senator Murray.

Senator Patty Murray: (01:02:02)
Thank you, Dr. Hahn, you heard I am very concerned about the delays in testing. I have people in my state who may have been exposed. They cannot get answers about where to go and health officials are telling us that they fear that this virus has been circulating for weeks undetected. We were relieved a month ago when CDC began to ship diagnostic tests to our state and local labs, but within days many labs reported validation issues with those tests leading to inconclusive results and CDC and FDA began to work on remedying that, but it wasn’t until February 27th that CDC began distributing new test kits and at the same time academic medical centers across the country were raising concerns about the lack of availability of diagnostic testing and burdensome requirements the FDA was imposing. For example, FDA asked labs to submit information about a hundred tests at a time when only 15 people in the US were known to be infected.

Senator Patty Murray: (01:03:03)
Now, FDA has worked to address these issues with the guidance on lab testing that it issued this past weekend, but press reports now indicate the publication of this guidance was delayed within HHS. I was glad to read last night that you now believe you’re going to be able to do a million tests by the end of the week, but frankly I’m hearing from professionals that that is unrealistic. I wanted to ask you first of all, what happened at the department that created these delays and how can you clarify that that estimate of a million tests is accurate?

Dr. Hahn: (01:03:37)
Thank you, Senator. First of all, with respect to the timeline of the development of the tests, CDC obtains the sequence of the virus, that’s where it starts, and they’re able to develop a test based upon the identification of that sequence. They moved rapidly to develop this PCR-based test as it was just described. We received the validation information around that test on February 3rd and on February 4th we issued the emergency use authorization to allow that test to be used. During the scale-up process, which occurred in the week or so afterward and sending it out to the public health labs, as you mentioned, it was identified at some of the public health public health labs, not all of them, that they weren’t able to reproduce and validate the test. CDC heard that information, came to FDA and the we worked to correct that issue. At the same time, simultaneously, we were working with the private sector to actually scale up the use of the CDC-based test and that’s where we came into the most recent estimate regarding how we can scale up in manufacturing.

Senator Patty Murray: (01:04:39)
I understand that. Was the publication guidance delayed within HHS? Was it? Yes or no?

Dr. Hahn: (01:04:45)
No, it was not.

Senator Patty Murray: (01:04:47)
It was not delayed?

Dr. Hahn: (01:04:48)

Senator Patty Murray: (01:04:49)
Do you really believe that a million tests will be available by the end of this week?

Dr. Hahn: (01:04:53)
Senator, let me just explain that one. The companies that we’re working with on this, they have the capacity to develop enough to test kits to send out by the end of the week. This is a dynamic process. Every day we’re hearing from additional manufacturers that they can do this, 2,500 test kits by the end of the week. That should give us the capacity in the hands of laboratories, once they validate, to perform up to a million tests.

Senator Patty Murray: (01:05:19)
2,500 kits will-

Dr. Hahn: (01:05:21)
Kits and 500 tests per kit.

Senator Patty Murray: (01:05:23)
Well, I heard Dr. Kadlec say that the point of where someone goes in to get a test in a rapid, we are months away from that. Correct, Dr. Kadlec?

Dr. Kadlec: (01:05:35)
Yes, ma’am.

Senator Patty Murray: (01:05:36)
Well, I’m hearing from a lot of people in my state that are really concerned about what they should do if they are infected or if they know they were within range of someone with coronavirus. Right now the CDC’s website says if you suspect you are infected you should, quote, “Stay home except to get medical care.” Well, right now, we know that 27% of private sector workforce in the US do not have the ability to stay home from work without losing pay or if they have a loved one who’s sick. In fact, the US is one of only two OCED countries that doesn’t provide paid leave for personnel illness. If we are telling people to stay home, just think about the facility that’s been impacted. It’s a senior center, low-income workers there. All of them are being told to stay home for two weeks. Dr Schuchat, I just have to ask you, would it be beneficial for a public health reason right now while we combat this to have policies in place that make it possible for people to stay home from work without losing a paycheck?

Dr. Anne Schuchat: (01:06:44)
Yes, absolutely.

Senator Patty Murray: (01:06:46)
Okay. Well, I think that’s something we do need to consider with this. Dr. Schuchat, I want to ask you also, I am very concerned by news reports about HHS staff who are deployed to assist with potentially infected passengers returning from abroad and despite face-to-face contact with passengers the staff were reportedly not appropriately trained to handle this type of public health emergency or in how to wear protective equipment. They were not quarantined, monitored or tested for the virus and some have since taken commercial flights and returned to work. It is not clear to me that HHS took necessary steps to protect staff and the public to either during this time or after concerns were raised with senior leadership about what happened.

Senator Patty Murray: (01:07:34)
I’ll ask both Dr. Kadlec and Dr. Schuchat, is the situation I’ve just described consistent with protocol, and what should’ve been done once the senior leadership were aware that frontline staff may have been exposed?

Dr. Anne Schuchat: (01:07:49)
I can speak for CDC that we take the health of our workforce very seriously, the health and safety and have pre-deployment, deployment, and post-deployment guidance. This is a totally new virus and so we’re learning as we go, but when we identify problems we want to resolve them absolutely quickly.

Senator Patty Murray: (01:08:07)
But is what I just described to you consistent with the protocols?

Dr. Anne Schuchat: (01:08:10)
I don’t have the full information of that, but I believe Dr. Kadlec can probably say more.

Senator Patty Murray: (01:08:15)
Dr. Kadlec?

Dr. Kadlec: (01:08:15)
Ma’am, I’ll just say we’re looking into that very closely because this is not, again to echo what Dr. Schuchat has said, we take the protection of our healthcare workers in HHS very seriously. During that operation, in particular, we are evaluating what may have been a breach. We owe it to you as well as been identified by the whistleblower report to report back to you on that.

Senator Patty Murray: (01:08:37)
Mr. Chairman, I would just say that we need people to speak up when they see this situation. It is unacceptable if any of these workers on the front lines are intimidated, indistinct, silent, or believe that they’re going to be retaliated against these issues. We have to keep the protection of public in first, foremost in our minds. I want this looked at and I want to make sure anybody who speaks up is protected.

Senator Lamar Alexander: (01:09:02)
Thank you, Senator Murray. Senator Paul.

Sen. Rand Paul: (01:09:06)
Dr. Fauci, you mentioned remdesivir, and I’m intrigued by the fact that they say that it’s effective against MARS, MERS, and SARS in animal models. Do you take that as a very encouraging sign that it may work in humans too?

Dr. Anthony Fauci: (01:09:19)
Yes, I do. I do.

Sen. Rand Paul: (01:09:20)
Okay. With regard to the children, I think it’s fascinating that there aren’t many cases, and I would suspect that it’ll be improbable that they’re not being infected.

Dr. Anthony Fauci: (01:09:29)

Sen. Rand Paul: (01:09:30)
That somehow they have some blanket immunity. One important thing of maybe putting this into perspective and maybe putting a better look on the overall outbreak would be if we had numbers. I don’t know if someone would suggest to China that they do some random testing of kids in a real hotbed, where there’s a huge number to see. If we got 10,000 kids that weren’t getting sick or 100,000 kids, our percentage of fatality would go way down.

Dr. Anthony Fauci: (01:09:55)

Sen. Rand Paul: (01:09:55)
Did you have a comment, Dr. Schuchat?

Dr. Anne Schuchat: (01:09:56)
Yeah. There are some data about that, that attack rates may not be as zero in children, but they may be asymptomatic. There are data from a few places that are looking at that.

Sen. Rand Paul: (01:10:07)
It seems more likely that they’re asymptomatic.

Dr. Anthony Fauci: (01:10:09)

Sen. Rand Paul: (01:10:10)
Or less symptomatic.

Dr. Anthony Fauci: (01:10:11)
I think we’re going to get some data from the Chinese. They’ve actually been now quite cooperative in sharing data. We had a group that was under the auspices of the WHO that went to China. There was an individual from the CDC and an individual from the NIH who have now returned and we’ll soon get a good look at the report of what they’ve had. That was one of the questions we asked, because as you mentioned, Senator, that is a very important issue.

Sen. Rand Paul: (01:10:43)
With regard to treating the severe and potentially fatal cases in bacterial or viral infections, it seems sometimes it’s sort of trying to fight off the cause of the infection as well as the body’s response to that. In some bacterial infection, steroids, like with the flesh-eating strep, sometimes you actually give massive steroids inside, in the setting of an infection, and some of these people survive. In the fatal cases, are they finding that steroids in addition, well we won’t really have an antiviral treatment, but are they using some steroid treatment in the real severe cases and having any success?

Dr. Anthony Fauci: (01:11:15)
They’ve done it in an empiric non-control way and there doesn’t seem to be any difference, that there’s any effect positive or negative.

Sen. Rand Paul: (01:11:23)
Right. Well, I guess in a bacterial infection, we would never do it unless we were also giving antibiotics. If you had an antiviral plus steroids, it might be a different scenario. Thank you. That’s all I have.

Senator Lamar Alexander: (01:11:33)
Thank you. Senator Paul. Senator Casey.

Sen. Robert Casey: (01:11:36)
Thanks very much. I want to thank the chairman and the ranking member for the hearing and also obviously our witnesses and the expertise in the work by each individual here for many years.

Sen. Robert Casey: (01:11:49)
I think I’ll start today with what is the obligation of every elected official in the federal government? We’ve got members of the House and the Senate in both parties and we have two individuals in the executive branch, the president, the vice president. The obligation’s real simple here by every elected official, every one of us is charged with working constructively to at least do the following: Slow the spread of the virus, taking steps to do that, working with all of you and the folks who work with. Number two, to support state and local preparedness efforts. Three, provide complete and accurate, always, always accurate information to the public to address their concerns about this challenge.

Sen. Robert Casey: (01:12:34)
I know this committee has worked in a bipartisan fashion on a range of issues for years. We’re continuing that today. I appreciate especially the work that Senator Burr has done, working with him as I have for the last number of years, in the Pandemic All Hazards Preparedness Act and the reauthorizations. But we’ve got to make sure that we do our job even as we’re indicating what should come next.

Sen. Robert Casey: (01:13:02)
I want to start with Dr. Kadlec and Dr. Schuchat with regard to the tragedy that’s unfolded in the state of Washington in nursing homes, as Senator Murray outlined. I guess I want to start with just that venue for this challenge. We know that the early indications suggest that the virus propose, or opposes, I should say, a significant and even deadly risk to, number one, our older adults, number two, people with disabilities and, number three, folks with underlying health conditions. The risk obviously is heightened in nursing homes where residents and workers don’t have the option to distance themselves. The residents, in particular, they’re in their home, so there’s no staying home to avoid it. Obviously, the workers have a challenge.

Sen. Robert Casey: (01:13:55)
Dr. Schuchat or Dr. Kadlec, depending on who wants to go first, tell me two things about what the administration is doing. What’s the administration doing to protect both, number one, the residents and, number two, the workers in longterm care settings?

Dr. Kadlec: (01:14:10)
Sir, I’ll start and then turn it over to Dr. Schuchat. I mean, I think the key thing is as we’ve learned more about this outbreak, and last Thursday the Chinese posted a fairly significant report on epidemiology of their outbreak that included a record of 44,000 confirmed cases in China, which gave us a pretty good understanding of what are the relative risks. To Dr. Fauci’s points earlier, about 20 to 15% of people who are over the age of 70, in particular, and with comorbidities are at risk.

Dr. Kadlec: (01:14:41)
From that, I think Saturday, and I won’t steal Dr. Schuchat’s thunder, they released guidelines on how we could basically warn and inform people with vulnerabilities. We have actively worked to reach out to them specifically through mass calls and through briefings to inform them of those risks and guidelines they can follow, which are CDC guidelines. We’ve been very proactive and aggressively trying to respond to this as we learn more in a way that would ensure that we can warn proprietors of those facilities. But it’s not just longterm care facilities, it’s potentially dialysis clinics and other areas where we have cancer therapies given where people who are immunologically at risk can basically be taken care of and shielded from this virus.

Dr. Kadlec: (01:15:33)
Dr. Schuchat?

Dr. Anne Schuchat: (01:15:34)
Yes. Just to say that CDC has issued a number of guidance documents and for the past several weeks has been doing outreach with clinicians and health systems. Through the weekend, I spoke many times with Seema Verma from CMS and the full armamentarium of assets that CMS has, including inspectors and so forth, is being directed to help us with this challenge. Obviously, individuals in the skilled-nursing facilities and acute hospitals have lots of other things going on and the best we can do to protect them from infections acquired there, it’s really our responsibility.

Sen. Robert Casey: (01:16:15)
Just make a comment and then I just have one question for Dr. Hahn.

Sen. Robert Casey: (01:16:19)
We’ve had a debate about healthcare and I’ve been working, as many have, to combat the use of these so-called junk plans. We got a report where a guy got tested for the flu to make sure he didn’t have coronavirus. He finds out that his insurance is one of those short-term limited duration plans. Doesn’t cover basic testing. You get the picture. These junk plans are a problem. I hope this challenge we’re facing will convince the administration that junk plans or the advancement of junk plans are really dangerous, especially when we face this kind of a threat. I hope they would rethink their deregulatory strategy going forward.

Sen. Robert Casey: (01:17:02)
But Dr. Hahn, the last-

Senator Lamar Alexander: (01:17:03)
Senator Casey, we’re over time.

Sen. Robert Casey: (01:17:05)
Just one quick question. On testing.

Senator Lamar Alexander: (01:17:05)
I’m trying to keep everybody to five minutes.

Sen. Robert Casey: (01:17:07)
Just one question on testing.

Senator Lamar Alexander: (01:17:08)
If we have a succinct answer.

Sen. Robert Casey: (01:17:10)
How many people this week can be tested in the United States of America? This week?

Dr. Hahn: (01:17:16)
Senator, that depends upon the deployment by the manufacturer to private companies, academic centers, et cetera, and their ability to validate it and do the tests. The capacity will be there by the end of the week, but those are the necessary steps to actually get that deployed to the American people.

Sen. Robert Casey: (01:17:33)
Well, I hope we can get a number on people.

Senator Lamar Alexander: (01:17:35)
Thank you. Senator Casey. Senator Cassidy.

Sen. Bill Cassidy: (01:17:39)
Thank you all. I have about seven or eight questions. I’ll ask you to be succinct in your answers and if I interrupt, it’s not to be rude, just to get through them. CDC, we discussed beforehand, I’ve discovered that the Canadians have not been as strict in terms of people returning from Huawei province. If you’re febrile, they quarantine you. If you’ve just been there and you’re not febrile, God bless you, go home and don’t infect anybody. Now, you had mentioned that there is screening at the US/Canadian border. What percent of those folks coming from Canada in say Washington state are actually being screened either by a questionnaire as to travel history, exposure and our temperature, et cetera?

Dr. Anne Schuchat: (01:18:18)
Yeah, I don’t have the percent, but we’ve worked closely with Dr. Kadlec’s team and the US Public Health Service as well as the CBP-

Sen. Bill Cassidy: (01:18:26)
But can you give me a ballpark? Is it 10%, 50%?

Dr. Anne Schuchat: (01:18:29)
There’s a protocol that is assessing everybody who’s crossing at the key borders to alert it to where the flights are coming in and so forth, but I can’t give you a percentage. Sorry.

Sen. Bill Cassidy: (01:18:41)
But it could be as low as 5%?

Dr. Anne Schuchat: (01:18:42)
It could be.

Sen. Bill Cassidy: (01:18:45)
Yeah. Secondly, is CDC using Google location data or something similar in terms of tracking contacts?

Dr. Anne Schuchat: (01:18:54)
Not for contacts. We are for travel patterns and for other means.

Sen. Bill Cassidy: (01:18:57)
Let me ask, so going to this nursing home in Seattle, clearly somebody came who had been exposed to the coronavirus. Law enforcement at a scene of a crime will get a warrant, will ask Google to give this data. We’ve been reviewing the statutes. Just to be clear, CDC is not currently using that same sort of thing law enforcement is to track contacts?

Dr. Anne Schuchat: (01:19:19)
You have to recognize that right now the chances that a person with a fever and cough have coronavirus versus influenza are very low …

Sen. Bill Cassidy: (01:19:28)
No, no, no. That’s not my-

Dr. Anne Schuchat: (01:19:28)
… so exactly what we’d be tracking, I’m not sure.

Sen. Bill Cassidy: (01:19:31)
My point is if somebody went to that nursing home and you can follow their location data and it turns out they had contact with somebody who had traveled to Huawei, perhaps in Canada, they had going back and forth, then they’re obviously a candidate for, to be in the vector. I would encourage, because I think the answer is no, that you do use that location data. It seems as if that would expedite the epidemiology of how this is being spread among the community. Next, Dr. Hahn, those 26 APIs that India is not allowing to be exported, are any of those the active pharmaceutical ingredient for any of the candidate therapeutic drugs?

Dr. Hahn: (01:20:17)
Senator, I don’t know the answer to that question. We’re going through that list right now to actually assess the effect on essential medications.

Sen. Bill Cassidy: (01:20:24)
Okay. Next, one of the recommendations that Senator Murphy and I had in a request in a drug shortage report from the FDA which was released last year, recommendation number two, was to establish a quality supply chain rating system. Now, should Congress enact this quickly because clearly if we’ve got supply chains overseas that we can’t inspect and they are basically interdicting the flow of that active pharmaceutical ingredient to the US and it could be one of these Canada drugs, again, should we now enact that recommendation number two?

Dr. Hahn: (01:20:56)
Senator, we stand behind and are working on the development of this rating, excuse me, rating system. We also have some legislative proposals as part of the president’s budget that relate to this.

Sen. Bill Cassidy: (01:21:06)
Okay. Next. We have a problem with antibiotics in which if you had a very expensive antibiotic for some terribly resistant drug it’s difficult for us to currently pay for them with capitated payments to MA plans, for example, or DRGs to hospitals. We could have the same situation with antivirals whereby the antiviral might be very expensive and that would kind of blow the lid off of the DRG or you see where I’m going with this. Again, I would like Congress to act upon this quickly to create some sort of carve out for these essential but expensive drugs to develop. Your thoughts?

Dr. Hahn: (01:21:45)
We have implemented the authorities given to us in the Gain Act and also in the Cures Act to help with this. We are very much facilitating the development of antibiotics in this group.

Sen. Bill Cassidy: (01:21:54)
But I think this would be a payment policy on the part of CMS. I think we’d have to give them the authority to do an epi-payment, if you will, for the use of such drugs.

Dr. Hahn: (01:22:02)
I know that we have a pilot project with CMS to bridge this gap to the payment side. I defer the payment questions to CMS, sir.

Sen. Bill Cassidy: (01:22:08)
Dr. Fauci, we’re looking for quick diagnostics. Obviously, a PCR takes a little bit longer than a swab or a blood test for IgM or an IgG. How close are we to having an IgG or an IgM blood test that could be quickly turned around in a community hospital?

Dr. Anthony Fauci: (01:22:26)
Yeah, I think pretty close because that’s clearly one of the things we want to get. In fact, it’ll be very important from broader surveillance in the country of exposed people who never come to medical care.

Sen. Bill Cassidy: (01:22:36)
I want to finish up by saying this, we need to know from y’all what authorities we need. As I look at this, we need expanded telehealth with expanded use authority. We need to give appropriate reimbursement for that tele-health. Granted, that’s all CMS, but we also need home health.

Sen. Bill Cassidy: (01:22:52)
Ms. Murray was saying how we’ve got to send people home. I think we need to do something there and I think those are my questions. If you need authority from us, please let us know. It may be the expanded authority Senator Burr already referred to, but we need to know what else you need. I yield back. Thank you.

Senator Lamar Alexander: (01:23:08)
Thank you, Senator Cassidy. Senator Murphy.

Sen. Chris Murphy: (01:23:11)
Thank you very much, Mr. Chairman. Thank you so much for your service. Thank you for being here today. Dr. Fauci, thank you for your, I think, very clear articulation this morning about a realistic timeline for treatment and vaccine. I do think it’s worth saying that it is pretty extraordinary that we have to have our medical and health professionals counter-message the President of the United States, that they have to spend their time trying to correct the record. We have become normalized to this administration’s, to this president’s, loose association with the truth, but it becomes particularly dangerous in the middle of a pandemic response. Thank you for being here and sharing facts with us today.

Sen. Chris Murphy: (01:23:55)
We all have lots of questions, so we’ll all try to get in as many as we can. Dr. Hahn, let me follow up on Senator Cassidy’s questions about new authorities. One of the things you said in your testimony was that while you feel you’ve gotten good cooperation from medical device and equipment companies, they’re not required to tell you when there’s a shortage. Senator Rubio and I had sent you a letter, thank you for your response, about trying to catalog the shortage areas. It sounds like it’d be helpful to have a simple, easy legal requirement that they alert you ahead of time when they see a shortage coming.

Dr. Hahn: (01:24:31)
Senator, thanks for the question. We have sent several legislative proposals as part of the budget. I think one of the things we’ve learned from this and other shortages is that it’s a very complicated supply chain. The most important thing is redundancy and also an effort around advanced manufacturing. We have had great cooperation, but this is complicated. For example, the one drug that is currently in shortage related to this isn’t actually related to an API or the final drug form. It’s related to a chemical that’s before the active pharmaceutical agreement, so the whole supply chain is complicated and more information would be better.

Sen. Chris Murphy: (01:25:08)
Great. I think Senator Murray asked you a question, you might not have gotten around to answering, and I think it’s an important one. The right information is key, but also setting realistic expectations is key as well. Your estimate that by the end of the week there are going to be a million tests out there does sound a little aggressive, given the fact that we’ve only tested 3000 people and New York state is saying their goal is to do a thousand a day. Tell us why you think by Friday of this week we’re going to have a million tests when thus far we’ve only done 3000?

Dr. Hahn: (01:25:43)
Again, want to distinguish between the ability to get the test kits out to the laboratories with the ability of the labs to actually do the tests; but we have been working very closely, Senator, for the last three or four weeks with all manufacturers, private, academic, et cetera, CDC to build on this platform that CDC has developed. We have been in touch with this particular manufacturer over the last three or four days. We have reiterated this. We’ve worked with them closely. We know them well. They have estimated that they’re going to be able to scale up to deliver 2,500 kits by the end of the week to providers of the test.

Sen. Chris Murphy: (01:26:19)
Dr. Schuchat, well, let me ask you, how do we make sure that those are in the right hands?

Dr. Anne Schuchat: (01:26:27)
Yeah, thanks. CDC’s been providing the public health labs with kits and expect by the end of this week that there would be sufficient for 75,000 people to be tested. But as you say, not everyone needs a test and we don’t want to go through all our tests on low-risk situations and not be able to really address the care and the contacts that are going to be critical. We have guidelines for this kind of thing for influenza about who needs to seek care, who can stay home and have adapted them for this. We’ve also broadened our definition of who we think is a, what we call, person under investigation, that really needs to be tested, not just related to travel to China, but all the other areas, and also to say people with severe respiratory disease who don’t have an obvious diagnosis should be tested. We know that many of the cases in Washington state are detected through that or because there was an outbreak being investigated.

Sen. Chris Murphy: (01:27:21)
I think this question of where these tests end up and making sure that they’re in the right hands is going to be a really important one for us and you to have oversight on.

Sen. Chris Murphy: (01:27:29)
Finally, Dr. Schuchat, let me ask you a question about protocols that we’re recommending to school districts. One of the biggest disruptions that can happen in a family’s life is the closure of a school. As Senator Murray pointed out, given the fact that many families have two parents working, that’s really difficult for a day, nevermind a week. What are the recommendations and protocols that we are telling school districts about what they should do if they have a child who tests positive, a family member, a teacher who tests positive? What’s the best protocol today?

Dr. Anne Schuchat: (01:28:07)
Yeah, thank you. We absolutely recommend a child who is ill should stay home, whatever they have, so that they don’t spread. But we have worked closely with local and state public health on this issue and essentially decisions about school dismissals, school closures or changes in school policies are very much locally driven, but we provide guidance.

Sen. Chris Murphy: (01:28:31)
What is the guidance though?

Dr. Anne Schuchat: (01:28:33)
Yeah, so the general principle is to minimize disruption. You have this balance between the earlier you act the more impact it can have in slowing the spread and the enormous disruption we see with school closures. You may remember in 2009, we saw hundreds of thousands of students sent home in the first couple weeks of the pandemic. As we learned more about the virus and its spread, we realized that was too disruptive. The virus was relatively mild compared to what we were expecting. We’ve dialed that back to instead shift to staying home when you’re sick, perhaps canceling assemblies, changing the patterns of what’s done in class, but trying to keep classes going because so many depend on school lunches and other services that are at school. It’s a local decision. If there’s too many people sick, of course, you can’t keep going, but really trying to protect the vulnerable and reduce the spread, but not disrupt the families and all those parents who will be staying home if their kids are home.

Sen. Chris Murphy: (01:29:37)
Thank you, Mr. Chaiman.

Senator Lamar Alexander: (01:29:37)
Thank you, Senator Murphy. I let that go on because that’s such an important answer, but I hope everyone will try to stick to five minutes so that we can allow all senators to ask their questions. Senator Roberts.

Sen. Pat Roberts: (01:29:51)
Mr. Chairman, I think I can do that right off the bat. You asked my question and got a pretty good answer, and Senator Jones stole my rural question-

Senator Roberts: (01:30:02)
You stole my rural question. Bob Casey summed up where we ought to be. The distinguished ranking member said, “Look, we ought to get this money appropriated. Get it to the President.” The President by the way said, “Whatever figure you give me, I’ll take it. We’ll work with it.” I just want to thank you both. You indicated we needed information. I think we’re doing that in this process largely because of the wonderful job that these witnesses do. I want to thank Senator Murray for that.

Senator Roberts: (01:30:34)
This is a very unique committee along with the sometimes powerful Senate Agriculture Committee. We are bipartisan. There’s a lot of partisan elbows out there right now. We don’t need to politicize a pandemic. I would recommend that we monitor what people say. I would yield to the Chairman for that decision along with the ranking member and maybe we ought to quarantine people for 14 days if they just shut up about the politics and tossing around the partisan things. We can do better. I think we need to get the funding to the President and then let’s get these kits out. A million at the end of the week, that’s good progress.

Senator Roberts: (01:31:15)
Dr. Schuchat and Dr. Kadlec, I do want to underscore again our rural areas. We have 83 critical access hospitals in Kansas. Probably that’ll be reduced just simply because of what’s going on. We’re older, a lot of nursing homes, a lot of long-term care enterprises that’s just ripe for this kind of thing. I might point out in the Senate, we have quite a few people have reached that age as well. But I hope that we can follow the chart here that the good Senator Cassidy has suggested. I think it’s an awfully good thing.

Senator Roberts: (01:31:57)
I’d say one other thing. I think part of our job is to stand with you when you’re taking the boos and stand behind you when you’re taking the bows. All of you should take a bow. I think we ought to have this situation where we have your back not so much to criticize, we’re trying to work with you. We’re going to get this done. We are going to get this done. I would say Mr. Chairman, that in today’s Wall Street Journal, last summer for $7 bucks, $7.85 … where is that? You could get this for $7.85. If you want to go to Amazon today, it’s $114.97.

Speaker 3: (01:32:42)
I’ll give it to you for $50.

Senator Roberts: (01:32:47)
If you bought a liter of this, it was $14 bucks, now it’s $229. That’s ridiculous. I guess that’s the supply and demand situation that Amazon thinks it would be the case. I want to ask one other thing. The term that I was, and I think a lot of people are confused about, is community spread. Spread is a verb, but it doesn’t say that this disease will spread throughout the community. It just indicates there is one person where we don’t know where the source was. Is that correct?

Dr. Anne Schuchat: (01:33:25)
Yeah, that’s right. We’re really just differentiating it from spread from a close contact or travel-associated. It doesn’t mean the whole community is affected. What it really means is that if we threw enormous resources at it, we could probably map out each of the links, but it’s more important to go from man to man to zone when you start to see that community recognition. To put the most effort where it can be the most impactful and perhaps less on the individual contact tracing and more on the readying the healthcare system, readying the schools and so forth.

Senator Roberts: (01:34:01)
I thank you very much. I yield back.

Senator Alexander: (01:34:04)
Senator Roberts, you did a better job of asking your own question than I did. Thank you for doing that.

Senator Kaine: (01:34:10)
Senator Kaine. Thank you Mr. Chairman. Mr. Chair, I express condolences about the tornadoes in Tennessee yesterday that were devastating.

Senator Alexander: (01:34:18)
Thank you.

Senator Kaine: (01:34:18)
I want to thank the witnesses and actually thank the chair in ranking. This committee has had a number of round table sessions and these witnesses have been here and presented to us. The first one was on the 24th of January. That’s positive. I will say when we had that briefing on the 24th and we’ve had briefing sense and then when the White House appointed the Special Committee on the 29th, it made me surprised when I looked at the President’s budget that came to us on the 10th of February to see that in that budget there was a 52% proposed cut to the World Health Organization and cuts between 5% and 10% to the NIH, the CDC and the overall HHS budget. It does not seem to me to be a wise time to take a scalpel or a meat axe to the public health infrastructure. I hope as we’re looking at what we do from an appropriation standpoint, we’re not only coronavirus, but also looking at the pieces of the budget that fund the public health infrastructure so that we don’t do damage to that at this time.

Senator Kaine: (01:35:17)
Similarly, the budget contains significant cuts to Medicaid. Although it’s described somewhat euphemistically, it’s pretty clear that the Medicaid cuts are going to cut people in states that have adopted Medicaid expansion under the Affordable Care Act. And the administration is right now in courts as they’ve been every day during this administration trying to eliminate the Affordable Care Act. The Supreme Court announced yesterday that it will take up a case later this year. It is not a good time. It is not a good time to take a meat axe or a scalpel to the public health infrastructure. It is not a good time to scare people about whether or not they’re going to have health insurance.

Senator Kaine: (01:35:56)
I’m not sure there is good time to do that, but you could not do it at a worst time when you’re doing it as people are concerned about a pandemic. Dr. Fauci, I want to ask you a question. Like Senator Alexander, I was looking forward to your presentation at the Senate lunches today, but during the middle of this hearing, I got a notice. I don’t know if it’s accurate that you will no longer be presenting at the Democratic lunch. Is that accurate?

Dr. Anthony Fauci: (01:36:21)
To my knowledge, no. I mean, I’m planning leaving here and being at both lunches. This is what my, right? ~ Yes. What? I’m just told it’s changed, but I don’t know why.

Senator Kaine: (01:36:39)
I just want to be clear about this. It was notified yesterday that you and the Vice President would be presenting to both the Democratic and the Republican lunches. I got a note from the Democratic leader that came into all of us at about 9:25 that said you would no longer be presenting and Ambassador Birx would be presenting instead. But that’s the first you’ve heard of this right now?

Dr. Anthony Fauci: (01:36:59)
What you just mentioned to me is the first I’ve heard of it, yes.

Senator Kaine: (01:37:02)
Do you have any idea why you’ve been disinvited to the lunches?

Dr. Anthony Fauci: (01:37:06)
I don’t know.

Senator Kaine: (01:37:06)
All right. Let me ask a question about a population that … I will say that is not a confidence builder. It is not a confidence builder when the person who … let me finish. When the person who we have a lot of faith in in really knowing this stuff, who’s done it for presidents of both parties for decades, who is advertised as coming to advise us at lunch, we are now notified you’re not coming to lunch.

Dr. Anthony Fauci: (01:37:29)
One correction. I’m sorry, but you took me by surprise. Am I going?

Speaker 4: (01:37:33)

Dr. Anthony Fauci: (01:37:34)
I’m going.

Senator Kaine: (01:37:35)
You’re going. But well, I thought your staff told you you weren’t going 30 seconds ago. What is the answer to this?

Dr. Anthony Fauci: (01:37:41)
What is the right answer?

Speaker 4: (01:37:41)
Yes. You are attending.

Dr. Anthony Fauci: (01:37:42)
I am?

Speaker 4: (01:37:43)

Dr. Anthony Fauci: (01:37:44)
I am invited, yes.

Senator Kaine: (01:37:46)
Why did your staff tell you that you were not invited and then 30 seconds later change it? Am I that persuasive?

Dr. Anthony Fauci: (01:37:53)
I don’t-

Senator Kaine: (01:37:56)
We’ll see what happens at the lunch. It’s not a confidence builder. I will say it’s not a confidence builder. Let me ask about a population that is of significant concern in Virginia and everybody here, which is the military. We don’t have a DOD person there, but I know you must be working in tandem. We have a lot of Virginians who are deployed at Vicenza, Italy. We had a lot of Virginians who are deployed in South Korea. We have a lot of Virginians deployed in Sigonella, Sicily, Italy. Just thinking of two of the countries that have been mentioned as places where there’s significant coronavirus.

Senator Kaine: (01:38:26)
My understanding is, at least in the Vicenza base, families are being urged to stay on base. Talk a little bit about your interaction any of you who kind of deal with this. Your interaction with the DOD, are we likely to see more of this? Is there a sort of quarantine or stay on the base in South Korea? Are we likely to see it in Germany? That’s the last question that I have.

Dr. Kadlec: (01:38:47)
First of all, my interaction with the DOD is daily. We basically have a call at 12:00 with the entire enterprise of the Department of Defense, officer of secretary of defense, joint staff, Defense Health Agency, Defense Logistics Agency. What they’re doing is basically abiding by CDC’s rules and guidelines in these circumstances. Obviously a base circumstance is different, particularly overseas where you have the means to basically isolate the population on there.

Senator Kaine: (01:39:14)
Are we doing on-base, “Please stay on base,” other than in Vicenzo right now?

Dr. Kadlec: (01:39:19)
Sorry, I don’t know the particulars of that at that base. But we can certainly get the folks-

Senator Kaine: (01:39:24)
I’ll ask that direct. I’ll ask.

Dr. Kadlec: (01:39:24)
… at the Defense Department to answer. But they do conform with CDC’s guidelines in what should be done to protect their dependents in the military force.

Senator Kaine: (01:39:31)
My time has expired.

Senator Alexander: (01:39:34)
Thank you, Senator Kaine.

Senator Kaine: (01:39:35)
Senator Romney.

Senator Romney: (01:39:36)
Thank you Mr. Chairman. I appreciate the work that’s been done by the public health community in our country to delay the arrival of the COVID-19 in the United States. It’s really quite remarkable to me that while other countries have seen so many cases, whether it’s Italy or Iran, South Korea, Japan, that we’ve been able to delay it. Clearly you can’t keep it away forever. We already have the community transmission, which you predicted.

Senator Romney: (01:40:03)
I want to turn to another issue, however, which is whether we as Congress and administrations, Republican and Democrat, have done enough to prepare protective equipment for our medical professionals and for our public at large. I don’t want to point at anybody. This isn’t you. This is us responsible for funding, which is given the fact that our medical professionals need masks, gowns, gloves, and so forth, what percent of what would be needed by medical professionals if we were to have a full-blown pandemic, and I hope we don’t, but if we were to have one, what percentage of what we would need for our medical professionals is in the Strategic National Stockpile?

Senator Kaine: (01:40:39)
Sir, I can give you a rough order of magnitude. It depends what kind of like you said severe pandemic. 10% of what we need right now if it were to be a severe event, we would need 3,500,000,095 respirators. We have about 35 million.

Senator Romney: (01:40:49)
So about 10%.

Senator Kaine: (01:40:53)
10% and are working actively in that.

Senator Romney: (01:40:55)
That scenario where I’ve been most concerned that it strikes me that we should have substantially more than 10% that what would be needed for a substantial pandemic. We should have that in stock. I can’t believe that we Congress, I’m not blaming the administration, this is Congress and appropriating and it’s prior administrations as well. That should be in place.

Senator Romney: (01:41:14)
Do masks help for the general public? Let’s say we have a major pandemic and people are concerned. They’re going to the grocery store. They know other people there might be infected. Do masks actually help? Do they prevent or reduce the likelihood of being exposed to the disease, Dr. Fauci?

Dr. Anthony Fauci: (01:41:31)
It depends on the mask. If you look at the N95 masks, they are much better than those sort of floppy masks. In general right now, I think the question you’re asking Senator-

Senator Romney: (01:41:42)
I’m really asking if we were to have a major outbreak of some kind.

Dr. Anthony Fauci: (01:41:46)
The most important thing for a mask would be if someone is infected to prevent them from infecting others. The other is the healthcare provider to protect them.

Senator Romney: (01:41:54)
Of course.

Dr. Anthony Fauci: (01:41:55)
The general public who could wear them, that could certainly prevent gross droplets from going when someone sneezes and coughs on you. But it doesn’t provide the kind of protection that people think it does. Therefore there are some downsides because people keep fussing with the mask.

Senator Romney: (01:42:12)
It’s better than nothing. Do we have masks in our Strategic National Stockpile for the general public? We do not. Turn to aircraft. If someone on an aircraft is infected and sneezes, how many people are going to be exposed to that disease? Is it just a couple of people, the people sitting next to them? Is it the whole aircraft?

Dr. Anne Schuchat: (01:42:33)
For this kind of virus, we’re thinking just the couple rows around it. For other types of infections, it might be broader.

Senator Romney: (01:42:41)
Should our flight attendants not on our instruction tell them not just to fasten in their seatbelt, but that if you cough or sneeze you should cough into fabric or into your sleeve or whatever? I mean, I keep going on an airplane, someone coughs or sneezes and I hear it barking out. It’s like my goodness. In a condition like this, just the general flu, given the fact we have the flu going on and colds, should we not be telling people on airplanes, “You may not cough or sneeze unless you’re covering your mouth.” I think I know the answer to that.

Senator Romney: (01:43:10)
Let me ask another question, which is let’s say we do get a vaccine that tests positively and so forth and goes through Phase 1 and Phase 2 clinical trials, what does it take to get a major production done? How long does it take to actually kick the production up and how long does that take it and who does that? Who’s doing the manufacture once we know this is a vaccine that works?

Dr. Anthony Fauci: (01:43:33)
That’s a very good question, Senator. That was really one of the things that was discussed yesterday when the President and the Vice President brought in the CEOs of a number of companies. That’s really important because what I was talking about a year to year and a half, if you don’t have the production capacity to make tens and tens of millions of doses, it may take even longer. The ones who can do that essentially are the pharmaceutical companies. The federal government is not going to be able to make hundreds of millions of doses. It’s going to have to be partnership with the private sector.

Senator Romney: (01:44:06)
Do we have that capacity in the United States? Is this capacity outside the US? I guess the question I’m looking for is whether legislatively or from an appropriation standpoint, we should provide funding to have the capacity to make large numbers of vaccines. We should have that capacity in the US and have it ready at the go in case if this isn’t the pandemic that we’re worried about, if another one comes down the road. Is this something we should actually have a ready to go?

Dr. Kadlec: (01:44:32)
Yes, sir. In fact, right now the only capacity we have is really aid production, which wouldn’t be relevant to the vaccine candidate or the candidates we at BARDA are pursuing. We would have a longer than a six month wait to basically produce vaccines on scale.

Senator Romney: (01:44:48)
Yeah. I want to underscore that is an area we ought to consider making an investment in. Thank you, Mr. Chairman.

Senator Alexander: (01:44:55)
Thank you, Senator Romney. Senator Smith.

Senator Smith: (01:44:57)
Thank you very much, Terry Alexander and ranking member Murray. I want to just thank again all of you for being here today and also please extend my thanks to your amazingly hardworking professional staff who I can only imagine have just been going nonstop for months now. Thank you. I want to start by asking a question about sort of the misinformation and flat-out falsehoods about the coronavirus that has been circulating and amplified. I worry that it’s being amplified for political reasons.

Senator Smith: (01:45:28)
To the point of Senator Roberts and others that we don’t want to politicize this. My question is what is the impact of this misinformation and what should we do about it? I’m sort of looking at Dr. Schuchat and Dr. Fauci in particular. I mean, it’s embarrassing to go through all of the things that have been said on national media, including honestly by our President. Dr. Fauci, it’s not true is it that this is just like a common cold and that we can expect that this is going to be gone when the weather warms up? Is that true or not?

Dr. Anthony Fauci: (01:46:01)
Let me explain. In general, respiratory illnesses such as the prototypic influenza virus is seasonal. That when the weather gets warmer as will happen in March, April and May, you will inevitably see a marked diminution in influenza. The same holds true for other respiratory viruses including some of the common cold coronaviruses. This could happen with this, but we don’t know it. The reason we don’t know it is because this is a brand new virus with which we have no experience. Even though the concept that when warm weather comes, many respiratory viruses diminish, we have no guarantee at all that this is going to happen with this virus.

Senator Smith: (01:46:48)
It might come back again.

Dr. Anthony Fauci: (01:46:50)
It certainly might.

Senator Smith: (01:46:51)
I mean, it’s not like we’re going to all be, “We don’t have anything to worry about once the-,”

Dr. Anthony Fauci: (01:46:53)
No. I mean it is conceivable given the degree and the efficiency of transmissibility of this virus that we might have a cycle. It may come and be seasonal and comeback. That’s quite possible. We don’t know that, but that’s possible.

Senator Smith: (01:47:10)
We’ve heard so much misinformation. I mean it’s been said that this virus was developed as a tool to wage economic war on the United States. It’s been said that this is part of a strategy to try to bring down the economy. It’s ridiculous and it’s harmful. But could you as public health professionals comment on why this makes it more difficult for us to address this epidemic and what we should do to combat this kind of misinformation?

Dr. Anthony Fauci: (01:47:40)
No, I think we need to speak out often and loudly about how much nonsense this is. This is not new with coronavirus. There are always conspiracy theories when there’s a new disease that people are afraid of and that is really novel to them. I have to say, I’m thinking back now about 35 or 37 years ago, I sat in this room trying to explain to the committee then that HIV was not a virus that was developed by the CIA to essentially eliminate certain populations. It’s crazy, but this is what happens when you have outbreaks. There’s a lot of misinformation.

Senator Smith: (01:48:27)
Well, then there’s consequence. My point is that there’s consequence to this misinformation that makes it more difficult for public health professionals to respond and to take care of the population in the ways that we need to. That’s what worries me.

Senator Smith: (01:48:39)
I want to just, I know I don’t have much time, but I want to ask another issue that is extremely important to my folks at home. I’m very proud of the Minnesota Department of Health. They do great work. They’re very worried about what’s going to happen, the capacity pressures that they’re going to be experiencing as they try to address the coronavirus on top of everything else that they’re addressing. My question is first this, it’s not only a question of getting the diagnostic tests out so that people can respond, but also these labs need to have the people in order to do the testing. Because they’re already, it’s not like they’re sitting around with nothing to do right now, right? Maybe Dr.-

Dr. Anne Schuchat: (01:49:16)
Yeah, absolutely. The public health labs are short staffed on a good day. This is a very big challenge. That is one of the reasons that we are keen to get the clinical labs up and running with the test. I think you bring out the point that it’s not just the laboratory capacity for public health, but it’s all the other things they do. They’re very busy with contact tracing. They’re busy with following up on the people who traveled, who they’re supposed to follow. They’re spread really thin. I think it illustrates the principle that in this type of evolving situation, we really need to put the most effort where it can do the most good and not get distracted with smaller things.

Senator Smith: (01:49:56)
It’s also why it’s so important as we work on these emergency appropriations that we’re making sure that these departments at the local level are reimbursed for the work that they’ve already done, right?

Dr. Anne Schuchat: (01:50:05)
Yeah, absolutely.

Senator Smith: (01:50:06)
Absolutely and that they have sufficient dollars so that they’re not dipping into money they would have gotten anyway to do the work that they don’t really have the funding to do right now. Great.

Senator Alexander: (01:50:15)
Thank you, Senator Smith. Senator Scott.

Senator Scott: (01:50:18)
Thank you, Mr. Chairman, and thank you to the panel for being here this afternoon almost. You’ve spent quite amount of time with us. The one thing I’m not concerned about frankly is whether or not Congress will provide the necessary resources in a timely manner to deal with the challenges that we face with the coronavirus. I’m not going to ask you questions that have been asked several times by several different senators as it relates to what will happen if.

Senator Scott: (01:50:44)
I do think what we have not had a lot of conversation about is putting this virus in context. Context where the average person in this nation can digest very quickly and understand the actual risks that are associated with the virus. Rather it’s the 2003 SARS or it’s the 2009 swine flu, rather it’s the current flu season, the number of Americans that have died because of the flu, whether it’s the even overnight Tennessee lost 19 people because of a tornado. I would appreciate it if you all would take just my time to help us in putting context what 80% of the people would experience if they were infected by the coronavirus, which seems to be a fever and a cough. Maybe that’s downplaying it. If it is, please let me know. Then the 20% folks who are elderly who may have disabilities and comorbidities that may be at a heightened risk.

Senator Scott: (01:51:50)
If you would just use my three minutes that I’ll have left by the time I finish with my opening comments, help me and the rest of the folks in South Carolina who are seeing this issue on every screen and oftentimes seeing it really from my perspective hyped up in a way that is not helpful.

Senator Scott: (01:52:10)
I’ll close with this. I think there are those who are alarmist who are really painting a picture that is very difficult to digest. Then there are those who are acting with a sense of urgency. I think the four of you are acting with a sense of urgency, but not being alarmist at all. Can you now use two minutes and 48 seconds to help me understand the situation? I’ll start with Dr. Hahn and maybe work my way through.

Dr. Hahn: (01:52:36)
Senator Scott, I can address the regulatory issues. We have worked with urgencies. We’ve issued two EUAs to help facilitate both masks and diagnostic tests in support of these terrific public health colleagues.

Dr. Kadlec: (01:52:49)
Sir, I’m going to yield my time to Dr. Fauci and Dr. Schuchat. My job is to think of the worst case, so I’ll let them talk about the real case.

Senator Scott: (01:52:58)
Thank you.

Dr. Anthony Fauci: (01:52:59)
Senator Scott, you really bring up a good point. It really has to do with what you consider relative risk and how that relates to the unknown. The thing about what’s going on now is that since it is a new virus, we don’t really know exactly where it’s going to go. If you look at the disease burden, morbidity and mortality, every single year influenza does a significant amount of health damage, not only to our country but to the rest of the world.

Dr. Anthony Fauci: (01:53:32)
The thing about influenza is that although there are many things about it that are unpredictable, we kind of know the bracket of how many people are going to get sick and how many people are going to die. It’s tragic. It’s death. It’s suffering. We don’t like it, but we kind of know. When you’re in the area of the unknown, you have to walk a delicate balance of not overshooting and having panic, but not also undershooting and being in a situation where you don’t respond as aggressively as you should.

Senator Scott: (01:54:01)
A sense of urgency.

Dr. Anne Schuchat: (01:54:05)
Just to add that while in a large population, most people who get infected will probably have very mild symptoms. Some will have severe illness, pneumonia, and be critically ill. What’s unknown right now is what that full total will be. Will we have many more cases a year than we have with flu, which would be very difficult to handle? Or will we be able to slow the spread and protect the healthcare system?

Dr. Anne Schuchat: (01:54:34)
It’s this balance that Dr. Fauci mentioned of not overreacting, but not under-reacting. Because the risks of under-reacting could be that we have second and third order complications. We don’t want to have the healthcare system flooded with people who don’t need to be there, but we really need to build it up because if this is going to be like a really bad flu, we’re going to need to build up that healthcare system.

Senator Scott: (01:54:57)
Excuse me, out of the 90,000 known cases we’ve had how many deaths?

Dr. Anne Schuchat: (01:55:04)
Right now it’s about 3,000.

Senator Scott: (01:55:05)

Dr. Anne Schuchat: (01:55:08)
There are biases in the early information. Some countries have good information about very mild disease.

Senator Scott: (01:55:14)
A lot of countries do not.

Dr. Anne Schuchat: (01:55:15)
Others you can only keep up with the severe disease.

Senator Scott: (01:55:17)
I would just end my comments, Mr. Chairman, with the fact that I think 3,000 deaths should get everyone’s attention. We should be acting with a sense of urgency, but not buying into hysteria that will make it even more difficult for healthcare providers. My mother has worked at a hospital for about 45 years. Make it more difficult for healthcare providers have the resources and the equipment necessary for them to take care of those folks walking in the hospitals and needing assistance. Thank you.

Senator Alexander: (01:55:47)
Thank you, Senator Scott. Senator Hassan.

Senator Hassan: (01:55:49)
Well, thank you Mr. Chairman and ranking member Murray. Thank you to the panelists and to your entire teams. You all have been working tirelessly. We know that and we are very, very grateful. I wanted to start to get at the issue Dr. Schuchat with you of diagnostic testing capacity. I know the administration’s ordered an independent review of the CDC lab about problems that arose in the manufacturing of the diagnostic tests kit. What is clear at this point is that the domestic testing capacity has been significantly lower here in the United States than what we’ve seen in countries like South Korea and Italy. So Dr., are you confident that the policies put in place by CDC and FDA over the past few days will allow states to test for coronavirus at a level commensurate with what this rapidly evolving outbreak requires?

Dr. Anne Schuchat: (01:56:42)
I am optimistic, but I want to remain humble because we see emerging infectious diseases surprises.

Senator Hassan: (01:56:51)
One of the things that we’re dealing with right now, for instance, my state, which had its first confirmed case yesterday, has a dwindling number of kits. They tell me they have to do two tests per patient, because if you get a negative then you’re going to retest the next day. We’re still having to send tests into CDC for confirmation even when we do them at the state level. When do you expect to reach a point where CDC will no longer have to perform confirmatory testing on samples from state labs?

Dr. Anne Schuchat: (01:57:20)
Yeah, that should be very soon state by state as they verify their procedures. We’ve worked closely with FDA to expedite that.

Senator Hassan: (01:57:27)
Okay. Has a lack of federal resources or personnel within CDC played a role in what appears to have been a lack of ability to scale response efforts in order to meet the demand for diagnostic testing across the country?

Dr. Anne Schuchat: (01:57:41)
Not to my knowledge.

Senator Hassan: (01:57:43)
Okay. To Dr. Fauci and Dr. Kadlec, I’m concerned that the delays in making test kits widely available means we don’t yet have a full sense of the scope of the problem. I mean if we can’t test everybody who has these symptoms yet, we may not know what the full scope is. Having an accurate accounting of the problem we face is critical for your ongoing preparedness and response efforts. Dr. Fauci and then Dr. Kadlec, how has our limited diagnostic testing capacity impacted your response efforts? What steps are you taking to mitigate those challenges?

Dr. Anthony Fauci: (01:58:21)
That’s actually not something that I’m involved with, but I’ve been happy to give you an opinion of that. I mean obviously you would want to be able to have as many tests as you need to be able to do. That’s what the CDC right now is ramping up in collaboration with the state and local health departments. The first level is to get individuals in multiple states, they started off with six and it’ll probably be more, if I’m not mistaken, to be able to test people who come in with symptoms that would be suggestive of a respiratory illness, either flu or coronavirus. If they don’t have flu to determine if in fact it is coronavirus. As we improve and get better and better at that capacity, we’ll have a much more accurate assessment of what is going on in the community.

Senator Hassan: (01:59:09)
Thank you and Dr. Kadlec briefly.

Dr. Kadlec: (01:59:11)
Yes, ma’am. I think the thing is there’s two elements there. One is a trigger in terms of action. How do you respond in early warning? I think one of the things that CDC has been doing, and I’ll let Dr. Schuchat comment on this, is using its influenza-like illness network and the tests that they do there to be able to test broadly to see surveillance. There’s a trigger to respond. Then there’s the more important one I think in terms of understanding what’s circulating, which is really zero prevalence of this virus in terms of being able to detect antibodies in people’s blood broadly to understand what’s the denominator of people who may be asymptomatic. Both of those have a significant importance for our part. With BARDA, we basically have been funding commercial laboratories and basically trying to develop point of care diagnostics to advance that.

Dr. Kadlec: (01:59:56)
Dr. Schuchat.

Senator Hassan: (01:59:58)
Quickly, because I have another question to get to.

Dr. Anne Schuchat: (02:00:00)
We’re doing that community surveillance in the six cities and hope to …

Dr. Anne Schuchat: (02:00:03)
Yeah, we’re doing that community surveillance in the six cities and hope to expand it broader so we see what the tip of the iceberg, what the bottom of the iceberg really is.

Senator Hassan: (02:00:10)
Thank you. I wanted to turn to Commissioner Han for just a moment. The FDA has such an important and wide ranging role to play in our ongoing response efforts. As you know, your announcement last week regarding an unnamed drug shortage that was attributed to disruptions in China due to the Coronavirus caused some confusion among public health experts and just now, you said you couldn’t name it. For those of us who either ourselves or have loved ones who have multiple medications, the notion that there’s a shortage but we don’t know if it’s ours is a really difficult thing for the public, and for people who depend on pharmaceuticals.

Senator Hassan: (02:00:48)
Yesterday, you stated that the US labs could perform up to 1 million tests this week. While public health experts have said that they hope to see US labs complete 10,000 tests per day and tests take time and they take staff. I understand it’s fast moving, but it does seem to me like FDA’s messaging has been confusing and at times, contradictory over the past few days. I am over time, so I actually won’t ask you to respond right now, but I would urge you and perhaps we can have this conversation offline to get a process in place so that you are making sure that your communications are clear to the public and that they’re integrated and I’d look forward to having that conversation with you at a little bit later. Thank you, mister Chairman.

Senator Lamar Alexander: (02:01:35)
Thank you, Senator Hassan. Senator Loeffler?

Sen. Loeffler: (02:01:41)
Thank you Chairman Alexander, ranking member, Murray. Chairman Alexander, I want to express my condolences to your state for the loss in the tornadoes this morning. I know we’re all monitoring that situation and thank you all for your time here today. If you look at where we are now in terms of the capacity for preparedness for response, we’ve obviously come a long way. However, the evolving nature of infectious diseases means that we need to continue to innovate. Your agencies have taken significant strides to improve our national health security capacity, but in America much innovation also comes from the private sector. I commend your steps taken with this administration to address this emergency. What can we do, however, to ensure that the private sector supports the response and in these situations going forward, that they can quickly, these innovations can quickly reach the American people?

Dr. Anne Schuchat: (02:02:45)
Sure. I can start. We’ve been taking steps to reach out to the business community, the private sector community and just yesterday I was on a call with over 1,000 companies about what this epidemic means to them and also how they can help. We also, a few of us met with the pharmaceutical industry yesterday, a number of the big companies about both drugs and therapeutics. Knowing that you’re from Georgia, we have a really phenomenal collaboration with Georgia Tech Research Institute, really to help us modernize some of the data challenges that plague public health. Those are a few areas to to mention. You may want to go on.

Dr. Anthony Fauci: (02:03:23)
Just on the score, I was very encouraged by the enthusiasm of the CEOs of the pharmaceutical companies yesterday. Then when we met in the cabinet room of the White House, it was really very gratifying to see the fact that they really wanted to do anything they could to help with us. As I mentioned in response to a previous question, we’re not going to get the kind of production of interventions unless we partner with a pharmaceutical company.

Dr. Kadlec: (02:03:50)
Ma’am, if I could just comment one thing, two programs within Asper Barter Drive and Asper Next are two things that are looking specifically at innovations around medical counter measures and other things that would enhance our responses. Barter Drive basically met with 1,500 companies looking for particular things, diagnostics to work on this and Asper Next is looking particularly on the supply chain issues as it relates to pharmaceuticals.

Dr. Hahn: (02:04:16)
We’ve been working with diagnostic companies with vaccine, biologics and with drug manufacturers both around the shortages issue but the development of products to address this outbreak.

Sen. Loeffler: (02:04:29)
Thank you all.

Senator Lamar Alexander: (02:04:32)
Thank you, Senator Loeffler. Senator Baldwin.

Sen. Baldwin: (02:04:36)
Thank you, mister Chairman. I want to start with the idea of the fact that we have an emergency spending bill going through the Congress quite rapidly and some of the issues that have been raised, I’m hoping that we will properly address those in this appropriations bill, but also then be able to follow up and make sure that the right policies are in place. What I’ll start with the discussion we’ve been having about a domestic production of things that are essential in fighting epidemic. I remember in my former life as a member of the House of Representatives, an instance where one of the manufacturers of flu vaccine in England was shut down and there was a shortage and there was a lot of worry and we rationed the flu vaccine that year, changed the standards of who should seek one and who should not.

Sen. Baldwin: (02:05:51)
I remember also in the year that I believe we were fearing a very serious strain of flu, inquiring about our domestic production capacity for the flu vaccine and we had none. None. I asked, should we assume, I think I might’ve even asked this to you, Dr. Schuchat, all those years ago that should we assume if we had put in an order with a foreign manufacturer for however many doses, but there was a huge breakout in that foreign country that they will commandeer that for their own public health purposes. I think the answer I got at the time was yes, that would be a prudent and safe assumption on the part of policymakers. As we’re moving forward with a very significant, I hope, appropriation of funds to address this emergency, I hope that we assure that we don’t make those mistakes again. I think I’ve heard all of you testify that having a domestic capacity is very crucial in this. Am I correct? Everyone’s nodding, but okay.

Sen. Baldwin: (02:07:16)
The second thing I wanted to get into is we’ve talked about lab and testing capacity in the US. I’m not sure we’re all agreeing on the meaning of the words and things. For example, when I heard the interchange between Senator and Dr. Cassidy, there was a lot of initials. I understand PCR to be polymerase chain reaction-based testing, IGG to be immunoglobulin, globin globin, whatever, and it’s IGG, IGM and IGA, and he was talking about can we have that test soon? That’s a blood test. If I recall, CDC is using a three sample test, is that correct? That has a nasal swab, a throat swab and a blood sample?

Dr. Anne Schuchat: (02:08:11)
There’s a difference. We’re recommending a throat swab and a nose swab for that polymerase chain reaction. We have been developing a serologic test for those antibodies Dr. Senator Cassidy was talking about, the IGG or could be IGM and that’s really more for the population level to understand who’s already immune, how much disease has there been that didn’t even come to care and that test isn’t there yet.

Sen. Baldwin: (02:08:41)
Since I want to get in a couple more questions, can I just assume that we’re going to have a PCR test for a while that we rely on?

Dr. Anne Schuchat: (02:08:48)
Right, the PCR is a key tool for a while with the private sector and public sector and then potentially a point of care some months or years ahead.

Sen. Baldwin: (02:08:57)
I want to just get into the lab capacity. We’ve talked about public health labs, clinical labs, there’s been a reference to academic labs, private labs. I don’t know if those are four separate classes of labs. If they are, I want to add one other idea if we need to surge our capacity for testing and that is, I’m aware of veterinary labs that look at these same sort of tests, but they’re not usually looking at humans. They’re looking at either pets at veterinary clinics or domesticated animals or the Fish and Wildlife Service also studies zoological infections. If there were an emergency, I don’t know if you’ve ever thought about tapping into that capacity, but I’m thinking particularly of the skilled workforce that deals with level three labs, et cetera, that may be a crazy idea. If it’s not, I hope you discuss it and think about it if we need to have a surge in our capacity to surveil the transmission of this disease.

Senator Lamar Alexander: (02:10:06)
Thank you. Senator Baldwin. Senator Collins.

Sen. Collins: (02:10:10)
Thank you, mister Chairman. Dr. Hahn, I’m going to follow up on the first question that Senator Baldwin raised with you. The FDA reported its first Coronavirus-related drug shortage last week and this morning, you indicated that India had restricted a number of active pharmaceutical ingredients. The FDA has testified previously that only 28% of the manufacturing facilities making APIs to supply the US market are located in our country. By contrast, the remaining 72% of API manufacturers supplying our American market are overseas and 13% are in China. You and I have discussed previously the legislation that I’ve introduced with Senator Smith, the mitigating emergency drug shortages or (MEDS) Act, which has been endorsed by more than 50 organizations and our bill contains new reporting requirements that would help FDA gain far greater visibility into the drug supply chain, including where certain critical drugs are manufactured, the source of active pharmaceutical ingredients and manufacturing contingency and redundancy plans. Given the problems that we’re already seeing, do you believe that the concepts included in our legislation, our MEDS drug shortage bill, that I’ve introduced with Senator Smith would be helpful?

Dr. Hahn: (02:12:12)
Senator, thank you for your question and we really appreciate your leadership on this issue. This has been an ongoing problem prior to the Coronavirus outbreak and continues to be in just as highlighted by what we’ve seen over the last several weeks. The agency totally shares your goal with mitigating and increasing redundancy for manufacturing, particularly in the area of advanced manufacturing. We look forward to working with you on that. With respect to your particular bill, you know that we’re going to be generating written response to that so that we can provide the technical assistance and we very much look forward to working on that bill with you, Senator. With respect to the one drug that you mentioned that we last week announced was in short supply because of the Coronavirus outbreak. We, and I’ve mentioned this before and again this morning, we have already listed that on our drug shortage list. That is available to the American public and the American providers and have done so since the beginning of the time when we identify that as a shortage.

Sen. Collins: (02:13:10)
Thank you, and mister Chairman, I’m hopeful that we might be able to move that bipartisan bill. Dr. Schuchat, in mainland China, the Coronavirus case fatality rate among older patients is significantly higher. The estimate I’ve seen that 15% of inpatients 80 and older do not survive compared to just over 2% in the general population of patients. In addition to the figure from China, there is the tragic situation evolving in Washington state regarding the spread of the virus in a long-term care facility. This is of particular interest me because I represent the state that is the oldest in the nation by median age and I also chair the Senate aging committee. I know Senator Casey brought this up generally with you as well. My question for you is what is the administration doing and what is the CDC doing in all aspects of response to ensure that we have best practices in assisted living facilities and nursing homes or long-term care facilities?

Dr. Anne Schuchat: (02:14:41)
Yeah. Thank you so much for that question. I’ve been speaking regularly to the administrator from CMS, Seema Verma, who is extremely concerned about this issue as well, and they are sending a liaison to our emergency response and we are using our guidance adapted to the situation. They’re using their field staff to make sure that practices around the country are best practices suited for this concern. Infection control is always an issue in the different levels of of healthcare and the elderly are very vulnerable to respiratory viruses. We see that same differentiation in mortality with influenza as well that the elderly are very, very vulnerable.

Sen. Collins: (02:15:24)
Thank you.

Senator Lamar Alexander: (02:15:25)
Thank you. Senator Collins. Senator Rosen will ask our last round of questions so that our respected professionals who are here may go have, some of them are going to go have lunch with United States Senators and explain more. We’ll be able to finish by 1230 then I’ll call on Senator Murray for any questions or comments she have. We’ll wrap up by about 12:30 so that you can leave. Senator Rosen.

Sen. Rosen: (02:15:51)
Thank you. Thank you for all bringing this hearing here. Thank you for your, I know round the clock work on this. We are so very grateful for lifetime of work and care in this avenue, but I want to speak about the issue of access and capacity and how we can use Telehealth and our evaluations to potentiate our response, because many of our constituents are worried about the spread of Coronavirus. They have questions about their own health and since the symptoms of Coronavirus can present like a cold or the flu, I can only imagine with what people are seeing in the news that they’re going to seek out care. People are a little nervous, needless to say. In Nevada, we have large areas of rural population far away from city centers and an increase in those seeking care and having to travel is not only hard on them but creates a burden on the system.

Sen. Rosen: (02:16:48)
Depending how of course, how easily this virus spreads, how can we use Telehealth as a first response to help people in their own homes that could contain the virus, relieve a burden on our emergency rooms, so what are your recommendations? I have a two-part question on addressing the barriers to accessing Telehealth and do you have any plans potentially to operate a national hotline or a web portal for initial screenings through some kind of Telehealth hub and then people could be referred to their local care or further out if needed? Please.

Dr. Anne Schuchat: (02:17:24)
We’ve made a lot of progress since the 2009 pandemic where this was a huge issue just getting a nurse triage line developed in one state. We had more lawyers than we had health people trying to figure out how to do that, but most of the health plans have actually worked out some of these kinks and we’ve already been contacted by a number that are adapting their nurse triage lines, the hotlines that you talk about really for their state or for their clinically-covered individuals. We also have been working with Telehealth together with other parts of government to try to understand what kind of approaches are appropriate in the rural areas as well as what the coverage will be. That’s one of the things that the CMS is looking at now.

Dr. Kadlec: (02:18:09)
Ma’am, one thing that we’ve been doing for the last two years, we funded two pilot programs called the Regional Disaster Health Response System, one in Mass General and one at University of Nebraska. In Nebraska particularly, looking at the nuances of how we could use Telehealth to expand outreach to not only Nebraska but to other parts of the region in that way, and feel it evaluating whether both the legal and practical limitations to that.

Sen. Rosen: (02:18:33)
Can I ask a question about telehealth? Because this would have to do with insurance and Telehealth. Considering that this could be a global pandemic or we have other issues, regional issues, rural issues, I wouldn’t want insurance to be a barrier for someone being able to at least access a Telehealth hub or get the care because germs do not care whether you’re insured or not, Democrat, Republican, old or young, et cetera, et cetera. How do we address this issue of people feeling like they couldn’t call or use this because of insurance limitations?

Dr. Anne Schuchat: (02:19:08)
Yeah, I can just say the strategy that we’re thinking through at CDC is really trying to identify the right level of care for the right situation, whether it’s Telehealth, Urgent Care, nurse hotline or emergency room or office, and in the circumstances that we could see keeping people out of the healthcare system physically could be in everybody’s interest to preserve it for those who need it most. The insurance issues in a pandemic would probably be somewhat different than in routine times. It looks like Dr. Kadlec wants to say something there.

Dr. Kadlec: (02:19:43)
No, I just would just like to add in Declared Disaster Stafford Act, we have the opportunity to declare individuals as NDMS patients, National Disaster Medical System patients where they get reimbursed or the provider gets reimbursed to 110% of Medicare rates and there would be an interesting way to look at how you could evaluate it in a pandemic or something of this sort to use that more in conversations, initial conversations with CMS to understand if that could be utilized in this way.

Sen. Rosen: (02:20:12)
This could be really impactful negatively or positively if we don’t address this in the right way. Understanding that what additional resources or what should we be looking at as we’re going to be voting on some funding and resources hopefully this week, next week that you would need to to address this issue. Anyone?

Dr. Kadlec: (02:20:36)
Ma’am, can I get back to you on that?

Sen. Rosen: (02:20:37)

Dr. Kadlec: (02:20:38)
Thank you.

Sen. Rosen: (02:20:38)
Perfect. Thank you, and I’ll yield back.

Senator Lamar Alexander: (02:20:41)
Thank you very much, Senator Rosen. Senator Murray.

Senator Patty Murray: (02:20:43)
Mister Chairman, first of all, thank you for having the hearing. I do have to ask each one of you, because this is a very serious challenge, we’re seeing the impact in my state. Even though it may not be a serious illness for each individual that has it, they can come in contact with somebody who is medically fragile, so containing this is absolutely critical.

Senator Patty Murray: (02:21:06)
I just think it’s really important right now and I’m concerned that people trust the information that they are hearing so they do the right thing for themselves and their communities and our country as this moves forward. I mean, where do you turn for trusted information? It’s the experts like all of you and that’s who people need to be listening to. I think you have heard the concern expressed here that the president has made some statements contradicting all of you, our nation’s top experts and even criticize the media for covering this. I think it’s really important for us to hear from all of you, yes or no. Can the American people count on you to be 100% transparent on this virus and the government’s response, even if you have to contradict a tweet or something that someone says?

Dr. Anne Schuchat: (02:21:58)

Dr. Anthony Fauci: (02:22:00)

Dr. Kadlec: (02:22:01)

Dr. Hahn: (02:22:02)
Yes, Senator.

Senator Patty Murray: (02:22:03)
Thank you, and we need to count on that because this virus is moving quickly and we’re seeing it in my state. We will see it in others and I think that’s so important. Mister Chairman, as families across the country watch the latest news and worry about the threat of this Coronavirus, I’m really glad that we are taking the opportunity in this committee to ask some of these urgent questions that I’ve been hearing from home and we’re all going to continue to hear and to talk about what we’re doing as well and how we can prepare for the text. I would tell all of you that since we have been in this room in this hearing since this started, we have now learned of the first full closure of a federal facility due to this virus. It’s a DHS center in Tukwila, Washington in my home state.

Senator Patty Murray: (02:22:48)
It was just closed short time ago, so it really is clear by the minute just how serious this is for people in my state of Washington, as well as the rest of the country and this administration, as you all know, owes them answers about the Coronavirus and they’re going to keep hearing from me until I get the answers including apparently from Vice President Pence shortly and several of you. This is really critical and we need to stay on top of it. I want to say again, thank you to Senator Alexander, he said he and I’ve been holding bipartisan meetings on this. We want to continue to work together. Having that information I can’t tell you is so important for the people in my state of Washington. We need to get these tests out. People need to know the answers. There are real time decisions being made right now in my home state about school closures, about whether to go to entertainment, what businesses should be telling people and as these numbers continue to grow, this is only going to be more intense, so we’re counting on all of you.

Senator Lamar Alexander: (02:23:49)
Thank you, Senator Murray. At a time when we’re not in the middle of what we’re in the middle of now, I want to have some more discussion about the extent to which we rely on other countries for our medical supplies and medicines and what we should be doing about it that we’re not. It’s an interesting twist. We have debates in this committee about importing prescription drugs and I’ve often thought that the way we talk about that’s all mixed up because we import a lot of drugs as we now see, but the difference is they’re manufactured under FDA supervision and they have a supply line that FDA supervises to make sure they’re safe. When we do that, we have lots of drugs that are made overseas. Maybe the national academies should do a study on this.

Senator Lamar Alexander: (02:24:41)
I’ve talked to some other senators who are concerned about it, but I think one of the areas that this committee should look at and several senators have mentioned it, is the extent to which we rely on other countries and sole sources of supply. I mean if Chick-fil-A sells mac and cheese, it doesn’t have one source of mac and cheese. It has at least two to make sure it doesn’t run out. We should certainly do the same with life-saving drugs. Also, want to endorse what Senator Murray said about our appreciation for your telling us the truth and giving us accurate information about what’s going on. We believe you do that. That’s why we have such respect for you and your professionalism. That’s why you’re here today. This hearing has been all about how do we provide accurate information to the American people so they could know what to do and how do we provide accurate information to Congress so we can know what else we need to do, and we expect you to tell us that, whether it’s unpleasant news or not.

Senator Lamar Alexander: (02:25:43)
We thank you for your professionalism, your extra hours during this period of time. Thank you for coming today. I read at the beginning of the hearing the comment on the front of the New York Times Sunday that ended, it said, “Most experts agree the United States is among the country’s best prepared to prevent or manage such an epidemic.” Your performance today suggests why that is true. The hearing record will remain open for 10 days. Members may submit additional information for the record within that time if they would like. Thank you for being here. The committee will stand adjourned.

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