[Senate Hearing 116-504]
[From the U.S. Government Publishing Office]
S. Hrg. 116-504
AN EMERGING DISEASE THREAT:
HOW THE U.S. IS RESPONDING TO
COVID-19, THE NOVEL CORONAVIRUS
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING AN EMERGING DISEASE THREAT, FOCUSING ON HOW THE
UNITED STATES IS RESPONDING TO COVID-19, THE NOVEL
CORONAVIRUS
__________
MARCH 3, 2020
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Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-217 PDF WASHINGTON : 2021
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
KELLY Loeffler, Georgia JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, MARCH 3, 2020
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 5
Witnesses
Statement of Schuchat, Anne, M.D., Principal Deputy Director,
Centers for Disease Control and Prevention, Atlanta, GA........ 8
Prepared statement........................................... 10
Statement of Fauci, Anthony, M.D., Director, National Institute
of Allergy and Infectious Diseases, National Institutes of
Health, Bethesda, MD........................................... 12
Prepared statement........................................... 13
Statement of Kadlec, Robert, M.D., Assistant Secretary for
Preparedness and Response, Department of Health and Human
Services, Washington, DC....................................... 15
Prepared statement........................................... 17
Statement of Hahn, Stephen, M.D., Commissioner, U.S. Food and
Drug Administration, Silver Spring, MD......................... 19
Prepared statement........................................... 21
QUESTIONS AND ANSWERS
Questions by Senator Murkowski submitted for the Record:......... 56
AN EMERGING DISEASE THREAT:
HOW THE U.S. IS RESPONDING TO
COVID-19, THE NOVEL CORONAVIRUS
----------
Tuesday, March 3, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room 430, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Burr, Paul,
Collins, Cassidy, Roberts, Murkowski, Scott, Romney, Braun,
Loeffler, Murray, Casey, Baldwin, Murphy, Kaine, Hassan, Smith,
Jones, and Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. 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, with nearly 90,000 cases in 65 countries and 3,000
deaths, according to the World Health Organization.
But most people in the United States are at low risk.
Here is what the New York Times said on its front page 2
days ago on Sunday in describing the situation in our country.
``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 countries best prepared to prevent or manage such an
epidemic.'' That's from the front page of the New York Times 2
days ago in describing where we are in our country.
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.
In addition to the human suffering the virus is causing, it
is disrupting the global economy.
According to our trade representative, more than 20 percent
of everything we import is from China--medicines, car parts,
cell phones, televisions.
China has shut down factories and locked down 16 cities
where 760 million people live. Now 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 long
term, the production of these materials could shift, and there
would be implications on jobs and prices there.
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 are doing, and I want to take a moment to
emphasize their backgrounds.
Dr. Anne Schuchat, she spent 30 years at the Centers for
Disease Control and Prevention. She is 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, and the 2009 flu pandemic.
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 led the agency's response to HIV/AIDS in
the 1980's and 1990's and the emergence of the West Nile virus
in 1999, SARS in 2003, and the Ebola outbreaks in Africa in
2014 and 2018. For these professionals, this is not their first
rodeo.
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.
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 U.S.
Food and Drug Administration, the FDA. Most recently he was
Chief Executive of the University of Texas' MD Anderson Cancer
Center, a large organization with 21,000 employees.
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 want it ourselves to know what else we
should be doing to limit the damage of the coronavirus to the
American people and the American economy.
Before we talk about what else needs to be done, I want to
briefly summarize what we have already done.
Let's start with Congress. It's not the first public health
threat we have faced. There are some Senators and staff members
who are here today who were here 20 years ago when the anthrax
attack occurred; in 2003, SARS, another coronavirus similar to
the one we are seeing today; the 2009 flu pandemic killed an
estimated 151,000 to 575,000 people worldwide; and then there
was the Ebola outbreak in 2014 and 2018.
Following the anthrax attacks 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, and improved the Public
Health Emergency Fund.
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.
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 has already used $105 million
from the Rapid Response Fund, and using authority Congress has
given him, he is transferring $136 million from other programs
in his department to respond to the coronavirus. And the Trump
administration has requested an additional $2.5 billion. Others
in Congress have made suggestions, and we're likely to vote on
that in the Senate this week.
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 has had years of experience
dealing with infectious diseases, to be a principal deputy
leading that effort.
On January 31st, at a time when there were only six
confirmed cases 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 have
traveled to China in the last 14 days.
At 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.
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
had not taken these steps, we would have had many more cases
right now.
A third example of executive action is developing a test to
diagnose the coronavirus. The FDA authorized that on February
4th. It has 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. It is working with 65 other private-sector developers,
including academic medical centers and commercial labs, to
increase the availability of these tests.
Fourth, Dr. Fauci has said that we're developing a vaccine
for coronavirus more rapidly than we have ever developed any
other vaccine, and drug manufacturers met with the President
yesterday to see if vaccines and other treatments could be made
available more rapidly.
Finally, scientists at our national laboratories--Oak
Ridge, Argonne, and Livermore--are using their super-computing
and imaging capacity to try to understand this virus better.
Of course, in addition to the impact on us in our
individual lives, there's the impact on the global economy. The
trade representative says about 20 percent 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.
Thirteen percent of the facilities that make active ingredients
for drugs are in China, according to the FDA. Some people have
said that 80 percent 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 have 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 medicines 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.
It's not just medicines that are affected. In Tennessee we
have Eastman Chemical. They have nine manufacturing plants. The
CEO said the recent Phase 1 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.
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 are 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.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. 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.
Mr. 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.
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. 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.
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 that 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 transmission 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. 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 are hearing from experts, and 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.
I was very heartened to hear your assurances, Dr. Fauci,
that contrary to reporting, you have not been muzzled by the
Administration. It is essential 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.
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 President
Trump's inadequate request 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.
I am 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
reauthorized the law underpinning so many of the Federal
efforts and resources we are seeing employed today.
especially want to thank you, Mr. Chairman, for our work
together, Senator Casey and Burr for their efforts on that.
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.
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.
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.
We also have to account now for the ways that some of the
harmful healthcare policies have undermined our ability to
respond to public health threats. 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.
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.
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 home. 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.
As is so often the case, this public health threat will
have hidden and higher costs for those who are low-wage workers
who don't have affordable child care, who don't have health
insurance, and who are experiencing homelessness. In my home
State, people are being told to stay home for 2 weeks if they
are sick. There aren't tests, so they can't get tested. Guess
who can't stay home? If you don't have child care, 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.
Situations like this remind us that we are all a community
in a very real sense. We all have a stake in one another's
well-being. 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 long term.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murray, and thank you for
your cooperation, which is typical of the way you work in
dealing with this issue.
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 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 5 minutes to give his or her testimony.
Then we'll go to a round of questions.
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.
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.
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.
Finally, Dr. Stephen Hahn, who is the Commissioner of the
U.S. Food and Drug Administration. He was formerly the Chief
Executive at the University of Texas MD Anderson Cancer Center
in Houston.
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.
STATEMENT OF DR. ANNE SCHUCHAT, PRINCIPAL DEPUTY DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Schuchat. 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 in pandemic influenza and other emergency
preparedness planning. Our response is dependent on support
from 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.
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.
CDC is responding with the following strategy. Our goal has
been to slow the spread of this virus through a multi-layered,
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 follow-up 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.
The situation today is evolving and dynamic. In just 2
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 long-
term care facility in Washington State.
Our hearts go out to the people affected by this virus
directly or indirectly, and to everyone who is working so hard
to counter it.
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.
While the immediate risk to the general American public
remains low, and the U.S. Government is 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 these types 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 have done a very
good job of managing it.
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 CDC.gov,
which you can see up there, and I want to say that I look
forward to answering your questions.
[The prepared statement of Dr. Schuchat follows:]
prepared statement of anne schuchat
In late December 2019, Chinese authorities announced a cluster of
pneumonia cases of unknown etiology centered on a local seafood market
in Wuhan, China, with an estimated case onset in early December. CDC
immediately began monitoring the outbreak, and within days - by January
7, 2020 - had established a Center-led Incident Management Structure.
On January 21, 2020, CDC transitioned to an Agency-wide response based
out of its Emergency Operations Center. This allows CDC to provide
increased operational support to meet the outbreak's evolving
challenges and provides strengthened functional continuity to meet the
long-term commitment needed to curb the outbreak.
CDC is assisting ministries of health in countries in every region
of the globe with their most urgent and immediate needs to prevent,
detect, and respond to the COVID-19 outbreak.
CDC's most expert and practiced infectious disease and public
health experts are dedicated to this response 24/7 to protect the
American people. CDC is a disease preparedness and response agency, and
this work is fundamental to our mission both domestically and
internationally. The Agency's approach to COVID-19 is built upon
decades of experience with prior infectious disease emergencies
including responses to SARS, MERS, and Ebola, and to pandemic
influenza.
To mitigate the impact of COVID-19 within the United States, CDC is
working alongside Federal, state, local, tribal, and territorial
partners, as well as public health partners. This public health
response is multi-layered and includes aggressive containment and
mitigation activities with an objective to detect and minimize
introductions of this virus in the United States so as to reduce its
spread and impact. It is impossible to catch every single traveler
returning from an affected country with this virus - given the nature
of this virus and how it's spreading. Our goal continues to be slowing
the introduction of the virus into the United States as we work to
prepare our communities for more cases and possible sustained spread.
To accomplish this, CDC is also working with multiple countries, in
collaboration with U.S. Agency for International Development (USAID)
and other federal agencies and WHO to support ministries of health
around the globe to prepare and respond to the outbreak. For example,
the U.S. Government is helping to support countries to implement
recommendations provided by WHO related to the identification of people
who might have this new infection, diagnosis and care of patients, and
tracking of the outbreak. CDC staff are also starting to work together
with interagency colleagues in those countries to conduct
investigations that will help inform response efforts going forward.
The Agency is using its existing epidemiologic, laboratory, and
clinical expertise to gain a more comprehensive understanding of COVID-
19. CDC is leveraging prior programmatic investments in domestic and
global public health capacity and preparedness to strengthen the
Agency's response to COVID-19. Thus far, this response has been built
largely on the foundation of our seasonal and pandemic influenza
program's infrastructure. The ongoing response to COVID-19 also
demonstrates CDC's continued commitment to strengthen global health
security. CDC has been engaged in global health security work for over
seven decades. Thanks to investments in Global Health Security, the
U.S. Government's work has helped partner countries build and improve
their public health system capacity. This global effort strengthens the
world's ability to prevent, detect, and respond to infectious diseases
like this new coronavirus.
This outbreak also underscores the need for the United States to
continue to play a leadership role on the global stage, and to
strengthen global capacity to stop disease threats at their sources,
before they spread. Furthermore, the outbreak demonstrates the
importance of continued investment in our nation's public health
infrastructure. Despite years of progress in domestic disease
prevention and response, efforts to help modernize our federal, state,
and local capability and health systems that are crucial to responding
to and understanding unprecedented threats continue.
The U.S. Government has taken unprecedented steps to prevent the
spread of this virus and to protect the American people and the global
community from this new threat and allow State, local, territorial, and
private partners time to prepare for any necessary response and
mitigation activities. Since February 2, 2020, pursuant to arrival
restrictions imposed by the Department of Homeland Security, flights
carrying persons who have recently traveled from or were otherwise
present within mainland China or other affected countries have been
funneled to designated U.S. airports with CDC quarantine stations. At
these airports, passengers are subject to enhanced illness screening
and self-monitoring with public health supervision up to 14 days from
the time the passenger departs the affected country. This enhanced
entry screening serves two critical purposes. The first is to detect
illness and rapidly respond to symptomatic people entering the country.
The second purpose is to educate travelers about the virus and what to
do if they develop symptoms.
These measures are part of a layered approach which includes our
other core public health efforts, including aggressively tracking
COVID-19 around the globe, building laboratory capacity, and preparing
the national healthcare system for community spread. These core
capabilities and expertise are essential to CDC's comprehensive
approach to addressing this outbreak.
While CDC believes that the immediate risk of this new virus to the
American public is low, CDC is preparing the nation's healthcare system
to respond to identification of individual cases and potential person-
to-person transmission of COVID-19 in the community, at the same time
ensuring the safety of its patients and workers. CDC has developed
guidance on appropriate care and infection control for patients with
COVID-19 and is engaging regularly with clinical and hospital
associations to confirm that its guidance is helpful and responsive to
the needs of the healthcare system.
Furthermore, understanding the current constraints of the global
supply of personal protective equipment (PPE), CDC is working with
industry and the U.S. health system to comprehend possible effects on
facilities' abilities to procure the needed levels of PPE, and to
provide strategies to optimize the supply of PPE.
Effective disease surveillance enables countries to quickly detect
outbreaks and continuously monitor for new and reemerging health
threats. CDC continues to monitor the COVID-19 situation around the
world.
CDC has begun working with domestic public health laboratories that
conduct community-based influenza-like illness surveillance and
leveraging our existing influenza and viral respiratory surveillance
systems so that we may begin testing people with flu-like symptoms for
the SARS-COV-2 virus. HHS is developing plans to expand this effort.
This collaboration with domestic public health labs is another
layer of our response that will help us detect if this virus is
spreading in a community. All of our efforts now are to prevent the
sustained spread of this virus in our communities, but we need to be
prepared for the possibility that it will spread. Results from this
surveillance could necessitate changing our response strategy.
CDC has issued guidance for people at high risk of exposure to the
virus, including flight crews, recent travelers to China, and
healthcare workers. Through its extensive Health Alert Network, CDC
shared guidance for clinical care for healthcare professionals and
state and local health departments. Health departments, in consultation
with healthcare providers, can evaluate patients and determine whether
someone may have the illness and should be subjected to additional
diagnostic testing.
CDC has a demonstrated record of innovative science and evidence-
based decision- making, and an experienced and expert workforce that is
working 24/7 to combat this public health emergency. The COVID-19
outbreak is evolving rapidly, and the U.S. Government is constantly
making adjustments to respond to the changing nature of this public
health emergency. Our goal continues to be slowing the introduction of
the virus into the United States and preparing our communities for more
cases and possible sustained spread. While leaning forward aggressively
with the hope that we will be able to prevent community spread, CDC
remains vigilant in confronting the challenges presented by this new
coronavirus.
______
The Chairman. Thank you, Dr. Schuchat.
Dr. Fauci, welcome.
STATEMENT OF DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH,
BETHESDA, MD
Dr. Fauci. 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 all-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 is already infected, and the other is in the area
of vaccines or prevention of infection for those who are not
infected.
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 and 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 have been
infected and the number of deaths that have occurred, about 80
percent of individuals who get infected do really quite well
without any specific intervention. Namely, they spontaneously
recover. However, about 15 to up to 20 percent 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.
We want desperately to have a therapy for these
individuals. There are a number of candidate therapies that
literally as I speak to you today are being tested in
randomized control 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 will 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.
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
data base to the time we actually stick a candidate into the
arm of someone, has gone down to literally be the fastest that
we have 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 1 study within about 2 months, or
maybe even 6 weeks. That would be a record. However, that is
not a vaccine, because it would take about 3 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 2 trial to show
that it works. And the reason is there are medical, ethical,
and other considerations. We'd be giving this to normal people
to prevent infection, so you must be sure of the edict of
medicine: First, do no harm. So we need to make sure it's safe,
and we need 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. So we're going to have a
multi-step process. We have the public health measures that
you've heard about from Dr. Schuchat. You'll hear about it from
Dr. Hahn and Dr. Kadlec.
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 will 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.
Hopefully we'll have the opportunity to update you on a
regular basis about where we are with that. Thank you.
[The prepared statement of Dr. Fauci follows:]
prepared statement of anthony fauci
The National Institutes of Health (NIH) is the HHS agency leading
the research response to the global health emergency of COVID-19.
Within the NIH, the National Institute of Allergy and Infectious
Diseases (NIAID) is responsible for conducting and supporting research
on emerging and re-emerging infectious diseases, including COVID-19.
NIAID is well-positioned to respond rapidly to infectious disease
threats as they emerge by leveraging fundamental basic research
efforts; a domestic and international research infrastructure that can
be quickly mobilized; and collaborative and highly productive
partnerships with industry. NIAID provides preclinical research
resources to scientists in academia and private industry throughout the
world to advance translational research for emerging and re-emerging
infectious diseases. These research resources are designed to bridge
gaps in the product development pipeline, thereby lowering the
scientific, technical, and financial risks incurred by industry and
incentivizing companies to partner in the development of effective
countermeasures including diagnostics, therapeutics, and vaccines.
NIAID also supports the Infectious Diseases Clinical Research
Consortium, which includes a network of Vaccine and Treatment
Evaluation Units (VTEUs). The VTEUs conduct clinical trials to
investigate promising therapeutic and vaccine candidates when public
health needs arise. NIAID collaborates with other Federal agencies,
including through the HHS Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE), to help advance progress against
newly emerging public health threats. In addition, partnerships with
academia, the biotechnology and pharmaceutical industries, domestic and
international researchers, and organizations such as the World Health
Organization (WHO) are integral to these efforts.
NIAID has a longstanding commitment to coronavirus research,
including extensive efforts to combat two other serious diseases caused
by coronaviruses: SARS and MERS. This research has improved our
fundamental understanding of coronaviruses and provides a strong
foundation for our efforts to address the challenge of SARS-CoV-2, the
novel coronavirus that causes COVID-19. NIAID has responded to the
newly emerging COVID-19 outbreak by expanding our portfolio of basic
research on coronaviruses. NIAID scientists have rapidly identified the
human receptor used by SARS-CoV-2 to enter human cells. In addition,
NIAID investigators and their collaborators recently identified the
atomic structure of the spike protein, an important SARS-CoV-2 surface
protein that is a key target for the development of vaccines and
therapeutics. NIAID scientists also are evaluating the stability of
SARS-CoV-2 on various ordinary surfaces and in aerosols to better
understand the potential for viral spread throughout the community.
NIAID-supported researchers are assessing the risk of emergence of
bat coronaviruses in China, including the characterization of bat
viruses and surveys of people who live in high-risk communities for
evidence of bat coronavirus infection. Such research is necessary to
better understand this emerging infection and to investigate optimal
ways to diagnose, treat, and prevent COVID-19.
The NIAID Centers of Excellence for Influenza Research and
Surveillance (CEIRS), which conduct influenza risk assessments in
multiple sites throughout the world particularly in Asia, have
responded rapidly to the COVID-19 outbreak. CEIRS researchers at the
University of Hong Kong are evaluating the epidemiology, transmission
dynamics, and severity of COVID-19. These scientists also have
performed environmental sampling of the Wuhan market where the first
COVID-19 cases were reported.
NIAID is working with CEIRS collaborators and the CDC to obtain
additional virus and biological samples from patients to further
advance research efforts on COVID-19. Recently, the NIAID-funded BEI
Resources Repository made samples of SARS-CoV-2 available for
distribution to domestic and international researchers at Biosafety
Level 3 laboratories. In addition, CEIRS researchers and other NIAID-
supported scientists are developing reagents, assays, and animal models
that can be used to evaluate promising therapeutics and vaccines. These
research resources also will be shared with the domestic and
international scientific community as soon as they become available.
On February 6, 2020, NIAID issued a Notice of Special Interest
regarding the Availability of Urgent Competitive Revisions for Research
on the 2019 Novel Coronavirus. This notice encourages existing NIAID
grantees to apply for supplements for research project grants focused
on the natural history, pathogenicity, and transmission of the virus,
as well as projects to develop medical countermeasures and suitable
animal models for preclinical testing of COVID- 19 vaccines and
therapeutics.
NIAID has responded to public health concerns about COVID-19 by
increasing ongoing coronavirus research efforts to accelerate the
development of interventions that could help control current and future
outbreaks of COVID-19. These activities build on prior NIAID research
addressing other coronaviruses, such as those that cause SARS and MERS.
The CDC has developed a real-time Reverse Transcription-Polymerase
Chain Reaction (rRT-PCR) test that can detect COVID-19 using
respiratory samples from clinical specimens. NIAID is accelerating
efforts to develop additional diagnostic tests for COVID-19, and NIAID-
supported investigators are developing PCR-based assays for SARS-CoV-2
to facilitate preclinical studies and aid in the development of medical
countermeasures. NIAID scientists also are developing reagents for an
enzyme-linked immunosorbent assay for SARS- CoV-2. CEIRS researchers at
the University of Hong Kong have developed a separate RT-PCR test and
made their protocol publicly available through the WHO. These NIAID-
supported investigators also have distributed assay reagents to 12
countries to facilitate the diagnosis of COVID-19.
NIAID is pursuing the development of antivirals and monoclonal
antibodies for potential use against SARS-CoV-2. NIAID has launched a
multicenter, randomized controlled clinical trial to evaluate the
safety and efficacy of the antiviral drug remdesivir for the treatment
of COVID-19 in hospitalized adults with laboratory-confirmed SARS-CoV-2
illness. The adaptive design of this trial will enable the evaluation
of additional promising therapies. NIAID plans to assess other existing
antivirals for activity against SARS-CoV-2, and NIAID scientists are
working to identify monoclonal antibodies with therapeutic potential
from COVID-19 patient samples as well as historical SARS patient
samples. NIAID-funded scientists also aim to delineate new viral
targets to facilitate the development of novel therapeutics with broad
activity against coronaviruses. Finally, NIAID is expanding its suite
of preclinical services to add assays that investigators can use to
accelerate research and development of therapeutics for COVID-19.
A safe and effective vaccine for SARS-CoV-2 would be an extremely
valuable tool to stop the spread of infection and prevent future
outbreaks. Public and private entities across the globe have announced
plans to develop SARS-CoV-2 vaccine candidates following the release of
the SARS-CoV-2 genetic sequence. NIAID is supporting development of
several SARS- CoV-2 vaccine candidates, and is utilizing vaccine
platform technologies that have shown promise against the coronaviruses
that cause SARS and MERS.
The NIAID Vaccine Research Center (VRC) is collaborating with the
biotechnology company Moderna, Inc., on the development of a vaccine
candidate using a messenger RNA (mRNA) vaccine platform containing the
gene that expresses the VRC-designed spike protein of SARS-CoV-2. NIAID
anticipates the experimental vaccine will be ready for clinical testing
in the NIAID VTEUs within the next two months and will conduct
preclinical studies as well as a first-in-human study of this COVID-19
vaccine candidate. The Coalition for Epidemic Preparedness Innovations
(CEPI) will fund the manufacture of the first clinical production lot
of this mRNA-based vaccine candidate using the Moderna rapid
manufacturing facility.
NIAID Rocky Mountain Laboratories (RML) scientists are
collaborating with Oxford University investigators to develop a
chimpanzee adenovirus-vectored vaccine candidate against SARS-CoV-2; in
addition, they have partnered with CureVac on an mRNA vaccine
candidate. RML investigators also have launched a collaboration with
the University of Washington and have begun early-stage testing of an
RNA vaccine candidate against SARS- CoV-2. In addition, NIAID-supported
scientists at Baylor College of Medicine and their collaborators are
evaluating an experimental SARS-CoV recombinant protein vaccine to
determine if it also provides protection against SARS-CoV-2. NIAID is
exploring additional collaborations with extramural research and
industry partners on other vaccine concepts. NIAID also is supporting
the development of standardized assays and animal models that will be
utilized to evaluate vaccine candidates.
With all these efforts, NIAID is coordinating closely with
colleagues at the CDC, BARDA, FDA, DOD, and other federal and
international partners.
To achieve the ultimate goal of having a SARS-CoV-2 vaccine
available to the public, it is important that NIAID and the entire
biomedical research community pursue a range of vaccine strategies in
order to be better positioned to overcome the scientific or technical
challenges associated with any particular vaccine approach. In this
regard, NIAID has dedicated resources toward preclinical research to
advance a robust pipeline of vaccine candidates into Phase 1 clinical
evaluation. Further vaccine research, including Phase 2 clinical
trials, will then be required. Additional research also is needed to
better understand the fundamental biology of coronaviruses and to
facilitate the design of vaccines that elicit optimal immune responses
and protect against infection.
While ongoing SARS-CoV-2 vaccine research efforts are promising, it
is important to realize that the development of investigational
vaccines and the clinical testing to establish their safety and
efficacy take time. Although we plan to begin early-stage clinical
testing of an NIAID-supported vaccine candidate in the next few months,
a safe and effective, fully licensed SARS-CoV-2 vaccine will likely not
be available for some time. Currently, the COVID-19 outbreak response
in the United States remains focused on the proven public health
practices of containment - identifying cases, isolating patients, and
tracing contacts.
NIH is committed to continued collaboration with other HHS agencies
and additional partners across the U.S. government and international
community to advance research to address COVID-19. As part of its
mission to respond rapidly to emerging and re-emerging infectious
diseases throughout the world, NIAID is expanding our efforts to
elucidate the biology of SARS- CoV-2 and employ this knowledge to
develop the tools needed to diagnose, treat, and prevent disease caused
by this virus. NIAID is particularly focused on developing safe and
effective COVID-19 vaccines. These efforts also help to expand our
knowledge base and improve our continued preparedness for the next
inevitable emerging disease outbreak.
______
The Chairman. Thank you, Dr. Fauci.
Dr. Kadlec, welcome.
STATEMENT OF DR. ROBERT KADLEC, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Dr. Kadlec. 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 in whole-of-government response to
the coronavirus situation.
I think you heard from Dr. Schuchat very well, and Dr.
Fauci, in terms of the evolving, rapidly evolving domestic
situation, and this morning I'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.
ASPR has a four-pronged approach to basically manage and
support the domestic preparedness and response, incident
management, direct support to states and other entities,
supporting the healthcare system of the United States, and also
medical counter-measure development.
In the area of developing counter measures, we are working
very closely with Dr. Fauci at NIH and our DOD colleagues to
see what kind of therapeutics and specifically diagnostics we
can rapidly bring to bear to this problem and see how quickly
we can field additional capabilities that CDC has already
fielded with commercial activities.
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 promising candidates that
will take several months to bring online. But we're also
identifying potential 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 and made by Sanofi, and another one that is a
product of the candidate vaccine that was developed for the
Ebola crisis made by Janssen.
Those are very important and very active activities we're
moving on, first of all.
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 at CDC, we've been looking at how can we
basically work better to improve collaboration and coordination
amongst hospitals and the public health sector and other
entities like emergency medical services.
I just want to highlight one area that, again, 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 on 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.
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 formally
as of yesterday, an incident management network that really is
based on the national response framework. It's how can we bring
the whole of government to respond. This is the first time
we've done it 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.
The last area I'll just highlight is really around the
direct support to states and other entities. I mentioned our
repatriation efforts, 1,100 Americans brought back under very
difficult circumstances from Wuhan and from the Diamond
Princess, the first time that was ever done. But we had been
working 2 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 as a real thing. And so we executed that.
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 the 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
long-term 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.
Last, we're looking to actually employ and deploy some of
our national disaster medical system personnel, as well as
other Federal healthcare personnel to assist at the Evergreen
long-term treatment facility. So we're doing all these things
really together as a team to respond to this.
With that I'll pause and yield back the rest of my time.
Thank you, sir.
[The prepared statement of Dr. Kadlec follows:]
prepared statement of robert kadlec
Currently, there are no vaccines or therapeutics approved by the
FDA to treat or prevent novel coronavirus infections. The Biomedical
Advanced Research and Development Authority (BARDA), part of ASPR, is
working with counterparts across the government, including within HHS
and with the Department of Defense (DOD). The team is reviewing
potential vaccines, treatments, and diagnostics from across the public
and private sectors to identify promising candidates that could be
developed to detect, protect against, or treat people with coronavirus
infections. BARDA is working closely across the U.S. Government to
assess and identify potential partners and technologies suitable to
address the COVID-19 outbreak - both for prevention and treatment.
This has allowed BARDA to leverage existing partnerships,
accelerating the development of COVID-19 medical countermeasures,
including diagnostics, therapeutics, and vaccines.
Established partners, including Regeneron, Janssen, and Sanofi
Pasteur, have shown success in developing both prophylactic and
therapeutic medical countermeasures for emerging infectious diseases.
BARDA is collaborating with Regeneron to leverage their partnership
agreement to develop multiple monoclonal antibodies that, individually
or in combination, could be used to treat this emerging coronavirus.
Regeneron's monoclonal antibody discovery platform, called VelocImmune,
was used to develop a promising investigational three-antibody
therapeutic which was deployed to treat Ebola in the most recent
outbreak in the Democratic Republic of the Congo, and an
investigational two-antibody therapeutic to treat MERS. The technology
shortened multiple aspects of the product development timeline for
therapeutics to treat MERS and Ebola from years to months. The
technology helped shorten certain stages of drug development, including
the process of antibody discovery and selection, preclinical-scale
manufacturing, and clinical-scale manufacturing. BARDA and Regeneron
are working to utilize these monoclonal antibodies, produced by a
single clone of cells or a cell line with identical antibody molecules,
which will bind to certain proteins of a virus, reducing the ability of
the COVID-19 virus to infect human cells.
BARDA is working with Janssen to leverage their Ebola, Zika, HIV
vaccine platform to expedite development of vaccines that protect
against the SARS-CoV-2 virus. Using existing resources, BARDA will
share research and development costs and expertise with Janssen to help
accelerate Janssen's investigational COVID-19 vaccine into clinical
evaluation. Janssen will also scale-up production and manufacturing
capacities required to manufacture the candidate vaccine. This same
approach was used to develop and manufacture Janssen's investigational
Ebola vaccine with BARDA support; that vaccine is being used in the
Democratic Republic of the Congo as part of the current Ebola outbreak
response. Additionally, BARDA and Janssen are working together to help
develop treatments for coronavirus infections. Janssen will conduct
high throughput screening on thousands of potential antiviral compounds
in order to identify medicines that could safely and effectively be
used to reduce the severity of illness and treat COVID-19 infections,
as well as identify compounds that have antiviral activity against
SARS- CoV-2 as an initial step in developing new treatments. These
products include those in development to treat and prevent MERS or
SARS, which are caused by coronaviruses also related to COVID-19.
Finally, in their work with Sanofi Pasteur, BARDA is able to
leverage a licensed recombinant influenza vaccine platform to produce a
recombinant SARS-CoV-2 vaccine candidate. The technology produces an
exact genetic match to proteins of the virus. DNA encoding the protein
will be combined with DNA from a virus harmless to humans, and used to
rapidly produce large quantities of antigen which stimulate the immune
system to protect against the virus. The antigens will be separated and
collected from these cells and purified to create working stocks of
vaccine for advanced development.
BARDA has initiated early steps of medical countermeasures
development with partners and will continue to work to accelerate this
process. Availability of these medical countermeasures is essential to
save lives and protect Americans against 21st century public health
threats.
Our nation's healthcare system is better prepared than it has ever
been. For example, all 50 states have Pandemic Plans, as a requirement
of CDC's Public Health Emergency Preparedness Program (PHEP) and ASPR's
Hospital Preparedness Program (HPP). HPP was established after the
September 11, 2001, terrorist attacks, with the goal of improving the
capacity of local hospitals across the country to deal with disasters
and a large influx of patients in an emergency. Using HPP funding,
state grantees initially purchased equipment and supplies needed for
emergency medical surge capacity. Over time, the program has
successfully evolved to support local, coordinated healthcare
coalitions, including hospitals, public health facilities, emergency
management agencies, and emergency medical services providers.
Investments administered through PHEP and HPP have improved individual
healthcare entities' preparedness and have built a system for
coordinated healthcare system readiness. HPP is the only source of
federal funding to prepare the nation's mostly private healthcare
system to respond to emergencies, including COVID-19.
Beginning in 2018, ASPR has been supporting Regional Disaster
Health Response Systems (RDHRS) pilot projects. The RDHRS concept aims
to provide funding directly to hospitals and healthcare systems to
establish multi-state regional partnerships to increase preparedness
and response capability and capacity for hospitals and healthcare
facilities in advance of, during, or immediately following incidents,
including emerging infectious diseases. Two sites were selected in
September 2018 to begin development of RDHRS pilots. In 2019, two
grants were awarded to support new centers of excellence pilots focused
on pediatric disaster care. The RDHRS and Pediatric Disaster Care
Center of Excellence cooperative agreement requirements are
intentionally aligned to ensure synergy between the programs and
collaboration between all sites and facilities. Ultimately, these
efforts inform best practices to help ready healthcare delivery systems
for disasters and emergencies and are critical in aiding response and
limiting the impact of disaster. As you all are aware, the United
States is in the middle of influenza season. Many emergency departments
are at 90 percent capacity. If influenza worsens, or if COVID-19
intensifies domestically, emergency departments would be severely
strained, which is why supporting models such as the Hospital
Preparedness Program healthcare coalition network is so important.
The National Ebola Training and Education Center (NETEC) combines
the resources of healthcare institutions experienced in treating Ebola
to offer training, readiness consultations, and expertise to help
facilities prepare for Ebola and other special pathogens. The regional
Ebola and other special pathogen treatment centers, of which ASPR and
CDC funded 10 across the country, all have respiratory infectious
disease isolation capacity or negative pressure rooms for at least 10
patients, including pediatric patients. The NETEC and the regional
Ebola and other special pathogen treatment centers have been used to
support recent quarantine efforts.
Should the coronavirus infections increase domestically, these
centers will become critical in isolating infected persons and
providing adequate treatment.
ASPR and CDC also work to enhance medical surge capacity by
organizing, training, equipping, and deploying Federal public health
and medical personnel, such as National Disaster Medical System (NDMS)
teams, and providing logistical support for federal responses to public
health emergencies. NDMS was originally created during the Cold War to
take care of military casualties from overseas in U.S. civilian
hospitals. Today, NDMS teams are deployed to strategic locations across
the country, caring for U.S. citizens who may have been exposed to
SARS-CoV-2, effectively providing medical care and limiting the
potential spread of the disease.
Recently, to assist in the repatriation effort, ASPR stood up a
National HHS Incident Management Team (IMT) located in Washington, DC.
The IMT serves as the national command and control element, deploying
Public Health Service Commission Corps Officers and NDMS personnel.
In addition, HHS provided cache equipment, (e.g., medical supplies
and resources) to Travis AFB, Marine Corps Air Station Miramar,
Lackland, Air Force Base, and Camp Ashland to support evacuees
quarantined at these facilities. HHS deployed one Disaster Medical
Assistance Team (DMAT) and one IMT on February 12, 2020, to support
American citizens in Japan on the Diamond Princess cruise ship, as well
as the U.S. Embassy, to provide medical care, prescriptions, and
behavioral health support.
Many active pharmaceutical ingredients and medical supplies,
including auxiliary supplies such as syringes and gloves, come from
China and India. This outbreak demonstrates why ASPR is seeking
innovative solutions and partnerships to better protect national
security. ASPR is working to increase access to personal protective
equipment (PPE) by:
Coordinating with CDC and other Federal agencies to
share information about optimization of PPE, to prevent
overbuying and overuse of existing supplies
Engaging private sector partners who manufacture and
distribute PPE to share information and concerns, and to
explore options to anticipate and meet the needs of the U.S.
healthcare sector more effectively. During recent discussions,
for example, distributors informed us that they have
implemented allocations to help prevent stockpiling at
healthcare facilities. The allocation is a percentage of a
customer's previous orders and is designed to help protect the
healthcare supply chain and ensure the right supplies are
available for those who need it.
We are also partnering with other Federal agencies
such as DHS, DOD and the U.S. Department of Veterans Affairs
who are large buyers of PPE, to develop acquisition strategies
that incentivize industry to expand PPE production while not
exacerbating supply challenges.
The Strategic National Stockpile (SNS) holds thousands of
deployable face masks, N95 respirators, gloves, and surgical gowns that
could be deployed if state and local supplies are diminished due to the
current COVID-19 response and commercial supplies are exhausted. The
SNS is working hand-in-hand with commercial supply chain partners and
other Federal agencies to continue monitoring supply levels and to
prepare for a potential deployment of SNS personal protective gear if
it is needed.
______
The Chairman. Thank you, Dr. Kadlec.
Dr. Hahn, welcome.
STATEMENT OF DR. STEPHEN HAHN, COMMISSIONER, U.S. FOOD AND DRUG
ADMINISTRATION, SILVER SPRING, MD
Dr. Hahn. Thank you, Chairman Alexander, Ranking Member
Murray, and other Members of the Committee. I 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 have been affected by the novel
coronavirus and those who have lost their lives. That's why we
have 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.
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.
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.
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 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.
Please be assured that if other potential shortages or
disruptions in 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 percent 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
and have 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, other personal protective equipment for
healthcare--FDA, as you know, yesterday issued an emergency use
authorization to allow the use of NIOSH-approved disposal
filtering face-piece respirators--masks, basically--and to
allow some flexibility for healthcare workers, and to increase
the supply within the Nation. 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 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 and California, have also
notified that they have begun testing using this emergency EUA
approach.
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, in cooperation
with CDC, a significant expansion in the ability to perform
those tests. We have one manufacturer who is 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.
Thank you for the opportunity to update the Committee on
the FDA's response to this crisis, and I look forward to
answering your questions.
[The prepared statement of Dr. Hahn follows:]
prepared statement of stephen hahn
The FDA plays a critical role in overseeing our Nation's FDA-
regulated products as part of our vital mission to protect and promote
public health, including during public health emergencies. Our work
primarily focuses on four key areas: first, actively facilitating
efforts to diagnose, treat, and prevent the disease; second,
surveilling product supply chains for potential shortages or
disruptions and helping to mitigate such impacts, as necessary; third,
conducting inspections and monitoring compliance, including of
facilities that manufacture FDA-regulated products overseas; fourth,
helping to ensure the safety of consumer products.
A key focus area for the FDA is helping to expedite the development
and availability of medical products needed to diagnose, treat, and
prevent this disease. We're committed to helping foster the development
of critical medical countermeasures as quickly as possible to protect
public health. We provide regulatory advice, guidance, and technical
assistance to sponsors in order to advance the development and
availability of vaccines, therapies, and diagnostic tests for this
novel virus.
On February 4, 2020, the FDA issued an emergency use authorization
(EUA) to enable immediate use of a diagnostic test developed by the
CDC, facilitating the ability for this test to be used in CDC-qualified
laboratories. \1\ The FDA is dedicated to actively working with other
COVID-19 diagnostic developers to help accelerate development programs
and requests for EUAs. We have developed an EUA review template for
tests to detect the virus, which outlines the data requirements for a
Pre-EUA package that is available to developers upon request. To date,
we have shared the EUA review template with more than 100 developers
who have expressed interest in developing diagnostics for this virus.
---------------------------------------------------------------------------
\1\ FDA. 2019 Novel Coronavirus Emergency Use Authorization.
February 4, 2020. https://www.fda.gov/medical- devices/emergency-
situations-medical-devices/emergency-use-authorizations-
coronavirus2019. FDA Takes Significant Step in Coronavirus Response
Efforts, Issues Emergency Use Authorization for the First 2019 Novel
Coronavirus Diagnostic: Critical Milestone Reached in Response to this
Outbreak. https://www.fda.gov/news-events/press-announcements/fda-
takes-significant-step-coronavirus-response-efforts-issues-emergency-
use-authorization-first.
---------------------------------------------------------------------------
The medical product supply chain is always potentially vulnerable
to disruption, which makes our surveillance work and collaboration with
industry critical and why the Agency takes a proactive stance on any
potential impact or disruption to the supply chain. An outbreak of this
global scale has an impact on the medical product supply chains,
including potential disruptions to supply or shortages of critical
medical products in the United States. We are in contact with
manufacturers; global regulators, like the European Medicines Agency;
healthcare delivery organizations; and other participants in the
medical product supply chains to quickly identify and address any
supply concerns that come from issues related to China and other
locations in Southeast Asia sourcing raw materials for manufacturing
drugs.
We are also tracking reports of increased ordering of some
essential medical devices through distributors, such as personal
protective equipment (PPE) (e.g., respirators and surgical gowns,
gloves and masks). FDA is working proactively to stay ahead of
potential shortages or disruptions of medical products. The agency will
use all available authorities to react swiftly and mitigate the impact
to U.S. patients and healthcare professionals as these threats arise.
Monitoring the safety of FDA-regulated product supply chains is one
of the FDA's highest priorities. The FDA utilizes risk-based models to
identify firms for inspection and prioritizes inspections based on
specific criteria. Because of travel restrictions to China, the Agency
has postponed planned inspection activities in China. However, we are
currently continuing inspection and enforcement activities as normal
for the rest of our operations.
Inspections of facilities in China remain prioritized in our site
selection model and, when travel restrictions are lifted, inspections
of facilities in China will resume. Any travel to China that is deemed
to be mission-critical is being assessed on a case-by-case basis in
close coordination with other HHS components and with the Department of
State. FDA is committed to maintaining its scheduled inspections around
the globe to the extent possible, while maintaining the safety of the
staff involved. We will revisit this approach and adjust as necessary
as this outbreak continues to unfold. In the meantime, FDA is working
with our partner government agency, U.S. Customs and Border Protection
(CBP), to evaluate and adjust our risk-based targeting strategy to
ensure FDA-regulated products are safe when entering the United States.
While the outbreak is impacting our ability to conduct inspections
in China, it's important to underscore that the FDA's regular risk-
based process of surveillance testing of imported products, including
those from China, continues.
Inspections are one of many tools that the Agency uses to inform
its risk strategy for imported FDA-regulated products and to help
prevent products that do not meet the FDA's standards from entering the
U.S. market. Other tools include: import alerts, increased import
sampling, and screening. Inspections are also part of, among other
things, the new and generic drug approval process. While such pre-
approval inspections are on hold in China, we are working to mitigate
the impact on new and generic drug approval decisions by requesting
records that may be used in lieu of an inspection, depending on the
circumstances. Based on our evaluation of previous FDA inspection
history, a firm's previous compliance history and information from
foreign health authorities with which we have mutual recognition
agreements, we determine if the totality of the information would
suffice in lieu of such a pre-approval inspection.
All products offered for entry into the United States, including
items for personal use, are subject to the regulatory requirements of
CBP. Imported shipments of FDA-regulated products referred by CBP,
including those from China, are then reviewed by the FDA and must
comply with the same standards as domestic products. At this time, we
want to reassure the public that there is no evidence to support
transmission of COVID-19 associated with imported goods, including food
and drugs for people or pets, and there have not been any cases of
COVID-19 in the U.S. associated with imported goods.
We established a cross-agency task force to closely monitor for
fraudulent FDA- regulated products and false product claims related to
COVID-19 and we have already reached out to major retailers to ask for
their help in monitoring their online marketplaces for fraudulent
products with coronavirus and other pathogen claims.
FDA is utilizing all our existing authorities to address COVID-19
and we welcome the opportunity to work with Congress to strengthen our
response capabilities. There are four specific proposals included in
the President's Budget that would better equip the Agency to prevent or
mitigate medical product shortages.
(1) Lengthen Expiration Dates to Mitigate Critical Drug
Shortages
Shortages of critical drugs can be exacerbated when drugs
must be discarded because they exceed a labeled shelf-life due
to unnecessarily short expiration dates. By expanding FDA's
authority to require, when likely to help prevent or mitigate a
shortage, that an applicant evaluate, submit studies to FDA,
and label a product with the longest possible expiration date
that FDA agrees is scientifically justified, there could be
more supply available to alleviate the drug shortage or the
severity of a shortage.
(2) Improving Critical Infrastructure by Requiring Risk
Management Plans
Enabling FDA to require application holders of certain drugs
to conduct periodic risk assessments to identify the
vulnerabilities in their manufacturing supply chain (inclusive
of contract manufacturing facilities) and develop plans to
mitigate the risks associated with the identified
vulnerabilities would enable the Agency to strengthen the
supply chain by integrating contingencies for emergency
situations. Currently, many applicants lack plans to assess and
address vulnerabilities in their manufacturing supply chain,
putting them, and American patients, at risk for drug supply
disruptions following disasters (e.g., hurricanes) or in other
circumstances.
(3) Improving Critical Infrastructure Through Improved Data
Sharing: Requiring More Accurate Supply Chain Information
Empowering FDA to require information to assess critical
infrastructure, as well as manufacturing quality and capacity,
would facilitate more accurate and timely supply chain
monitoring and improve our ability to recognize shortage
signals.
(4) Device Shortages
FDA does not have the same authorities for medical device
shortages as it does for drugs and biological products. For
instance, medical device manufacturers are not required to
notify FDA when they become aware of a circumstance that could
lead to a device shortage or meaningful disruption in the
supply of that device in the United States, nor are they
required to respond to inquiries from FDA about the
availability of devices.
Enabling FDA to have timely and accurate information about
likely or confirmed national shortages of essential devices
would allow the Agency to take steps to promote the continued
availability of devices of public health importance. Among
other things, FDA proposes to require that firms notify the
agency of an anticipated meaningful interruption in the supply
of an essential device; require all manufacturers of devices
determined to be essential to periodically provide FDA with
information about the manufacturing capacity of the essential
device(s) they manufacture; and authorize the temporary
importation of certain devices where the benefits of the device
in mitigating a shortage outweigh the risks presented by the
device that could otherwise result in denial of importation of
the device into the United States.
______
The Chairman. 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
Senators' lunches with the Vice President, but that's us. So
we'd like for 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 5 minutes each so
every Senator has a chance to ask questions.
Dr. Fauci, I'm going to ask you a series of questions
within my 5 minutes, and these are the kind 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. Fauci. Community transmission means when there are
cases that are in the community for 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----
The Chairman. Let's talk about person to person. That means
we know who it is.
Dr. Fauci. Person to person, but you don't know what the
original source is. In the State of Washington----
The Chairman. No, that's good. I thought there was a
difference between person to person and community transmission.
Dr. Fauci. No. Any transmission of an infection is from a
person to a person, except----
The Chairman. What if you do know who it is? What do you
call that?
Dr. Fauci. 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----
The Chairman. 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. Fauci. That's person-to-person transmission.
The Chairman. All right. And community transmission means
if I get it and we don't know who caused it--is that right?
Dr. Fauci. Right, exactly, you don't know what the original
source is.
The Chairman. Well, are we at the peak of the flu season?
Dr. Fauci. Well, the answer is likely, and maybe even on
the way down. If you look at the curves----
The Chairman. We're just over the peak of----
Dr. Fauci. Well, it went up, it went down, it went up, and
it's starting to come back down again.
The Chairman. I'm talking about the ordinary flu we have
every year. About how many Americans, if you had to estimate,
have flu this year?
Dr. Fauci. There are probably around 30-plus million
infections, a couple of hundred thousand hospitalizations.
The Chairman. In the United States?
Dr. Fauci. In the United States.
The Chairman. How many Americans die every year from what
we call the flu?
Dr. Fauci. You know, it ranges from a low of 15,000 to
20,000, to the high year that we had in 2017-2018, which was
about 70,000-plus people.
The Chairman. About 70,000 people.
Dr. Fauci. In one of the worst years.
The Chairman. In one of the worst years.
Dr. Fauci. Yes.
The Chairman. The flu is a respiratory disease like
coronavirus; is that correct?
Dr. Fauci. That is correct.
The Chairman. Well, how do you know if you have the flu as
opposed to coronavirus?
Dr. Fauci. Well, the definitive test would be to get a test
of the flu or a test of the coronavirus.
The Chairman. You'd need a test.
Dr. Fauci. 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.
The Chairman. What's a lower respiratory----
Dr. Fauci. 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----
The Chairman. Fever and a cough is----
Dr. Fauci. Fever and a cough can be either of them.
The Chairman. Okay. What should you do if you have fever
and a cough?
Dr. Fauci. 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
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 could be helped by doing that.
The Chairman. Should we all be wearing masks?
Dr. Fauci. No.
The Chairman. Why?
Dr. Fauci. 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.
The Chairman. Why do healthcare workers wear masks in the
hospital, then?
Dr. Fauci. Well, because a healthcare worker who is taking
care of someone who is known infected with a transmissible
virus, that's different from walking around in the streets
wearing a mask.
The Chairman. Are children getting the coronavirus?
Dr. Fauci. 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.
The Chairman. What can we do or what can our families do to
protect ourselves? What's the most effective thing?
Dr. Fauci. 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.
The Chairman. My time is up.
Senator Murray.
Senator Murray. Thank you, Mr. Chairman. I'm going to yield
the first questioning to Senator Jones, who has to leave for a
flight. I will take the second round.
Senator Jones. Thank you, Senator Murray.
Dr. Fauci, I'd like to follow-up on that real quickly. So
if somebody right now in Alabama presents, they didn't get
their flu shot, so all of a sudden they've got fever and
they've got a cough, they go get a flu test. Will that test, if
they don't have the flu but have coronavirus, will that test
come back negative?
Dr. Fauci. If they don't have the flu, the flu test will
come back negative.
Senator Jones. They should be concerned if they present
some symptoms for the flu and that comes back negative.
A 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 are 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. Schuchat. Yes, 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.
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. How will the testing--how much more capacity
will we have by the end of this week versus 2 weeks, 3 weeks
from now?
Dr. Hahn.
Dr. Hahn. Yes, Senator. We work with the CDC on their test.
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. 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
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. We've got to make sure that we try to educate folks
so that those tests that we have, those limited ones, are for
the right reasons.
The second question I have, it concerns rural areas. In my
State alone, 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 will ask Dr. Kadlec.
Dr. Kadlec. Yes, sir. Thank you for the question. Frankly,
we've been monitoring that situation very carefully with our
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. So we're
looking and investigating 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. Individuals who may be at risk, particularly for
severe disease, should seek hospital care.
If Dr. Schuchat would like to follow-up 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 long-
term solution to that challenge.
Senator Jones. 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. We're in conversations with them on that.
Senator Jones. Perfect. Thank you.
That's all I have. Thank you.
The Chairman. Thank you, Senator Jones.
Senator Burr.
Senator Burr. Mr. Chairman, before my 5 minutes starts, can
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 Members that in 2005, when Senator Kennedy and I
passed PAHPA, 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. Dr. Hahn expressed that he just did two emergency use
authorizations. That's part of the work of this Committee. So
let's not be too quick to go out and encumber them with micro-
managing what they do.
The Chairman. So ordered. We'll go ahead with the unanimous
consent and put that in, and I look forward to reading it.
Senator Burr. Thank you, Mr. Chairman.
Senator Burr. Dr. Schuchat, I heard you say that you're
rapidly trying to reach testing. Now, as of March the 1st,
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 is right.
What I'm curious about is why on March the 2d did you take
the total number tested off the CDC website?
Dr. Schuchat. 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 also collected
other specimens from them.
The over 3,000 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. Dr. Schuchat, you've known about this
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 PAHPA $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 6 weeks, reaching possibly 1,500
individuals, yet we experienced what we have with this long-
term care facility, and clearly a cluster that we don't know
the magnitude of? How can that happen when we've invested so
much and been there early on and understanding we have to be
prepared?
Dr. Schuchat. 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.
The situation in Washington State is tragic. An outbreak in
a long-term 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-spreading events or super-spreading
individuals could cause very large amplification rapidly. And
so the concern about healthcare settings has been foremost in
our minds.
Senator Burr. 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 PAHPA, 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. Schuchat. 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 really built
our response around our influenza capacity, which has really
grown with the generosity of the American people through
Congress. So our coronavirus capacity is relatively small. We
built it up a little bit after MERS, but we're 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. 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 can also be used
for CDC facility construction. You know, 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 the $150 million did
not go directly to fund surveillance?
Dr. Schuchat. 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. I think if you'll check the appropriations in
all appropriations that go to CDC, there is an ability to move
money from that to construction facilities, and I would
encourage the appropriators on this Committee, especially as we
look at the emergency funding, for God's sake, let's make sure
it goes to response and not construction of a campus at this
time.
I yield back, Mr. Chairman.
The Chairman. Thank you, Senator Burr.
Did you have something else?
Dr. Schuchat. No, just that we'll follow-up for the record
with the accurate information.
The Chairman. Senator Murray.
Senator Murray. Thank you.
Dr. Hahn, as 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 FDA was imposing. For example, FDA asked labs to
submit information about 100 tests at a time when only 15
people in the U.S. were known to be infected.
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 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 estimate of a million tests is accurate?
Dr. Hahn. Thank you, Senator. First of all, with respect to
the timeline of the development of the test, 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
was just described.
We received the validation information around that test on
February 3d, 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 in
sending it out to the public health labs, as you mentioned, it
was identified that some of the 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 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----
Senator Murray. I understand that. Was the publication of
the guidance delayed within HHS? Was it? Yes or no?
Dr. Hahn. No, it was not.
Senator Murray. It was not delayed?
Dr. Hahn. No.
Senator Murray. Do you really believe that a million tests
will be available by the end of this week?
Dr. Hahn. Senator, let me just explain that one. So, the
companies that we're working with on this, they have the
capacity to develop enough test kits to send out by the end of
the week--and 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 Murray. Twenty-five hundred kits will?
Dr. Hahn. Yes, a 500-test kit.
Senator Murray. Well, I heard Dr. Kadlec say that the point
of where someone goes in to get a test on a rapid, we are
months away from that. Correct,
Dr. Kadlec.
Dr. Kadlec. Yes, ma'am.
Senator Murray. Well, I'm hearing from a lot of people in
my state who 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 ``stay home, except to
get medical care.'' Well, right now, we know that 27 percent of
the private-sector workforce in the U.S. do not have the
ability to stay home from work without losing pay or if they
have a loved one who is sick. In fact, the U.S. is one of only
two OECD countries that doesn't provide paid leave for personal
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 2
weeks.
Dr. Schuchat, I just have to ask you, would it be efficient
for a public health reason right now while we combat this to
have policies in place to make it possible for people to stay
home from work without losing a paycheck?
Dr. Schuchat. Yes, absolutely.
Senator Murray. 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 were 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 either during this time or after
concerns were raised with senior leadership about what
happened.
I'll ask both Dr. Kadlec and Dr. Schuchat, is the situation
I've just described consistent with protocol? And what should
have been done once the senior leadership were aware that
frontline staff may have been exposed?
Dr. Schuchat. 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 Murray. But is what I just described to you
consistent with the protocols?
Dr. Schuchat. I don't have the full information of that,
but I believe Dr. Kadlec can probably say more.
Senator Murray. Dr. Kadlec.
Dr. Kadlec. Ma'am, I'll just say we're looking into that
very closely because, again, to echo what Dr. Schuchat has
said, we take the protection of our healthcare workers in HHS
very seriously, and during that operation in particular we are
evaluating what may have been a breach, and we owe it to you,
as well as what's been identified by the whistleblower report,
to report back to you on that.
Senator Murray. Mr. Chairman, I would just say that we need
people to speak up when they see these situations. It is
unacceptable if any of these workers on the front lines are
intimidated into staying silent or believe that they're going
to be retaliated against on these issues. We have to keep the
protection of the public first and foremost in our minds, and I
want this looked at, and I want to make sure anybody who speaks
up is protected.
The Chairman. Thank you, Senator Murray.
Senator Paul.
Senator Paul. Dr. Fauci, you mentioned remdesivir, and I'm
intrigued by the fact that they say it's effective against MERS
and SARS in animal models. Do you take that as a very
encouraging sign that it may work in humans too?
Dr. Fauci. Yes, I do, I do.
Senator Paul. Okay. With regard to the children, I think
it's fascinating that there aren't many cases, and I would
suspect that it would be improbable that they're not being
infected, that somehow they have some blanket immunity. One
important thing of maybe putting this into perspective, 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, because if we got 10,000 kids who
weren't getting sick, or 100,000 kids, our percentage on
fatality would go way down.
Dr. Fauci. Right.
Senator Paul. Do you have a comment, Dr. Schuchat?
Dr. Schuchat. Yes. There are some data about that, that
attack rates may not be zero in children but they may be
asymptomatic. So there are data from a few places that are
looking at that.
Senator Paul. It's more likely that they're asymptomatic,
or less symptomatic.
Dr. Fauci. I think we're going to get some data from the
Chinese. They have actually been 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, and that was
one of the questions we asked because, as you mentioned,
Senator, that's a very important issue.
Senator Paul. With regard to treating the severe and
potentially fatal cases in bacterial or viral infections,
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 infections, like with the flesh-eating strep,
sometimes you actually have 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 don't really have an antiviral treatment, but are they
using some steroid treatment in the real severe cases and
having any success?
Dr. Fauci. They've done it in an empiric, non-controlled
way, and there doesn't seem to be any difference, that there's
any effect positive or negative.
Senator Paul. Right. I guess in a bacterial infection we
would never do it unless we were also giving antibiotics. An
antiviral plus steroids might be a different scenario.
Thank you. That's all I have.
The Chairman. Thank you, Senator Paul.
Senator Casey.
Senator Casey. Thanks very much. I want to thank the
Chairman and the Ranking Member for the hearing, and obviously
our witnesses for their expertise and the work by each
individual here for many years.
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 and
the Vice President. And the obligation is 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 you work with; No. 2, to support State and local
preparedness efforts; and three, provide complete and accurate,
always, always accurate information to the public to address
their concerns about this challenge.
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 on the
Pandemic and All Hazards Preparedness Act and the
reauthorizations. But we've got to make sure we do our job even
as we're indicating what should come next.
I want to start with Dr. Kadlec and Dr. Schuchat with
regard to the tragedy that has 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 poses
a significant and even deadly risk to, No. 1, older adults; No.
2, people with disabilities; and No. 3, 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, and obviously the
workers have a challenge.
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, No. 1,
the residents, and No. 2, the workers in long-term care
settings?
Dr. Kadlec. I'll start and then turn it over to Dr.
Schuchat. I think the key thing is that as we've learned more
about this outbreak, and last Thursday the Chinese posted a
fairly significant report on the 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 point earlier, about 20 to 15
percent of people who are over the age of 70 in particular, and
with comorbidities, are at risk, and 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, and 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 aggressive in 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 long-term 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. Schuchat.
Dr. Schuchat. 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.
Senator Casey. I'll just make a comment, and then I just
have one question for Dr. Hahn. You know, 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 has--
it's one of those short-term, limited-duration plans. It
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 would hope they would rethink their
regulatory strategy going forward.
But, Dr. Hahn, one last----
The Chairman. Senator Casey, we're over time. I'm trying to
keep everybody to 5 minutes.
Senator Casey. One last question on testing.
The Chairman. If we have a succinct answer.
Senator Casey. How many people this week can be tested in
the United States of America, this week?
Dr. Hahn. 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 test. 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.
Senator Casey. I hope we can get a number on people.
The Chairman. Thank you, Senator Casey.
Senator Cassidy.
Senator Cassidy. Thank you all. I have about seven or eight
questions, so I'll ask you to be succinct in your answers. And
if I interrupt, it's not to be rude.
CDC, we discussed beforehand, I discovered that the
Canadians have not been as strict as far as people returning
from Hubei 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 U.S.-
Canadian border. What percent of those folks coming from Canada
and, say, Washington State are actually being screened either
by questionnaire as to travel history, exposure, and/or
temperature, et cetera?
Dr. Schuchat. Yes. I don't have the percent, but we've
worked closely with Dr. Kadlec's team and the U.S. Public
Health Service, as well as the CDC----
Senator Cassidy. Can you give me a ballpark? Is it 10
percent? Fifty percent?
Dr. Schuchat. 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.
Senator Cassidy. But it could be as low as 5 percent.
Dr. Schuchat. It could be.
Senator Cassidy. Second, is CDC using Google location data
or something similar in terms of tracking contacts?
Dr. Schuchat. Not for contacts. We are for travel patterns
and other means----
Senator Cassidy. Going to this nursing home in Seattle,
clearly somebody came who had been exposed to coronavirus. Law
enforcement at the scene of a crime will get a warrant and will
ask Google to give this data. We've been reviewing the
statutes. So just to be clear, CDC is not currently using that
same sort of thing law enforcement is to track contacts?
Dr. Schuchat. You have to recognize that right now the
chances that a person with a fever and cough have coronavirus
versus influenza are very low, so exactly what we'd be
tracking, I'm not sure.
Senator Cassidy. The 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
Hubei, perhaps in Canada, they had gone back and forth, then
they're obviously a candidate to be in the vector. So I would
encourage, because I think the answer is no, that you do not
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. 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.
Senator Cassidy. Okay. Next, one of the recommendations
that Senator Murphy and I had in a request in a drug shortage
report from FDA which was released last year, recommendation
number 2, 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/or they are basically interdicting the flow of that
active pharmaceutical ingredient to the U.S., and it could be
one of these candidate drugs, again, should we now enact that
recommendation number 2?
Dr. Hahn. Senator, we stand behind and are working on the
development of this rating system. We also have some
legislative proposals as part of the President's budget that
relate to this.
Senator Cassidy. Okay. Next, we have a problem with
antibiotics in which if you have 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 at the 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 a 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. We have implemented the authorities given to us
in the GAIN Act, and also in the CURES Act, to help with this,
and we are very much facilitating the development of
antibiotics----
Senator Cassidy. 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. 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.
Senator Cassidy. Dr. Fauci, we're looking for quick
diagnostics. Obviously, a PCR takes a little bit longer than a
swab or a blood test for an 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. Fauci. I think pretty close because that's clearly one
of the things we want to get, and in fact it will be very
important for broader surveillance in the country of exposed
people who never come to medical care.
Senator Cassidy. I would finish up by saying this. We need
to know from you all what authorities we need. As I look at
this, we need expanded telehealth with expanded use authority.
We need to get appropriate reimbursement for that telehealth.
Granted that's all CMS, but we also need home health.
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.
The Chairman. Thank you, Senator Cassidy.
Senator Murphy.
Senator Murphy. 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.
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 thanking you for your
response about trying to catalogue the shortage areas. It
sounds like it would be helpful to have a simple, easy legal
requirement that they alert you ahead of time when they see a
shortage coming.
Dr. Hahn. Senator, thank you for the question. We have sent
several legislative proposals as part of the budget, and 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.
Senator Murphy. Great. I think Senator Murray asked you a
question that 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 3,000 people, and New York
State is saying their goal is to do 1,000 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 3,000.
Dr. Hahn. I 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 4 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 4
days. We have reiterated this. We've worked with them closely.
We know them well. They have estimated that they are going to
be able to scale up to deliver 2,500 kits by the end of the
week to providers of the test.
Senator Murphy. Dr. Schuchat, let me ask you, how do we
know that those are in the right hands?
Dr. Schuchat. Yes, thanks. CDC has been providing the
public health labs with kits and expects 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 what we call a 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, and we know that many of the cases in Washington
State are detected through that, or because there was an
outbreak being investigated.
Senator Murphy. 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.
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. And as Senator Murray pointed out,
given the fact that many families have two parents working,
that's really difficult for a day, never mind 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. Schuchat. 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,
and----
Senator Murphy. But what is the guidance, though?
Dr. Schuchat. Yes. 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 of 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, and we dialed that back to instead
shift to stay 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 in schools.
It's a local decision. If there are 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 families
and all those parents who will be staying home if their kids
are home.
Senator Murphy. Thank you, Mr. Chairman.
The Chairman. 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 5 minutes so that we can allow all
Senators to ask their questions.
Senator Roberts.
Senator Roberts. Mr. Chairman, I think I can do that right
off the bat. You asked my question and got a pretty good
answer, and then Senator Jones 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 and
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. And I
want to thank Senator Murray for that.
This is a very unique Committee, along with a 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, and 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 by the
end of the week. That's good progress.
Dr. Schuchat and Dr. Kadlec, I do want to underscore again
our rural areas. We have 83 critical access hospitals in
Kansas. Probably that will 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 who 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 that's an awfully good
thing.
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 seven bucks, $7.85--where is that?--
you can get this for $7.85. If you want to go to Amazon today,
it's $114.97.
Senator Cassidy. I'll give it to you for $50.
[Laughter.]
Senator Roberts. If you bought a liter of this, it was
$14.00. Now it's $229. That's ridiculous. I guess that's the
supply situation that Amazon thinks would be the case.
I wanted to ask one other thing. The term that I was and
that I think a lot of people are confused about is community
spread. ``Spread'' is a verb, but it doesn't mean that the
whole community--that this disease will spread throughout the
community. It just indicates there's one person where we don't
know where the source was. Is that correct?
Dr. Schuchat. Yes, 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,
and 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 readying the healthcare system,
readying the schools and so forth.
Senator Roberts. I thank you very much.
I yield back.
The Chairman. Senator Roberts, you did a better job of
asking your own question than I did, so thank you for doing
that.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman. Mr. Chair, I
express condolences about the tornados in Tennessee yesterday
that were devastating.
The Chairman. Thank you.
Senator Kaine. I want to thank the witnesses and actually
thank the Chair and Ranking. This Committee has had a number of
roundtable 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 briefings since, 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 percent
proposed cut to the World Health Organization and cuts between
5 and 10 percent 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. So I
hope we're looking at what we do from an appropriations
standpoint not only on 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.
Similarly, the budget contains significant cuts to
Medicaid. And 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 the 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. I'm not sure there is a good time to
do that, but you cannot do it at a worse time than when you're
doing it at a time when 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, and I don't know if it's accurate, that you will
no longer be presenting at the Democratic lunch. Is that
accurate?
Dr. Fauci. To my knowledge, no. I mean, I'm planning on
leaving here and being at both lunches.
Senator Kaine. Okay.
Dr. Fauci. This is--right? Yes?
I'm just told it's changed, but I don't know why.
Senator Kaine. I just want to be clear about this. I was
notified yesterday that you and the Vice President would be
presenting to both the Democratic and Republican lunches. I got
a note from the Democratic leader that came in to all of us at
about 9:25 that said you would no longer be presenting and
Ambassador Birx would be presenting. But that's the first
you've heard of this right now?
Dr. Fauci. What you just mentioned to me is the first I've
heard of it, yes.
Senator Kaine. Do you have any idea why you've been
disinvited to the lunches?
Dr. Fauci. I don't know.
Senator Kaine. 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 and
really knowing this stuff, who has done it for presidents of
both parties for decades, who is advertised as coming to advise
us at lunch, we are now notified you are not coming to lunch.
Dr. Fauci. One correction. I'm sorry, but it took me by
surprise.
Am I going?
I'm going.
Senator Kaine. You're going, but I thought your staff told
you that you weren't going 30 seconds ago. So what is the
answer to this?
Dr. Fauci. I am invited, yes.
Senator Kaine. Why did your staff tell you that you were
not invited and then 30 seconds later change it? Am I that
persuasive?
[Laughter.]
Senator Kaine. Well, we'll see what happens at 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 significance to
Virginia and everybody here, which is the military. We don't
have a DOD person here, but I know you must be working in
tandem. We have a lot of Virginians who are deployed in
Vicenza, Italy. We have a lot of Virginians who are deployed in
South Korea. We have a lot of Virginians deployed in Sicily,
Italy. So I'm just thinking of two of the countries that have
been mentioned as places where there is significant
coronavirus. My understanding is, at least at the Vicenza base,
families are being urged to stay on base.
Talk a little bit about your interaction, any of you who
deal with this, your interaction with the DOD. Are we likely to
see more of this, and is there a quarantine where you stay on
the base in South Korea? Are we likely to see it in Germany?
That's the last question I have.
Dr. Kadlec. First of all, my interaction with DOD is daily.
We basically have a call at 12 o'clock with the entire
enterprise of the Department of Defense, Office of Secretary of
Defense, Joint Staff, Defense Health Agency, Defense and
Logistics Agency. So 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 there.
Senator Kaine. Are we doing ``please stay on base'' other
than in Vicenza right now?
Dr. Kadlec. Sir, I don't know the particulars of that base,
but we can certainly get----
Senator Kaine. I'll ask them.
Dr. Kadlec. But they do conform with CDC's guidelines and
what should be done to protect their military force.
Senator Kaine. My time has expired.
The Chairman. Thank you, Senator Kaine.
Senator Romney.
Senator Romney. 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 have been able to
delay it. Clearly, you can't keep it away forever, and we
already have the community transmission, which you predicted.
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
point to anybody. This isn't you; this is us responsible for
funding. 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?
Dr. Kadlec. Sir, I can give you a rough order of magnitude.
It depends what kind of--like you said, severe pandemic, 10
percent of what we need right now. If it were to be a severe
event, we would need $3.5 billion in 95 respirators. We have
about 35----
Senator Romney. About 10 percent.
Dr. Kadlec. Ten percent, and they're working actively to--
--
Senator Romney. That scenario is where I've been most
concerned. It strikes me that we should have substantially more
than 10 percent, what would be needed for a substantial
pandemic, that 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.
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, it might be
infected. Do masks actually help? Do they prevent or reduce the
likelihood of being exposed to the disease, Dr. Fauci?
Dr. Fauci. It depends on the mask. If you look at the N95
masks, they're much better than those sort of floppy masks. In
general, right now, I think the question you're asking----
Senator Romney. No. I'm really asking if we were to have a
major outbreak of some kind----
Dr. Fauci. Yes. 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. Of course.
Dr. Fauci. The general public who can 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 masks, and you
could----
Senator Romney. Better than nothing.
Dr. Fauci. Yes.
Senator Romney. Do we have masks in our Strategic National
Stockpile for the general public? We do not. Okay.
Let's 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. Schuchat. For this kind of virus, we're thinking just
the couple of rows around it. For other types of infections, it
might be broader.
Senator Romney. Should our flight attendants, not on our
instruction, tell them not just to fasten 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 onto
airplanes, someone coughs or sneezes and I hear it barking out.
It's like, my goodness, in conditions like this, just the
general flu, given the fact that 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.
[Laughter.]
Senator Romney. 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? How long does that take, and
who does that? Who is doing the manufacturing once we know this
is a vaccine that works?
Dr. Fauci. That's a very good question, Senator, and 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. And that's really important, because what
I was talking about, a year to a 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. And 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. Do we have that capacity in the United
States? Is this capacity outside the U.S.? I guess the question
I'm looking for is whether legislatively or from an
appropriations standpoint we should provide funding to have the
capacity to make large numbers of vaccines, we should have that
capacity in the U.S. 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 ready to go?
Dr. Kadlec. Yes, sir. In fact, right now the only capacity
we have is really egg production, which wouldn't be relevant to
the vaccine candidate or the candidates that we at BARDA are
pursuing. So we'd have a longer than 6-month wait to basically
produce vaccines on scale.
Senator Romney. Yes, Okay. I want to underscore that is an
area that we ought to consider making an investment in.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Romney.
Senator Smith.
Senator Smith. Thank you very much, Chair 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 hard-
working, professional staff, who I can only imagine have just
been going non-stop for months now. So, thank you.
I want to start by asking a question about the
misinformation and flat-out falsehoods about the coronavirus
that have been circulating, and amplified. I worry that it's
being amplified for political reasons, 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. Fauci. Let me explain. In general, respiratory
illnesses such as the prototypic influenza virus is seasonal,
and 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. And the
reason we don't know it is because this is a brand new virus
with which we have no experience. So 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. It might come back again.
Dr. Fauci. It certainly might.
Senator Smith. It's not like we're going to all be--we're
not going to worry about----
Dr. Fauci. 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 come back. That's
quite possible. We don't know that, but that's possible.
Senator Smith. 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. I mean,
it's ridiculous, and it's harmful.
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. Fauci. 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 and tried 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. 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, and
that's what worries me.
I want to just--I know I don't have much time, but I want
to ask about 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, and 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 that 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?
Dr. Schuchat. Yes, absolutely. The public health labs are
short staffed on a good day, and so this is a very big
challenge, and that is one of the reasons that we are keen to
get the clinical labs up and running with the tests. 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 with the people who traveled who they're supposed
to follow. They're spread really thin, and 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. 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. Schuchat. Yes, absolutely.
Senator Smith. 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.
Thank you very much.
The Chairman. Thank you, Senator Smith.
Senator Scott.
Senator Scott. Thank you, Mr. Chairman. And thank you to
the panel for being here this afternoon, almost. You've spent
quite an 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. I do think what we have not had a lot of
conversation about is putting this virus in context, context
that the average person in this Nation can digest very quickly
and understand the actual risks that are associated with the
virus.
Whether it's the 2003 SARS or the 2009 swine flu, whether
it's the current flu season, the number of Americans that have
died because of the flu, whether it's even that overnight
Tennessee lost 19 people because of a tornado, I would
appreciate it if you all would just take my time to help us put
in context what 80 percent 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. And then the 20 percent of folks who are
elderly, who may have disabilities and comorbidities that may
be at a heightened risk.
If you would just use my 3 minutes that I will have left by
the time I finish with my opening comments to 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.
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, and 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 2 minutes and 48 seconds to help me understand the
situation?
I'll start with Dr. Hahn and maybe work my way through.
Dr. Hahn. Senator Scott, I can address the regulatory
issues. We have worked with urgency. We've issued two EUAs to
help facilitate both masks and diagnostic tests----
Senator Scott. Absolutely.
Dr. Hahn ----in support of these terrific public health
colleagues.
Dr. Kadlec. 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. Thank you.
Dr. Fauci. Senator Scott, you really bring up a good point,
and it really has to do with what you consider relative risk
and how that relates to the unknown.
Senator Scott. Yes.
Dr. Fauci. 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. 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----
Senator Scott. Yes.
Dr. Fauci ----of not overshooting and having panic, but not
also undershooting and be in a situation where you don't
respond as aggressively as you should.
Senator Scott. A sense of urgency.
Dr. Fauci. Yes.
Dr. Schuchat. 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, and what's unknown right now is what that 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? And
it's this balance that Dr. Fauci mentioned of not overreacting
but not underreacting, because the risks of underreacting 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 are
going to need to buildup that healthcare system.
Senator Scott. It seems to me, out of the 90,000 known
cases, we've had how many deaths?
Dr. Schuchat. Right now it's about 3,000.
Senator Scott. Three thousand?
Dr. Schuchat. There are biases in the early information.
Some countries have good information about very mild disease--
--
Senator Scott. A lot of countries do not.
Dr. Schuchat ----and others you can only keep up with the
severe disease.
Senator Scott. I would just end my comments, Mr. Chairman,
with the fact that I think 3,000 deaths should get everyone's
attention, and 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 to have the resources and the equipment necessary for
them to take care of those folks who walk into hospitals
needing assistance. Thank you.
The Chairman. Thank you, Senator Scott.
Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chair and Ranking
Member Murray.
Thank you to the panelists and your entire teams. You all
have been working tirelessly, and 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
has ordered an independent review of the CDC lab about problems
that arose in the manufacturing of the diagnostic test 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.
Dr. Schuchat, 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. Schuchat. I am optimistic, but I want to remain humble
because we see in emerging infectious diseases surprises.
Senator Hassan. Right. And one of the things that we're
dealing with right now--so, for instance, my State, which had
its first confirmed case yesterday, has a dwindling number of
kits, and they tell me they have to do two tests per patient,
because if you get a negative, then you're going to re-test the
next day, and 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. Schuchat. That should be very soon, State by State, as
they verify their procedures, and we've worked closely with FDA
to expedite that.
Senator Hassan. Okay. And 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. Schuchat. Not to my knowledge.
Senator Hassan. 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. And
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, and
what steps are you taking to mitigate those challenges?
Dr. Fauci. That's actually not something that I'm involved
with, but I'd be 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, and 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 will 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, and 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. Thank you.
Dr. Kadlec, briefly?
Dr. Kadlec. Yes, ma'am. I think the thing is there are two
elements there. One is the trigger in terms of action, how do
you respond and early warning, and 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. So there's a trigger to respond, and then there's
the more important one, I think, in terms of understanding
what's circulating, which is really seroprevalence 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. So both of those have a significant
importance.
For our part with BARDA, we basically are funding
commercial laboratories and basically trying to develop point-
of-care diagnostics to advance that.
Dr. Schuchat.
Senator Hassan. Quickly, because I have another question to
get to.
Dr. Schuchat. Yes. We're doing that community surveillance
in the 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. Thank you. I wanted to turn to Commissioner
Hahn 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, and 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.
Yesterday you stated that the U.S. labs could perform up to
1 million tests this week, while public health experts have
said that they hope to see U.S. labs complete 10,000 tests per
day, and tests take time, and they take staff. So 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. I look forward to having that
conversation with you a little bit later.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Hassan.
Senator Loeffler.
Senator Loeffler. Thank you, Chairman Alexander, Ranking
Member Murray.
Chairman Alexander, I want to express my condolences to
your State for the loss in the tornados this morning. I know
we're all monitoring that situation.
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 these innovations can quickly
reach the American people?
Dr. Schuchat. Sure, I can start. You know, we've been
taking steps to reach out to the business community, the
private-sector community. 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. So those are a few areas to mention.
You may want to go on.
Dr. Fauci. Just to underscore that I was very encouraged by
the enthusiasm of the CEOs of the pharmaceutical companies
yesterday 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 us. And 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 the
pharmaceutical companies.
Dr. Kadlec. Ma'am, if I could just comment on one thing,
two programs with ASPR, BARDA DRIVe and ASPR Next, are two
things that are looking specifically at innovations around
medical counter-measures and other things that would enhance
our responses. BARDA DRIVe basically met with 1,500 companies
looking for particular things, diagnostics, to work on this,
and ASPR Next is looking particularly at the supply chain
issues as it relates to pharmaceuticals.
Dr. Hahn. We've been working with diagnostic companies with
vaccines, biologics, and with drug manufacturers both around
the development issues, but the development of products to
address this outbreak.
Senator Loeffler. Thank you all.
The Chairman. Thank you, Senator Loeffler.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. 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.
I want to start with a discussion we've been having about
domestic production of things that are essential in fighting
epidemics. 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.
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.
And I asked should we--I think I might have even asked this to
you, Dr. Schuchat, all those years ago, that should we assume
that if we had put in an order with a foreign manufacturer for
however many doses but there was a huge outbreak in that
foreign country, that they will commandeer that for their own
public health purposes, and 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
heard all of you testify that having domestic capacity is very
crucial in this. Am I correct?
Everyone is nodding. Okay.
The second thing I wanted to get into is we've talked about
lab and testing capacity in the U.S. I'm not sure we're all
agreeing on the meaning of the words and things. So, for
example, when I heard the interchange between Senator/Dr.
Cassidy--there's a lot of initials--I understand PCR to be
polymerase chain reaction-based testing, IgG to be
immunoglobulin, whatever. And it's IgG, IgM, and IgA, and he
was talking about can we have that test soon. So 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. Schuchat. 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
that Dr. Cassidy was talking about, the IgG, or it could be
IgM, and that's really more for the population level to
understand who is already immune, how much disease has there
been that didn't even come to care.
Senator Baldwin. 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. Schuchat. PCR is a key tool for a while with the
private sector and public sector, and then potentially a point-
of-care some years ahead.
Senator Baldwin. Okay. I wanted to 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, 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 3
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.
The Chairman. Thank you, Senator Baldwin.
Senator Collins.
Senator Collins. Thank you, Mr. 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 percent of the manufacturing facilities making
APIs to supply the U.S. market are located in our country. By
contrast, the remaining 72 percent of API manufacturers
supplying our American market are overseas, and 13 percent 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. 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. Senator, thank you for your question. We really
appreciate your leadership on this issue. This has been an
ongoing problem prior to the coronavirus outbreak and continues
to be, 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 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 identified that as a shortage.
Senator Collins. Thank you.
Mr. 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 is that 15 percent of patients 80 and older
do not survive, compared to just over 2 percent 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 to 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. Schuchat. Yes. Thank you so much for that question.
I've been speaking regularly to the Administrator of 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
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.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Rosen will ask our last round of questions so that
our respected professionals who are here, some of them are
going to go have lunch with United States Senators and explain
more. We'll be able to finish by 12:30. Then I'll call on
Senator Murray for any questions or comments she has. We'll
wrap up by about 12:30 so that you can leave.
Senator Rosen.
Senator Rosen. Thank you. Thank you for bringing this
hearing here. Thank you for your round-the-clock work on this.
We are so very grateful for a 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 in 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. So depending on how easily this virus spreads,
how can we use telehealth as a first response to help people in
their own homes? This could contain the virus, relieve a burden
on our emergency rooms.
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.
Dr. Schuchat. 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, and that's one of the things that the CMS
is looking at now.
Dr. Kadlec. Ma'am, one thing that we've been doing for the
last 2 years, we funded two pilot programs called the Regional
Disaster Health Response System, one in Mass General and one in
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 evaluating what are both the legal and practical
limitations to that.
Senator Rosen. 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 to 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 or Republican, old
or young, et cetera, et cetera. So how do we address this issue
of people feeling like they couldn't call or use this because
of insurance limitations?
Dr. Schuchat. Yes, 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. 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.
Senator Rosen. Yes.
Dr. Kadlec. I would just like to add that in declared
disasters, we have the opportunity to declare individuals as
NDMS patients, National Disaster Medical System patients, where
they get reimbursed, the provider gets reimbursed for 110
percent of Medicare rates. That would be an interesting way to
look at how you could evaluate it in a pandemic or something of
this sort to use that, and we're in conversations, initial
conversations with CMS to understand if that could be utilized
in this way.
Senator Rosen. It could be really impactful, negatively or
positively, if we don't address this in the right way. So
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 or next week that you would need
to address this issue? Anyone?
Dr. Kadlec. Ma'am, can I get back to you on that?
Senator Rosen. Yes.
Dr. Kadlec. Thank you.
Senator Rosen. Perfect. Thank you.
I yield back.
The Chairman. Thank you very much, Senator Rosen.
Senator Murray.
Senator Murray. Mr. 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. 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 have even criticized the media for covering this. So I
just 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
percent transparent on this virus and the government's
response, even if you have to contradict a tweet or something
that someone says?
Dr. Schuchat. Yes.
Dr. Fauci. Absolutely.
Dr. Hahn. Yes.
Dr. Kadlec. Yes, Senator.
Senator Murray. 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.
Mr. 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 are doing as well and how we can prepare
for the rest.
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. It
was just closed a short time ago.
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
some 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. As he
said, he and I have 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, about 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.
The Chairman. 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 is 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 Academy should do a study on this. 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 as sole sources of supply. When 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, and we should certainly do the same with lifesaving drugs.
I also want to endorse what Senator Murray said about our
appreciation for you 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 can 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 tell us that whether it's
unpleasant news or not.
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 said most experts agree the United
States is among the countries 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.
QUESTIONS AND ANSWERS
Questions by Senator Murkowski to Anne Schuchat, Anthony Fauci, Robert
Kadlec, and Stephen Hahn \1\
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\1\ Witnesses did not submit written responses
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(1) Although there is debate from public health groups,
Republicans, and Democrats, on the amount we need to
appropriate to address this public health threat, my biggest
concern is that the State of Alaska has the resources it needs
to continue a sustainable response. We need to work together to
ensure that Alaska has the funding to create quarantine
facilities, invest in equipment, and invest in supplies for a
sustained response. I also want to make sure that tribes and
tribal organizations have access to supplemental funding and
that our rural areas are prepared for a response. My
understanding is that by declaring a public health emergency
under the Public Health Service Act, states have been
instructed to reallocate funding from current CDC grants to
respond to the virus. However, there are many unanswered
questions surrounding this instruction. Is it practical or
ethical to ask states to use funding that has already been
allocated for this year to public health prevention programs,
to be used for their response?
(2) My good friend and the other Senator from Alaska,
Senator Sullivan, has consistently raised an issue in which a
``loophole'' is allowing cargo plane crew members from China to
disembark their planes in Anchorage without any screenings.
Alaska is a hub for cargo planes and cargo ships. One of these
ports is the International Port of Dutch Harbor in Unalaska.
This port is the No. 1 fishing port in the United States, but
is extremely isolated. Currently, there is no Federal agency in
Dutch Harbor to ensure that the international crews coming to
port are in compliance with Federal guidelines to protect the
community from the virus. I am concerned about inter--agency
coordination on guidance and protocol moving forward. From
working with DHS, FAA, the Coast Guard, DOD, State Department--
how will CDC make sure that the Federal Government is
communicating a clear message through all of the Federal
guidance being issued?
(3) Doctors, while the protection of our children from
infection must be a top priority, I want to bring to your
attention another high-priority issue-the food insecurity of
far too many children across the country. As you may be aware,
many families rely on the USDA's child nutrition programs to
help stretch their meager household budget and ensure their
children are able to access enough nutritious food to get them
through the school day and school vacations. As we learned
after the November, 2018 earthquake that hit Alaska, schools
and community groups that provide these programs are not
reimbursed unless the children eat in a congregate setting or
the President has issued a disaster declaration. As the
earthquake happened during the government shutdown, FEMA did
not transmit the disaster declaration to the White House
timely. As a result, students in Anchorage were required to be
fed on running school busses parked outside their schools in
the middle of an Alaska winter. My question is this: Given that
closing schools for an extended period of time to avoid having
children congregate during a viral outbreak may be the prudent
thing to do, how will you help ensure that food-insecure
children do not go hungry.
[Whereupon, at 12:30 p.m., the hearing was adjourned.]
[all]