[Senate Hearing 115-712, Part 1]
[From the U.S. Government Publishing Office]
S. Hrg. 115-712
FACING 21ST CENTURY PUBLIC
HEALTH THREATS:
OUR NATION'S PREPAREDNESS
AND RESPONSE CAPABILITIES, PART I
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING FACING 21ST CENTURY PUBLIC HEALTH THREATS, FOCUSING ON OUR
NATION'S PREPAREDNESS AND RESPONSE CAPABILITIES
__________
JANUARY 17, 2018
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC IS NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
28-404 PDF WASHINGTON : 2019
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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
JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky MICHAEL F. BENNET, Colorado
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
TODD YOUNG, Indiana ELIZABETH WARREN, Massachusetts
ORRIN G. HATCH, Utah TIM KAINE, Virginia
PAT ROBERTS, Kansas MAGGIE HASSAN, New Hampshire
LISA MURKOWSKI, Alaska TINA SMITH, Minnesota
TIM SCOTT, South Carolina DOUG JONES, Alabama
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Democrat Staff Director
John Righter, Democrat Deputy Staff Director
(ii)
C O N T E N T S
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STATEMENTS
WEDNESDAY, JANUARY 17, 2018
Page
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening Statement......................... 5
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 2
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 1
Casey, Hon. Robert P. Jr., a U.S. Senator from the State of
Pennsylvania................................................... 6
Witnesses
Kadlec, Robert, M.D., Assistant Secretary for Preparedness and
Response, Department of Health and Human Services, Washington,
DC............................................................. 8
Prepared statement........................................... 10
Gottlieb, Scott, M.D., Commissioner, U.S. Food and Drug
Administration, Silver Spring, MD.............................. 14
Prepared statement........................................... 15
Redd, Stephen C., M.D., RADM, Director, Office of Public Health
Preparedness Response, Centers for Disease Control and
Prevention, Atlanta, GA........................................ 20
Prepared statement........................................... 21
FACING 21ST CENTURY PUBLIC
HEALTH THREATS:
OUR NATION'S PREPAREDNESS
AND RESPONSE CAPABILITIES, PART I
----------
WEDNESDAY, JANUARY 17, 2018
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:04 a.m. in
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr,
presiding.
Present: Senators Alexander, Burr [presiding], Isakson,
Collins, Cassidy, Young, Murkowski, Murray, Casey, Bennet,
Murphy, Warren, Kaine, Hassan, Smith, and Jones.
Opening Statement of Senator Burr
Senator Burr [presiding]. I would like to call this hearing
to order, the Senate Health, Education, Labor, and Pensions
Committee.
This morning, we are holding a hearing titled, ``Facing the
21st Century Public Health Threats: Our Nation's Preparedness
and Response Capabilities.'' We will hear from Dr. Robert
Kadlec, the Assistant Secretary for Preparedness and Response
at the Department of Health and Human Services; Dr. Stephen
Redd, Director of the Office of Public Health Preparedness and
Response at the Centers for Disease Control and Prevention; and
Dr. Scott Gottlieb, Commissioner of the Food and Drug
Administration.
This is the first of two hearings we plan to have on this
topic. The second will be noticed for Tuesday, January 23.
Senator Murray and I each have an opening statement, then I
am going to turn to Senator Alexander and Senator Casey for any
opening remarks they might have. After that, we will introduce
our panel of witnesses and hear their testimonies. And then
each Member will have up to 5 minutes for any remarks and
questions.
First, I would like to welcome the Chairman and thank him
for giving me the opportunity to hold the gavel today. This
hearing discusses a topic that is critical to our national
security and has seen many years of bipartisan work in this
Committee and in this Congress.
Together, we have developed and strengthened the framework
to ensure we are prepared for chemical, biologic, radiological,
and other nuclear threats with the potential to jeopardize the
health of all Americans.
The Pandemic and All-Hazards Preparedness Act of 2006
created a framework which has grown and changed as we have
learned from each public health experience we have been
through. We should be proud of the accomplishments under PAHPA
and the progress made over the last decade.
Our work has resulted in strong partnerships with our
states and local counterparts, created greater certainty and
accountability to bring forward medical countermeasures, and
established a clear strategy with which we can combat the full
range of public health threats we face today and those we may
encounter in the future.
Despite this progress, we are not fully prepared and more
work remains to accomplish our goals. The Blue Ribbon Study
Panel on Biodefense stated in their 2015 report that there are,
and I quote, ``Serious gaps and inadequacies that continue to
leave the Nation vulnerable to threats from nature and
terrorists alike.''
As we move forward in revisiting this successful and
bipartisan law, I want to make it very clear to my colleagues
that this is a reauthorization of a national security bill, and
I look forward to working with each of you on this important
issue.
The threats we face continue to evolve and it is critical
that we bring, with this discussion, the vigilance, urgency,
and resolve this mission demands. We are in an unprecedented
era of technological and biomedical innovation and advancement.
In November 2016, the President's Advisory Council on
Science and Technology warned that, and I quote, ``While the
ongoing growth of biotechnology is a great boon for society, it
also holds serious potential for destructive use by both states
and technically competent individuals.''
I urge the U.S. Government's past ways of thinking and
organizing to meet biological threats needs to change to
reflect and address this rapidly developing landscape. For this
reason, it is critical that fostering and advancing innovation,
particularly in the development of medical countermeasures, is
top of mind and that we work through this reauthorization
process to ensure CDC, FDA, ASPR, BARDA have what they need to
keep pace with these rapidly changing and evolving threats.
This Committee has worked to push the Federal Government,
and HHS in particular, to meet these challenges. An HHS that
fosters innovation in the development of medical
countermeasures and across PAHPA's framework provides the
greatest hope to ensure the safety of the American people. The
witnesses we have before us today will be able to provide
insight into the urgency of this mission and the promise
innovation holds if properly leveraged.
I look forward to hearing from each of you about the
progress that we have made, and where we can continue to
improve policies and programs to realize their full potential
to save Americans' lives.
Now, I would like to turn to Senator Murray for any
comments she might have.
Statement of Senator Murray
Senator Murray. Thank you very much.
And thank you, to all of you, for joining this hearing on
our Nation's preparedness to combat public health threats as we
look toward now reauthorizing the Pandemic and All-Hazards
Preparedness Act later this year.
I especially want to thank Senator Casey and Senator Burr
for their bipartisan work and leadership on this really
important issue.
Local Washington state papers show why today's discussion
is so important to families across this country. We have
headlines like, ``Flu Deaths And Cases Increasing In Pierce
County.'' And, ``Flu Outbreak In Snohomish County Kills Five;
50 Hospitalized.''
A bad flu season can be a nightmare for families and too
often ends in horrible tragedy. Just as we must continue to
improve our public health response across the board to prevent
those tragedies on the local level, we have to also make sure
we are vigilant against pandemics of a global scale.
A pandemic could affect half a billion people, more than
the entire population of the United States; and that is not
speculation. It happened 100 years ago. The 1918 influenza
epidemic was a tragedy more deadly to the human race than World
War I. And today, the threat of pandemic flu is joined by new
threats.
What have we learned in the last century? Are we better
prepared for the next catastrophe?
When we consider Ebola and how the Centers for Disease
Control and Prevention, and so many partners, supported Nigeria
as they instituted evidence-based policies and tracked the path
of that disease, and contained it when the outbreak reached
Lagos, the answer is clearly, yes.
When you consider our Strategic National Stockpile which
can deliver 50 tons of emergency medical supplies anywhere in
the U.S. in 12 hours, the answer is clearly, yes.
When you consider the FDA's approval of new medical
countermeasures to combat anthrax, and flu, and radiation, and
plague, the answer is clearly, yes.
However, our track record is far from perfect. We still can
do better.
We can do better than the President's way too slow response
in Puerto Rico and the U.S. Virgin Islands after Hurricane
Maria. The storm left many Americans without access to clean
water, and electricity, and healthcare for months.
We can do better than the Administration's response to the
opioid epidemic. President Trump declared the crisis a public
health emergency 83 days ago and has taken little meaningful
action since.
So I am glad this Committee will continue its bipartisan
work to address the opioid crisis in another hearing soon.
We can also do better than our slow response in approving
funding to combat Zika in 2016. The World Health Organization
declared Zika a global health emergency in February. Instead of
a fast response with needed funding, the response got
politicized around some Republicans who pushed to undermine
women's healthcare and access to contraception, which was a key
requirement to prevent the virus from causing devastating birth
defects.
As a result, that took Congress 9 months to pass emergency
funding for a public health crisis that endangered mothers, and
babies, and families across the world. That delay hurt people
and it harmed families in ways they are going to carry for the
rest of their lives. So we have to do better.
We are most successful at protecting our families against
pandemic threats when we respond with quick, bipartisan action.
We need decisions based in science and expert medical
opinion, not ideology, especially when it comes to women's
health.
We need Federal, state, and local agencies to hire the
people, and capacity, and have the funding they need to protect
communities. Hiring freezes and funding cuts make us less
prepared, not more.
We need to plan for everyone. We cannot overlook the young
or the elderly. We cannot forget pregnant women, or individuals
with disabilities, or those fighting chronic diseases like
diabetes.
We need innovative medical countermeasures to protect us
from today's threats like a universal flu vaccine and
antibiotics to combat resistant bacteria. And we must continue
strong partnerships with industry that will allow us to rapidly
respond to new threats.
We need to stop fear and uncertainty before they create
panic by getting families helpful and accurate information from
sources that they trust. We cannot allow anyone to undermine
the science of proven solutions like vaccines.
We need to respond to global health crises abroad before
they travel here to home. Diseases are not stopped by borders,
or walls, or bans. This is a place where the United States can,
and should, lead.
We should continue to show our international partners that
we are focused on these issues and will be their ally in
preparing for, and addressing, public health threats.
Congress has a strong, bipartisan track record of
addressing these challenges through the PAHPA, which
strengthened our Nation's public health preparedness and
created new roles, and programs, and authorities for public
health emergency response.
Reauthorizing the Act in 2013, we built on that record and
enhanced medical surge capacity. We modernized biosurveillance
capabilities and increased our focus on at-risk individuals.
I am hopeful we can continue that progress with legislation
that focuses on the science and evidence based policies we know
work to mitigate public health crises, that considers the needs
of everyone, and puts families and women before politics,
supports state and local public health officials, ensures
communities do not spend months waiting for emergency
resources, and enables us to respond to the next crisis with
foresight rather than learn from the next tragedy with
hindsight.
We do not know what the next public health threat will be.
We do not know where, or when, or even how it will start. But
we do know that being prepared starts now.
All of you here today have a critical role to play in
keeping our communities healthy and safe. The Food and Drug
Administration helps facilitate the development and review of
medical countermeasures and grants emergency use authorizations
for products that are needed on the frontlines.
The Assistant Secretary of Preparedness and Response guides
our Nation's preparedness planning. They help ensure our
healthcare system is ready to face any emergency. And it
invests in the medical countermeasures pipeline through
biomedical advanced research and development authority.
The Centers for Disease Control and Prevention is on the
frontlines supporting state and local public health
departments, overseeing the Strategic National Stockpile,
gathering and analyzing key data, and serving as a trusted
source of information to the public.
I am interested to hear from all of you today about your
work to fulfill these important roles and keep our country
safe.
Mr. Chairman, I do want to say I am frustrated that
Director Fitzgerald is, once again, unable to join us here
today. Due to conflicts of interest presented by investments,
our CDC Director still has to recuse herself on some of the
important health issues that we face, including issues related
to data collection and information sharing, which are very
relevant to the conversation that we are having today. I am
concerned that she still cannot give her full attention to all
the pressing health threats we face and hope that these
conflicts of interest will be resolved soon.
Thank you, Dr. Redd, for joining us in her place and I look
forward to hearing from you.
Thank you, Mr. Chairman.
Senator Burr. Thanks, Senator Murray.
Senator Alexander.
Statement of Senator Alexander
The Chairman. Thank you, Senator Burr.
Senator Burr, thank you for your willingness to chair this
hearing.
In March 2013, President Obama signed into law the
bipartisan Pandemic and All-Hazards Preparedness
Reauthorization Act. Senator Burr was the author of that
reauthorization and the original legislation, which became law
in 2006. He worked with many Senators on this Committee, both
Democratic and Republican, and I thank them all for that.
Senator Murray, Senator Casey, and others, Senator Isakson was
another of those. So Senator Burr is chairing the hearing and I
thank him for that.
I would also like to welcome Senator Smith from Minnesota,
who is joining our Committee and replacing Senator Franken, who
was a valuable Member of the Committee.
Senator Jones, from Alabama, is also a new Member of the
Committee. We welcome him. He replaced Senator Whitehouse, who
was a very valuable Member of the Committee, and who has taken
a lesser assignment on the Finance Committee for some reason.
[Laughter.]
The Chairman. But we will miss Sheldon and his work on this
Committee.
Mr. Chairman, I am going to withhold my comments, although
what I would like to do is call on Senator Isakson for 1
minute, just to make some comments, and then we will go to
Senator Casey.
Senator Burr. Senator Isakson.
Senator Isakson. Thank you, Mr. Chairman.
I just wanted to, in reference to the statements made by
the ranking Member, Senator Murray, whom I have talked to about
Dr. Fitzgerald. I talked with Dr. Fitzgerald yesterday.
As chairman of the Ethics Committee, I have gotten her in
touch with the appropriate people to deal with the issue. She
is forthrightly dealing with it to the best I can determine and
I am working expeditiously to see we get it done as quickly as
possible, so she will not have any conflict to testify
whatsoever. And that is her desire as well.
Thank you.
Senator Burr. Senator Casey.
Statement of Senator Casey
Senator Casey. Thank you very much, Senator Burr.
I am grateful for this hearing, and grateful to be working
with you again on this reauthorization, and commend your work
on this for many, many years.
I also want to thank, of course, the Chairman, Chairman
Alexander and Ranking Member Murray for this bipartisan hearing
on the Nation's preparedness and response capabilities in
advance of the reauthorization of the Pandemic and All-Hazards
Preparedness Act known as PAHPA.
I will give you one story, one brief story, but I think,
instructive about how important preparation is. This is a good
example of preparedness infrastructure that PAHPA supports, in
this case, in the aftermath of a tragedy, a train derailment
that occurred in Philadelphia in May 2015.
The train was carrying 238 passengers. When it derailed,
eight people lost their lives. Over 200 were injured in that
derailment.
Fortunately, through funding from PAHPA's Hospital
Preparedness Program, which we know by the acronym HPP, the
Pennsylvania Department of Health and a regional healthcare
coalition had long been working together to prepare local
healthcare systems for emergencies that could cause a surge in
patients.
When the train derailed, HPP funded systems were tracking
bed availability in local hospitals and providing that
information in real time to emergency responders who were at
the scene, helping them to effectively triage patients, send
them to hospitals that had the capacity to accept additional
patients so they could begin to receive the care they needed.
Because these systems were in place before the train
derailed, they were ready to protect both health and to save
lives when seconds, literally seconds, counted.
Yet, health security threats are increasing in frequency
and intensity due to a combination of factors including newly
emerging infectious diseases, extreme weather events, and our
aging infrastructure.
So now, more than ever, we must continue to build our
Nation's resiliency by investing in countermeasure development,
surveillance, and supporting state and local partners to reduce
the impact of health events in the country.
So I would like to thank today's witnesses for their
service. It is important to mention your service to the
country, as well as your commitment to protecting America's
public health.
We look forward to the hearing and grateful for the work
that we can do today at this hearing.
Thank you, Mr. Chairman.
Senator Burr. Senator Casey, thank you.
Thank you for your continued help and work on this issue.
Let me just remind Members that this is the start of the
reauthorization of PAHPA. Now, having been in Congress for 24
years, I realize that when you get involved in HHS legislation
and FDA legislation, there is always a temptation to fix other
things.
I want to encourage you to fight the urge. Let us keep this
focused on perfecting PAHPA. It has been successful. We still
have work to do, but if we become distracted and create a fight
over changes within the FDA that have nothing related to this,
or HHS, or somewhere else because the sheer geography that just
PAHPA allows us to get into, we will lose the focus of what we
are doing, and that is trying to make PAHPA even more effective
in the future.
So with that, I would like to introduce our witnesses,
which each have up to 5 minutes to give their testimony.
I am pleased to welcome today Dr. Robert Kadlec. Dr. Kadlec
is the Assistant Secretary for Preparedness and Response at the
Department of Health and Human Services. If he does not like
the title, he was the one that created it.
It was with Dr. Kadlec's help that we created the ASPR
position as part of PAHPA to establish a clear line of
authority in the event of a public health emergency. The APSR
is the person at HHS solely responsible for leading and
coordinating the Federal medical and public health preparedness
and response effort across all the agencies within HHS
including FDA and CDC.
Dr. Bob, delighted to have you back today.
Next, we will hear from Dr. Scott Gottlieb. Dr. Gottlieb is
the Commissioner of the Food and Drug Administration.
The FDA plays a critical role in our emergency preparedness
and response capabilities through its review of medical
countermeasures, including drugs, vaccines, diagnostic tests,
and by ensuring these countermeasures are safe and effective.
Further, the 2013 reauthorization of PAHPA aimed to improve
regulatory certainty and predictability for medical
countermeasures under review at the FDA, while also providing
the agency with the additional authorities to support rapid
response to public health emergencies.
Scott, we are delighted to have you here and delighted to
have you in that position at FDA.
Finally, we will hear from Dr. Stephen Redd. Dr. Redd is
the Director of the Office of Public Health Preparedness and
Response at the Centers for Disease Control and Prevention.
The CDC serves a number of roles under the PAHPA framework
and has built strong relationships with state and local public
health departments, an important aspect of preparing for, and
responding to, emergency public health threats.
The CDC also works to make sure we have the information we
need in advance of and during a public health emergency. As
part of this effort, the CDC houses an expansive epidemiology
laboratory capacity and is responsible for biosurveillance and
public health data collection activities.
Again, we welcome all of you.
Let me just say at the beginning, I believe the hurdle that
is in our way is not available innovation. I believe the hurdle
that is in our way is government. Clearly defining what it is
that our need is, and the certainty of a pathway for getting
the approvals that we need for those to actually be deployed.
So I hope you will keep those in mind as you go through,
not just your testimony, your questions, but more importantly
in the roles that you carry out after leaving. Understand that
you are on the frontlines at making this happen.
Dr. Bob, the floor is yours.
STATEMENT OF ROBERT KADLEC, M.D., ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Dr. Kadlec. Well, thank you, sir. Sorry for the false start
there. I was excited to be here, sir. I was ready to go.
Good morning, Mr. Chairman, both of you, sirs and Senator
Murray, and distinguished Members of the Committee.
I assumed this role 5 months ago just a week before
Hurricane Harvey struck Texas. It has been an interesting
experience so far and I have much to share from that
experience.
I appreciate the opportunity to appear before you today as
you prepare to consider the second reauthorization of PAHPA.
This Committee championed the bipartisan effort to draft and
pass this groundbreaking legislation and I want to thank you
for your continuing commitment to this endeavor.
I am proud to have played a part in the original
legislative process during my tenure with this Committee, and
acknowledge the vision and leadership of Senator Burr and the
late Senator Ted Kennedy.
This morning, I will share with you my perspective on the
national security imperative of PAHPA, the mission and duties
of ASPR, and my vision for areas of improvement.
The Constitution states that one of the Federal
Government's fundamental obligations is to provide for the
common defense, to protect the American people, our homeland,
and our way of life. The strength of our Nation's public health
and medical infrastructure, as well as the capabilities to
quickly mobilize a coordinated national response to pandemics,
attacks, and disasters are essential to save lives and protect
all Americans.
Therefore, improving national readiness and response
capabilities for 21st century threats is a national security
imperative, as Senator Burr outlined earlier, and is the crux
of my efforts as the ASPR.
The 21st century health security environment is
increasingly complex and dangerous. It demands that we react
with urgency. Having recently left my job with the Senate
Select Committee on Intelligence, I know these threats all too
well.
Terrorist organizations remain determined to attack the
United States. State actors now directly threaten our homeland
with nuclear weapons and have the means to employ both chemical
and biological weapons.
Further, we have witnessed the increased frequency of
naturally occurring disasters as well as disease outbreaks and
are currently monitoring potential emerging infectious diseases
that could cause a pandemic such as the H7N9 influenza strain
circulating in China.
The bottom line is whatever happens, your constituents, the
American people, expect our Federal Government to be ready to
respond to save lives.
When APSR was originally established by PAHPA a decade ago,
the objective was to answer a simple question: who is in charge
of all Federal public health and medical preparedness and
response functions? The approach adopted was based on the
Goldwater-Nichols Act that created the Unified Combatant
Commands at the Department of Defense.
APSR's mission is to save lives and protect Americans from
these threats by recruiting the entire weight of the federal,
medical, and public health assets and recruit support of the
public health sector to support state and local activities and
responses to help Americans in distress.
As APSR, I have four key priorities.
First, provide strong leadership. Focus on coordination,
planning, and preparing for events that threaten the national
health security.
Second, develop the national disaster healthcare system.
Third, advocate for CDC's sustainment of a robust and
reliable public health security capabilities.
Last, but certainly not least, advance an innovative
medical countermeasure enterprise.
Two areas of progress and opportunity I will elaborate on
are operational healthcare readiness capacity and the medical
countermeasures enterprise.
The importance of the national healthcare readiness and
medical surge capacity was highlighted during this hurricane
season. After Hurricanes Harvey, Irma, and Maria, ASPR led
federal medical and public health response and recovery
activities under the national response framework. We worked
closely with FEMA, and state, and territorial health officials
to augment healthcare with HHS disaster medical assistance
teams, as well as V.A. and DOD assets.
We learned from these disasters that ASPR needs to update
its incident command and deployable medical capabilities, as
well as enhance our support for the healthcare infrastructure
across the country.
As with medical countermeasures, the Nation's healthcare
delivery infrastructure is mostly a private sector enterprise
that must be effectively engaged in improving readiness.
To address the potential catastrophic medical consequences
of the 21st century threats, we need a tiered regional system
that is based on existing local healthcare coalitions and
trauma centers that integrates all medical response
capabilities, including Federal assets, as well as emergency
medical services, the frontline of our response capabilities.
We must expand specialty care expertise and trauma,
behavioral healthcare and chemical, biological, radiological
nuclear response. And certainly, but not least, incentivize the
healthcare system to integrate measures of preparedness into
daily standards of care. I call this the foundation of a
national disaster healthcare system.
The second area is our medical countermeasure enterprise,
and I am grateful that Dr. Rick Bright behind me--Rick, why do
you not wave to the crowd--who is the Director of BARDA, is
joining me today.
BARDA was established as part of PAHPA and is a component
of ASPR to bridge the so-called ``valley of death'' in the late
stage development of vaccine, drug, and diagnostic development
when many products historically languished or failed.
By using flexible, nimble authorities, multiyear advanced
funding, strong public-private partnerships, and cutting edge
expertise BARDA has successfully pushed many innovative
products from advanced development to stockpiling FDA approval.
To this date, 34 products have been approved by the FDA for the
purposes of responding to disasters to the credit of Dr. Bright
and his predecessor, Dr. Robin Robinson and the team at BARDA.
We have opportunities to further improve this enterprise by
streamlining our internal decisionmaking processes, finding new
ways to support innovation, promoting flexible, fast response
capabilities, and increasing our collaboration with Federal
interagency partners.
We also must work closely with our state and local
partners, as well as the private sector to enhance the
capability to quickly distribute and dispense medical
countermeasures in an emergency.
In times of great challenge, we have the opportunity to
build on the great progress made and further improve our
national readiness and response capabilities.
I look forward to working with you and your staff. And
thank you, again, for your bipartisan support and commitment to
national security.
I am happy to answer any questions you have.
[The prepared statement of Dr. Kadlec follows:]
prepared statement of robert kadlec
Good morning Mr. Chairman, Senator Murray, and other distinguished
Members of the Committee. I am Dr. Bob Kadlec, the Assistant Secretary
for Preparedness and Response (ASPR) at the Department of Health and
Human Services (HHS). I assumed this role 5 months ago, a week before
hurricane Harvey struck Texas. I appreciate the opportunity to appear
before you today as you prepare to consider the second reauthorization
of the Pandemic and All-Hazards Preparedness Act (PAHPA), which expires
at the end of this fiscal year.
Building upon years of incremental legislative changes in the prior
decade, this seminal legislation transformed the Federal Government's
medical and public health preparedness for threats to our national
security. This Committee championed the bipartisan oversight and
analysis that led to the drafting and passage of this groundbreaking
legislation. I want to thank you for continuing that commitment here
today.
I am proud to have played a part in that original legislative
process, when during the 109th Congress, I was Staff Director of this
Committee's Subcommittee on Bioterrorism and Public Health
Preparedness, led by Senators Burr and Kennedy. In the decades before
and after PAHPA was passed, I worked in various government capacities
focused on biodefense and national security. I spent more than 20 years
in the United States Air Force as an officer and physician, and served
as Special Advisor for Counter Proliferation Policy within the Office
of the Secretary of Defense during 9/11 and the 2001 anthrax attacks. I
served two tours of duty at the White House Homeland Security Council,
first as the Director for Biodefense then as Special Assistant to
President Bush for Biodefense Policy from 2007 to 2009. Most recently
before taking my current position, I served as the Deputy Staff
Director for the Senate Select Committee on Intelligence.
This morning, I will share with you my perspective on the national
security imperative of PAHPA, the mission and duties of ASPR, the
status of our Department and our Nation's public health and medical
preparedness and response capabilities, and my vision for areas of
improvement. I welcome the opportunity to engage with you and your
staff in the months ahead as you continue your oversight and
legislative drafting.
The National Security Imperative
The Constitution states that one of the Federal Government's
fundamental responsibilities is to provide for the common defense--to
protect the American people, our homeland, and our way of life. The
strength of our Nation's public health and medical infrastructure, and
the capabilities necessary to quickly mobilize a coordinated national
response to emergencies and disasters, are foundational for the quality
of life of our citizens and vital to our national security. Therefore,
improving national readiness and response capabilities for 21st century
health security threats is a national security imperative and is my
singular focus as the ASPR.
The 21st century health security environment is increasingly
complex and dangerous; it demands that we act with urgency and singular
effort: to save lives and protect Americans. Terrorist organizations
such as ISIS and al-Qaida remain determined to attack the United States
as we experienced first-hand in 2001. ISIS has demonstrated no
compunction about using chemical and other unconventional weapons in
attacks overseas. State actors, such as North Korea, have already
threatened our homeland with nuclear weapons, and have the means to
employ both chemical and biological weapons; the Syrian regime has
already used chemical weapons against its own citizens.
Furthermore, we have witnessed the impacts of naturally occurring
outbreaks such as influenza, Ebola, and SARS, and we are monitoring
other potential emerging infectious diseases that could cause a
pandemic, such as the H7N9 influenza strain circulating in China. 2018
marks the 100 year anniversary of the 1918 influenza pandemic, which
killed more people than World War I. During that pandemic, more than 25
percent of the U.S. population became sick and 675,000 Americans, many
of them young, healthy adults, died from the highly virulent influenza
virus.
Cyber-attacks like the WannaCry incident remind us that
technological advancements have tradeoffs in the form of new
vulnerabilities and risks, as our health delivery systems become more
networked.
Finally, we face extreme weather events, such as the recent 2017
hurricane season in which Hurricanes Harvey, Irma, and Maria caused an
unprecedented amount of damage, reminding us of the awesome destructive
power of nature.
These are threats that most of us would rather not think about.
However, when natural disasters, disease outbreaks, or attacks occur,
the people expect our government to be ready to respond to save lives
and protect Americans.
The ASPR Mission & Duties
When ASPR was originally established by PAHPA a decade ago, the
objective was to create ``unity of command'' by consolidating all
Federal nonmilitary public health and medical preparedness and response
functions under the ASPR. This approach was modeled on the Goldwater-
Nichols Act that created the Department of Defense (DoD) combatant
commands; the impetus was the disorganized and fragmented response to
Hurricane Katrina in 2005.
ASPR's mission is to save lives and protect Americans from 21st
century health security threats. ASPR is, in effect, the national
security mission manager for HHS. As such, on behalf of the Secretary
of HHS, ASPR leads the public health and medical, preparedness,
response and recovery to disasters and public health emergencies, in
accordance with the National Response Framework (NRF) and Emergency
Support Function No. 8 (Public Health and Medical Services). It is my
responsibility to coordinate the Nation's medical and public health
capabilities to help Americans during such events, whatever their
cause. ASPR also coordinates with other components of HHS with respect
to HHS's role in ESF No. 6 (Mass Care, Housing, and Human Services) and
HHS's lead role as the coordinating agency with respect to the Health
and Social Services Recovery Support Function.
ASPR coordinates across HHS, the Federal interagency, and supports
state, local, territorial, and tribal health partners in preparing for
and responding to emergencies and disasters. ASPR, in partnership with
HHS agencies, works to enhance medical surge capacity by organizing,
training, equipping, and deploying Federal public health and medical
personnel and providing logistical support for Federal responses to
public health emergencies. ASPR supports readiness at the state and
local level by coordinating Federal grants and cooperative agreements
and carrying out drills and operational exercises. ASPR oversees
advanced research, development, and procurement of medical
countermeasures (e.g., vaccines, medicines, diagnostics, and other
necessary medical supplies), and coordinates the stockpiling of such
countermeasures. ASPR manages the Biomedical Advanced Research and
Development Authority (BARDA), Project BioShield, and the Public Health
Emergency Medical Countermeasures Enterprise.
HHS and ASPR have made significant progress since PAHPA was enacted
in 2006 and was reauthorized in 2013, which I will discuss shortly. The
ASPR organization is filled with very capable, committed, and mission-
driven staff; I am proud to lead them. It is my goal to further improve
national public health and medical readiness and response capabilities,
which have been developed by my predecessors who worked long hours to
establish ASPR and build the capabilities that exist today. I aim to do
that through four key priority areas:
First, provide strong leadership, including clear policy
direction, improved threat awareness, and secure adequate resources.
Second, seek the creation of a ``national disaster
healthcare system'' by better leveraging and enhancing existing
programs--such as the Hospital Preparedness Program (HPP) and the
National Disaster Medical System (NDMS)--to create a more coherent,
comprehensive, and capable regional system integrated into daily care
delivery.
Third, advocate for the sustainment of robust and
reliable public health security capabilities, primarily through the
Centers for Disease Control and Prevention (CDC), but also through
other components of HHS, including an improved ability to detect and
diagnose infectious diseases and other threats, as well as the
capability to rapidly dispense medical countermeasures in an emergency.
Fourth, advance an innovative medical countermeasures
enterprise by capitalizing on additional authorities provided in the
21st Century Cures Act, as well as advances in biotechnology and
science, in order to develop and maintain a robust stockpile of safe
and efficacious vaccines, medicines, and supplies to respond to
emerging disease outbreaks, pandemics, and chemical, biological,
radiological, and nuclear incidents and attacks.
The State of Public Health and Medical Preparedness and Response
Capabilities
In 2006, when then-Secretary of Health and Human Services Michael
Leavitt testified before this Committee in advance of PAHPA's passage,
he told Senators that we had the ability to ``become the first
generation in history to be prepared for a possible pandemic.'' At that
time, HHS was closely watching the H5N1 influenza virus, and was
concerned about the potential for another human influenza pandemic.
Congress invested heavily by passing emergency supplemental
appropriations bills, which were used to greatly expand our domestic
vaccine manufacturing infrastructure, invest in new vaccine
development, and provide funding to state and local governments to
enhance medical and public health readiness.
Today, our capabilities are far greater than they were then; for
example, we have sufficient domestic vaccine manufacturing capacity to
produce bulk vaccine for every American within 6 months. However, we
have exhausted the emergency supplemental funding balances at a time
when we are now closely watching the H7N9 influenza virus circulating
in China, and we are concerned with the ominous trends that we are
seeing. While building domestic manufacturing capacity may be a one-
time expenditure, maintaining that capacity as well as sustaining,
testing, and strengthening the readiness of our medical and public
health infrastructure at the state and local level requires continuous
support and an enduring commitment to the Public Health Emergency
Medical Countermeasures Enterprise.
Last month, a report by the public health organization Trust for
America's Health found that half of states scored five or lower out of
10 on health emergency preparedness. Earlier in 2016, the National
Health Security Preparedness Index from the Robert Wood Johnson
Foundation found that health security metrics showed modest 1.5 percent
improvement overall during 2016, reaching the highest level of 6.8 out
of 10 total; however, levels of readiness varied significantly across
the country. So, while we have made progress in the last decade, we
still have work to do.
Two areas of progress and opportunities I would like to highlight
are our medical countermeasures enterprise, specifically BARDA, and our
healthcare readiness capacity.
Medical Countermeasures Enterprise--BARDA
PAHPA established BARDA to bridge the so-called ``valley of death''
in late stage development of medical countermeasures where many
products historically languished or failed. By using flexible, nimble
authorities, multi-year advanced funding, strong public-private
partnerships, and cutting edge expertise, BARDA has successfully pushed
innovative medical countermeasures, such as vaccines, drugs, and
diagnostics, through advanced development to stockpiling and FDA
approval or licensing.
In the last decade, BARDA's strong partnerships with the National
Institutes of Health, other HHS components, and biotechnology and
pharmaceutical companies have led to 34 medical countermeasures
approved or licensed by the FDA, which is a staggering accomplishment.
BARDA has supported the development of 27 medical countermeasures
against Department of Homeland Security (DHS)-identified national
security threats through Project BioShield, including products for
smallpox, anthrax, botulinum, radiologic/nuclear emergencies, and
chemical events. Fourteen of these products have been placed in the
Strategic National Stockpile and are ready to be used in an emergency.
BARDA also has supported the development of 23 influenza vaccines,
antiviral drugs, devices, and diagnostics to address the risk of
pandemic influenza. As a result of this progress, more medical
countermeasures than ever before are eligible to be acquired for the
SNS, thereby creating new challenges in terms of acquiring and
maintaining sufficient quantities of medical countermeasures for
identified threats.
We are supporting the development and stockpiling of many more
novel medical countermeasures within the next few years, such as H7N9
influenza vaccines, next generation anthrax vaccines, enhanced smallpox
vaccines, biodosimetry diagnostic devices, thermal burn radiation drug
and skin replacement therapies, radiation cell therapies, new
antibiotics, and new chemical antidotes.
We also have opportunities to further improve our national security
medical countermeasures enterprise by streamlining our internal
decisionmaking processes, finding new ways to support innovation,
promoting flexible, fast response capabilities, and increasing our
collaboration with Federal interagency partners, such as DoD and
Department of Veterans Affairs (VA). We also must work closely with our
state, local, territorial, and tribal partners, as well as the private
sector to enhance the capability to quickly distribute and dispense
medical countermeasures in an emergency--if we can't get these products
to the right place, at the right time, then the enterprise has failed.
Healthcare Readiness to Respond
The 2017 hurricane season highlighted the importance of national
healthcare readiness and medical surge capacity. ASPR led the public
health and medical responses to Hurricanes Harvey, Irma, and Maria
under the National Response Framework Emergency Support Function No. 8
mission. We worked closely with state and territory health officials in
affected areas to augment care with NDMS teams, VA personnel and
facility support, and DoD transportation, facilities, and clinicians.
Personnel under the supervision of HHS treated over 36,000 patients,
and HHS deployed over 4,500 personnel, evacuated nearly 800 patients,
awarded over 200 contracts, and provided nearly 950 tons of equipment.
During the response, due to the combined efforts of ASPR and the
Centers for Medicare & Medicaid Services (CMS), we utilized the
innovative HHS emPOWER program to identify and treat at-risk
individuals requiring electricity-dependent medical and assistive
equipment (e.g., ventilators, oxygen concentrators, feeding machines,
intravenous infusion pumps, suction pumps, dialysis machines,
wheelchairs). In one instance, ASPR teams used this data and worked
with Urban Search and Rescue teams to identify all of the dialysis
patients in the U.S. Virgin Islands and evacuate those patients for
treatment since the local dialysis centers were destroyed.
Despite our successes, we also learned that ASPR needs to improve
its internal capabilities as well as enhance our support for the
healthcare infrastructure across the country. As with medical
countermeasures, the Nation's healthcare delivery infrastructure is
mostly a private sector enterprise. We must better leverage and enhance
existing Federal programs--such as the Hospital Preparedness Program
and NDMS--to create a more coherent, comprehensive, and capable
regional system integrated into daily care delivery I call this the
foundation of a ``national disaster healthcare system.''
Conclusion
Through this second reauthorization of PAHPA, we have the
opportunity to build on the great progress made and further improve our
national readiness and response capabilities for 21st century health
security threats. The Department looks forward to working with you in
the months ahead to consider any legislative changes needed to achieve
this objective. I am committing the entire ASPR team's grit, ingenuity,
expertise, and perseverance to this mission. Thank you, again, for your
bipartisan commitment to this national security imperative, and I look
forward to continuing to work together to enhance our Nation's health
security. I am happy to answer any questions you may have.
______
Senator Burr. Thank you, Dr. Bob.
Dr. Gottlieb.
STATEMENT OF SCOTT GOTTLIEB, M.D., COMMISSIONER, U.S. FOOD AND
DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Gottlieb. Senator Burr, Ranking Member Murray, and
Members of the Committee.
Thank you for the invitation to testify today about genome
editing technology.
Our Nation has faced many emerging public health challenges
and unfortunately, will face additional challenges in the
future. Thankfully, our preparedness and the ability to respond
to such challenges has improved greatly since the original
enactment of the Pandemic and All-Hazards Preparedness Act.
Each emergency is unique. Many are the result of emerging
infectious threats, but the technology for manipulating science
for diabolical purposes is becoming more ubiquitous and widely
understood. So we face new and pervasive risks.
2017 was marked by the risks posed by several extreme
natural disasters, which caused significant devastation and
human suffering. These tragedies tested our Nation's
capabilities to respond.
Today, I am going to focus my remarks on the impact of
these storms on medical products manufactured in Puerto Rico
and the actions we are taking to mitigate existing and
potential product shortages.
The impact of Hurricane Maria showed the importance of
Puerto Rico to our medical product manufacturing base, as well
as the intricate and sometimes fragile nature of that supply
chain.
I want to focus on the complexities of the saline shortage
because it has stressed our system and I know that many of you
are deeply and rightly concerned by this situation.
Saline solution has been in and out of shortage for several
years. There are only a small number of primary manufacturers.
So when one manufacturer lowers production, even for routine
maintenance, there is stress on the entire system.
One of the largest manufacturers of I.V. saline is Baxter,
and their primary sites for small volume bags are located in
Puerto Rico. These sites struggled to regain power and return
to full capacity following the storm when roads to some of the
manufacturing plants were disabled.
We worked closely with Baxter in partnership with the
Department of Homeland Security, and Puerto Rico authorities,
and Bob--so thank you for your support, as well--to ensure that
they were able to get back on the power grid on a priority
basis to stabilize production.
We also worked with various saline manufacturers to find
other manufacturing facilities globally that could help supply
the U.S. until Baxter's Puerto Rico location was back up and
running and the shortage was addressed.
To mitigate that shortage, we worked with manufacturers on
the importation of saline from locations in Ireland, Australia,
Mexico, Canada, Germany, and most recently, Brazil. When we
import from international facilities, generally, the
manufacturers adjust their distribution to send some product to
the U.S., but there is no actual increase in the total global
production of product.
Baxter's manufacturing facilities in Puerto Rico are now
stable and on the grid, although the power situation on the
island is still fragile. We expect their return to normal
production will improve the situation.
Before the storms hit, and in anticipation of the crisis,
FDA also prioritized the approval of saline products by two
manufacturers, Fresenius Kabi laboratories, and Grifols. Both
should start production soon, and having these two additional
manufacturers online will help increase the overall supply of
saline produced and distributed in the U.S.
But this shortage has also had ripple effects. In order to
find workarounds for the filled saline bags that were in
shortage, providers have put various mitigation strategies in
place. One strategy has hospitals compounding product
themselves and this has caused an increased demand for empty
I.v. bags. There have been signals indicating that this
increased demand is putting pressure on the supply of empty
I.v. bags. The FDA is taking steps to address that situation
and determine which manufacturers could potentially increase
capacity if necessary.
I have reached out to some of these medical device
manufacturers personally to inquire about their capacity to
increase production as demand for I.V. containers continues to
increase.
The scope of the flu outbreak across the country has also
added to the strain on this tight supply chain. The shortage,
and the impact of the crisis in Puerto Rico, underscores the
need to continuously elevate our preparedness.
There are going to be lessons learned from this episode,
and already, we have made some key observations about our
ability to detect device shortages. Since we lack authority to
require notification of device shortages, we have had to depend
on manufacturers and distributors reaching out to the FDA or
had to seek them out proactively.
Our work in the shortage situation is an example of how the
FDA has reacted in response to emergency situations. At the
same time, we continue to work hard to improve our regulatory
clarity and predictability for the development of medical
countermeasures. That is an essential component of our national
preparedness strategy.
Today, we released draft guidance on Material Threat
Medical Countermeasure and Priority Review Vouchers which
explains how the FDA is implementing the PRV program to
incentivize the development of certain drug and biologics
medical countermeasures.
I look forward to working with Congress to continue to
increase our readiness for emergencies, and look forward to
answering your questions today.
[The prepared statement of Dr. Gottlieb follows:]
prepared statement of scott gottlieb
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, thank you for the opportunity to appear today to discuss
reauthorization of the Pandemic and All-Hazards Preparedness Act
(PAHPA). PAHPA, which was passed in 2006 and reauthorized in 2013, is a
key piece of legislation that--along with other significant legislative
achievements such as the Project BioShield Act of 2004, the Public
Readiness and Emergency Preparedness (PREP) Act (2005), and the 21st
Century Cures Act (Cures Act) enacted in 2016--has served to
significantly strengthen our country's preparedness for, and response
to, public health emergencies involving chemical, biological,
radiological, and nuclear (CBRN) threats as well as emerging infectious
disease threats, such as the Zika virus and pandemic influenza.
The Pandemic and All-Hazards Preparedness Reauthorization Act of
2013 (PAHPRA), in particular, recognized the key role the Food and Drug
Administration (FDA or the Agency) plays in emergency preparedness and
response, and codified and built on FDA's ongoing efforts to augment
review processes and advance regulatory science to enable FDA to better
respond to public health emergencies. The provisions in PAHPRA--as well
as in the other key pieces of legislation I mentioned--have provided
FDA with essential tools that continue to support us in our mission to
protect and promote public health.
FDA's Public Health Emergency Preparedness and Response Mission
FDA plays a critical role in facilitating preparedness for and
response to CBRN and emerging infectious disease threats. These threats
can and often do emerge without warning as was the case with the
anthrax attacks of 2001, the 2009 H1N1 influenza pandemic, the 2014
Ebola outbreak in West Africa, as well as in the ongoing Zika virus
outbreak.
FDA's role in facilitating preparedness for, and response to, CBRN
and emerging infectious disease threats focuses largely on facilitating
the development and availability of medical countermeasures--such as
vaccines, therapeutics, and diagnostic tests--to respond to these
threats. FDA works closely with its HHS and other U.S. Government
partners through the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE), as well as
with regulated industry and non-governmental organizations (NGO's), to
build and sustain the medical countermeasure programs necessary to
effectively respond to public health emergencies. FDA is also committed
to working closely with the Department of Defense (DoD) to facilitate
the development and availability of medical countermeasures to support
the unique needs of our Nation's warfighters. The Agency is already
actively implementing the legislation enacted at the end of last year
to further prioritize this critical work with DoD. Senior leadership at
the Agency is leading these efforts, and we look forward to keeping
Congress informed of our progress in these critical areas.
FDA's Medical Countermeasures Initiative (MCMi)--established in
2010--brought additional resources to FDA that enabled FDA to hire
additional expert staff and to become more deeply and thoroughly
engaged in medical countermeasure activities. This program continues to
be key to establishing clear regulatory pathways for medical
countermeasures, advancing medical countermeasure regulatory science to
support regulatory decisionmaking, and advancing important policies and
mechanisms to facilitate the timely development and availability of
medical countermeasures. FDA's goal is to be modern and efficient in
its regulation of safe and effective medical products, and that
includes medical countermeasures.
FDA's operations within its medical countermeasures mission cover a
broad range of activities vital to facilitating the development of, and
access to, safe and effective medical countermeasures, including:
Reviewing medical countermeasure marketing applications
and approving those that meet standards for safety and efficacy;
Providing regulatory advice, guidance and technical
assistance to sponsors developing medical countermeasures, as well as
to U.S. Government partners, international regulators, and
international organizations such as the World Health Organization;
Supporting efforts to establish and sustain an adequate
supply of medical countermeasures, including averting supply
disruptions when feasible and, in certain situations, allowing products
to be used beyond their expiration dates when supported by appropriate
scientific evaluation;
Enabling access to medical countermeasures that are not
yet approved for use--when necessary--through an appropriate mechanism,
including through FDA's Emergency Use Authorization (EUA) authority;
Proactively identifying and resolving regulatory
challenges associated with medical countermeasure development and
ensuring that FDA regulations and policies adequately support medical
countermeasure development and enable preparedness and response
activities;
Fostering the professional development of FDA scientists
to ensure that FDA personnel maintain the skills and abilities to
support the medical countermeasure mission; and
Supporting regulatory science to create the tools,
standards, and approaches necessary to develop and assess the safety,
efficacy, quality, and performance of medical countermeasures.
FDA is also a critical partner in preparing for, and responding to,
natural disasters, as demonstrated by its ongoing 2017 hurricane
recovery efforts, including its work in Puerto Rico following Hurricane
Maria. FDA performs extensive preliminary work in advance of storms to
help prepare for potential impacts. For example, FDA utilizes storm
prediction data and firm registration data bases to prepare maps to
identify FDA-regulated firms, including those that manufacture critical
products that could be impacted by the storms. Where necessary, FDA may
take contingency steps to help ensure a continuous supply of critical
medical product manufacturing. The most significant role that FDA plays
comes after the storm, as facilities come back on line and may need
remediation, and farmers seek to put crops or farmland that were
damaged back into commercial use. FDA has supported the many
pharmaceutical and medical device manufacturers in Puerto Rico to help
address and prioritize recovery operations based on the potential for
medical product shortages based on public health needs. Many of the
requests FDA received were for infrastructure support, primarily
getting a reliable source of power, and FDA worked with partners at the
Department of Homeland Security to support getting critical
manufacturing back online. Through product registrations and
communications with manufacturers, FDA was able to identify the
medically necessary products manufactured in Puerto Rico and determine
which were the top public health priorities. FDA continues to be
focused on storm-related shortage issues, including shortages of saline
solution and amino acids, as well as the cascading increase in demand
for other medical products, such as empty IV containers which are now
being used in higher quantities for compounded products. FDA has been
in direct communication with manufacturers, distributors, hospitals and
other health care providers, including the Department of Veterans
Affairs (VA), and we are assessing existing product supply, demand
trends and manufacturer capacity to increase availability of the empty
IV containers.
Fostering Innovation in Medical Countermeasure Development
At FDA, we fully appreciate that the development of medical
countermeasures can present complex and unique challenges. For example,
it is not ethical to conduct human studies for many of the high-
priority threat agents. In these situations, the Animal Rule, which
enables animal efficacy studies to substitute for efficacy trials in
humans if the results can reasonably be extrapolated to the expected
human use, can be used to facilitate the development and availability
of medical countermeasures. PAHPRA recognized the importance of the
Animal Rule; and in 2015, FDA finalized guidance for product
development under the Animal Rule, incorporating the learnings of
considerable product development experience and providing scientific
and regulatory expectations for animal data intended to support medical
countermeasure approval.
To date, 12 medical countermeasures have been approved under the
Animal Rule, including inhalational anthrax therapeutics, a botulism
antitoxin, antibiotics for the treatment and prophylaxis of plague, and
treatments for acute radiation syndrome. These approvals underscore the
critical role the Animal Rule and animal studies can play in advancing
medical countermeasures for some of the most challenging threats. Of
note, through the use of regulatory science, FDA was able to approve
the inhalational anthrax therapeutics and the botulism antitoxin for
use in children as well as adults, despite the fact that pediatric
patients were not actually studied in clinical trials, due to ethical
concerns.
However, for many threats there are not yet adequate regulatory
science foundation, such as animal models to support medical
countermeasure development or sufficient biomarkers to enable the
extrapolation of data generated in animal models to humans. Without
such tools, it is difficult to generate the data necessary to support
regulatory decisionmaking.
FDA has established a broad and robust portfolio of cutting-edge
research under MCMi's Regulatory Science Program to help develop these
tools and promote innovation in the development of medical
countermeasures. A few examples of projects include: supporting the
development of organs-on-chips models to assess radiation damage in
lung, gut, and bone marrow, and then using these models to test
candidate medical countermeasures; collaborating to establish a
publicly available genomic sequence reference data base for use by
developers seeking to validate candidate multiplex in vitro diagnostic
tests that could be used to diagnose multiple pathogens simultaneously;
developing reference materials for developers to use to validate
nucleic acid-based and serological diagnostic tests for Zika virus;
supporting a project to identify and correlate biomarkers of host
response to Ebola virus infection in animal models and humans to
support medical countermeasure development; developing methods for
obtaining safety and limited efficacy data from patients who receive
medical countermeasures during public health emergencies; and
establishing the Animal Model Qualification Program designed to support
medical countermeasure development by promoting the development of
animal models for use across multiple product applications, thereby
minimizing duplication of effort and resources.
PAHPRA also provided authorities to ensure that FDA personnel are
well-trained in how to review medical countermeasure applications for
approval. Under these authorities, FDA has established a professional
development program, including speakers' series and academic
certifications, to ensure that FDA scientists are working through the
regulatory challenges posed by new areas of science and technology as
they relate to medical countermeasure development. FDA also has spent
considerable energy and resources establishing an efficient approach to
conduct and support training within the agency.
More recently, the Cures Act included several provisions that are
intended to advance innovation in medical product development more
generally, but will also help to facilitate the development of medical
countermeasures, including the provisions to encourage novel trial
designs, and to develop new antimicrobial drug products.
Through the Cures Act, Congress also provided a new priority review
voucher (PRV) program to help incentivize the development of material
threat medical countermeasures. Under this program, FDA will award a
PRV upon approval of a material threat medical countermeasure
application provided that certain criteria are met. The PRV may in turn
be used by the sponsor who receives it, or sold to another sponsor, who
may then use it to obtain priority review for a product application
that would otherwise not receive that benefit, enabling a developer to
potentially bring a product to market sooner than otherwise possible--
something that may be of great value to product developers. FDA plans
to issue guidance to address medical countermeasure-specific
considerations with the intent to implement the program consistently
with the other PRV programs, such as the Neglected Tropical Disease
Voucher Program.
There are tremendous opportunities to continue to further the
development of groundbreaking, innovative medical countermeasures, and
the Agency intends to fully seize and build upon these opportunities.
Toward that goal, this past July FDA announced the launch of a
comprehensive Innovation Initiative aimed at making sure its regulatory
processes are modern and efficient so that safe and effective new
technologies, including medical countermeasures, can reach patients in
a timely fashion.
Facilitating Access to Safe and Effective Medical Countermeasures
Enabling access to medical countermeasures when they are needed is
a high priority for FDA. Amended and new authorities provided by
Congress have enabled the Agency to further prepare for, and better
respond to, emerging public health threats. For example, PAHPRA amended
FDA's EUA authority to provide additional flexibility for issuing EUAs.
These additional flexibilities have enabled FDA to better support
responses to emerging health threats by issuing nearly 40 EUAs to
enable the emergency use of in-vitro diagnostic devices for H7N9
Influenza virus, Enterovirus D68 (EV-D68), Middle East Respiratory
Syndrome Coronavirus (MERS-CoV), Ebola virus, and Zika virus. FDA also
issued an EUA to enable the emergency use of an auto-injector medical
countermeasure to maintain preparedness for chemical threats, which has
been critical for supporting both warfighter and first responder
preparedness goals related to an emergency involving nerve agents. The
authority for prepositioning medical countermeasures provided in PAHPRA
also proved useful to allow the manufacturer to ship, and the U.S.
Government stakeholders to receive, certain strengths of the unapproved
auto-injectors that were not yet authorized for use under that EUA.
PAHPRA also provided FDA with several new streamlined authorities
to facilitate the emergency use of approved medical countermeasures
without the need for issuing an EUA. For example, PAHPRA provided FDA
with the authority to issue emergency dispensing orders (including mass
dispensing at a point of dispensing (POD)) for approved medical
countermeasures during an actual CBRN emergency without requiring an
individual prescription for each recipient of the medical
countermeasure, if permitted by state law or in accordance with an
emergency dispensing order issued by FDA. FDA has used this authority
to issue emergency dispensing orders to permit emergency dispensing of
doxycycline and ciprofloxacin for post-exposure prophylaxis of
inhalational anthrax, to ensure government stakeholders can rapidly
provide these therapies in the event of an anthrax attack. \1\
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\1\ The term ``stakeholder(s)'' means the public agency or its
delegate that has legal responsibility and authority for responding to
an incident, based on political or geographical boundary lines (e.g.,
city, county, tribal, state, or federal), or functional (e.g., law
enforcement or public health range) or sphere of authority to
prescribe, administer, deliver, distribute, or dispense oral
doxycycline products in an emergency situation.
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Another new FDA authority created by PAHPRA is the explicit ability
to extend expiration dating of eligible FDA-approved medical
countermeasures stockpiled for use in CBRN emergencies, if the
extension is supported by an appropriate scientific evaluation. This
authority streamlines FDA's ability to authorize expiration dating
extensions without the need to issue an EUA, which will enable faster
response, and has been crucial to FDA's ability to support preparedness
efforts. For example, when production stopped after quality issues were
identified in the manufacturing process of auto-injectors used for the
treatment of nerve agent and insecticide poisoning, FDA used this
authority to help prevent shortages of auto-injector products to help
ensure that the Nation's warfighters and first responders continue to
have ready access to these products. FDA also used this authority to
extend the expiration date of certain lots of doxycycline capsules held
in strategic stockpiles by the Centers for Disease Control and
Prevention, state and local public health, and other response
stakeholders and issued draft guidance to provide recommendations to
government stakeholders on testing that can be conducted to support
future extensions, in order to help sustain preparedness levels.
The Cures Act also amended the EUA and related emergency use
authorities to clarify their applicability to animal drugs. FDA
encourages anyone interested in utilizing these authorities to contact
FDA to discuss how to proceed.
Most recently, Congress passed H.R. 4374, legislation that amends
FDA's EUA authority to enable FDA to issue EUAs for medical products to
reduce deaths and mitigate injuries from agents that may cause
imminently life-threatening and specific risks to United States
military forces. Prior to the passage of this legislation, the EUA
authority was only applicable to medical products to address CBRN
threats. In addition, the legislation contains provisions codifying
enhanced collaboration between FDA and DoD, in order to facilitate the
development of medical products and countermeasures for the warfighter.
FDA is working closely with DoD to implement these new and amended
authorities as quickly as possible.
Conclusion
At FDA, we have made it a priority to proactively work with our
private sector and government partners to help facilitate the
translation of breakthrough discoveries in science and technology into
innovative, safe, and effective medical countermeasures. FDA takes its
responsibility seriously to help drive and foster innovation as part of
advancing public health and our national security. Active FDA
involvement is essential to encouraging industry engagement in medical
countermeasure development. FDA remains deeply committed to working
closely with its partners and continuing to use the authorities
Congress provides to the fullest extent to help facilitate the
development and availability of safe and effective medical
countermeasures. We believe that partnership and innovation will
continue to be key drivers to success in the medical countermeasure
space and are taking steps to further empower FDA's scientific and
clinical experts to drive the innovation necessary to help protect the
Nation from the threats we may face.
FDA appreciates Congress's support in continually delineating,
clarifying, expanding, and extending its authorities--and providing
resources--to enable FDA to achieve its public health emergency
preparedness and response mission. FDA stands ready to work with
Congress and stakeholders to enable us to better achieve this critical
work.
Thank you for inviting FDA to testify today. I am happy to answer
any questions you may have.
______
Senator Burr. Thank you, Scott.
Dr. Redd.
STATEMENT OF STEPHEN C. REDD, M.D., RADM, DIRECTOR, OFFICE OF
PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR DISEASE
CONTROL AND PREVENTION, ATLANTA, GA
Dr. Redd. Senator Burr, Chairman Alexander, and Ranking
Member Murray.
I am Dr. Stephen Redd, the Director of the Office of Public
Health Preparedness and Response at the Centers for Disease
Control. And I am pleased to be here to talk with you today
about the role the CDC plays in public health preparedness and
response, including those responsibilities under the Pandemic
and All-Hazards Preparedness Reauthorization Act.
The CDC is the common defense of the country against health
threats. Our work to prepare and respond to health emergencies
require that we build on our day to day in two particular
areas.
No. 1, our longstanding partnership with state and local
health departments and;
No. 2, our medical, scientific, and program expertise.
I will describe the three pillars of our defense strategy:
science, surveillance, and service.
First, the CDC has a unique collection of scientific
expertise that exists nowhere else in the world. We have the
ability to identify agents causing illness, whether that
illness is caused by an infectious microbe, or a chemical, or a
radiation exposure.
We are ready to respond to a broad range of threats
including diseases like Ebola, small pox, and H7N9 influenza.
The CDC plays a key role in discovering new and emerging
infectious diseases using advanced detection techniques to
identify pathogens quickly and more accurately.
Every year, laboratories from all over the world send
hundreds of thousands of specimens to the CDC for testing.
The second pillar enabling the CDC's common defense of the
country is surveillance. Public health surveillance is the
collection, analysis, and use of data to target public health
prevention and response. It is basically making sure the best
information is used to make the right decisions.
Examples of this work include what we do to track
influenza, the National Syndromic Surveillance system and the
Global Disease Detection Program.
Influenza is probably the greatest natural health threat we
face. Influenza viruses change continuously and require
vigilance to detect these changes. The CDC provides support to
every state, to several major cities, and to a number of
ministries of health throughout the world to conduct influenza
surveillance and laboratory work.
With the National Syndromic Surveillance Program, the CDC
collects de-identified health information on causes of
emergency room, urgent care, and hospital visits. We, along
with state and local health departments, use the data in real
time to detect abnormal situations requiring public health
response.
The CDC's Global Disease Detection Operation Center
monitors 30 to 40 outbreaks every day across the globe, 24/7,
and assesses the potential risk to the United States from these
events. In addition to science and surveillance services, the
final pillar is supporting the CDC's common defense of the
country.
Let me focus on three particular programs, the Public
Health Emergency Preparedness Program, the Strategic National
Stockpile, and the Cities Readiness Initiative.
In each of these programs, the keys to success are the
close collaboration between CDC and state and local public
health departments, and the connection of these programs to
CDC's scientific expertise.
The Public Health Emergency Preparedness grants go to every
state and support staff, enable exercises to test and validate
capabilities, and pay for laboratory and communications
equipment.
The Strategic National Stockpile is a $7 billion repository
of pharmaceuticals, medical supplies, and medical equipment
that is available for rapid delivery to support responses to
health emergencies.
The CDC's Cities Readiness Initiative enhances preparedness
in the Nation's 72 largest cities where nearly 60 percent of
the U.S. population resides. These funds are used to develop,
test, and maintain plans to receive countermeasures from the
CDC's Strategic National Stockpile and rapidly dispense them.
I would like to leave the Committee with three primary
points about the CDC's role in public health emergency
preparedness and response.
First, the CDC is the common defense of the country against
health threats.
Two, CDC's preparedness work is built on a day to day
foundation of our broad and deep scientific medical and program
expertise.
Three, the CDC's longstanding partnerships with state and
local health authorities are essential.
Thank you for the opportunity to testify today.
[The prepared statement of Dr. Redd follows:]
prepared statement of stephen c. redd
Chairman Alexander, Senator Murray, and other Members of the
Committee. I am Rear Admiral Stephen Redd, Director of the Office of
Public Health Preparedness and Response at the Centers for Disease
Control and Prevention (CDC). I appreciate the opportunity to be here
today to discuss CDC's public health preparedness and response mission,
and the agency's role in implementing the Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (PAHPRA).
CDC provides for the common defense of the country against public
health threats. Through our dedication to science, surveillance, and
service, CDC focuses on protecting the public health of the Nation from
threats such as emerging infectious diseases, natural disasters, and
terrorism.
In carrying out the mission set forth under the Pandemic and All
Hazards Preparedness Reauthorization Act, CDC draws on expertise from
throughout the agency. CDC's expertise includes world-class laboratory
testing, surveillance (for disease detection), epidemiology, guidance
to healthcare providers, incident management, logistics, emergency risk
communication, disease control programs, distribution of medical
countermeasures, human and animal medicine, and responder health and
well-being. Our multidisciplinary workforce enables an integrated
national system that is nimble and prepared to detect and respond to
any developing situation that could affect the health of people in the
United States. In addition, CDC draws on its long-standing
relationships and close collaboration with state and local partners to
protect the health of communities across the country, and collaborates
closely with the Assistant Secretary for Preparedness and Response
(ASPR), the Food and Drug Administration (FDA) and other Federal
partners.
CDC experts lead and staff every activation of the agency's
Emergency Operations Center (EOC), ensuring response activities are
effective and efficient. HHS/CDC has an emergency management program
accredited by the Emergency Management Accreditation Program. CDC
activated its incident management system for 67 responses over the last
16 years, between September 2001 and December 2017. During a response,
CDC's EOC rapidly deploys scientific experts, coordinates the delivery
of supplies and equipment to the incident site, monitors response
activities, provides resources to state and local public health
departments, and disseminates timely and accurate information within
government, to health care providers, and to the public. During the
agency's Zika and Ebola responses, CDC deployed over 1,700 and 3,700
staff, respectively. CDC also responds to public health events that do
not require EOC support. In fiscal year 2017, CDC assisted state,
local, and overseas public health authorities in 23 epidemiologic
investigations of emerging infectious disease outbreaks as well as more
than 20 environmental responses.
CDC Programs under the Pandemic and All Hazards Preparedness
Reauthorization Act
The Pandemic and All Hazards Preparedness Reauthorization Act of
2013 (PAHPRA) reauthorized several public health preparedness programs.
The discussion immediately below focuses on two of those programs:
CDC's Public Health Emergency Preparedness cooperative agreement
program (which includes the Cities Readiness Initiative (CRI)) and the
Strategic National Stockpile (SNS). Later in the testimony I will
discuss CDC's work related to a third PAHPRA program, biosurveillance.
Public Health Emergency Preparedness Cooperative Agreement (PHEP)
Program: The PHEP cooperative agreement program is the largest CDC
state program and provided approximately $600 million to state, local,
and territorial public health departments in 2017. The program
developed the first playbooks for public health preparedness and
response, and has been instrumental in integrating state and local
health departments into their jurisdictions' emergency response
structures. PHEP currently supports 62 awardees--including all 50
states, eight territories and freely associated states, and directly
funded cities (New York City; Washington, DC.; Chicago; and Los
Angeles). Funding is awarded according to a base-plus population
formula prescribed by statute, which ensures a minimum amount of
funding to each awardee. These funds support preparedness and response
staff, enable exercises to test and validate capabilities, provide for
timely training, and pay for laboratory and communications equipment
essential to maintaining preparedness. In addition, CDC personnel
support PHEP awardees by helping to identify and address gaps in
preparedness capabilities, providing planning resources to ensure the
needs of at-risk individuals are incorporated into response strategies,
and improving response capabilities from experience gleaned during
public health responses, most recently to Ebola and Zika.
Strategic National Stockpile (SNS): The SNS is the largest
federally owned repository of vaccines, drugs, medical supplies,
Federal Medical Stations, and medical equipment available for rapid
delivery to support federal, state, and local response to health
security threats. The SNS was created in 1999 to ensure the Nation's
readiness against public health emergencies by ensuring delivery of
lifesaving medical countermeasures (MCMs) during deliberate or
naturally occurring outbreaks and other events that threaten public
health. Since its inception, SNS products and staff have been deployed
more than 100 times for events ranging from natural disasters to
infectious disease outbreaks. CDC works with the HHS Assistant
Secretary for Preparedness and Response and with other Federal agencies
through the Public Health Emergency Medical Countermeasures Enterprise
(PHEMCE) to prioritize Federal investments in medical countermeasures
based on analysis of risk, benefits to the American people and
sustainability of the MCM pipeline.
Management of the SNS and deployment of its assets are complex
endeavors which rely on a broad range of scientific expertise,
surveillance systems, public health communications systems, and state
and local partners. The SNS ensures that the right medical
countermeasures and supplies are available when, where, and in the
quantity needed to stop or slow a public health emergency and save
lives. And, scientific experts ensure that medicine and supplies
expeditiously get to our public health partners at the state and local
levels, who have had the necessary training, exercises, and clinical
guidance to effectively and efficiently receive those assets from the
SNS and get them to those who need them.
Cities Readiness Initiative (CRI): CRI, funded through the PHEP
cooperative agreement, enhances preparedness in the Nation's largest
population centers, where nearly 60 percent of the population resides.
The 72 cities (at least one in every state) use CRI funds to develop,
test, and maintain plans to quickly receive medical countermeasures
from the SNS and distribute them to local communities. This program,
through reliance on local boots on the ground, enables effective
response to large-scale public health emergencies needing life-saving
medications and medical supplies.
Public Health Preparedness through Science, Surveillance and Service
In carrying out its public health mission CDC's subject matter
experts from across the agency collaborate to detect and respond to
emerging threats that could affect Americans' health.
Science:
Exceptional and world-renowned scientific expertise and world-class
laboratories ensure CDC is ready and able to respond to a broad range
of threats, including highly hazardous and infectious diseases like
Ebola, smallpox, and H7N9 influenza. For example, CDC's research on the
smallpox virus helps find better drugs to treat the disease, stop the
virus from spreading, make safer vaccines, and improve tests to detect
the virus. Additionally, CDC's global influenza capacity-building
efforts helped facilitate the rapid detection of the novel Asian linage
influenza A (H7N9) virus in 2013. Most human infections resulted from
exposure to infected poultry, but CDC assesses that the virus poses the
greatest pandemic risk of all influenza viruses not yet circulating
among humans, and is working with global health partners to monitor
that virus and detect changes in it that could trigger a pandemic. CDC
has developed two candidate vaccine viruses and shared them with
vaccine manufacturers, for use in BARDA-supported vaccine production
and in clinical trials by NIH's National Institute of Allergy and
Infectious Disease. If the H7N9 virus develops the capacity to spread
among humans, an effective vaccine would be key for preventing a
pandemic.
CDC plays a critical role in discovering new and emerging
infectious diseases, using advanced molecular detection techniques that
combine next-generation genomic sequencing, high-performance computing,
and epidemiology to identify pathogens faster and more accurately.
Laboratories from all over the world send specimens to CDC, often in
cases where the cause of illness is unknown. Annually, CDC receives
hundreds of thousands of specimens to examine and helps diagnose
hundreds of cases of unexplained illness or death. Through advanced
molecular detection investments, CDC is seeing improvements in faster
detection of outbreaks (catching them when they are smaller) and in
faster development of diagnostics, applying these technologies in
dozens of areas such as foodborne disease, influenza, antimicrobial
resistance, hepatitis, pneumonia, and meningitis. CDC shares genetic
sequencing technologies with state and local health departments, and
funds them to acquire new technology that helps them to respond quicker
and more efficiently at a local level.
CDC is critical to preparing for the next influenza pandemic. In an
influenza emergency, CDC's public health and infectious disease experts
use advanced molecular detection techniques to identify disease strains
that could cause a pandemic, release recommendations for the
prevention, diagnosis, and treatment of disease, and provide
communication to the Nation about the pandemic. For example, each human
case of infection with a new animal influenza virus represents the
potential for a pandemic. CDC receives and studies viruses like these
in its laboratories to better understand where and how they spread and
the nature of illness they cause. This informs development of clinical
and public health recommendations before and during emergency
responses. In the event of an influenza pandemic, CDC's scientific
experts use the best epidemiologic and laboratory data available to
update or develop guidance to inform purchasing, distribution, and use
of medical countermeasures including vaccines, antiviral drugs,
respirators or masks, and ventilators. CDC also develops and evaluates
solutions to lessen the impact of an influenza pandemic through non-
pharmaceutical interventions or actions that people and communities can
implement to help slow the spread of influenza, such as staying home
when ill, coordinating school closures, and postponing mass gatherings.
CDC has longstanding collaboration with countries and institutions
around the world. These strategic partnerships coupled with forward
deployment of our scientists stationed in more than 60 countries enable
CDC to identify new pathogens, assess risks, and devise effective
control measures. Our partnerships provide the platforms for timely
sharing of laboratory specimens, innovations and distribution of
diagnostic materials and technologies to prevent epidemics, and
promptly respond to disease outbreaks before they cross international
borders.
Vector-borne diseases present another preparedness challenge, as we
saw in the Zika emergency. CDC is one of the Nation's public health
authorities on vector-borne diseases, like Zika, plague, and dengue.
CDC scientists who specialize in vector-borne disease have deep
expertise in entomology, microbiology, virology, veterinary medicine,
zoology, and public health that does not exist elsewhere. These experts
develop diagnostic tools and clinical guidance, as well as methods of
treatment, prevention, and vector control, in order to slow the spread
of these diseases. For example, CDC scientists have determined that a
natural plant ingredient called nootkatone effectively repels and kills
the mosquitoes and ticks that can spread disease. Nootkatone appears to
work differently than available insecticides, and it could help fight
mosquitoes that are resistant to existing insecticides.
CDC's scientific experts protect people from environmental health
threats like contaminated water, radiation, and chemical emergencies.
To do so, CDC identifies the environmental exposures that make people
sick, investigates how those exposures are transmitted in the
environment, and finds ways to eliminate the threat to people's health.
For example, CDC's radiation guidelines help public health officials
and clinicians prepare for, and respond to, radiation emergencies and
treat exposures.
The list of CDC's scientific expertise is much longer than I have
detailed, including myriad chronic diseases and also includes
foundational scientific expertise critical to effective public health
impact such as in the areas of workforce, laboratory systems, and data
sciences.
Surveillance:
Public health surveillance--the collection, analysis, and use of
data to target public health prevention and intervention activities--is
the foundation of public health practice. CDC monitors health
surveillance information around the clock to detect and track diseases
and protect Americans. As one example, following 9/11, CDC made
investments in enhancing syndromic surveillance--using health-related
data based on patient symptoms that precede diagnosis--as an early
warning system for bioterrorism. This system now allows officials to
detect a much wider range of health threats--from opioid overdoses to
chemical spills to disease outbreaks. Moreover, CDC collects, analyzes,
and interprets human, animal, environmental, and food surveillance
data, in order to identify and respond to potential health threats
before they become emergencies. In aggregate, CDC's specialized
surveillance systems provide prompt situational awareness and early
warning for unknown or unexpected threats. CDC's surveillance
activities directly support states in their primary responsibilities in
protecting the public's health. Surveillance data, collected in
collaboration with domestic and international partners, inform CDC's
threat assessments and ensures response actions are at the right speed,
scope, and scale to protect Americans.
CDC supports integrated disease surveillance activities at the
state and local level through funding and provision of surveillance
tools and services. The following are examples of the surveillance
systems and support that CDC provides to state, local, and territorial
public health departments to develop and strengthen their surveillance
activities:
National Notifiable Diseases Surveillance System (NNDSS):
NNDSS is a nationwide system that enables all levels of public health--
local, state, territorial, Federal, and international--to collect and
share data on approximately 100 diseases and conditions that are
required to be reported in all 50 states, and keeps them under
continuous surveillance. This system provides comprehensive, timely,
and high-quality data for public health decisionmaking, enabling CDC
programs to work with state partners to better monitor disease
occurrence, identify potential outbreaks, recognize emerging trends,
track the impact of public health interventions, and respond..
Influenza Surveillance: Influenza viruses are constantly
changing, and, thus, require continued vigilance to protect the United
States and the rest of the world from both seasonal and pandemic
influenza threats. Influenza surveillance, both epidemiologic and
virologic, is at the core of influenza preparedness. The surveillance
platforms used year round to combat seasonal influenza threats serve as
the foundation for pandemic influenza surveillance. CDC provides
support to every state, and several major municipalities and
territories, to conduct influenza surveillance and laboratory work. For
many decades, CDC has served as an international leader in global
influenza surveillance. We have partnered with more than fifty
countries to establish, maintain, and expand influenza surveillance and
laboratory capacity, in order to find influenza viruses where they
emerge as quickly as possible to mitigate their potentially devastating
impact on the United States. Domestic funding supports seasonal
influenza surveillance through a network of interrelated systems that
provide data on where influenza and influenza-like illnesses,
hospitalizations, and deaths occur.
National Syndromic Surveillance Program (NSSP): CDC, through state
and local collaborations, collects de-identified health information on
emergency room, urgent care, and hospital visits, as well as pharmacy
and laboratory data. This investment has revolutionized public health
surveillance to include this new type of data collection on top of
traditional type and methods of data collection. States and local
public health departments use the syndromic data to detect and
characterize abnormal situations meriting further public health
investigation. This strengthens local public health capacity to detect,
respond to, and manage, outbreaks and other critical public health
events. CDC has negotiated access to the data to enable situational
awareness at regional and national levels. The series of three recent
hurricanes presents a poignant example that demonstrates the usefulness
and flexibility of this asset. Before the hurricanes, CDC and ASPR had
begun establishing a mechanism to share National Disaster Medical
Assistance Team (DMAT) data during mass gatherings. As the hurricanes
hit, CDC and ASPR established data flow mechanisms and rules, and in 2
days put in place a system to receive hourly data from DMATs, resulting
in timely information that helped responders target communities at
greatest need for public health interventions.
Vector-Borne Surveillance: CDC operates systems that
allow for national and state-based monitoring of specific vectors, such
as ticks and mosquitoes, which carry diseases and pose risks for
outbreaks. These systems monitor laboratory documented cases of
disease, allowing for the early detection of outbreaks and helping
decisionmakers determine when and how to act in the interest of the
public's health. State, territorial, city, and local health departments
populate CDC's surveillance systems to inform vector control and
management activities.
Antibiotic Resistance Surveillance: Beginning in fiscal
year 2016, Congress recognized the large and growing threat of
antibiotic resistance and appropriated funding to CDC to detect and
respond to resistant pathogens, prevent the spread of resistant
infections, and collaborate with partners to encourage innovation for
new prevention strategies. CDC has multiple surveillance systems that
can detect and track resistant threats across healthcare, food, and the
community. One important investment begun in 2016 is CDC's Antibiotic
Resistance Laboratory Network (ARLN), which supports nationwide
laboratory capacity to rapidly detect antibiotic resistance in
healthcare, food, and the community, and inform local responses to
prevent spread and protect people. The ARLN includes seven regional
laboratories, the National Tuberculosis Molecular Surveillance Center,
and laboratories in 50 states, five cities, and Puerto Rico. The ARLN
is vital to detecting new and emerging resistant pathogens, including
those that are untreatable, to trigger infection control response
measures to prevent spread. The ARLN collects actionable data on
threats including the ``nightmare bacteria,'' carbapenem-resistant
Enterobacteriaceae (CRE), Candida auris, and Neisseria gonorrhoeae;
some strains of these pathogens have become resistant to all or nearly
all available antibiotics. In addition, samples from the ARLN can be
made available to researchers to support innovations in antibiotic and
diagnostic development.
Global Disease Detection: CDC's Global Disease Detection
(GDD) Operations Center monitors outbreaks 24/7 across the globe,
assesses their potential risk to the United States and communities
around the world, and improves global public health surveillance. The
GDD Operations Center monitors approximately 30-40 public health
threats each day, including outbreaks, disasters, poisonings, and
chemical, radiological, or nuclear events. Since 2007, CDC has tracked
more than 170 unique diseases globally and identified outbreaks in more
than 190 countries. This tracking provides the agency with critical
early warning and response capabilities.
Global Polio Surveillance: CDC, as part of the Global
Polio Eradication Initiative, supports polio surveillance to track
potential cases and circulating viruses and to effectively target polio
immunization efforts. The goal of these efforts is polio elimination in
every country and eventual worldwide eradication, and we are closer
than we have ever been to achieving that monumental accomplishment. In
2017, the Global Polio Eradication Initiative identified just 20 wild
poliovirus cases worldwide, down from 350,000 cases in 1988 when the
global eradication initiative began. The global polio surveillance
system, coupled with the CDC-supported Global Poliovirus Laboratory
Network (comprised of 145 laboratories around the world), also detects
and assists in the diagnosis of other epidemic prone diseases such as
measles, rubella, and yellow fever.
Taken together, these surveillance systems provide an early warning
alert, allowing CDC to protect the health of Americans through rapid,
evidence-based action.
Providing Public Health Services:
State and local public health agencies are the cornerstones of
preparedness and response. When states are prepared to respond,
communities are better protected and more resilient in the face of
threats. CDC has long-established relationships with state and local
officials, and coordinates with them effectively and efficiently during
public health emergency responses. CDC also collaborates with foreign
ministries of health to protect global health security that directly
impacts United States health security. Examples of CDC's critical
support of state, local, and foreign health agencies to ensure they are
ready to respond to emergencies include:
24/7 public health consultation and disease expertise.
Enabling a quality public health laboratory system while
maintaining critical laboratory infrastructure and specimen testing
support.
Managing and delivering medical countermeasures.
Public health workforce development that complements
preparedness-specific provision of guidance, training, and exercises to
ensure jurisdictions are ready to detect and respond to an emergency.
In the event of an outbreak, bioterrorist attack, or chemical or
radiological release, laboratory capacity is essential to quickly
detect, diagnose, and treat those who are impacted. CDC's Laboratory
Response Network (LRN) maintains an integrated network of state and
local public health, Federal, and international laboratories that can
respond to all types of public health threats. The linking of state and
local public health laboratories, and veterinary, agriculture, and
water-and food-testing laboratories is unprecedented and provides for
training, rapid testing, timely notification, and secure messaging of
laboratory results. With the LRN, CDC has developed and deployed tests
to combat our country's most pressing infectious and non-infectious
health issues, from Ebola to Zika to ricin toxin to nerve agents.
CDC ensures the Nation is able to respond to influenza pandemics,
vector-borne or vaccine-preventable disease outbreaks, other emerging
infectious disease threats, and environmental health threats by
supporting planning efforts among health departments, hospitals, and
emergency responders. CDC tests its pandemic influenza response
capabilities with federal, state, and local partners through virtual
tabletop and functional exercises. CDC evaluates and improves its
response plans based on lessons learned from previous responses and
exercises. CDC supports state and local health departments directly
during vector-borne and environmental health incidents by developing
and evaluating novel repellents and other prevention tools; improving
and deploying diagnostic tools and tests; responding to toxic health
threats; and providing unique expertise and training regarding
radiation.
The existing public health system, its people, networks and
resources, form the basis for response to health emergencies. For
example, CDC's National Center for Immunization and Respiratory
Diseases funds state infrastructure awards, manages vaccine shortages,
prevents disease outbreaks and responds early and rapidly should they
occur, and stands ready to respond quickly and comprehensively to other
urgent emergencies requiring vaccination such as a pandemic or biologic
attack. CDC also funds state and local public health agencies through
the Epidemiology and Laboratory Capacity for Infectious Diseases
cooperative agreement (ELC). This funding allows jurisdictions to
strengthen their basic epidemiologic and laboratory capacity to address
infectious disease threats. Multiple CDC programs use the ELC platform
to protect the public health and safety of the American people by
supporting health departments to effectively detect, respond to,
prevent, and control a wide range of known and emerging (or re-
emerging) infectious diseases. These CDC programs and others provide
ongoing support to prevent, prepare for, and respond to public health
emergencies.
An outbreak that starts in another country can hit our shores in a
matter of hours. Strengthening global health security protects
Americans' health. New diseases, like MERS and influenza H7N9, can
emerge without warning and have the potential to cause widespread
infection and fear. CDC works with 31 Global Health Security Agenda
partner countries to help them build the core public health capacities
necessary for identifying and containing outbreaks before they become
epidemics that could affect us all. This work is focused on
strengthening four critical areas: surveillance, laboratory, workforce
development, and rapid response capability. In addition, CDC medical
and public health officers staff United States Quarantine Stations that
are located at 20 ports of entry and land-border crossings where the
majority of international travelers arrive. These health officers are
the first line of defense to prevent the introduction and spread of
infectious diseases.
Conclusion
I want to leave the Committee with three primary points about CDC's
role in public health emergency preparedness and response.
CDC is the common defense of the country against threats
to public health,
CDC's preparedness work is built on a foundation of our
broad and deep scientific, medical, and programmatic expertise, and
CDC's longstanding partnerships with state and local
public health authorities are essential to the health security of our
country.
Through the three interconnected pillars of science, surveillance,
and service, CDC plays a critical role in working to ensure that the
United States is ready to respond to public health emergencies. CDC has
over 70 years of experience in bringing top scientific expertise to
health emergencies and remains a trusted partner in the United States
and around the world. CDC stands ready to do its part to protect the
health and well-being of the American public and save lives. We cannot
necessarily predict the next disaster, but we know that being prepared
protects health, saves lives, and prevents economic losses.
Thank you for the opportunity to testify.
______
Senator Burr. Dr. Redd, thank you very much.
You won the award for getting the closest to the 5 minutes
of all our witnesses today.
[Laughter.]
Senator Burr. The Chair would recognize himself and the
Ranking Member, and then Senator Alexander, Senator Casey, and
then Members in the order of attendance to today's hearing.
Dr. Bob, my first question is simple. Are we prepared for
public health threats we face?
Dr. Kadlec. Sir, I would have to say equivocally for some,
but not all.
I think the reality is when this concept of PAHPA first
came up in 2005, we had witnessed the terrorist attacks of 9/
11. We were anticipating potentially a pandemic and we had just
experienced Katrina. But those are all in the rearview mirror
in terms of the threats that we are prepared to deal with.
Quite frankly, if you had to look at Nation State threats
that we are considering today, or multiple Nation States that
are willing to use terrible weapons against, both physical as
well as potentially cyber, I think we are not prepared. And
quite frankly, those are the things that keep me up at night as
well as a pandemic that could emerge again from Asia. As well
as the risks that have come up that Dr. Gottlieb identified
with synthetic biology tools now that allow nefarious people to
do unimaginable things potentially.
So I think we have a long way to go. We have done very well
in some areas; again, a compliment to the effort that was done
by the Federal Government in support of state and local
authorities. And again, for those three hurricanes nearly
consecutively, I think that was a great commitment of effort by
everyone.
But there is no time to rest on our laurels in that
respect.
Senator Burr. The statute is very clear on BARDA's specific
and targeted medical countermeasure mission to ensure that
BARDA is staying focused in bringing forward the
countermeasures we need to protect the American people from a
range of chemical, biologic, radiologic, and nuclear threats.
All of BARDA's work should be tied to this threat context.
Why is it important that BARDA's mission not be diluted by
matters or mandates that would require BARDA work on areas
outside of those tied to threats specifically? And how does the
comment of 34 innovations out of BARDA relate to a focus on its
mission?
Dr. Kadlec. Yes, sir.
Well, I think the key thing here is to remember what the
mission was originally. And again, BARDA was only part of the
puzzle here.
Project Bioshield, which was a 10-year advanced
appropriation, was another critical element of that formula of
success, which was a guaranteed market to manufacturers should
they get across the finish line.
But the key issue that you have raised, sir, is that we
cannot boil the ocean. Quite frankly, the BARDA model works.
The resources that have been given to BARDA to date have been
somewhat limited. We have had, literally in some circumstances,
to rob Peter to pay Paul given events that have transpired with
Ebola and other events.
We do not have a sustained level of funding necessarily, a
line item for pandemic influenza, for example. That would give
us great confidence that we would have a sustained,
uninterrupted funding stream.
So the answer is arguably, you could do more things, but
the answer is you cannot do more things with limited resources.
If we focus on the national security mission which, I think, is
vital--again, vital to the role of BARDA--then I think we have
to stick to our lane and highlight the fact that right now, to
use a defense analogy, we are operating with about half an
aircraft carrier of resources to basically do this mission. A
national security mission to basically protect 320 million
people and that is a challenge.
Senator Burr. Dr. Gottlieb, in your experience, what is
working well in the agency's review of medical countermeasures?
And what challenges have you seen in the medical countermeasure
pipeline?
Dr. Gottlieb. I think we are doing a much better job now. I
look at this over a 15 year period.
I came into the agency shortly after the animal rule was
implemented back in 2002. Between my two tours at the agency, I
think we are doing a much better job at leaning in with respect
to trying to bring some of these technologies forward; trying
to look at ways that we can lean forward and develop the animal
models that are going to form the basis of some of the product
approvals; trying to put out perspective guidance and talk to
manufactures and provide more regulatory clarity.
I think there are still challenges around the incentives in
this market. Frankly, I think having been on the other side of
this in the private sector, the prospect of being able to
commercialize something just for stockpiling purposes sometimes
is not enough of an incentive to offset the enormous capital
costs of some of these endeavors.
I think we are also looking at, we focused on some of the
immediate dangers, some of the pathogens we knew and we are
developing countermeasures on them. I think we are looking at a
future where it is going to be much easier to bioengineer some
of these things in ways that we cannot fully anticipate and
create very new risks.
Senator Burr. Senator Murray.
Senator Murray. Well, thank you very much to all of you.
In the wake of Hurricane Irma, as hospitals were
evacuating, the top priority was protecting vulnerable
populations including people and individuals with disabilities,
and children, and pregnant women.
In every public health emergency, we have to pay unique
attention to people with functional needs that put them
particularly at risk. That is true for preparedness planning
and for emergency response, including, for example, making sure
that there is adequate medical countermeasure development and
dosing guidance for children and pregnant women.
PAHPA actually acknowledges that there must be specific
attention paid to at-risk individuals, and we want to build on
that last authorization, because I think we can do better.
So I wanted to ask each of you to briefly describe your
agency's efforts to meet the needs of all people. And, what
more can we do to ensure that when it comes to public health
preparedness, we are prepared for everyone?
Dr. Redd, let me just start with you, and if we could, just
go down the panel.
Dr. Redd. Thank you for that question.
Let me just highlight a couple of things that we are doing
at the CDC.
First of all, our guidance through the Public Health
Emergency Preparedness Program requires that states have a plan
for persons with functional needs. So that is part of the
planning process.
We also work closely with the American Academy of
Pediatrics and the American College of Obstetrics and
Gynecology, depending on what the emergency is, but work with
them to make sure that those needs are being covered.
I would also say in the stockpile that we have made
progress in procuring products that are needed to treat
children.
For example, there are 100,000 treatment courses of
Oseltamivir in suspension form that are intended, or targeted,
for children.
Senator Murray. What could we do better?
Dr. Redd. I think there is always more work to do.
I think that we need to make sure that these plans are
exercised and that we have actually covered all the bases. That
they are not just written on paper, but that we actually are
able to execute the plans that we have made.
Senator Murray. Dr. Gottlieb.
Dr. Gottlieb. I would just highlight that PAHPA gave us new
authority to put forward, to your point, treatment guidelines
that can help guide the applications of some of these
therapeutics, particularly with respect to pediatric dosing,
which we have used. We have approved 12 drugs under the animal
rule; 7 have been approved with pediatric dosing requirements.
I think this is something that we can continue to do
better. I think one of the ways that we are going to do that is
to have better development of animal models that have better
natural histories associated with the pathogens in those animal
models that allow us to predict what the therapeutic impact is
going to be on a pediatric population.
So, this is some basic research that we need to do to
develop those models that are going to, then, allow us to
extrapolate into a pediatric population; and other populations,
for that matter, other vulnerable populations, to your point,
and allow us to have dosing guidelines for those populations.
Senator Murray. Is there anything we can do within PAHPA to
help improve that?
Dr. Gottlieb. I think to Senator Burr's point as well, I
think this, as a scientific basis, still needs further
development. PAHPA gave the agency resources and we have
developed discrete expertise in this area as a result of the
legislation.
I think that is a place where we can continue to make more
investment.
Senator Murray. Okay. Dr. Kadlec.
Dr. Kadlec. Thank you, ma'am, for the question.
I would just like to highlight during the hurricanes, we
actually did some very specific things around people with
functional disabilities.
I do not know if any of the Members have heard of emPOWER.
It is a program that allows us to basically identify, in the
CMS data base for Medicare, people who are dependent on durable
medical equipment.
Based on requests from states, we can provide actually very
specific information where these people live by ZIP Code and by
address. In cases like Irma, Florida was able to do a reverse
9-1-1 call to those people at-risk well before any evacuation
orders went out to the general public to advise them that they
should consider leaving before things got worse.
In the cases of Maria, we actually used that data to
identify, on the islands St. Thomas and St. Croix, people who
were dialysis dependent. And after the storm passed, we were
able to basically link up with the urban search and rescue
teams, and actually recover dialysis dependent people, and
basically evacuate them to safety. So there is that part of it.
One of the limitations currently is that it is only for
Medicare data. The State Medicaid data is limited. We can do
that if we have access to that and provide the same
information. So that is one area that we could probably benefit
from working with you all to see how we can have the states
work collaboratively to use that information prospectively.
To add to the points that were made by the other gentlemen,
clearly BARDA has looked at specific products for pediatric
patients, as well as people with immunocompromise, and there
are products that are in the stockpile today that are to
benefit both of those populations.
One of the areas, and I highlighted it in my testimony, is
on the National Disaster healthcare System. One of the specific
areas we would like to do is take the learnings or lessons
learned from Ebola where we created a national Center of
Excellence at Nebraska University for infectious disease and
replicate that for other very important trauma-related or
disaster-related areas like pediatrics.
We think that that would be a way where not only can you
create the necessary, if you will, critical mass of expertise,
but also teach through telemedicine and through
teleconsultations to provide support during disasters.
The last area I would like to do, and a shout out to our
V.A. colleagues, is the V.A. was a very significant contributor
to our response to Harvey. HHS responded and took care of
36,000 patients. The V.A. provided care to 21,000 patients,
many of those were V.A. beneficiaries, but some of those, many
of those were families of V.A. beneficiaries. And then a larger
number were actually the general public.
The V.A. has unique capabilities as it relates to geriatric
populations, and that is one area that we can probably benefit
from in terms of utilizing some of their expertise.
Senator Murray. Thank you very much.
Senator Burr. Chairman Alexander.
The Chairman. Thanks, Mr. Chairman.
Dr. Kadlec, Dr. Gottlieb, let us talk about the flu. This
is the 100th anniversary of the 1918 influenza pandemic that
killed an estimated 50 million people worldwide; 600,000 in the
United States.
According to the Centers for Disease Control, year in and
year out, between 12,000 and 56,000 Americans die as a result
of seasonal flu.
We heard last week in our opioids hearing that opioids kill
more Americans than car accidents. And those statistics that I
just read would suggest that in a severe year, so could the
flu.
Dr. Collins, the head of the National Institutes of Health,
has made the prediction before our Committee that if we keep up
our investments in biomedical research--which Senator Blunt,
and Senator Murray, and the rest of us have been doing pretty
well the last 3 years--that we may have a universal flu
vaccine, as well as a vaccine for Zika, within the next decade.
Dr. Fauci at NIH has said that the most effective method
for protecting Americans against another pandemic influenza is
to encourage and invest in the development and stockpiling of
influenza vaccines that will broadly protect against the virus.
Well, in Tennessee right now, the hospitals are filling up
with people with the flu. So Dr. Kadlec and Dr. Gottlieb, if
researchers at NIH, or any partners with them, discover a
platform technology that could speed the development of a
universal flu vaccine, what would BARDA do to support the
advanced research and development of that technology?
Dr. Gottlieb, what is the FDA ready to do to encourage the
use of that technology for new and innovative vaccines?
I have 3 minutes.
Dr. Kadlec. Chairman, I will be very brief, then, in the
sense that BARDA has an integrated portfolio with NIAID. So
once a product gets through Phase 2a clinical trials, it would
be transitioned over to BARDA, which would take the advanced
development through to fruition. So that part of it is done.
They have the capacity to basically identify manufacturers
who could produce that either in eggs, or tissue cell culture,
or emerging technologies.
The Chairman. Dr. Gottlieb.
Dr. Gottlieb. Yes. I will just quickly add, we already
have, in development, vaccines that might be universal flu
vaccines that, presumably, could elicit a T-cell response and
could achieve what you are outlining.
We continue to provide advice to clinical developers and
manufacturers on the proper pathway for looking at trying to
bring those new technologies through.
I would point to one place where the legislative suite that
we have adopted to try to address some of these biological
threats has been helpful in the development of manufacturing
capacity. That could greatly aid in the scope of these new
vaccines, particularly cell-based manufacturing, which we have
made a lot of investments in, as you know, that could provide
the proper platform for the development of these vaccines.
The Chairman. Dr. Gottlieb, this is a related matter.
We are all concerned about Puerto Rico and the impact of
the hurricane there. I think you told me at one point that
maybe one-third of the economy of Puerto Rico has to do with
medical technology.
Is that right?
Dr. Gottlieb. That is about right. It is about 30 percent.
The Chairman. And many of those facilities, as you
described, were destroyed.
Are they rebuilding in Puerto Rico, or are they rebuilding
other places, or do you know yet, because that could have a
major effect on Puerto Rico's future?
Dr. Gottlieb. Right. And we are obviously very concerned
about the situation in Puerto Rico for a host of reasons, not
the least of which is that the Puerto Rican economy is very
dependent upon that skilled manufacturing base.
I am happy to tell you that all of the facilities that we
are concerned about--that produce product that we were worried
could go into shortages if the facilities continued to remain
offline--are now back on the grid.
So the facilities themselves actually did not sustain a lot
of damage. It was the power grid and the infrastructure in
between the facilities to try to move equipment in and off the
island, and that sustained a lot of the damage. The facilities
actually were fairly hardened.
But the ones we were worried about are back on the grid.
There are still some facilities that are not on the grid, but
they have such redundant electric generation capacity that we
do not really have concerns about the product supply coming out
of facilities.
So the situation now looks a lot better than it did 4
months ago.
The Chairman. Mr. Chairman, I think my time is about up,
and I will give the rest of it back.
Senator Burr. Senator Casey.
Senator Casey. Thank you, Mr. Chairman.
I wanted to start with the reference that I made earlier to
the train derailment in Philadelphia as an example of good
preparation. Part of that has its origin in the fact that it
happened in an urban area where you have not just the
resources, but you have hospitals and the healthcare
infrastructure, which is close by way of distance, as well as
by way of coordination.
I represent a state that has 48 rural counties out of a
total of 67 counties. So we have a lot of small towns and rural
areas where you do not have the institutional capacity
necessarily. In the event of an emergency, that could be
exacerbated by distance and other challenges, so you have this
type of gap or potential gap, where some communities may be
particularly vulnerable.
I would start with Dr. Kadlec and then go to Dr. Redd.
In terms of the Hospital Preparedness Program, the so
called HPP, as well as PHEP, how do those programs attempt to
close the gap in preparedness among states and regions?
Dr. Kadlec. Thank you, sir, for the question.
I think the point is that the way we are structuring it
right now, we are trying to actually build healthcare or
promote healthcare coalitions which are collections of
hospitals, as well as other entities like emergency medical
services. So you can build a regional.
That is why we would like to expand that effort to
basically do it so not only would it cover specific regions
within a state, but statewide and across states so that you can
develop a much stronger backbone, if you will, to do this.
I think the idea of basically building out the National
Academy of Sciences' study on trauma systems is worthy of
reviewing because it highlights the important role that has a
foundational capability for the country. Not only for day to
day routine activities, but for these extraordinary events,
train derailments that happen not only in Pennsylvania, but in
the State of Washington, as an example, become a central piece
of that.
My interest in this is seeing how we can leverage all those
pieces together with some of the Federal assets the V.A.
identified. Madigan Army Medical Center was a critical first
responder in the train derailment in Washington State.
The thing is, how do we basically build, forge a public-
private partnership for those purposes that can basically
strengthen it? So not only do you have the transport mechanisms
with emergency medical services, but also telemedicine and
teleconsultation that would be available from this specialty
services, these Level I trauma service hospitals or Level I
expert hospitals like Nebraska to basically deal with a range
of topical areas.
Senator Casey. Doctor, before moving to Dr. Redd, I just
want to inject another question.
This is an authorizing Committee and a reauthorization
process. But I want to specifically ask, in light of the
question I posed, are there additional authorities you need or
additional dollars?
Dr. Kadlec. Sir, I would suggest both. We have a $3.3
trillion healthcare system for which, right now, we invest
approximately $250 million annually for preparedness and
resilience. I think it just highlights the fact that it is kind
of a drop in the bucket.
I do not think it is necessarily the role of the Federal
Government to pay for the whole bill, but certainly, we need to
look at a variety of incentives, whether that is through CMS
reimbursements, whether that is through insurance programs, or
tax benefits that would incentivize hospitals to do it.
Our conversations with some of the outside partners, we
held kind of a listening session with 35 stakeholders last
week, including hospital associations. They are all willing and
we have the hospitals volunteering to help. I think they are
just looking for a means to do this in a way that is mutually
beneficial.
Senator Casey. Thank you, doctor.
Dr. Redd, I only left you 45 seconds.
Dr. Redd. I will be brief.
We actually met with selected state health officials last
spring to ask this exact question that you asked. Are there
things that we should be doing differently to support rural
health departments?
The conclusion was, it was a little bit surprising to me
that the capabilities needed for rural districts and urban are
largely the same: detection capability, communications,
incident command or the structure to run responses. But there
are additional, as you mentioned, there are additional layers
of challenge with transport and access to medical care.
I think that this is an issue a little bit beyond emergency
response and I think the idea of telemedicine as a tool is a
great idea. But it is essentially a question of, how do we make
sure that those communities have access to medical care during
and not during emergencies?
Senator Casey. Thank you, Mr. Chairman.
Senator Burr. Senator Isakson.
Senator Isakson. Thank you, Senator Burr.
Thank you for your work on pandemics and on BARDA for a
long period of time. It is very valuable. The Committee has
worked on it a long time.
I appreciate Chairman Alexander and Senator Murray, and the
work that they have done.
Thanks, Dr. Kadlec, for calling out the V.A.
As Chairman of the Veterans Committee in the Senate, I have
learned a lot of things about our delivery system and
capabilities in terms of V.A. healthcare, which is the second
largest employer in the United State Government. A lot of
people do not realize that, but that is how big and pervasive
the V.A. is, and they provide significant healthcare to seniors
by virtue of their delivery system.
Your callout for them and what they did in Houston, Houston
has appreciated it.
Also, I would say that most of the research dollars that
are invested by the U.S. Government in control groups are
through the V.A. because you have a control group of patients
where you can do a good research sample. Our veterans, and our
Veterans Administration, provide a great service in terms of
that, which brings me to Admiral Redd.
You have your emergency preparedness grant that you give to
the local governments. When we had the incident we had happen
in Hawaii last week, where we had a false alarm on a missile
attack, which was rather unsettling to the people of Hawaii
and, quite frankly, it was unsettling to me. That is an
emergency grant challenge you want to make sure you do not ever
have with a pandemic where you get the wrong information going
out from a designated agency at the wrong time.
Do we concentrate a lot on that to protect ourselves from
bad information getting out on pandemics or on diseases?
Dr. Redd. I think that really gets to one of the core
requirements that we have, which is to be sure that the
information we are providing is as valid as it can be. And if
we are not certain, but we believe people need to know, we make
sure that those caveats are expressed.
It really gets to some of the basic principles of risk
communication to tell people what we know, what we do not know,
and what we are doing to find out those things that we do not
know.
Senator Isakson. Dr. Gottlieb, I appreciate your mention of
Priority Review Vouchers.
Senator Casey and I worked on PRV's for rare diseases that
affect children and successfully passed legislation. I think
the first drug has been approved now and put on PRV. It was
issued by the department, and we appreciate that.
Your use of that to expand the use of PRV's to encourage
the development of drugs that are either very costly to develop
or hard to develop is very important.
How do you intend to use that to expand the development in
terms of new pharmaceuticals?
Dr. Gottlieb. Well, as you know, the PRV program provides
an additional incentive for manufacturers to try to develop
products for these purposes. And so, I think it is one of the
tools that Congress contemplated to try to address some of the
challenges that we have already talked about that I mentioned,
which is that sometimes this is not a typical market where you
have the usual market-based incentives to try to make the
capital investments to develop these products.
There is work going on to look at what impact the PRV's
have had. We have implemented the program. We have seen
sponsors come forward and be awarded these PRV's and sell them
in the secondary market as a way to try to recoup some of the
cost of the investment.
Senator Isakson. On that same subject, I have done a lot of
work on a disease called Batten's, which is an incurable
disease of young people. I had a personal situation that piqued
my interest in my district when I was in the House, and I have
remained interested in that.
It is a very difficult disease for which there is no cure,
but with the gene therapy development and the delivery system
of pharmaceuticals to specific parts of the body, and the brain
in particular, there is hope and promise for that.
Do you issue guidance letters to research hospitals or
research facilities to give them guidance on how they can test
or develop to work on a breakthrough drug for a disease like
Batten's?
Dr. Gottlieb. Senator, I think one of the areas of the most
promise right now that we are looking on when we look across
our portfolio is what is going on, as I said, with biologics
with respect to cell based therapies, machine based therapies
where we have the ability to cure inherited disorders,
devastating inherited disorders that were not treatable just a
short time ago.
We are going to be putting out this starting probably this
spring, maybe a little earlier, a suite of products with
specific guidance on how sponsors can address certain disorders
with gene therapy to try to provide as much regulatory clarity
as possible.
We are going to look at some of the more common disorders
first, but we are going to try to work through some of these
rarer diseases to make sure that product developers have a lot
of clarity around what the pathway forward would be.
Senator Isakson. I commend you on the leadership you have
shown in that effort already and plan to support you in any way
we can to help you do that in the future.
Thank you very much. Thanks to all of you for testifying.
Senator Burr. Senator Smith.
Senator Smith. Thank you very much, Senator Burr, and Chair
Alexander, and Senator Murray.
I am so pleased to be able to serve on this Committee.
Thank you very much.
I would like to come back to something that Senator Murray
and, I think, several others have talked about, which is the
importance of a connection and support to local public health
organizations.
In the past year in Minnesota, we have dealt with three
infectious disease outbreaks: measles, multidrug resistant
tuberculosis, and also syphilis. And all of these outbreaks
have required a really immediate response, as well as a
sustained response, as we have gone forward.
Minnesota has traditionally, as I am sure you know,
invested heavily in emergency preparedness and dealing with
infectious diseases, probably because of our history in
agriculture more than anything.
But in these particular situations, the financial resources
that we had were not enough and so, we turned to the CDC for
support. And, of course, no fault of yours, there were no
resources there.
What we did is we moved forward with the state legislature
to pass an emergency public health response account so that we
could respond quickly because speed is of the essence when you
are dealing with these kinds of outbreaks.
My question is in what ways do you think that an emergency
response fund would strengthen our federal and state efforts
during an outbreak or after a disaster?
Maybe if you could just talk a little bit about that, that
would be helpful.
Dr. Redd. Thank you very much.
I think that resources are critical in responding to an
emergency. We had lengthy delays, both in the Ebola response
and in the Zika response before funding became available, and I
think that hindered what we were able to accomplish.
There has been discussion both in Congress and in the
Administration about how to do that, and I think that those
discussions will continue. But I think something along those
lines would be quite helpful.
Let me mention one thing that we have done specifically
once funds are available to make sure that they are used more
quickly.
We had a Notice of Funding Opportunity that we opened to
our grantees through the Public Health Emergency Preparedness
program and allowed them to apply for funds. There were no
funds in this award, but we have an approved, but unfunded,
grant mechanism so that we do not get delayed at the Federal
level once funding is appropriated.
Senator Smith. Thank you.
Dr. Kadlec. Senator Smith, if I could just add.
There exits already in authorizing language for a fund for
HHS that has $57,000 in it. Obviously, it is not an
authorization problem.
But I just want to highlight the fact that, yes, there is a
fund that is needed. It should be a fund that necessarily is
managed by the Secretary and based on a public health
emergency. There can be, if you will, distribution of funds
from that, and that it can be used across HHS, or to fund
states and locals in a way that would be rapid.
Obviously, there is going to be a need for, it would be
like the medical equivalent of the disaster relief fund, I
think. But I think there would be, obviously, a requirement to
notify Congress in those sorts of situations on a basis of
reporting back on some occasions to make sure the funds are
being spent appropriately.
Senator Smith. Right. Thank you.
Essentially, we need to make sure we have good
accountability.
Dr. Kadlec. Right.
Senator Smith. That the funds are being spent the way they
are supposed to be spent----
Dr. Kadlec. Yes, ma'am.
Senator Smith ----which I would completely agree with.
I realize that this is an authorizing question and not an
appropriating discussion here, but Dr. Kadlec, if such a fund
were to be made available, what would you advise in terms of
the level of funding that would be necessary to have this
actually be workable?
Dr. Kadlec. Well, ma'am, I would have to back in a firm
number, but I think what you probably looked at is what
happened with Ebola or the original pandemic influenza
appropriations, which are on the order of $2.5 to $3.5 billion.
Again, what you need to hedge is the opportunity for
Congress to weigh in fully, and again, on the basis of time. So
obviously, there are a lot of factors to be considered in
there, but there is a rich, historical record that could
probably be drawn upon to identify an appropriate level that
would get us through the initial crisis to the point where
Congress can basically perform its fiduciary responsibilities.
Senator Smith. Right. Thank you very much.
Senator Burr, I was struck by what you said about how we
need to stick to our knitting on this Committee and not expand
too much. And also how important it is to think about the
processes that we have in place with this authorized
legislation, to make sure that it works well.
I appreciate your comments. I think it gives us some good
food for thought as we consider how we can respond as quickly
as possible when there is an emergency.
Thank you.
Senator Burr. We, again, welcome you to the Committee.
Senator Young.
Senator Young. Well, thank you, Chairman.
The World Organization for Animal Health estimates that
roughly 60 percent of known human diseases are transmitted from
animals to people. They are of so called zoonotic origin.
Every year, an average of five human diseases appear such
as Ebola, HIV, and new strains of influenza; three of which are
zoonotic.
In my home State of Indiana, we suffered considerable
losses in the widespread bird flu outbreak, one that led to the
destruction of 400,000 turkeys. And this followed in 2015 and
the outbreak that led to the loss of 48 million poultry.
Dr. Kadlec, what are we doing now to prevent the spread and
transmission of diseases from animals to human beings?
Dr. Kadlec. Well, sir, I have to say that, quite frankly,
we need to do more.
The one health concept that you are outlining is an
important one. Influenza is not the only disease that is of
zoonotic importance that has pandemic potential; SARS and MERS
are examples of others.
But I think I need to really defer to Admiral Redd to talk
about the role of the CDC here and their role of surveillance
because, quite frankly, they are on the cutting edge to ensure
that you can recognize those events rapidly as they have in
Iowa, I think.
Senator Young. Thank you. Admiral.
Dr. Redd. Thank you, Dr. Kadlec and Senator Young.
We are working very closely with USDA on this issue and
particularly on influenza. We were really joined at the hip in
the response to this importation of these avian influenza
viruses.
Our role was to make sure that we understood the biology
and that if any human infections occurred, that those were
rapidly detected and treated, and to protect workers in the
process of the culling that was going on.
Senator Young. You, no doubt, do the best you can with the
resources and authorities you have.
No. 1, how are we doing with respect to tracking and then
the responding to these situations and preparing for the next
one?
Then secondarily, speak to any additional authorities or
resources you might need to optimize your efforts.
Dr. Redd. I think that given the strategy that we have,
which is a reactive one, I think we are doing well at detecting
and containing importations.
Senator Young. That predicate caught my attention.
Dr. Redd. Yes.
Senator Young. Given that our strategy is a reactive one.
Dr. Redd. Right.
I think that the ability to prevent importation of
influenza viruses that could be transmitted by migratory
waterfowl, for example.
Senator Young. Yes, sir.
Dr. Redd. It is very challenging.
I think there is a lot being done on the animal health
side. I think that it is a challenge and the basic strategy is
to identify and limit, to the extent possible, to one flock or
as small an area as possible. And through that process to
prevent human infection should the virus have the capability to
be transmitted or to be infectious to humans.
Dr. Gottlieb. If I may, just for 15 seconds.
I would also talk about the importance of thinking about
animal drugs in our approach. And Cures, as you know, extended
the EOA authority to animal drugs. We might also contemplate
trying to think about how we create incentives for the
development of animal drugs to target some of these threats
including maybe a breakthrough therapy designation for animal
drugs or other kinds of creative policy approaches to make sure
that that is a part of our approach as well.
Senator Young. Well, thank you.
I look forward to working with each of you. I will probably
have some follow-up questions I will submit in writing, and
hopefully we can improve our current systems for dealing with
these matters.
Senator Young. Dr. Gottlieb, you just once again mentioned
incentives in the animal context, but I would like to pivot to
our antibacterial resistance threats.
Every year, at least 2 million people in the U.S. acquire
serious bacterial infections that are resistant to one or more
types of antibacterial drugs.
However, as I understand it, there are very few companies
that are developing new antibiotics, and those that are focused
on the most serious bacterial threats are even fewer.
Is additional action needed to immediately incentivize the
development of drugs to combat this growing global problem? And
if so, what might new incentives look like? And what might we
do as Members of Congress to provide those incentives?
Dr. Gottlieb. Senator, thank you for the question.
As you know, Cures created a number of new vehicles, and
some incentives, for development in this space. We are
encouraged by the early interest we are seeing in those
pathways, things like the LPAD pathway. I think we are going to
have more information soon on how well they are working.
I mean, we can always contemplate additional policy steps,
and I would be happy to talk to your office and work with you
on that. I think that this is an area, to your point, that we
need to think about what more we can be doing.
But Congress has done, taken some steps recently that we
are very encouraged by. We are seeing a lot of good, early
interest in them.
Senator Young. Thank you.
Senator Burr. Senator Kaine.
Senator Kaine. Thank you, Mr. Chair, and thanks to the
witnesses.
I have great confidence in this Committee's ability to work
on this PAHPA reauthorization in a bipartisan way. I have two
observations and a concern. So an observation is this and some
of you have alluded to it, and Senator Isakson's questions
alluded to it.
One of the tasks of emergency preparedness is to prepare
for attack, and you have talked about chemical and biological.
Senator Isakson talked about the incident in Hawaii this
weekend.
I just want to say for the record and for the public. The
prospect of nuclear war is being discussed with a lot of
frequency in this building to a degree that I have not seen in
the time I have been in the Senate.
I am on the Armed Services and Foreign Relations
Committees. We have had a series of hearings, even open, where
there has been discussion about the prospect of land war on the
Korean peninsula.
We had an Armed Services hearing recently where a witness
volunteered in public--and it was sort of a non sequitur, why
he would bring it up as a Member of the Administration--about
what the likely cost of reconstructing Kansas City would be
after a nuclear attack.
I noticed an article in ``The New York Times'' a few days
ago. ``The C.D.C. Wants to Get People Prepared for Nuclear
War.'' That was supposed to happen yesterday.
``On January 16, the Centers for Disease Control and
Prevention will present a workshop titled 'Public Health
Response to a Nuclear Detonation,' for doctors, Government
officials, emergency responders, and others whom, if they
survive, would be responsible for overseeing the emergency
response to a nuclear attack.''
Quote, ``'While nuclear detention is unlikely,' the C.D.C.
stated on its Website, 'It would have devastating results and
there would be limited time to take critical protection steps.
Despite the fear surrounding such an event, planning and
preparation can lessen deaths and illness.'"
Quote, ``'Join us for this session of Grand Rounds to learn
what public health programs have done on a Federal, state, and
local level to prepare for a nuclear detonation. Learn how
planning and preparation efforts for a nuclear detonation are
similar and different from other emergency response planning
efforts.' '' That is off the CDC Website.
The article goes on to say, ``The agenda for the day
includes, 'Preparing for the Unthinkable,' to 'Roadmap to
Radiation Preparedness,' and, 'Using Data and Decision Aids to
Drive Response Efforts.'"
I understand the CDC rescheduled that, canceled it from
yesterday, and had a roundtable on the flu instead, but this is
a realistic discussion about these prospects. And then add to
it the ``Dr. Strangelove'' like incident over the weekend where
a state sent out a mass e-mail telling people there was a
ballistic missile incoming to Hawaii, which occasioned 38
minutes of panic.
Then on Tuesday, the Japanese state broadcaster, NHK, put
out a warning that North Korea had fired a nuclear missile and
urged Japanese citizens to take cover. That was retracted
within a very few minutes.
There is a lot of discussion, some very intentional and
some frightening, about the prospect of nuclear war that is
happening, and this is in the provenance of your agencies.
I just want to put that on the record that that is sort of
a normal area for discussion these days. I find it incredibly
frightening and the normality of it I find incredibly
frightening.
The second observation I want to make is this. This is a
discussion about national security. We are involved in a budget
debate right now. Right now, the spending bill ends January 19
and one of the points of argument is whether we might fund
defense accounts over the budget caps of nondefense accounts.
You are about national security. You are about national
defense and all of your agencies are funded through the
nondefense accounts of the Federal budget.
Any suggestion that we would increase defense budgeting,
but hold the line and put nondefense agencies subject to their
caps, would not really fund the national security priorities
that you are here about, and that is something we have got to
grapple with.
Here is my question.
I am very worried about this Hawaii incident because in a
time of heightened tension, we know from history that wars
often start accidentally. There is a miscommunication and a
misunderstanding; there is an overreaction. That is how World
War I started. That is how most wars start.
I know there is going to be a hearing later in the week, I
think, on the House Armed Services Committee about this. I am
sure that there is an investigation at the state level. But
part of the responsibility--and Dr. Kadlec, I guess this is
mostly directed to you--part of the responsibility in the
emergency preparedness and response side is accurate
communication. As a former mayor and Governor, that depends
heavily upon communication between Federal, state, and local
officials.
As you approach this thought of thinking about
reauthorization in this climate where things can sometimes be
pretty tense, how do you look at that state, local, and Federal
coordination effort, especially as it deals with the
communication of accurate information, and knocking down
inaccurate information?
As quickly as you can.
Dr. Kadlec. Well, sir, we take it very seriously, No. 1.
No. 2 is the experience we had with the hurricanes,
particularly Hurricane Maria, I think, highlighted some of the
challenges. In my testimony, I identified some of the incident
command issues that we have to address, which really is not
only information out, but information in.
I think the issues that we need to work with--not only with
our CDC brethren, but with state and local authorities, as well
with FEMA; I met with them just as of yesterday--talking about,
how do we integrate our efforts closer so that we have better
information exchange on these kinds of issues? Whether they are
hurricanes, pandemics, or whatever it is that, quite frankly,
you need to kind of think through, learn through not only
experience, as we did with the hurricanes, but exercises, as we
did.
Sir, just to highlight one thing, since I have been around
the block on these sets of issues. Going back to 2000, it has
been a routine practice in the U.S. Government, the Federal
Government at least, to exercise the idea of a nuclear
detonation. Most concerning then was terrorism as a matter of
an improvised nuclear device.
It is not necessarily new. Obviously, the context is
different.
But I think the point here, though, to your issue is it
does require a closer lash up with our Federal partners on
these issues to make sure that we have good cross lateral,
horizontal flow of information, as well as with our state and
local folks.
We are investigating with FEMA just as another example of
how we can basically work together in bed both our health and
disaster people in state and local state EOC's to, again, work
more seamlessly with our state colleagues.
We are looking at all kinds of options right now to that
effect.
Senator Kaine. I appreciate it.
Mr. Chair, thank you for letting me go over.
I hope you will follow the investigation of the Hawaii
incident for your own purposes because for purposes of having
good information and that coordination, I suspect there will be
some lessons that will come out of that that would be relevant
to other circumstances as well.
Thank you, Mr. Chair.
Senator Burr. Thank you, Senator Kaine.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
I want to applaud you for your leadership in this area.
More than a decade ago, we established a Port Security
Program that led to radiation portal monitors being installed
at our major ports so that they could screen incoming and
outgoing cargo, trucks, and individuals for radiological
material.
I contrast that port security effort with what I perceive
to be a real vulnerability in our ability to detect and
effectively and quickly respond to an attack using biological
or chemical agents.
Dr. Kadlec and Dr. Redd, I would like you both to address
the level of preparedness that we have to respond and detect,
first of all to detect, a biological or chemical attack and to
respond to it.
I would like specifically to know whether cities have used
some of the Federal funds that the Admiral referred to, to
install sensors that would be able to detect these agents.
I would also like you both to comment on the preparedness
of our hospitals to cope with the victims of a biological or a
chemical attack.
I remember being in Israel many years ago and being so
impressed with their preparation and their ability to convert
their hospitals to respond to that kind of attack.
Dr. Kadlec, why do we not start with you and then Admiral
Redd?
Dr. Kadlec. Thank you, Senator Collins. I think one of the
issues, and again, I have some insights on this historically.
But currently, the biologic program run by the Department
of Homeland Security provides area protection for cities. So I
think there is a real desire.
I have met with the new WMD, I do not know, directorate,
Assistant Secretary over at DHS about improvements we can make
to our chemical and biological attack kind of detection.
Quite frankly, our capabilities are fairly still limited
and primitive, quite frankly. And I think there is a sincere
desire on the part of DHS and HHS between ourselves to
basically do improvement to do that.
To your second issue, how well prepared we are. Certainly,
we have a Strategic National Stockpile that can address many,
but not all, of these threat agents. So there is work to do
there in terms of some of the development and procurement we
need to do on those issues.
But one of the critical areas that collectively the CDC and
our office are considering is really on the last mile of
distribution.
As mentioned by Senator Murray, we can move Strategic
National Stockpile resources anywhere in the country within 12
hours. The question is from that point forward getting it into
the hands and into the mouths of every American person who is
at risk is a significant challenge that, I think, collectively,
we need to work on.
But now, I will defer to Admiral Redd for his comments.
Dr. Redd. Thank you. I think this is a really important
question. If we are attacked in this way, the effectiveness of
our response will depend on the speed and the scale with which
we respond.
I think that the way that a biological attack would
manifest itself would probably be different than a chemical
attack. A chemical attack would primarily require a local, a
near-instantaneous local response.
The CDC's Strategic National Stockpile has deployed
antidotes for nerve agents. Over 1,000 different locations have
pallets of these antidotes that are available to supplement the
treatment that would be available immediately.
We also have and getting ever better capability to
determine exactly which toxin has been used. So there is a
laboratory element that the CDC is also responsible for.
On the biological side, we have made great strides with the
laboratory response network. Every state has at least one
laboratory that is able to use advanced techniques to diagnose
these infections. There are a total of 150 laboratories around
the world, including laboratories that can test food, can test
water, and environmental samples from animals.
So looking to the future, the technology of whole genome
sequencing is something that we need to continue to push out
that would allow very rapid----
We talked about faster and more accurate. This is actually
more information than we can get from current technologies;
things like resistance to antibiotics or relationships of
certain organisms to other, ``where did it come from?'' kinds
of questions.
Senator Collins. Thank you.
Dr. Kadlec. Ma'am, can I just add one thing?
Senator Collins. Yes.
Dr. Kadlec. To your question about how our hospitals would
do.
Senator Collins. Yes.
Dr. Kadlec. I think it was noted by the Chairman that even
a bad flu seasons, as the current one we have, is overwhelming
our hospital system.
Senator Collins. Exactly. That is one reason that I asked
the question.
Thank you.
The Chairman [presiding]. Thanks, Senator Collins.
Senator Jones, welcome. We are glad to have you a part of
this Committee. I acknowledged your new membership a little
earlier, but we are glad to have you here. This is a Committee
that has many different points of view, but works well
together. So this is another subject that we intend to have
some bipartisan success on.
Senator Jones. Thank you.
The Chairman. Senator Warren.
Senator Warren. Thank you, Mr. Chairman.
So we are here today to talk about PAHPA, the framework for
our response to all sorts of emergencies: natural disasters,
accidents with hazardous materials, terrorist attacks,
pandemics, you name it.
I returned, just a few days ago, from a trip to Puerto Rico
and I know some of my colleagues have also been to Puerto Rico
recently.
During my trip, it was clear that nearly 4 months after the
storm, the crisis in Puerto Rico is a daily reality for tens of
thousands, hundreds of thousands of people.
Dr. Kadlec, you are the top official in charge of
preparedness and response at HHS. What is the biggest thing you
have learned from the situation in Puerto Rico and the U.S.
Virgin Islands about how we need to strengthen our preparedness
and response capabilities?
Dr. Kadlec. Well, thank you, ma'am.
I think there are a couple of levels to go here.
One is improving the resilience of our innate hospital
healthcare structure. That is one area.
The other thing is really the resilience of our public
health system, which is a separate piece, but a related piece.
In Puerto Rico in particular there were, in the initial
stages--after that terrible devastation that literally
devastated the whole island and every life was touched--it was
very difficult for the local public health and medical
infrastructure.
There are some incredible heroic stories of doctors,
nurses, laboratorians who basically responded, public health
officials, who left their families, left their houses in
disarray and basically went to respond to help their neighbors
and their communities. But I think that is one piece of this
that needs to be addressed, what happens before the storm.
The second piece is, how quickly can we move in? We had
deployed teams to Puerto Rico in advance of both Irma and Maria
to be available once the storm passed, both storms passed, to
basically respond quickly. But even so, with the level of
devastation, that was a huge piece of it. And a huge piece of
it was the lingering devastation, not only the loss of
communications and electricity, but also the damage to the
ports and the airfields that limited some of the movement.
So I think one of the lessons learned was you want to go in
aggressively before the storm, if you can. We literally put
peoples' lives at risk from our response teams, including
people from Massachusetts, Massachusetts One, that responded to
all three storms.
Senator Warren. Yes.
Dr. Kadlec. They are great people and, again,
representative of your constituents from other states around
the country that responded.
But also, there is a piece of this that we have to somewhat
remove some of the dependencies in the responses. Seeing how we
can move quicker and faster, if that is possible. A lot of it
was dependent on being able to transport through air or barge,
again, responding to an island is a tough one.
Senator Warren. So I appreciate this and I am glad we are
trying to think about what we need to do and what we need to do
better, and to acknowledge heroic efforts, but we need a better
structure here.
But to apply these lessons, we also need good data. We need
to know not just what we got right or what we got wrong, but
when we got it right, when we got it wrong, by how much, and
what kind of difference it would make on the ground.
One of the things that struck me during my trip last week
was how sketchy the data are. For example, I met with the
Federal and Puerto Rican officials at FEMA's field office and
they said, ``No more issues with potable water.'' No waterborne
diseases, all the water is drinkable. And I asked this
specifically. Turn on the taps. You hold a glass under it. The
water will be drinkable, is drinkable, everywhere on the
island. It sounds great.
Not so much though.
I met with the Massachusetts State Police volunteers who
told me that they had observed raw sewage in the water. At the
public health center that I visited in Loiza, they said they
still do not have potable water, no drinkable water for their
patients. They said they serve 100,000 people and that none of
them have drinkable water.
We heard the same kind of contradictions when it came to
statements about how many people lacked power.
Dr. Kadlec, I get that public health emergencies are really
challenging circumstances, and it is hard to get good data. But
how does HHS and other agencies collect data in a way that is
reliable so that you can deploy your resources effectively,
hold yourselves accountable to get the job done that needs to
be done?
Dr. Kadlec. Well, ma'am, we learned a lot from the
experience in Puerto Rico and we are trying to rectify that.
Because of the loss of communications, cell towers, and the
like, the ability to get information either from local
authorities or local hospitals or clinics was practically nil.
We literally went to the point, at one time, to basically
use runners from the National Guard who would have satellite
phones to basically go to hospitals and clinics to report
information out.
But that is a major consideration and lesson that we are
still learning that we have to address because it is a major
shortfall. Because if you were to add, again, a terrible event
like this, a terrible earthquake or a nuclear or radiological
event, you could imagine that the circumstances would be even
more challenging.
But that is an area of great, intense concern, quite
frankly, and work that we have to do.
Senator Warren. I am very concerned about this and I do not
have time. I am out of time now, so I cannot ask Rear Admiral
Redd and Dr. Gottlieb about their work in Puerto Rico.
But Senator Cassidy and I sent a letter to Chairman
Alexander signed by seven other Members of this Committee
asking for a hearing on the recovery efforts in Puerto Rico and
the U.S. Virgin Islands, and I hope we will be able to hold
that hearing.
Puerto Rico might not be on the front pages anymore, but it
is a humanitarian crisis and we have a moral, and a
constitutional, responsibility to exercise oversight
responsibilities here. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Warren.
Senator Cassidy.
Senator Cassidy. Well, thank you.
Dr. Kadlec, I am going to put you on the payroll, man.
Earlier, you were responding to Senator Smith regarding a
possible bill. We have that bill.
The Public Health Emergency Fund, actually stimulated by
conversations with Dr. Frieden. He said that in the Ebola
crisis, ``There were ten different authorizations that had to
be signed off on,'' before he could get somebody to travel
immediately to Africa. Kind of crazy.
And, ``I kept on contrasting the authorization process we
were going through, which was cumbersome and slow with that
before and after Katrina.'' Before Katrina, FEMA had to come to
get the initial dollars. After Katrina, Congress recognized
that is not the best way, so there is a pot of money that can
immediately be accessed. And if it goes over that, then they
come back and get another authorization.
Senator Schatz and I have put together a bill that, one,
waives these contracting requirements for that immediate period
so you can actually deploy people.
Second, based upon--and Dr. Kadlec this is where you nailed
it--the previous 14 years of public health emergencies, we take
the average of that expenditure and we make those dollars
available upfront to be immediately drawn down.
Still accountability; GAO is going to do a report and make
sure that the CDC has not used it to go to Hawaii for a
conference as opposed to Africa to fight Ebola. No offense, Dr.
Redd. But still, the point being that we would have the
accountability built in, but we think it is a good bill.
Now, let me move onto something different.
Dr. Redd, I was struck speaking to people after Zika hit
that in retrospect--and of course, everything in retrospect, if
I could do things in retrospect I would be a millionaire on the
stock market--but in retrospect, you could have predicted what
was going to happen because supposedly Brazil was flying in
folks from the South Pacific to work on their Olympic stadiums
that Zika had been breaking out in the South Pacific where
these workers were coming from. Brazil is like a Petri dish for
Zika, and you could have predicted it.
Now, of course, it is retrospective. But the thought occurs
to me with Big Data, we can actually put in travel patterns. We
can put in areas of receptivity. We can put in where there are
outbreaks and make some, at least, first blush guess as to
where the next epidemic is going to be.
Is that just me, ``would that not be great,'' sort of thing
or is this something practical? And if it is practical, is the
CDC doing it?
Dr. Redd. I agree with your overall statement.
I think another way of looking at this is that the pathway
that Zika followed was very similar to Chikungunya just a few
years before where it existed in the Pacific and then caused
big outbreaks in Brazil and South America.
Another point that is the same is when we had outbreaks in
the Caribbean, we knew locations of lots of travel to the U.S.
and where the vector was, the Aedes aegypti mosquito lived. It
is the same place that we have seen small dengue outbreaks in
the past.
Senator Cassidy. So, can we use this predictively? Because
if we could use it predictively, if we could see, ``Well,
Brazilians are going to be having this problem. Let us go down
there and encourage them to spray for mosquitoes,'' et cetera.
Dr. Redd. I think it is hard to do that.
I think that the vector is very resilient and there were
some questions----
Senator Cassidy. Now, I was just giving the example of
spraying the mosquitoes as a concrete action. But what I am
asking about is not the vector of resilience.
Can we use Big Data just to look at travel patterns where
there is an outbreak and guess where there might be a spread of
such an outbreak?
Dr. Redd. I think we can. I think the challenge is what do
you do with that information. And is there a way to use that,
for example, to have prevented the Zika outbreak in Miami-Dade
County?
I think that the things that you do----
Senator Cassidy. So you were ahead of us. What you use the
information is different than if you can actually acquire the
information.
If it is practical and right, if you will, to acquire the
information, are we putting such systems in place?
Dr. Redd. Well, just to take the Zika example, there was a
lot of communication with Texas and Florida, Louisiana, the
Gulf Coast areas that have the Aedes aegypti mosquito
recognizing that----
Senator Cassidy. Okay. You are still after me because that
is after it hit Brazil and after we knew that there was going
to be travel from Brazil up.
I am actually trying to go proactively before that in that
we could see the Brazilians were bringing in lots of workers
from the South Pacific and therefore, it was predictable that
whatever was breaking out there was going to breakout here.
Now, that is taking the battle to the enemy, if you will.
Are we doing that?
Do we have a worldwide kind of map--and I have seen such a
map of hotspots of infectious diseases--overlaid with travel
patterns to guess whether or not? And I understand the CDC has
worldwide outposts.
So again, I am asking something closer to the point----
Dr. Redd. Sure.
Senator Cassidy ----than whether it gets to Texas.
Dr. Redd. I think the quality of information is variable. I
do not think we have----
For example, I think the information we have about
influenza is much better than we have about all the vector-
borne, all the mosquito-borne diseases that are out there where
we know what viruses are circulating in China because of the
known importance of influenza and the risk it poses for a
global pandemic.
Senator Cassidy. Now, I have seen maps--and I am overtime,
and I will stop after this--but I have seen maps put out by the
CDC and the World Health in which it shows, ``Oh, yes. Here is
this and there is that.'' And it is a hotspot of a particular
virus.
Can that not be, again, overlaid with travel patterns?
Dr. Redd. Well, there are parts of the world that some of
the discussion earlier about the number of zoonotic diseases
that are detected that cause infections in humans, there are
certain parts of the world that are more prone to those
emergences.
I think, again, your question is, how do we use that
information? We certainly do have travel maps of where people
travel to and from. We have information about where various
diseases occur at variable degrees of granularity. I think
those two things do go together.
I think how we would use that to take a preemptive action
is really, I think that is the question that you are getting
at.
Senator Cassidy. Okay. I yield back.
The Chairman. Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman.
This is incredibly informative. Thank you to all of the
witnesses.
I want to raise two concerns that I have emanating from
conversations I have had with companies in Connecticut that
operate in the pandemic response field.
The first is regarding response to an influenza outbreak
and this is for either Dr. Kadlec, I think, or Dr. Redd.
Dr. Kadlec, in your testimony, you write that we have
sufficient domestic vaccine manufacturing capacity to produce a
bulk vaccine for every American within 6 months.
But I want to ask either of you about the question of
vaccine delivery. This comes from conversations with a
manufacturer in Connecticut, B-D, which is one of the bigger
syringe manufacturers.
My understanding is that if you needed to get a vaccine to
everybody, you would need about 600 million drug delivery
devices. Now, B-D is one of the biggest manufacturers, but it
would take them 6 years to do 600 million units.
What are your thoughts on preparation to make sure that we
not only have the right amount of vaccine, but the right amount
of vaccine delivery devices?
Dr. Kadlec. Well, thank you, sir.
That is one of the issues, and then problems, that has to
be addressed, quite frankly, and I have my Director from BARDA,
if he wants to make a comment. He is welcome to at this point.
But I think part of the strategy we are looking at also is,
how can we innovate and either have better delivery devices? Or
specifically, can we make better vaccines that only require one
dose? Remember, the 600 million doses are for two per person.
The third thing is there are maybe new vaccine technologies
that allow you to do it orally, or intranasally, or a variety
of other means beside subcutaneously with a needle. So I think
all those issues are being evaluated and pursued.
But yes, there are some very significant shortfalls and
there are other disposables as well that are a matter of
concern when you get into that kind of circumstance.
Rick, do you have anything?
Senator Murphy. I am sorry.
Dr. Kadlec. I just wanted to make sure if I left something
out, if Dr. Bright could offer it.
Dr. Redd. I think this is a modeling problem. Particularly
from the supply standpoint, making sure that we are tapping
into the existing commercial market, and we are able to
leverage that system in addition to stockpiling what that
market cannot produce.
Senator Murphy. Dr. Kadlec, back to you, and my second
concern.
BARDA, as we have talked about, is such a wonderful model
and working with industry, you have developed 34 approved
medical countermeasures, 23 influenza vaccines.
Again, coming back to a company that BARDA has worked with
in Connecticut, Protein Sciences, which as you may know, has
come up with an innovative way to develop a vaccine; not the
traditional egg-based vaccine, but a recombinant DNA technology
mechanism.
They raised the issue of how you make sure that having
spent the money to develop these vaccines, there is a market so
that they can continue to develop processes and make sure that
they are available.
What is the responsibility of BARDA, or HHS or, I guess, if
the CDC wants to weigh in, on how you make sure that the money
being spent on research ends up on a marketable vaccine? And
that you are working with companies to make sure that a bridge
market exists so that they are available in the case that you
need them for a pandemic.
Dr. Kadlec. Well, clearly, that is one of the factors that
goes into this public-private partnership. And I would also
invite Dr. Gottlieb because it has been the case with the
PRV's, like with the vouchers, if you get through that you can
get some benefits. But we need to look at the whole variety of
incentives to not only get companies into the market, but keep
them in the market and keep them viable going forward.
There is this issue of ``the second valley of death,''
which has been raised at some point in time that once you have
delivered your vaccine--and if you do not get either the
opportunity to replenish or use that technology for some other
commercial purpose--that the company may still be at risk, and
you may still basically be confronted by the limitations that
you do not have the producer.
So these are issues that are still pretty thorny and, quite
frankly, that is one of the areas, I think, that probably
deserve a little more consideration during your
reauthorization.
Senator Murphy. I do not mean to keep Dr. Gottlieb out of
this conversation.
You raised this in some of your earlier testimony, some of
the market disincentives here and I would love to hear your
thoughts.
Dr. Gottlieb. Yes, I think you raise a very valid point,
Senator.
If you are talking about a countermeasure that does not
necessarily have a dual use for another public health
application, you only market is going to be in preparedness and
presumably the only market is going to be for stockpiling. And
if it is not something that turns over a lot, so you are not
going to have to constantly replenish your stockpile.
Depending on what you are developing, the cost of capital
to try to develop that product might be too high to justify the
investment. I saw this when I was on the other side of this
equation.
We have tried to offset some of that with the PRV's, but I
will say that the value of the PRV's in the marketplace have
diminished as we had more PRV's. So the value of the incentive
has also gone down over time.
So I think this is something we should all contemplate.
Senator Murphy. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murphy.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman.
Appreciate the discussion here this morning.
Dr. Kadlec, you recognized, in response to Senator Warren's
question, the challenge that Puerto Rico faced after the
devastating hurricanes. I mean, it is difficult in an island
area where you are not connected, where you are remote.
Well, that brings it close to home to me. We are not an
island in Alaska, but we are not connected to the continental
United States, and we are really big, and we do not have a lot
of roads.
It was just about 75, 78 years ago that we had a diphtheria
outbreak in Nome and we were able to deliver the serum by
dogsled. We are not doing that anymore, thankfully.
But it does speak to the reality of how to respond when you
have an outbreak, and your ability to move in quickly is
limited either because of weather or just access limitations.
We were reminded of this at 9/11 when all the airspace was
shutdown, when you now have 80 percent of your communities that
have no way to get things in and out. A major earthquake that
can take out a major port that serves access or airports. And
so, for us particularly in Alaska, we had to be our own little
island when it comes to response.
But when you are trying to get stockpiles of vaccines or
the like, that makes it very, very challenging. And I do not
recall whether it was you, Dr. Kadlec or Admiral Redd,
mentioned that you can get stockpiles, I believe, of vaccines
anywhere in the United States within 12 hours.
Did I hear that correctly?
[All nod in assent.]
Senator Murkowski. Should I be worried in a small, remote,
not accessible by road, shut out by weather? We cannot even get
a state trooper in for 3 days into certain of our villages at
certain points in time.
What can you do to assure me that we can be that responsive
in our more rural areas? That is one part of the question.
The other part is when it comes to infrastructure itself.
Several years back, we had the first sizable cruise ship
going through the Arctic. We had all kinds of emergency
preparation drills and it was not because we were most fearful
of an oil spill from a ship that might hit the ice. But an
issue on a ship where you now have 500 passengers who need some
level of healthcare and there is no healthcare facilities to be
had in the region.
So for purposes of how we can be responsive when there is a
public health crisis, whether it is an outbreak or some kind of
a disaster, manmade, natural, or otherwise, what assurances can
you give us from these rural states?
I will turn to Dr. Kadlec and you, Admiral.
Dr. Kadlec. Well, thank you, ma'am.
That is a challenge. I think the reality is the Strategic
National Stockpile can get anywhere to be delivered to the
state authorities within 12 hours.
Senator Murkowski. So that would get to?
Dr. Kadlec. To Anchorage, for example. And then, it is
really the state's responsibility to basically get those
products, or those vaccines, or drugs to the last terminal mile
to those people who need them.
That is an issue, quite frankly, I think ASPR and the CDC
share concern, that that is an area where concerted work has to
be done because there are other places in the country that
probably would have similar challenges.
Admiral Redd, do you want to?
Dr. Redd. Yes, I think this is a very challenging scenario
and I think that if it were a challenge to move product to a
location, there would be other challenges as well;
understanding the problem of the disease in that location.
We might have telecommunication, but access to
laboratories, access to epidemiologic investigation, those
would also be things that would be limited.
I think this probably needs to be thought of as a broader
set of capabilities that are needed to assure the protection of
these populations. Not just the stockpile, but medical care and
really situational awareness as to what is happening in those
locations.
Senator Murkowski. Well, and it is something, of course,
that we clearly think about.
The last thing I am going to leave you with. The State of
Alaska just conducted an Alaska Health Impact Assessment. It
was a framework based on the current National Climate
Assessment predictions and the impact to Alaska as a state that
is seeing the impact of climate change as warming temperatures.
You might not feel it here on the East Coast, but it is warmer
back home.
It outlines some of the potential health effects that could
be coming our way several decades out. We recognize that.
But one of the concerns, of course, is infectious diseases
that are particularly associated with vector borne. Usually, we
are able to freeze those nasty mosquitoes and they cannot move
these levels of outbreaks.
But it is something that, as we think about public health
emergencies, we are so focused on the here and the now, and the
disaster of the day, but I do think it is important that we be
thinking long term about the changes that might be headed our
direction.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murkowski.
Senator Jones.
Senator Jones. Thank you, Mr. Chairman.
Once again, thank you for your kind welcome to this
Committee.
To kind of followup on, I think, Senator Casey may have
highlighted it and Senator Murkowski was talking about the
rural health areas.
I can understand the challenges when there is a pandemic
and you need to get access, but I have a state that is also
very rural, but we have roads. We have the ability to get serum
in and things like that. But yet, we are in Tornado Alley. We
are in Hurricane Alley. It comes through.
My concern is the preparedness for healthcare delivery on
an immediate basis when you have those disasters because in
Alabama, like so many other states, rural healthcare is
disappearing, and that is a real challenge.
So I would like to have you address what is being thought
about, what is being done to prepare for those types of
emergencies for those communities that do not have the daily
healthcare that they have got, so that immediate healthcare
needs can be given to them.
Dr. Kadlec. Sir, I would just say one of the areas I
touched in my written testimony is on this idea of creating a
National Disaster Healthcare System, really taking advantage of
the nascent trauma system that we have in our country that
clearly needs to be amalgamated or, if you will, kind of
unified.
We would like to basically use the Hospital Preparedness
Program as a means to do that. It certainly would need more
resources to do that. But basically expand the regional
coalitions to not only cover states, but regions, Mississippi,
Alabama, that part of the country where you can actually share
resources and basically do better coordination, mutual aid in
those kinds of situations. Build the kind of relationships
where you know about bed availability, work with the EMS
systems in terms of transportation to basically identify the
appropriate places to take people with different injuries or
different kinds of casualties to the right place to ensure
their survival.
There is a lot that can be done and quite frankly, we think
by regionalizing this will help. Because Alabama has a few
major cities, Mobile, clearly there are some great facilities
there, as well as other parts of the state, as well as adjacent
parts in Mississippi. If you can build that coalition on a
regional basis, you can probably address some, but not all, of
those issues.
Dr. Redd. This is a little bit beyond preparedness, but one
of the things we had done at the CDC is to examine rural
health. The way that we have done that as a first step is to
actually examine the data that we have.
There are a series of publications on issues related to
rural health in our in-house journal, ``The Morbidity and
Mortality Weekly Report,'' and we would be happy to get those
to you to define the problem.
Senator Jones. Okay, that would be great.
I also was going to ask a similar question about citizens
with disabilities.
Do you have specific guidelines, things that you do to take
care of those with disabilities, whether it is a physical
disability, a mental disability, or whatever?
Dr. Kadlec. Sir, we have a program at HHS and the ASPR that
basically uses CMS data, Medicare data to basically identify
people in different regions or in states by ZIP Code, by home
address, even by phone number to identify people who are
dependent on durable medical equipment.
So in advance of a hurricane, for example, we provide the
states, like in the case of Florida and, I believe, in Alabama
too prior to Norm, before that hit that we identified people
who would be at-risk to power outages or who need probably
special assistance if they needed to be evacuated. That is one
piece of the problem.
Quite frankly, we do not have that data from Medicaid from
individual states. So that would be another way to enhance that
if we could get data on that.
But that is just one way to basically pre-identify people
at-risk and it goes a long way to basically take care of folks.
Senator Jones. All right.
Dr. Redd. Just three quick things.
Senator Jones. Sure.
Dr. Redd. We require our state grantees to include a
section on vulnerable populations in their emergency response
plans. So that is one thing.
The second is that we work with professional associations--
predominantly, I am thinking more of the American Academy of
Pediatrics, the American College of Obstetrics and Gynecology--
when there is an emergency to make sure that we are addressing
those populations.
Also, when we activate our operations center for an
emergency response, there is a functional desk on vulnerable
populations to try to deal with the kinds of issues that come
up.
Senator Jones. Great, thank you. Thank you, gentlemen.
Thank you for your testimony.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Jones.
Senator Casey, do you have any questions or concluding
remarks you would like to make?
Senator Casey. Mr. Chairman, just some concluding remarks,
and I will read through them quickly.
I want to thank our witnesses, obviously, for their
insights and expertise today and their ongoing as part of the
Federal Government to develop and maintain the necessary public
health preparedness capabilities.
I will have some questions for the record in addition to
the ones I asked already.
Senator Casey. Next week, we look forward to hearing from
nongovernmental stakeholders about how we can continue to
strengthen our readiness for future public health emergencies
and keep the American public safe.
As we heard today, preparedness is continuous and must
evolve to face new and different types of threats. I remain
committed to ensuring we sustain the progress we have already
made in preparing for public health emergencies, while
continuing to work to anticipate the next threat.
We have a strong, bipartisan history of working together on
this Committee to improve our communities' ability to respond
to all manner of public health threats, and I look forward to
continuing that tradition in the months ahead.
Mr. Chairman, I want to thank you for your work on this, as
well as Ranking Member Murray and Senator Burr, of course.
Thank you.
The Chairman. Thank you, Senator Casey.
Senator Casey is exactly right. This is one of the many
areas that this Committee has effectively worked on, both in
the authorization and reauthorization of legislation to prepare
our country for the unexpected disaster that might occur to us.
A lot of progress has been made and I want to thank Senator
Casey and Senator Burr, especially, for their leadership over
the years in this area.
As he indicated, we will be having our second hearing on
this topic next Tuesday, January 23 working with Senator
Murray, Senator Casey, Senator Burr, and others. We hope to be
able to write legislation revisiting this Act, and mark it up
in Committee this spring, and present it to the Senate for
bipartisan action.
I thank the witnesses for coming today. The testimony has
been very helpful. The attendance has been good.
The hearing record will remain open for 10 days. Members
may submit additional information within that time, if they
would like.
The Chairman. Our Committee will meet again tomorrow on a
different topic at 10 a.m. for a hearing entitled,
``Reauthorizing the Higher Education Act: Financial Aid
Simplification and Transparency.''
We have been working for more than 4 years on taking a new
look at the Federal Government's relationship to our colleges
and universities. There are 6,000 of them. Our major role is
that we appropriate about $34 or $35 billion a year in grants
for students to attend colleges. There is more than $100
billion of new student loans each year.
In connection with all of that money, there is a lot of
opportunity and a lot of need for us to take a look at
accreditation, innovation, simplification, getting through the
jungle of red tape, another whole set of activities.
That will be our major focus during this year and we hope
also to have that bipartisan legislation to the Senate floor
some time this spring.
Thank you for being here today.
The Committee will stand adjourned.
[Whereupon, at 12:08 p.m., the hearing was adjourned.]
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