[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
                                
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        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

                              ----------                              

                               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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