[Senate Hearing 112-797]
[From the U.S. Government Publishing Office]







                                                        S. Hrg. 112-797

 A NATION PREPARED: STRENGTHENING MEDICAL AND PUBLIC PREPAREDNESS AND 
                                RESPONSE

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                                   ON

  EXAMINING STRENGTHENING MEDICAL AND PUBLIC HEALTH PREPAREDNESS AND 
                                RESPONSE

                               __________

                              MAY 17, 2011

                               __________

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                                Pensions




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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

BARBARA A. MIKULSKI, Maryland      MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico          LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington           RICHARD BURR, North Carolina
BERNARD SANDERS (I), Vermont       JOHNNY ISAKSON, Georgia
ROBERT P. CASEY, JR., Pennsylvania RAND PAUL, Kentucky
KAY R. HAGAN, North Carolina       ORRIN G. HATCH, Utah
JEFF MERKLEY, Oregon               JOHN McCAIN, Arizona
AL FRANKEN, Minnesota              PAT ROBERTS, Kansas
MICHAEL F. BENNET, Colorado        LISA MURKOWSKI, Alaska
SHELDON WHITEHOUSE, Rhode Island   MARK KIRK, Illinois
RICHARD BLUMENTHAL, Connecticut    

                    Daniel E. Smith, Staff Director
                  Pamela Smith, Deputy Staff Director
     Frank Macchiarola, Republican Staff Director and Chief Counsel

                                  (ii)












                           C O N T E N T S

                               __________

                               STATEMENTS

                         TUESDAY, MAY 17, 2011

                                                                   Page

                           Committee Members

Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina.......................................................     2
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of 
  Pennsylvania, prepared statement...............................     4
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming, 
  prepared statement.............................................     5
Blumenthal, Hon. Richard, a U.S. Senator from the State of 
  Connecticut....................................................    14
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas.......    18
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    22

                            Witness--Panel I

Lurie, Nicole, M.D., M.S.P.H., Assistant Secretary for 
  Preparedness and Response, U.S. Department of Health and Human 
  Services, Washington, DC.......................................     7
    Prepared statement...........................................     9

                          Witnesses--Panel II

Kadlec, Robert P., M.D., MTH&H, MA, Vice President, Global Public 
  Sector, PTRM Management Consultants, Washington, DC............    25
    Prepared statement...........................................    27
Arthur, Phyllis, Senior Director, Vaccines, Immunotherapeutics 
  and Diagnostics Policy, Biotechnology Industry Organization, 
  Washington, DC.................................................    31
    Prepared statement...........................................    33
Anderson, Michael R., M.D., FAAP, Vice President and Associate 
  Chief Medical Officer at University Hospitals and Associate 
  Professor of Pediatric Critical Care at Rainbow Babies & 
  Children's Hospital, Cleveland, OH.............................    38
    Prepared statement...........................................    40
Cooper, Susan R., MSN, RN, Commissioner, Tennessee Department of 
  Health, Nashville, TN..........................................    47
    Prepared statement...........................................    49

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Barbara A. Mikulski..................................    62
    Senator Kay R. Hagan.........................................    63
    Governor, Lowell P. Weicker, President of the Board of 
      Directors, Trust for America's Health......................    64

                                 (iii)



 
                    A NATION PREPARED: STRENGTHENING
              MEDICAL AND PUBLIC PREPAREDNESS AND RESPONSE

                              ----------                              


                         TUESDAY, MAY 17, 2011

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:37 p.m. in Room 
430, Dirksen Office Building, Hon. Tom Harkin, Chairman of the 
committee, presiding.
    Present: Senators Harkin, Enzi, Casey, Whitehouse, 
Blumenthal, Burr, Hatch, and Roberts.

                  Opening Statement of Senator Harkin

    The Chairman. The committee on Health, Education, Labor, 
and Pensions will come to order.
    I am pleased to convene this hearing today on a very 
important issue, defending our Nation against public health 
threats. Such threats are diverse in origin and include 
exposure to chemical, biological, radiological or nuclear 
agents. Sometimes these threats occur naturally, the 2009 H1N1 
pandemic influenza, for example, or they can be the result of 
malicious intent, such as the intentional release of the 
anthrax in 2001. A recent and very challenging example is the 
radiation leak that occurred at the nuclear plant damaged in 
Japan's massive earthquake.
    It is not just known threats that place the health and 
well-being of Americans at risk, there are just as many 
emerging or unknown threats against which protection is 
critical. Because the impact of these threats could be 
catastrophic, it is imperative we continue to strengthen the 
Nation's ability to adequately prepare for and appropriately 
respond to a public health emergency. Building our Nation's 
response capacity requires close collaboration among Federal, 
State and local governments, hospitals and healthcare 
providers, businesses, schools, and indeed all Americans.
    I have long taken very seriously the Federal Government's 
role in being prepared for a public health emergency, public 
health preparedness, as it is called. We have made tremendous 
progress in preparedness during the last decade. One important 
aspect of public health preparedness is the advanced 
development and procurement of medical countermeasures. These 
are the vaccines, therapies and diagnostics needed to prevent 
or respond to a bioterrorism event or other public health 
emergency.
    In an effort to ensure that we have the appropriate medical 
countermeasures, we need to continue to support innovative 
research into promising new products and ensure that products 
are readily available during a time of emergency. We also need 
to address the scientific challenges of identifying safe and 
effective medical countermeasures when human trials are not 
available or ethical. Such scientific challenges pose 
regulatory issues that we will hear more about from our 
distinguished panel of witnesses today.
    Underlying all of our preparedness activities is the issue 
of how to ensure that our most vulnerable citizens will be 
protected should disaster strike. We know that many 
populations, including individuals with disabilities, seniors 
and children may have unique needs that we have the 
responsibility to address during a public health emergency. 
This came to the forefront during Hurricane Katrina and people 
with disabilities. In the past, when faced with catastrophic 
events, we have too often seen such needs go unmet.
    The purpose of this hearing is to learn more about the 
significant progress our Nation has made in preparing for and 
responding to public health threats and challenges and the 
barriers that may exist. It is even more important to discuss 
ways in which we can use lessons learned to create a stronger 
and more prepared Nation.
    So I look forward to hearing suggestions from our witnesses 
on ways to strengthen our public health preparedness as this 
committee begins its work on reauthorizing the Pandemic and 
All-Hazards Preparedness Act, known as PAHPA, hopefully during 
this congressional session.
    I yield to Senator Enzi for an opening statement.
    Senator Enzi. Mr. Chairman, I am going to yield to Senator 
Burr for a statement. If you have two on your side, then I will 
have one as well. If you don't, I will put mine in the record. 
But I need to have Senator Burr do an opening statement because 
in 2006 he was the lead----
    The Chairman. That is right.
    Senator Enzi [continuing]. On doing this particular bill 
and I sat with him in a number of negotiation sessions with 
Senator Kennedy and Senator Dodd, as they worked out all of the 
issues that we were aware of at that time. And he did just a 
masterful job and really understands this bill and was really 
in charge of it and it is largely thanks to him that we were 
able to get it done.
    And of course we were worried about bird flu at that time 
and we had the measures in place. So I would yield to Senator 
Burr.

                       Statement of Senator Burr

    Senator Burr. Mr. Chairman, thank you. And Senator Enzi, 
thank you for yielding to me for an opening statement. I 
welcome our entire panels, especially Dr. Lurie for being here.
    Mr. Chairman, one of the committee's greatest 
responsibilities is ensuring that our Nation has the medical 
and public health preparedness and response capabilities 
necessary to respond to all hazards and all threats, whether 
natural or manmade. The Pandemic and All Hazard Preparedness 
Act answered the critical question of who is in charge through 
the creation of the Assistant Secretary for Preparedness and 
Response. This law strengthened our medical surge capabilities 
and improved State and local public health security. PAHPA also 
enhanced medical countermeasure research, development and 
procurement through the creation of the Biomedical Advanced 
Research and Development Authority.
    As we work to reauthorize the Pandemic and All Hazards 
Preparedness Act and BioShield, it is critical that this 
committee take a hard look at what is working well and what is 
not working well. The good news is that we have come a long 
way, and as H1N1 demonstrated, we are better prepared to 
respond to the public health emergencies today than we were 5 
years ago. But while we have come a long way, we know that much 
work remains to be done, and we cannot lose sight of the 
urgency surrounding our work in this area.
    Just today, news broke that the department plans to make 
cuts to preparedness programs. This raises significant 
questions as to how the administration is prioritizing and 
coordinating their preparedness and response mission. Medical 
and public health preparedness and response is a matter of 
national security. PAHPA's reauthorization is the opportunity 
to make the targeted and strategic changes to the medical and 
public health preparedness and response authorities and 
programs necessary to strengthen and improve our capabilities 
to successfully respond to all threats.
    We have the opportunity to draw upon the lessons learned 
after 5 years, the 2009 H1N1 influenza pandemic, the Haiti 
disaster, the Gulf oil spill and the recent disaster in Japan. 
Many of these incidents underscore the ability of Mother Nature 
to throw us a biological curve ball with the potential to wreak 
havoc on the scale of the 1918 pandemic. The death of Osama bin 
Laden is a sobering reminder that the 21st century threats are 
real and we must be prepared to address chemical, biological, 
radiological and nuclear threats.
    The Commission on the Prevention of WMD Proliferation and 
Terrorism has repeatedly warned that it is,

          ``more likely than not, that a weapon of mass 
        destruction will be used in a terrorist act by the end 
        of 2013 and that we must make bioterrorism a higher 
        priority.''

    Just last year the WMD Commission again warned that we are, 
``woefully behind in our capability to rapidly produce vaccines 
and therapeutics,'' which we all know is critical for 
responding to CBRN threats, whether natural or manmade.
    Last year the administration's Public Health Emergency 
Medical Countermeasures Enterprise review concluded,

          `Our Nation must have the nimble, flexible capability 
        to produce medical countermeasures rapidly in the face 
        of an attack or threat, known or unknown, including a 
        novel, previously unrecognized, naturally occurring 
        emerging infectious disease.''

    If we are to achieve the shared goal of having a prepared 
Nation capable of responding to all hazards and all threats, we 
must ensure the continuity of critical medical preparedness and 
public health preparedness authorities and programs. We must 
ensure that these programs are targeted, sound in achieving the 
measured results and returns American taxpayers expect and 
deserve.
    Where we have not gotten the policy exactly right, we must 
take this opportunity to refocus, to strengthen and to improve 
these programs and authorities. This includes ensuring that our 
medical countermeasures public/private partnerships reflect 
modern day threats and the Food and Drug Administration 
provides the regulatory certainty and support to ensure a 
robust medical countermeasure enterprise. We must foster and 
accelerate the development and innovation of medical 
countermeasures, which includes fully funding BARDA's advanced 
research and development. Let me restate that, which requires 
fully funding BARDA's advanced research and development 
funding.
    We have always been able to come together in a bipartisan 
manner on this issue when it comes to prioritizing medical and 
public health preparedness and response. Our work in this area 
is a matter of national security.
    And to the Chairman and the Ranking Member I look forward 
to again partnering with my colleagues to reauthorize PAHPA and 
BioShield and to do it in this Congress. I thank the Chair.
    The Chairman. Thank you, Senator Burr and thank you also 
for your great leadership on this whole issue, as Senator Enzi 
said, going back several years when you led the effort in this 
committee. Thank you for that leadership very much.
    And Senator Casey, also, I guess the two of you are co-
sponsoring the reauthorization bill this year. I would 
recognize Senator Casey for an opening statement--if you want.

                       Statement of Senator Casey

    Senator Casey. I will submit a statement for the record. 
Thank you, Mr. Chairman.
    [The prepared statement of Senator Casey follows:]

                  Prepared Statement of Senator Casey

    I'd like to thank my distinguished colleagues, Senator 
Harkin, Senator Enzi and Senator Burr, for their efforts to 
ensure that our Nation is prepared for a medical emergency. I 
am honored to be working with you on a bipartisan 
reauthorization of the Pandemic All Hazards Preparedness Act.
    I'd also like to recognize our distinguished panelists here 
today--Dr. Lurie it is good to see you again--and thank you for 
your tireless work on protecting Americans from public health 
threats.
    Few issues are as central to the role of the Federal 
Government as protecting its citizens from a public health 
emergency--be it natural or manmade.
    Recent disasters from the past few years--the earthquake in 
Haiti and in Japan, and the H1N1 outbreak closer to home--have 
illuminated both the strengths and weaknesses of our 
preparedness and response capabilities.
    In light of the recent capture of Osama Bin Laden, many 
have suggested that the United States needs to be even more 
vigilant about a possible terrorist attack.
    I, like many Americans, am concerned about what progress we 
have made in the past few years since the Pandemic All Hazards 
Preparedness Act was passed in developing and licensing 
medicines that will help inoculate and cure the greatest health 
threats we face.
    Since 2004, the Department of Homeland Security has 
determined that 13 chemical, biological, radiological, and 
nuclear agents pose a high consequence in terms of people 
exposed to the pathogens. These are anthrax, glanders, 
melioidiosis, botulism toxin, Ebola virus, tularemia, a variety 
of hemorrhagic fevers, typhus, smallpox, plague, and 
radiological and nuclear materials.
    Through my work with Senator Burr on the Weapons of Mass 
Destruction Caucus, I know all too well how real these threats 
are and what a catastrophic disaster such an attack would 
impose.
    I know, too, that we have made progress in some of these 
areas when it comes to developing medical countermeasures. But 
I am concerned about reports that progress is coming along very 
slowly--and that we do not have the right level of scientific 
knowledge and resources devoted to this priority.
    I look forward to hearing your testimony today and 
discussing what else we, in Congress, can do to support the 
public health preparedness and response enterprise.

    The Chairman. I appreciate that very much, Senator Casey.
    Senator Enzi.

                       Statement of Senator Enzi

    Senator Enzi. Mr. Chairman, I'll submit mine to the record. 
And I will turn over the Ranking Member duties to Senator Burr. 
I have to be at another meeting.
    I do want to thank Senators Hatch and Roberts for their 
work on this issue as well, before, and the leadership they 
provided and the fact that they're here to participate today, 
too.
    [The prepared statement of Senator Enzi follows:]

                   Prepared Statement of Senator Enzi

    Good afternoon. From the start, I would like to thank the 
Chairman for holding this hearing and for his attention to 
public health and medical preparedness and response. I would 
also like to thank Assistant Secretary Lurie and the 
distinguished panel of witnesses who made time in their busy 
schedules to appear here today to discuss these matters 
critical to our national security. Thank you for your time in 
appearing before the committee and I look forward to your 
testimony.
    In 2006, our Nation took a critical step in shoring up the 
national security and safety of all citizens when Congress 
passed the Pandemic and All-Hazards Preparedness Act. I want to 
thank Senator Burr for his continued leadership on this 
critically important issue. I would also like to thank my 
colleagues on both sides of the aisle; this issue enjoys broad 
bipartisan support and leadership from many members.
    We have made tremendous progress in the past 5 years to 
ensure that we are prepared to meet all known and unknown 
hazards that threaten our citizens. At the same time, there are 
still gaps in the system that need to be filled and threats yet 
to be addressed. We have seen first-hand the critical need for 
a robust and active public health system that is able to 
anticipate and respond to threats quickly and effectively. We 
experienced the H1N1 pandemic that tested our Nation's ability 
to meet the public health needs of our citizens, learned from 
the public health emergency response in Haiti, and more 
recently, took action in helping to mitigate the nuclear crisis 
in Japan. We need to take these experiences and incorporate the 
lessons learned as we continue to strengthen our preparedness 
and improve our response capabilities.
    One of the areas we can always improve on is coordination 
and accountability. Along each step of the process it is 
essential to ensure that Federal, State and local entities are 
working in concert with each other. It is critical that roles 
and responsibilities are well-defined so that there is no 
uncertainty in a time of crisis and so attention can be focused 
on the threat at hand. One thing that we can be certain of is 
that our enemies will be coordinated in any attack against us; 
therefore we need a clear strategy for preventing and 
responding to such potential threats.
    PAHPA invested in the development, production, and 
procurement of medical countermeasures to ensure we are 
prepared to address any potential chemical, biological, 
radiological, or nuclear threats, particularly against those 
who would do us harm. It is important that we continue the 
momentum achieved by the creation of BARDA and BioShield. This 
is one area in which I particularly look forward to hearing 
from the witnesses about the successes and challenges for 
future countermeasure development.
    As always with government programs, I strongly emphasize 
and encourage responsible use of Federal funding. When it comes 
to national public health preparedness programs, we have the 
important responsibility to be careful stewards of Federal 
funds and at the same time strengthen our safety systems. 
Building in more metrics to improve accountability across the 
full public health emergency enterprise helps encourage 
enhanced fiscal management and better outcomes.
    While the Federal Government plays a critical role, it is 
truly the dedicated professionals at the State and local level 
who respond to public health emergencies. State and local 
governments have risen to the challenges of the past 5 years, 
and the people who serve in all levels of government know 
first-hand the challenges of preparing and responding to public 
health threats. I am proud of their work and applaud their 
often unseen efforts to make sure every citizen is safe in the 
event of a public health crisis.
    The very real threats facing our Nation are serious and 
sobering. I am, however, confident in the enterprising spirit 
of Americans and our ability to protect our country. Faced with 
the realities of the world we live in, we need to harness our 
abilities to think beyond the expected threats and prepare for 
those we don't know.
    Thank you, Chairman Harkin. I look forward to hearing from 
this excellent panel of witnesses.

    The Chairman. Thank you very much, Senator Enzi. Now I have 
the privilege of introducing Dr. Nicole Lurie and then I am 
going to turn the chair over to Senator Casey.
    So, I would like to welcome Dr. Nicole Lurie, the Assistant 
Secretary for Preparedness and Response at the Department of 
Health and Human Services.
    Dr. Lurie comes to us today with significant experience in 
the field of public health and preparedness. For the last 
several years she has worked with HHS, the Department of 
Veterans Affairs and State and local health departments on H1N1 
preparedness. Prior to joining HHS, Dr. Lurie directed the RAND 
Corporation's Center for Population Health and Health 
Disparities and served as co-
director of RAND's Center for Domestic and International 
Health.
    We thank you, Dr. Lurie, for joining us today and sharing 
your expertise with the committee.
    That will be our first panel. And then we will go to our 
second panel after that. And Dr. Lurie, your statement will be 
made a part of the record in its entirety.
    I am going to turn the chair over to Senator Casey at this 
time. But please proceed, as you so desire.

STATEMENT OF NICOLE LURIE, M.D., M.S.P.H., ASSISTANT SECRETARY 
 FOR PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND 
                HUMAN SERVICES, WASHINGTON, DC.

    Dr. Lurie. Thank you, Chairman Harkin, Ranking Member Enzi 
and distinguished members of the committee and especially the 
papa of PAHPA here, Mr. Burr.
    Recent events serve to remind us----
    [Laughter.]
    Dr. Lurie [continuing]. Of the significant challenges that 
we face from an ever present terrorist threat to unprecedented 
weather events and how quickly and unpredictably the call to 
support the American people can arise. Since joining ASPR 
almost 2 years ago I've had the privilege to share with you 
some of our accomplishments, many of which were made possible 
by the authorities provided in PAHPA and were a direct result 
of coordinated and collaborative efforts across HHS. In fact, 
every aspect of HHS has been involved with our office during 
responses over the past 2 years.
    H1N1 tested our ability to adapt and respond to a novel 
influenza stream. The experience highlighted the 
interdependence of public health, the healthcare system and 
community and business organizations. It confirmed that 
emergencies, particularly large ones that tax an entire health 
and public healthcare system, requires us to innovate. One 
result is that we are looking at how we can be more flexible in 
getting the right resources, whether countermeasures or 
healthcare professionals, to where they are needed in an 
emergency, and at the right time.
    Both H1N1 and the Japanese nuclear situation demonstrated 
the importance of deploying medical countermeasures as quickly 
as possible after an incident. We are advancing efforts to 
strengthen the development of new and promising countermeasures 
and to ensure that safe, effective countermeasures can be 
quickly delivered to populations in need. Our efforts in this 
area are aligned through the Public Health Emergency 
Countermeasures Enterprise, or PHEMCE, an interagency body that 
defines and prioritizes medical countermeasures requirements, 
research, investments and procurements. The Secretary's 
Countermeasures Enterprise Review included recommendations to 
strengthen and improve this enterprise so that we get the 
products we need to manage an unprecedented health emergency.
    One critical demonstration of the U.S. Government's 
commitment to ensuring we have the tools to treat the affects 
of these agents is the BioShield Program. Since its inception 
we have successfully procured products for the Strategic 
National Stockpile to treat the affects of anthrax, botulism, 
smallpox and products for radiologic and nuclear events.
    As you may have heard, just last week we announced a major 
BioShield contract for a smallpox antiviral. This award is a 
prime example of how the system is supposed to work. Taking a 
product without a viable commercial market from early research 
through advanced development under BARDA, to procurement, 
significantly strengthening our ability to protect the United 
States from a bio threat.
    The Haiti earthquake demonstrated the readiness of our 
country to extend extraordinary humanitarian assistance and 
taught us valuable lessons that we are now acting on. For 
example, we are strengthening how we do domestic operations 
within the National Disaster Medical System to best serve 
stakeholders and are approving methods for collecting health 
data through the NDMS electronic medical record to better 
identify specific populations needs to ensure that we have a 
nimble and flexible NDMS response that is right-sized and 
focused on the right need.
    As we work to address the needs of at-risk population, we 
join FEMA in adopting a whole community approach to our 
planning. We have taken steps to ensure that at-risk 
individuals, children, pregnant women, seniors and other 
individuals who have specific needs, are included at every step 
of our planning for medical countermeasures. The whole 
community approach leads us to focus on the local level, 
including State and local government and private sector 
partners in strengthening preparedness efforts and in being 
innovative in how we do so.
    PAHPA authorized two cooperative agreement programs that 
have been critical to ensuring that State and local 
jurisdictions have the resources to prepare for public health 
incidents, the Hospital Preparedness Program and the Public 
Health Preparedness Cooperative Agreements. And while these 
programs aim to strengthen different parts of the system, they 
share common objectives. A key priority for me is the alignment 
of these programs to ensure efficient use of limited resources 
and eliminate duplicative or conflicting programmatic guidance 
and reducing the programmatic burden for grantees.
    State and local jurisdictions rely on these programs to 
enhance preparedness and response and there are now numerous 
examples of States being able to handle events without Federal 
augmentation. A few weeks ago I visited areas of the south 
impacted on by the recent tornados and I heard firsthand how 
important these programs were to effective response. These and 
other experiences have confirmed the critical importance of a 
single point of contact for coordinating preparedness and 
response envisioned by PAHPA.
    The experience, since its passage, has shown clearly that 
every part of the public health and medical community is 
critical to making our Nation and our communities more 
resilient. And the national health security strategy, that you 
envisioned, charts our way forward.
    We applaud Congress' wisdom in enacting PAHPA as the 
foundation for this approach and I look forward to working with 
all of you as PAHPA is reauthorized in this Congress. I would 
be happy to take any questions that you might have.
    [The prepared statement of Dr. Lurie follows:]
           Prepared Statement of Nicole Lurie, M.D., M.S.P.H.
    Good afternoon Chairman Harkin, Ranking Member Enzi, and 
distinguished members of the committee. I am pleased to be here today 
on behalf of the U.S. Department of Health and Human Services (HHS) to 
testify on national public health preparedness and response. My name is 
Nicole Lurie and I serve as the HHS Assistant Secretary for 
Preparedness and Response. Today, I will discuss how critically 
important the Pandemic and All Hazards Preparedness Act (PAHPA; the 
Act) is to our public health preparedness and the progress we have made 
since its enactment in 2006.
    First, I would like to recognize the Congress, and especially this 
committee, for its strong leadership in advancing the public health and 
preparedness of our Nation by enacting this important legislation in 
2006. PAHPA has supported our efforts to foster stronger, more 
resilient communities able to respond to and recover from public health 
emergencies. PAHPA established the foundation for a consolidated and 
thorough response to emergencies and HHS has since built on these 
authorities to ensure the Nation has the tools necessary to save lives.
the pandemic and all-hazards preparedness act established a formalized 
                 approach to public health preparedness
    PAHPA strengthened our country's foundation for public health 
preparedness by helping us fix some of the problems our Nation 
encountered when preparing for and responding to disasters in the past. 
As we have seen from a variety of recent emergencies and disasters as 
of late--including tornados, floods, influenza pandemic, earthquakes, 
damage to a nuclear facility and a large oil spill--there is always a 
significant impact to the public's medical care and public health.
    The Pandemic and All-Hazards Preparedness Act has been instrumental 
to support State and local preparedness and response efforts. Since the 
passage of the Act, HHS has implemented a number of initiatives to 
strengthen preparedness and response efforts. We look forward to 
working with you on improvements to strengthen our public health and 
medical preparedness and response.
    The Pandemic and All-Hazards Preparedness Act designated the HHS 
Secretary as the lead Federal official for public health and medical 
response to emergencies and incidents covered by the National Response 
Plan and its successor plans, and created my office, the Office of the 
Assistant Secretary for Preparedness and Response (ASPR). Under the 
Act, ASPR serves as the principal advisor to the Secretary on all 
matters related to Federal public health and medical preparedness and 
response and plays a pivotal role in coordinating emergency response 
efforts across the various HHS agencies and among our Federal 
interagency partners.
    Guided by the authorities in PAHPA, HHS established organizational 
priorities and enhanced its operations and response capabilities. 
Moreover, to carry out PAHPA authorities, ASPR's mission was defined as 
leading the country in preparing for, responding to, and recovering 
from health effects of emergencies and disasters by supporting our 
communities' abilities to withstand adversity, strengthening our health 
and response systems, and enhancing national health security. The 
future of Federal public health and medical preparedness and response 
is a ``whole community'' approach. This approach requires that we 
institutionalize community resilience by building practices nationally 
that strengthen preparedness efforts implemented by local institutions 
including State and local government and private sector partners; 
creating a fundamental body of knowledge for preparedness, response, 
and recovery; and encouraging innovative efforts to build the Nation's 
capacity to stabilize and recover from an event. We are also working to 
ensure that our public and private sector partners are promoting a 
culture of budget preparedness to quickly and efficiently get resources 
where they are needed before and after a disaster.
 the national health security strategy established a common strategic 
            framework to align national preparedness efforts
    Since the enactment of PAHPA in 2006, HHS has had many significant 
accomplishments preparing for and responding to public health 
incidents. To help better align efforts internally, support and promote 
coordination efforts with Federal, State, local, and private sector 
partners, and be efficient stewards of Federal dollars, in December 
2009 we released the National Health Security Strategy (NHSS)--a 
blueprint for preparedness and response. PAHPA required the completion 
of a NHSS as a first step in ensuring we have a fully integrated and 
coordinated strategy to address how various sectors of our medical and 
public health systems will work together to respond to emergencies and 
save lives.
    The principle at the heart of the strategy is that our public 
health security is about ensuring resilient communities; health systems 
that coordinate and work together during disasters; and public and 
private sectors working together. National health security is a shared 
responsibility--from individuals and families, to private industry, to 
every level of government. It recognizes that to build community 
resilience we need effective public health systems working seamlessly 
in collaboration with a strong healthcare system. The NHSS also 
promotes building more resilient communities by including at-risk 
populations in planning and day-to-day operations. Supporting this 
strategy, HHS has taken steps to ensure that at-risk individuals--
children, pregnant women, senior citizens, individuals with 
disabilities, and others who have special needs--are included in all 
planning scenarios, guidance documents, plans, and will be effectively 
treated in the event of a public health emergency.
    Recognizing that we have learned a great deal about these strategic 
planning processes in the past 4 years, we are interested in efforts 
that enhance operational and long-term planning efforts while also 
streamlining requirements. In support of the principles of the NHSS, 
State and local jurisdictions have operational plans that describe 
operations during pandemic influenza incidents. These plans--required 
by PAHPA--include a framework that guides communications and logistics, 
and coordinates general response efforts during pandemic influenza 
incidents. At the time PAHPA was enacted, these plans were a relatively 
new concept--the original provision was to ensure that any plan in 
place was strong and relevant. To ensure the Nation is prepared for 
threats beyond pandemic influenza, we believe these plans should 
include planning for all-hazards.
    the medical countermeasure review established the strategic and 
          operational plan for hhs countermeasure preparedness
    To ensure the Nation has adequate countermeasures available to 
respond quickly and efficiently following a chemical, biological, 
radiological, nuclear (CBRN), or other public health emergency, HHS 
released the Public Health Emergency Medical Countermeasures Enterprise 
Review (MCM Review) in August 2010. The MCM Review identifies 
``processes, policies, and activities required to take a product 
concept derived from a national requirement through research, early and 
advanced development, manufacturing, regulatory approval, procurement, 
and stockpiling.'' This ground-breaking review looked across the entire 
spectrum of product development, from early discovery through 
regulatory approval, and identified the choke points where product 
development was stalling or failing. To address these choke points, 
which create technical, business, and regulatory risks for small 
innovator companies and form the basis of the medical countermeasure 
``valley of death,'' the MCM Review proposes:

     The establishment of a Concept Acceleration Program at the 
National Institutes of Health (NIH) National Institute of Allergy and 
Infectious Diseases to work with partner agencies, academic researches, 
biotechnology companies, and large pharmaceutical companies to identify 
promising scientific discoveries and expedite their transformation into 
practical, usable products;
     The establishment of a nonprofit Strategic Investor firm 
to spur innovation and create a viable biodefense business sector by 
supporting companies that possess strategic technologies applicable to 
both commercial and government needs, but which might otherwise lack 
the necessary financial capital or business acumen to develop a 
commercially viable, approved product;
     The establishment of U.S.-based Centers for Innovation in 
Advanced Development and Manufacturing; and,
     An increased investment in regulatory sciences and review 
capabilities at the Food and Drug Administration (FDA) focused on 
pandemic influenza, chemical, biological, radiological, and nuclear 
(CBRN) medical countermeasures (MCMs).

    The Concept Acceleration Program (CAP) will leverage existing 
intramural and extramural research programs as well as applied and 
translational resources throughout the NIH, Centers for Disease Control 
and Prevention (CDC), FDA, and Department of Defense (DOD) to expedite 
the translation of promising concepts into candidate MCMs. We are 
committed to applying $50M towards CAP activities in fiscal year 2011. 
Evaluations are in progress to identify CAP biological product 
candidates.
    With congressional authorization, the Strategic Investor initiative 
will spur innovation and provide the kinds of business and financial 
services and support that venture capital firms typically provide, 
while mitigating the risk that biotechnology firms face. The Strategic 
Investor initiative will promote the transition of MCM development and 
procurement from a ``one bug, one drug'' approach to an enterprise 
capable of responding to any threat at any time. It is important to 
note that the Strategic Investor is intended to work in concert with 
the BioShield program, not replace it.
    In March, we published a request for proposals for the Centers for 
Innovation in Advanced Development, that we will create to reduce risk, 
increase domestic manufacturing and surge capacity for MCM, and reduce 
total life-cycle costs through flexible manufacturing. These U.S.-based 
Centers are expected primarily to provide, on a routine basis, core 
services to commercial partners who collaborate with HHS's Biomedical 
Advanced Research and Development Authority (BARDA). These services 
include advanced development and manufacturing capabilities and other 
technical services needed by the developers of medical countermeasures 
for MCMs to address national preparedness and response priorities and 
needs. In the event of a pandemic, the Centers will also be available 
to manufacture influenza vaccine and other biologics, as well as 
provide training opportunities for the pharmaceutical workforce.
    Finally, expanding regulatory science and review capabilities at 
the FDA will strengthen and clarify the MCM regulatory process, which 
will expedite MCM development and availability. Regulatory uncertainty 
is a major barrier to engaging MCM developers in the MCM Enterprise. 
This initiative will provide private sector partners with greater 
access to regulators and greater clarity about the pathways to product 
approval, which will reduce uncertainty and foster greater engagement 
and program success.
    Collectively, once implemented, these initiatives will help us 
establish a more nimble and diversified approach in preparing for and 
responding to CBRN, pandemic influenza and other public health threats.
       pahpa helped spur development and procurement of medical 
                            countermeasures
    Prior to PAHPA, the Project BioShield Act of 2004 authorized the 
Project BioShield program and established the Special Reserve Fund 
(SRF). The Project BioShield Act provides additional and more flexible 
authorities and funding to support and expedite the development and 
procurement of CBRN medical countermeasures. The SRF is a secure 
funding source for the procurement of critical medical countermeasures, 
such as vaccines, therapeutics, and diagnostics that are close to or 
have achieved licensure. The SRF, as industry partners and other non-
governmental stakeholders have continually asserted, is a market 
guarantee for medical countermeasure development and clearly 
demonstrates U.S. Government's commitment to the procurement of 
security countermeasures. Finally, the Project BioShield Act provides 
the Secretary with the authority to authorize the emergency use of 
unapproved products or the unapproved use of approved products, if 
certain standards are met.
    Since its inception, we have drawn steadily on the use of Special 
Reserve Funds and have developed and procured:

     Anthrax therapeutics and vaccines;
     Heptavalent botulinum antitoxin;
     Smallpox vaccine for immunocompromised persons; and
     A number of MCM products intended for use after 
radiological or nuclear events.

    PAHPA included authorities that strengthened Project BioShield and 
HHS was able to leverage these authorities to promote successful 
collaboration and procurement to keep the Nation safe against CBRN 
threats. In order to improve the Federal coordination of government 
policy, investments, and activities related to the development and 
procurement of medical countermeasures for CBRN threats, in July 2006, 
HHS established the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE). ASPR leads the PHEMCE, which includes principal 
representatives of CDC, FDA, and NIH. PHEMCE also includes key 
interagency partners from DOD, the Department of Homeland Security 
(DHS), the Department of Veterans Affairs (VA), and the Department of 
Agriculture (USDA).
    The overarching mission of PHEMCE is to:

     Define and prioritize requirements for public health 
emergency medical countermeasures;
     Coordinate research, early and late stage product 
development, and procurement activities addressing these requirements; 
and
     Set deployment and use strategies for medical 
countermeasures held in the Strategic National Stockpile (SNS).

    Using its Advanced Research and Development (ARD) authority, HHS 
bridges the ``valley of death'' funding a gap that exists between the 
early stages of product development and the procurement of medical 
countermeasures under Project BioShield. Congress recognized that since 
commercial markets do not exist for many of the products we are trying 
to develop, robust funding for ARD is essential if we are to build and 
sustain a substantial pipeline of products to diagnose and treat 
illness, or prevent the effects of CBRN agents. Current priority 
investment areas include anthrax vaccines and treatments, broad 
spectrum antimicrobial drugs, and treatments and diagnostics for 
illnesses associated with exposure to radiation. In fiscal year 2012, 
the President's Budget requests $765M from Project BioShield balances 
to support these priorities.
    While the imminent threat of H1N1 influenza has subsided, avian 
influenza viruses continue to circulate, and critical work continues to 
prepare for the next influenza pandemic. One of the functions of the 
Centers for Innovation in Advanced Development and Manufacturing 
mentioned earlier, in addition to providing development and 
manufacturing of medical countermeasures to CBRN threats, will be to 
expand domestic pandemic influenza vaccine manufacturing surge 
capacity. HHS continues to develop flu antiviral drugs and vaccines and 
a more robust domestic vaccine manufacturing capability. We are focused 
on ensuring the Nation has access to safe and effective vaccine as soon 
as possible following the start of an influenza pandemic. We continue 
to implement strategies that work toward producing influenza vaccine 
more rapidly during an influenza pandemic, including the development 
and implementation of more rapid testing methods for vaccine release 
and the establishment of domestic recombinant and cell-based vaccine 
manufacturing capabilities. Supporting this effort, shortening the 
timeframe for vaccine availability with new and faster product testing 
and next generation influenza vaccines made in the United States will 
achieve better products faster. I am pleased to inform you that we are 
already making great progress in these efforts.
    hhs has significant accomplishments since the enactment of pahpa
    We have accomplished much since the passage of PAHPA and were able 
to respond to a number of public health emergencies including:

     The first pandemic in 40 years;
     An earthquake in the western hemisphere's poorest country;
     The largest oil spill in history;
     The 2011 Japan earthquake, tsunami, and associated 
radiological contamination event; and,
     Other domestic events including hurricanes, floods, and 
tornadoes.

    In addition, as I mentioned previously in my testimony, we were 
also successful in procuring and stockpiling medical countermeasures to 
protect against CBRN threats, as well as against pandemic influenza and 
other emerging infectious diseases.
    Since I was sworn in as the Assistant Secretary for Preparedness 
and Response, one thing has been clear--the investments we've made in 
the last decade have had a positive effect on our ability to respond to 
emergencies. In each response, HHS provided support to State, local, or 
international partners and in return learned valuable lessons to guide 
future response operations. We are working internally to strengthen and 
incorporate the lessons learned from these and other recent responses 
to ensure future response efforts are enhanced.
    The Japanese earthquake and subsequent nuclear reactor crisis is an 
example of a catastrophic scenario that would present formidable public 
health and healthcare challenges to the United States should such an 
event occur here. We already knew the importance of deploying medical 
countermeasures as quickly as possible following an incident. However, 
as a result of this crisis, we have expedited efforts internally to 
ensure adequate countermeasures are stockpiled and can be deployed as 
soon as possible following incidents. It is critical that we have the 
flexibility to use and deploy countermeasures as soon as possible 
following the start of a public health incident to help reduce 
morbidity and mortality.
    Beyond medical countermeasures, many lessons learned during our 
2009 H1N1 pandemic response will strengthen HHS's ability to respond to 
other emergency events. The 2009 H1N1 experience stressed the 
interdependence of the public health, pre- and post-hospital care, 
primary care, hospital care systems and community and business 
organizations. It also confirmed the need for a ``whole of community'' 
approach in planning and responding to a disaster, and confirmed that, 
going forward, we must address the entire healthcare community in our 
preparedness activities. The Department is considering proposals to 
strengthen the ability for medical and public health professionals to 
be of assistance in an emergency situation.
    Lastly, after our response to the Haiti earthquake we have taken 
actions to: streamline internal operations to ensure providers are 
adequately supported; provide needed services quickly and efficiently 
following disasters; and, ensure we have access to information that 
supports surveillance of the spread of illness. I am pleased to inform 
you that we have been working to strengthen the National Disaster 
Medical System (NDMS). NDMS is a federally coordinated system closely 
linked to the Hospital Preparedness program that augments the Nation's 
medical response capability. The primary purpose of the NDMS is to 
supplement an integrated National medical response capability for 
assisting State and local authorities in dealing with the medical 
impacts of major peacetime disasters. NDMS now uses an Electronic 
Medical Record (EMR) system that standardizes recordkeeping and 
promotes enhanced health surveillance during disasters. This, and other 
enhancements we have made, enable us to better identify population 
needs as we respond, including in the area of pediatrics. These 
developments in identifying the needs of populations, specifically 
pediatric and at-risk populations, will support a better and more 
focused response in the future.
    All of the accomplishments I have just described were supported 
through the close collaboration of many HHS partners including CDC, 
NIH, FDA, ASPR as well as the Centers for Medicare and Medicaid 
Services (CMS), the Substance Abuse and Mental Health Services 
Administration (SAMHSA), and the Indian Health Service (IHS), just to 
name a few.
    HHS has a number of programs and tools that aid State and local 
response and coordinate efforts during disasters. The ASPR Hospital 
Preparedness Program (HPP) has advanced the preparedness of hospitals 
and communities in numerous ways, including through planning for all-
hazards, increasing surge capacity, tracking the availability of beds 
and other resources using electronic systems, and developing 
communication systems that are interoperable with other response 
partners. We recently issued a report on the Hospital Preparedness 
Program that describes the achievements of our State partners in 
building healthcare preparedness across the Nation, and illustrates how 
States have used the capabilities developed and funded through the 
program in both large and small incidents. One specific accomplishment 
detailed in this report is that more than 76 percent of hospitals 
participating in the HPP met 90 percent or more of all program measures 
for all-hazards preparedness in 2009. This is a significant 
accomplishment and clearly demonstrates participants' commitment to 
investing in preparedness. Copies of this report were provided to each 
member of the committee in advance of this afternoon's hearing.
    In addition to HPP, CDC's Public Health Emergency Preparedness 
(PHEP) cooperative agreements provide funding to enable State and local 
public health departments to have the capacities and capabilities to 
effectively respond to the public health consequences of not only 
terrorist threats, but also infectious disease outbreaks, natural 
disasters, and biological, chemical, nuclear, and radiological 
emergencies.
    To promote coordination and efficient use of resources, we are 
working together to determine the best path forward for alignment of 
the HPP and PHEP grant programs to ensure we are efficient with 
resources and that we eliminate duplicative or conflicting programmatic 
and administrative efforts for grantees. Once we complete our internal 
alignment process, we will engage interagency partners to examine 
additional opportunities for synergy with other Federal preparedness 
grants. Consistent with Presidential Policy Directive 8, we are working 
toward a framework for priority-setting, review, and reporting 
measures; development of a common pathway to focus dollars, measure 
outcomes, reduce duplication, and enhance return on investment and 
reporting; and enhanced data sharing for improved situational awareness 
during a response.
    PAHPA authorized the HPP and PHEP grant programs. These programs, 
as I have just mentioned, are critical to ensuring State and local 
jurisdictions have the tools and resources to prepare for public health 
incidents.
                               conclusion
    The experiences since the passage of PAHPA have shown clearly that 
every part of the public health and medical community is critical to 
building resilience. We applaud Congress' wisdom in enacting PAHPA as 
the foundation for this approach, which is so critical to our 
preparedness.
    At this time I would be happy to address any questions you may 
have.

    Senator Casey [presiding]. Doctor thanks very much. I 
appreciate your testimony. We will have questions and we will 
do it in the order that the Senators arrived. I will start with 
Senator Blumenthal and then I will take myself out of the line 
up temporarily, for questions, and we will go to Senator Burr 
and then Senator Hatch.
    Senator Blumenthal.

                    Statement of Senator Blumenthal

    Senator Blumenthal. Thank you very much, Mr. Chairman and 
thank you for your work on this issue which has been 
instrumental and Senator Burr as well. And thank you for being 
here, Dr. Lurie.
    I have a number of questions raised by your written 
testimony. First, you speak briefly about some of the thermal 
burn countermeasures, and I know that you have focused on this 
issue. I wonder if you are satisfied that we have procured 
sufficient quantities and quality? Whether HHS and BARDA has 
done enough to ensure there are sufficient quantities and 
quality, because I think they are vital to have in our national 
stockpile.
    Dr. Lurie. Thank you for that question.
    One of the very important things that PAHPA did was provide 
us the flexibility and funding to be able to do advanced 
development of products. I think at first we thought maybe we 
could just go out and buy them or that, you know, having a fund 
for procurement would be enough of an incentive for industry to 
come and make all the products that we need.
    It turned out that there really wasn't very much in the 
pipeline. And I think thermal burns is a great example of where 
there really wasn't very much in the pipeline to start. And so 
we have really had to, as I think you know, reach back in the 
system and have developed, through Dr. Robinson and BARDA, a 
very sophisticated advanced research and development program so 
that we can develop these products to the point that they could 
at least be used under emergency use authorization, not through 
licensure and then procure it through the stockpile.
    Senator Blumenthal. Do you think there is a bottleneck in 
either the development or the procurement process? And if so, 
where would it be?
    Dr. Lurie. The Secretary's Medical Countermeasures Review 
took a really hard look at this last year and we identified a 
number of bottlenecks in the process and have now set to work 
on each of these and maybe sort of taking them in some order. 
The first really comes from taking early concepts at NIH and 
pulling them through to a point where the developers can get 
the help they need to be ready for an advanced development 
process.
    A second has to do with the way we support companies. And 
you know that the President's budget is seeking authority for 
what we are calling a strategic investor, to help companies 
leverage venture capital and on the business end to be able to 
move some of these forward.
    A third major area, for example, is in the area of 
regulatory science. And I think we have all recommended a 
fairly big push here in the area of regulatory science.
    I could go on and on about bottlenecks, but I will also 
just comment that we have made pretty radical changes in how we 
do the governance of the medical countermeasures inside. And so 
already in doing that I think we have eliminated a number of 
the bottlenecks and already been able to speed up our 
contracting processes.
    Senator Blumenthal. I thank you for that answer and I will 
follow up perhaps to seek additional information. I want to 
sort of switch topics.
    As a member of the Armed Services Committee I am aware of 
the 2006 Quadrennial Defense Review and its focus on the need 
for a more integrated military/civilian response in this area. 
And I know it is not directly within your purview, but I 
wonder, as the point person, so to speak, on the overall 
emergency issue, would you agree that there is a need to 
formalize the pathway for improving a civilian/military 
integrative response?
    Dr. Lurie. I think actually we have been making tremendous 
progress in that area. In the countermeasures development end 
of this we have an integrated portfolio where we and DOD sit 
together and talk about what to do. We now formally have 
liaisons between our two offices so that we can coordinate 
better. And we actively work with our DOD partners on a number 
of issues including patient movement in a disaster and worked 
closely with them in Haiti.
    You know, right now the large national level exercises 
going on around, ironically, an earthquake on the New Madrid 
fault and speaking at this moment we are exercising patient 
movement with our DOD colleagues.
    Senator Blumenthal. My time has just about expired but I 
have one last, quick question and I would like to followup on 
this one as well. I have become very concerned about the 
shortages of certain kinds of pharmaceutical drugs for 
hospitals, which seems to be quite alarming and increasingly 
prevalent, in Connecticut and around the country. And I wonder 
if that issue is one that has been factored into your planning 
for emergency preparedness.
    Dr. Lurie. It is something that we look at quite a bit and 
we have a whole critical infrastructure protection program that 
looks at this, including partnerships with private sector 
companies, big box stores so that we can look at the 
availability of products. We started a whole initiative to be 
able to do a better job tracking products through the pipeline. 
But I agree with you, that there is a lot more work to do here 
and I would love to be able to follow up with you about that.
    Senator Blumenthal. Thank you. Thank you very much, Dr. 
Lurie and thanks for your great work in the department.
    Dr. Lurie. Thank you.
    Senator Blumenthal. Thank you, Mr. Chairman.
    Senator Casey. Thank you, Senator Blumenthal.
    Senator Burr.
    Senator Burr. Thank you, Mr. Chairman. My hope is, and I 
pledge to Senator Blumenthal, if the committee will look into 
the drug shortage I will be right there with him.
    Senator Blumenthal. Thank you.
    Senator Burr. I think it falls well outside the space that 
we are here to talk about today, but indeed it is a problem and 
it is a problem that leads us then to the FDA and to other 
areas that need examination by this committee and other 
committees.
    Nicki, welcome. Let me just ask you, one of the most 
important questions of the PAHPA legislation was this 
determination of who is in charge and we chose, when we wrote 
it, that we would create this new entity and it would in fact 
be the Assistant Secretary for Preparedness and Response. I 
would like you to sort of share with us, in your own words, 
describe what it is you do.
    Dr. Lurie. That is a great question and I thank you for it. 
And I also want to thank you, again, for the wisdom in 
determining that there really needed to be a focal point for 
this issue and leadership in the department, really somebody in 
an office that focuses on preparedness day-to-day and 
coordinates all of the HHS aspects of response.
    Let me talk first about the response end of things and then 
go back to the other end of things. In response, the Assistant 
Secretary for Preparedness and Response is in charge of 
coordinating the HHS aspects of emergency response and working 
with the rest of the interagency. So we stand up, through our 
Secretary's operations center, for all of our components. 
Thanks to PAHPA, the National Disaster Medical System is moved 
back to us and we are prepared to mobilize a very robust health 
and public health response.
    At the same time we mobilize the policy components of the 
response so that there is rapid decisionmaking and coordination 
across all of the department. I kid you not when I say that 
every aspect of the department, ranging from the Agency for 
Child and Families to the Office of Refugee Resettlement or the 
Agency on Aging has been involved with us in response.
    Between disasters, and often during them, we look at how we 
can better prepare, whether it is through our healthcare system 
preparedness or public health preparedness, strengthening our 
NDMS and strengthening our medical countermeasures enterprise 
and working on a set of policies related to that. Again, all of 
these involve a tremendous amount of coordination across the 
department with our partners at CDC, NIH, FDA, SAMSA, etc. and 
with the interagency partners such as DHS, DOD, the VA and 
others.
    I think having this focal point for leadership has proved 
to be really important. And I would like to think that the way 
that we have handled all the responses in the past 2 years has 
been a real testament to that.
    Senator Burr. You alluded to the relationship with these 
other agencies and I think it is important for members to 
understand that there are certain things that we moved under 
your jurisdiction and we moved them from these other agencies. 
But, you are a customer to them from a standpoint of what 
threats might exist, because that is determined at----
    Dr. Lurie. Yes.
    Senator Burr [continuing]. The Department of Homeland 
Security. And there are other aspects that are controlled at 
the Centers for Disease Control. Are there areas that you feel 
would be beneficial in addressing the comprehensive nature of 
your role that we should look at as we reauthorize this to move 
out of other agencies and consolidate within your direct 
supervision?
    Dr. Lurie. I think it is a really good question. I think as 
we have worked through particularly the countermeasures aspects 
of this over the past couple of years, I think we have 
developed a much closer and more collaborative relationship 
with DHS on the issues that relate to the determination of 
threats. And I think we have been able to make much more robust 
our requirement setting process so that we actually can work 
much more collaborative with the other agencies around setting 
those requirements and then actually doing the research and 
development and getting the countermeasures made and licensed.
    Likewise, we've worked much more closely with DOD in the 
integrated portfolio aspects of this.
    Senator Burr. I agree we have made tremendous strides with 
DOD. But let me just point this out publicly, creating your 
slot was to have a single individual we could look at when 
there might have been a breakdown and say, ``Okay, it is your 
responsibility, what happened.'' So as we go through this 
reauthorization, if in fact there are areas that we need to 
look at, legislatively, that need to move to or from where they 
currently are, I sort of put you in charge of letting us know 
before we get this legislation done. If not, you have areas 
that you have no control over that we are going to point to you 
as the--or to whoever is in your slot--as the person to 
directly hold responsible. And they are going to say, ``You 
know, I didn't have jurisdiction over it. Tell us now.''
    Dr. Lurie. Fair enough. I appreciate that very much and 
will continue to give it some thought and be happy to talk more 
about it.
    Senator Burr. During the H1N1 pandemic the government made 
a substantial commitment to adjuvants to the Strategic National 
Stockpile, however today an adjuvanted vaccine could only be 
made available under an emergency use authorization since it 
has not been approved by the FDA. Adjuvanted seasonal influenza 
vaccines have been used in Europe for over 12 years. Last year 
the President's Council on Advisors on Science and Technology 
issued a report recommending, ``a goal of approving a minimum 
of two adjuvant vaccines in the next 2 years.'' We are almost a 
year into this recommendation, without approval of an adjuvant.
    Given the potential public health benefit of this 
technology for patients for both seasonal and pandemic 
influenza vaccines, how will you ensure the approval of 
adjuvants is appropriately prioritized?
    Dr. Lurie. Great question. We have invested and are 
continuing to invest in the development of safe and effective 
adjuvants and understand that adjuvants may be--well be one of 
the answers to more effective influenza vaccines going forward.
    My understanding right now is that FDA is poised to act on 
applications for adjuvanted vaccines when they receive them. 
And I think for a seasonal flu vaccine that is the current 
situation. We are continuing to work very closely with FDA to 
move along products in the regulatory pathway and pipeline. We, 
as I commented before, have been really redoing the way we do 
some of the governance, so there should be fewer delays and 
fewer surprises when things get to that point. And the 
investment in regulatory science ought to help FDA be able to 
do a lot of the things it needs to do in the regulatory area, 
faster and better.
    Senator Burr. Thank you. Mr. Chairman, you have been kind 
with the time.
    Let me just point to members something that the Secretary 
has alluded to and I mentioned briefly and that is the 
emergency use authority that is required for nonFDA-approved 
product to be used. We have products in the stockpile today 
that are yet to be FDA approved. They can only be used if there 
is an emergency use authorization. So, given that it is very 
difficult to determine how you expedite things at the FDA, and 
I am being generous in the way I said that, and hopefully 
diplomatic, it is very important that members understand we are 
going to have quite a discussion before PAHPA reauthorization 
comes up, about whether we need to redefine emergency use 
authority and whether we set a new threshold for that.
    If we don't, we could find ourselves in a situation that we 
have a real threat, we have an inability to respond in a timely 
fashion and much like we were faced with H1N1 where there were 
some delays in emergency use authorization, we actually had 
kids in this country die because we couldn't initiate that fast 
enough. And there is no one person that is to blame, it is a 
process that had never thought through the speed with which we 
might need to do that. And I just warn the members to flag that 
as we move forward.
    I thank the Chair.
    Senator Casey. Thank you, Senator Burr.
    Senator Roberts.

                      Statement of Senator Roberts

    Senator Roberts. Thank you, Mr. Acting Chairman, the 
Senator from New Jersey--or pardon me, Pennsylvania. You can be 
New Jersey too if you would like. Start a trend.
    [Laughter.]
    Senator Casey. Senator, I would note for the record, our 
witness was educated at the University of Pennsylvania.
    I just want to throw that in.
    Senator Roberts. All right.
    [Laughter.]
    That is why she is so learned and uses those 25, 35 cent 
words in the right place. I am going to ask a follow up on the 
Richard Burr dynamite question, and I want to thank Senator 
Burr for really highlighting this. He was very generous in his 
comments and diplomatic. Obviously I won't be.
    In your testimony you suggest a need for an increased 
investment in the regulatory sciences and review capabilities 
at FDA focused on pandemic influenza, chemical, biological, 
radiological, nuclear and medical countermeasures, I might toss 
in agra-terrorism, but I am told by staff not to do that.
    At any rate, can you be more specific on the Senator's 
question and my question on what you mean by investment in the 
regulatory sciences and the review capabilities. Do you mean 
more funding for FTE folks, or do you mean--what? What do you 
mean?
    The reason I am asking is that I don't think we are--we 
lack specificity in the guidelines for FDA and what we don't 
need is additional regulations. I don't know whether you want 
the full-time employees and I am not sure what that means in 
terms of investment in regulatory sciences and review 
capabilities.
    We have to speed this up. The Senator is exactly correct, I 
come from the Ag Committee and we go over all sorts of threats 
all the time to the Nation's food supply. If that happens, it 
happens. We can't just wait until that happens and then try to 
figure out what to do. As a first responder, it is the sheriff 
out there usually in one of my small towns in Kansas.
    I am talking more rather than listening. Would you like to 
respond?
    Dr. Lurie. I would defer to the FDA about the FTE issue. 
But I would observe that as we did the countermeasures review 
one of the things that we heard, both from FDA and from our 
partners in industry, was an issue that if you would get to the 
end of the line you would want to move a product forward for 
licensure and the science to be able to do that just wasn't 
there. That is not the time to think about doing the science.
    And because you are from Kansas and talked about animals, I 
will talk about the animal rule in that regard. You know, we 
have a notion that for things that can't be tried in people, it 
would be a good idea to test them in animals under the animal 
rule. But it turns out, for example, that we don't have really 
good animal models, because we haven't invested in the science, 
as an example, to figure out how to use that most effectively 
so that we can do the science to know if a product is going to 
be safe and effective and move it on toward licensure. The same 
thing with different kinds of assays, the same thing with 
different kinds of staff and expertise, for example. So that 
investment in science is really intended to speed up the--and 
clarify a number of the regulatory issues involved.
    I know we had a discussion internally just last week about 
new diagnostics. For example, for flu vaccine. In order for FDA 
to be able to look at those and regulate them, there is 
probably some science that needs to get done first. And we 
ought to be doing it now, so 2 or 3 years from now, when those 
products are ready to come to FDA we are ready to meet the 
companies where they are.
    Senator Roberts. If you can put a little Zocor or Lipitor 
in the pipeline so we don't have so much cholesterol, that 
would be very helpful.
    [Laughter.]
    Many of the recommendations and suggested changes for 
consideration during the reauthorization also suggest a need 
for additional resources, of which we don't have any. 
Considering the current and economic and fiscal crisis, if you 
had to prioritize these suggestions, which would you say is the 
No. 1 need?
    Dr. Lurie. Prioritize which suggestions?
    Senator Roberts. Which one would you say is the No. 1 need? 
Of the recommendations of the suggestions, of the changes for 
consideration during the reauthorization, in the entire 
reauthorization bill, what is your No. 1 priority goal, given 
the limited resources that we have?
    Dr. Lurie. I actually think you are asking me to choose 
among my children here. And as the mother of three boys that is 
probably a dangerous thing to do.
    Senator Roberts. Yes, it is.
    Dr. Lurie. But I would offer a couple of things. I would 
offer that continuing to focus on our Medical Countermeasure 
Enterprise is critically important. I would offer that 
strengthening day-to-day systems in public health and 
healthcare preparedness are also really, really critical as we 
go forward here.
    Senator Roberts. I thank you very much. Thank you for the 
job you are doing.
    Dr. Lurie. Thank you.
    Senator Roberts. Thank you, Mr. Chairman.
    Senator Casey. Thank you, Senator Roberts.
    I might jump in here. I was second on the list, so I gave 
up my spot. But let me just----
    Senator Roberts. Thank you.
    Senator Casey. Let me just present a couple of questions to 
Dr. Lurie. First of all, thanks for your service in a tough 
time to be in government but also having the significant and 
burdensome responsibilities you have. We are grateful for that.
    I wanted to highlight, and I know you have addressed this 
today and at other times, but I wanted to highlight some of the 
process here to see where you are. Instead of using the 
acronym, I will read it all, the Pandemic and All Hazards 
Preparedness Act was passed, part of that, as you know better 
than I, was the implementation or the anticipated 
implementation of the National Health Securities Strategy. Can 
you give us kind of a brief sense of where that is in the 
process?
    And we know that over these years, I guess 5 years now 
roughly, there have been reports and reviews and studies 
concluded that inform what we are doing on these. And there are 
lots of ideas out there. But how do you report to us (a) on the 
progress of--or the timeline for the implementation plan, but 
also, (b) how do you incorporate all these other reviews or 
studies into that kind of a plan?
    Dr. Lurie. Great question. And we very much appreciated the 
opportunity to develop the National Health Security Strategy. 
It is the first really of its kind and that was released 
December 2009, on time. We have been working through, 
punctuated by a few disasters, completing the biennial 
implementation plan which has been out for public comment and 
is just about done.
    At the same time, we haven't waited for the implementation 
plan to begin to implement in a number of areas. As you know, 
the strategy is wide ranging and lays out really a set of 
capabilities for our Nation to be prepared and health secure. 
So whether it is through the Public Health Emergency 
Preparedness or the Hospital Preparedness grants, we have 
already begun, for example, to incorporate many of the concepts 
from the National Health Securities Strategy into grant 
guidance.
    The National Securities Strategy places a big focus on 
building community resilience, so there is a lot of work going 
on there, same with strengthening emergency preparedness and 
response systems. And our work with NDMS and others has 
continued to move us in those directions.
    So, a lot of the implementation is going on as the plan is 
being written. It is on track and I think we are moving 
forward.
    Senator Casey. I was noting in your testimony, I want to 
read it verbatim, on the bottom of page 2 when you describe 
your mission. You say, and I am quoting that your mission is 
defined as,

          ``leading the country in preparing for, responding to 
        and recovering from health effects of emergencies and 
        disasters by three things really, supporting our 
        communities' ability''--communities' abilities, I 
        should say--``to withstand adversity, strengthening our 
        health and response systems and third, enhancing 
        national health security.''

    That is a tall order for any person or any group of folks 
working on these difficult preparation, response and recovery 
issues. I would ask you kind of a basic question that is 
probably on the minds of a lot of citizens, but also those who 
are enacting public policy or legislating in this area. What do 
you feel most secure about in terms of the work you have done 
to date, in terms of your work as it relates to our own 
security?
    What keeps you up at night? What worries you the most in 
terms of not just the threats, there are plenty of them that we 
can all imagine and articulate. But I am not talking about what 
worries you about the threat, I want to know more about what 
are you most worried about in terms of our preparation and our 
response to what we know are a long list of significant 
threats.
    Dr. Lurie. Right. No, it is a great question and I do feel 
like we have made a lot of progress over the last decade and I 
think we still have a lot of progress to make.
    I would glibly tell you that if I didn't sleep at night I 
couldn't do my job during the day. But the things that I worry 
most about, No. 1, are a threat that we have never thought 
about and anticipated before coming our way, our ability to 
recognize it when we see it and to act quickly on it. That is 
why there is so much focus on the rapid, nimble, flexible 
capacity to make a countermeasure against something we have 
never seen before.
    It is also why we have placed so much focus on capabilities 
rather than planning for scenarios, what capabilities do we 
need to have in place so that we can mix and match and pull off 
a shelf and respond to whatever comes our way. It is building 
those capabilities that I think is terribly important. Those, I 
think, are really the issues that keep me up at night.
    The other thing that keeps me up at night is knowing that 
the Federal Government can't do this all alone, you know, that 
our State and local partners and our private sector partners 
are in this with us and indeed the National Health Securities 
Strategy lays that out. In these really tough financial times 
when everybody is kind of stretched to the limit, I actually 
worry that we could backslide on some of our progress and that 
would be a dangerous situation for us to be in.
    Senator Casey. I'm over my time, and I want to turn to 
Senator Whitehouse. But, let me just ask you this. If you had, 
as you do in hearings like this, the opportunity to say, ``I 
need x, or we need x'', to complete the mission that I just 
read from and outlined from your testimony, what would you hope 
you would have that you don't have now in terms of authority 
and then more particularly, tools or the removal of impediments 
that we all know are part and parcel of often what we try to do 
in the Federal Government.
    Dr. Lurie. I think we are here because the authorities in 
PAHPA are so important and I think we need to continue and 
reauthorize those authorities that we have, maybe with a little 
bit of tweaking around the edges to be able to act on some of 
the lessons learned and do some of the things that we need to 
do a little bit better. I think the authorities that we have to 
make and procure countermeasures continue to be really 
important and things that we need to reauthorize.
    And then we need to work very closely with our partners 
around the country, some of whom are represented on the next 
panel. You know, whether it is State and local public health, 
the healthcare community, industry, faith-based organizations 
or others, because as I said, we are all in this together at 
the end of the day. It is really my responsibility to keep all 
the spinning plates up in the air, to keep us all together and 
coordinated and moving forward, working together there.
    Senator Casey. Senator Whitehouse.

                    Statement of Senator Whitehouse

    Senator Whitehouse. Thanks, Chairman Casey and welcome, Dr. 
Lurie.
    Just to take off on your last answer about the unforeseen 
threat and our capacity to, as you said--have a rapid, flexible 
and nimble capability to build a medical countermeasure. How do 
you evaluate our current capabilities for rapid response in the 
event of an attack using an unknown biological agent? How can 
we facilitate this rapid, flexible and nimble development of 
medical countermeasures? And is the new advanced development 
and manufacturing initiative at BARDA adequate to meet those 
standards?
    Dr. Lurie. Great question. So I think the first thing I 
would say is the first challenge that we face is the ability to 
recognize, as quickly as we can, that this threat is upon us, 
to be able to detect it, figure out what it is so that we know 
what to do about it. And that is an issue of strengthening our 
public health and surveillance systems, not just at the CDC but 
both internationally and--
    Senator Whitehouse. We are going to go into that in a 
moment. But go on ahead to the development of the 
countermeasures.
    Dr. Lurie. So in the development of the countermeasures, 
the move toward advanced development and manufacturing the 
flexible, nimble capacity, the way to get there, we believe, is 
through the initiatives outlined in the Medical Countermeasures 
Review including the advanced development and manufacturing 
facilities which we think will be central to being able to do 
that.
    Senator Whitehouse. How do you keep the biggest players who 
are the custodians of yesterday's technology from using their 
political brawn and their economic might to crowd out new 
entrants who may actually have a better technology but would 
cause economic harm to the bigger players if they are--if that 
competition were added into the mix? What is the way in which 
you particularly look out for the new technologies and keep the 
process from being captured by those who have a vested interest 
in the status quo?
    Dr. Lurie. What we look out for and we look for those new 
technologies through the Concept Acceleration Program at NIH. 
Through, if authorized, the strategic investor, so that we 
can--and we can put different kinds of investments into those 
new players and those new technologies. Also new are the 
technology but not necessarily the business skills to be able 
to pull it off and get to where they need to get to, then 
through providing those core services through the advanced 
development and manufacturing facilities so that they can 
actually take their projects to scale and move forward to a 
point where we are able to move to a full product development 
and licensure.
    So those are all different ways in which we want to look 
out for the innovators and welcome any and all innovation to 
the table and be sure that the playing field is level for them.
    Senator Whitehouse. And is the BARDA process--how would you 
evaluate that in this light?
    Dr. Lurie. I think the BARDA--remember, BARDA got stood up 
from scratch a couple of years ago. I think the BARDA process 
is working incredibly well. I would note that compared to where 
we were a couple years ago, we now have 70 projects under 
advanced development, which is really stunning considering that 
we started at zero. So I think it is working quite well and we 
have identified ways to make it even more nimble and more 
welcoming for innovators.
    Senator Whitehouse. And back to your point about the 
ability to detect the threat in the first instance. The draft--
Biennial Implementation Plan from July 2010 specifically 
mentions linking your National Health Security infrastructure 
into the developing National Health Information infrastructure 
which got such a boost from the American Recovery and 
Reinvestment Act. And it specifically mentions incorporating 
the role of health information exchanges to advance real-time 
information dispersal.
    Rhode Island is one of the States that is at the forefront 
of developing health information exchange. It is a very 
difficult thing to develop. And compared to the value to be 
returned on a successful health information exchange, I think 
we are very under-invested in supporting the HIE, the Health 
Information Exchange development, particularly out at the head 
of the trail where the real work is being done.
    I am wondering what you see as your role, from a public 
health perspective, in trying to support and facilitate the 
development of these health information exchanges. At the local 
level, are you working with ONCHIT on this? Are you engaged in 
that part of it? How important do you see this as a priority?
    Dr. Lurie. We work with ONC all the time, including around 
the sort of constructs that relate--and the regs that relate to 
meaningful use and how to move forward. It was really 
interesting, during the pandemic, what you saw were some real 
breakthroughs, consistent with the CDC's bio-surveillance 
strategy in how we use real-time healthcare data to do 
surveillance, to do, tracking of antiviral prescriptions, to do 
a number of things.
    I agree with you that there is a long way to go, but I 
think over the past year we have started to see a lot of 
progress in that area. We will continue to work very closely 
with ONC going forward.
    The other place we work with them, by the way, is in the 
electronic health record for the National Disaster Medical 
System, another place that enables us to have real-time 
situational awareness of what is happening in a disaster and to 
be able to pivot quickly if we need to.
    Senator Whitehouse. Thank you. Thank you, Mr. Chairman.
    I know that Pennsylvania has been a real leader in this 
area as well. But as we transform from a health information 
infrastructure that basically has computers on doctors' desks, 
but you still have to go out and get the information from the 
hospital, from the lab, from the pharmacy, from the imaging 
place, from the specialist into a really integrated health 
information infrastructure, the Health Information Exchange is 
the key infrastructure that links all that together. And that 
is really, I think, going to be the accelerator in terms of our 
ability, from a safety and cost savings perspective, or a 
public health perspective, to have rapid access to that 
information so that we can do that early detection. And so I 
hope that we will continue to focus on that and see that as an 
area for investment on this public health and safety side, not 
just through the ONC. Thanks very much.
    Senator Casey. Thanks, Senator Whitehouse.
    Doctor, we are going to let you go in a moment. I just have 
one quick question. I think you spoke to this before, if not 
directly but in part. One of the things that often will 
confront the Federal Government is how you work in 
coordination, the old problem with silos and the inability of 
agencies or offices to coordinate and work together. It is 
especially maddening to taxpayers when they have to work 
together in their lives and sometimes government can't.
    But when you, in terms of what BARDA does day-to-day and 
then with regard to coordination, which I hope is a lot of 
coordination with both FDA and NIH, just if you could, for a 
moment, speak to that coordination that is so important in 
getting this right.
    Dr. Lurie. One of the things that we instituted since I 
have been there has been both a series of what we call 
portfolio reviews. So everybody sits down at the table 
together, including the DOD, and shares what it is they are 
doing. This was really the first time that kind of thing had 
happened and it spun a whole lot of collaboration.
    Going forward, working in BARDA, they are using a system 
which I, as a primary care doctor, sort of call case 
management. You know, we have the scientists from NIH and FDA 
and CDC at BARDA sitting down, often with the developers of new 
products, at regular intervals, starting at the beginning, to 
identify what the issues are and work them out and work them 
out often on a quarterly basis, again, so that we are 
coordinated, there aren't surprises, we identify where there 
are gaps that need to be filled through this portfolio review 
process. And again, it is my job to bring everybody together to 
coordinate and get those gaps filled.
    I have been actually quite pleased with how it is working. 
I am sure it is a work in progress, that we can continue to do 
better. Quality improvement has been one of the centerpieces of 
sort of how I do business in our office and will continue to 
adapt that philosophy to continue to make things better and 
better.
    Senator Casey. Doctor, thank you very much.
    Dr. Lurie. Thank you.
    Senator Casey. We appreciate your testimony and your 
service.
    Dr. Lurie. Thank you. It has absolutely been an honor to 
serve the American people in this time.
    Senator Casey. Thank you.
    Now we will move to our second panel and maybe as we are 
getting organized, I can, with the assistance of Senator Burr, 
read through some of the biographical and background material 
for our next panel.
    Senator Burr, would you like to start or--I have the 
introductions of three, but Dr. Kadlec, would you like to do 
that first?
    Senator Burr. I would love to do that.
    Senator Casey. Great, thank you.
    Senator Burr. It is an honor and a privilege to introduce 
Dr. Bob Kadlec who many on this committee affectionately call 
Dr. Bob. I have had the pleasure of knowing Bob for many years. 
He served our Nation in many distinguished capacities. He 
served 26 years as a military officer and physician in the 
United States Air Force, serving in senior positions in the 
White House, the Department of Defense and as a senior staffer 
here in the U.S. Senate.
    Dr. Bob is a veteran of Operation Desert Storm and Iraqi 
Freedom. His military decorations include the Bronze Star and 
the Joint Distinguished Meritorious Service Medal with Hope 
Leaf Cluster. Until January 2009 Bob served as a special 
assistant to the President and senior director for bio-defense 
policy on the Homeland Security Council. Dr. Bob is currently a 
member--or a director in public health practice at PRTM.
    I am also told--and I can see her now--I am pleased to say 
that Dr. Bob's wife, Dr. Ann Vertis, and his daughters, 
Margaret and Samantha, are in attendance today. I am glad to 
see that you could join us. Let me say to your daughter's, Bob, 
you should be very proud of your dad and the work he has done 
to protect the American people and serve this Nation.
    I look forward to your testimony, Bob, as I do to the rest 
of our witnesses today.

STATEMENT OF ROBERT P. KADLEC, M.D., MTH&H, MA, VICE PRESIDENT, 
GLOBAL PUBLIC SECTOR, PRTM MANAGEMENT CONSULTANTS, WASHINGTON, 
                               DC

    Dr. Kadlec. Thank you, Senator Burr, for that very generous 
introduction. I have to admit my family is here as part of my 
human shield program.
    [Laughter.]
    It is great to be back in the familiar setting such as 
this, Mr. Acting Chairman, members that are here today. And 
also know that it is a very different viewpoint from this side 
of the dais than up there. And so I am very sensitive to that, 
but really what I hope to focus in on, and my comments will be 
very brief and to the point. One thing that I would like to 
just mention, that in my military career I spent a long part of 
that in the special operations community for which I had the 
privilege to serve with many joint special operation activities 
and units, but the thing I took away from that critical thing 
was the necessity for unity of command, and I will get to that 
point a little bit later on.
    I just want to start out by saying there is nothing more 
sacred than protecting and defending the constitution of this 
country. But I would say a very close second is protecting and 
saving American lives in the event of a deliberate attack on 
our Nation. And that is obviously what the conversation here is 
today and I believe it is something that all members of 
government, all parties, all branches of government certainly 
have as a sacred duty.
    And with that, in preparing for this testimony, I really 
spent a little time looking at the history of this issue, the 
issue for preparing our country for national security 
emergencies, and found that there was an Executive Order, 
11490, and I am sure nobody remembers it, signed by Richard 
Nixon in 1969, that was the predetermining step before he 
actually renounced the Offensive BW Program in the country. And 
that Executive order, which placed health and education and 
welfare department in charge of responding to public health 
emergencies, that was the result from radiological, chemical or 
biological events, was reaffirmed by Reagan in 1988, Clinton by 
1998 and obviously during the Bush administration several 
presidential directives and Executive orders were yielded.
    But I want to point out the essential role of Congress in 
this, because if you look at the history of this, very little 
measurable progress was done. And I don't want to say we lived 
the Einstein definition of insanity, but clearly these 
Executive orders didn't have the power or weight behind them to 
do what was needed. And yet, in 2000, before the events of 9/
11, this committee, this Congress and Members of the House 
basically started a very deliberate, incremental movement with 
the passage of the Public Health Preparedness Act in 2000 (just 
to note, the chairman, Chairman Harkin, Senator Enzi were part 
of that, Representative Burr, I think he is related, sir, did 
it from the house side), but the point is beginning before this 
they recognized this as a serious issue.
    And then since 2000 until the PAHPA Act was passed six 
major pieces of legislation were passed by this Congress. And 
so the whole notion that the power of authorization, oversight 
and appropriations are key to basically addressing this issue. 
I certainly applaud the efforts by this Chairman and the 
Ranking Committee Members and certainly Senator Burr and 
Senator Casey, yourself and the other Members, to basically 
take this task forward.
    The one thing I want to point out and the three areas that 
I think deserve special attention is, when this was created--
the ASPR--it was really about leadership, leading the effort 
around Emergency Support Function Number Eight subject to 
training, organizing, equipping the health assets of the 
country, primarily Federal, to basically respond to 
catastrophic events.
    I would say that we have made some half steps in that 
direction, but quite frankly, we are not there yet.
    It does take some scrutiny to look at the entities within 
HHS that don't necessarily formulate that critical operational 
control or span of control for Dr. Lurie as she sits here 
today. If you ask, who deploys the Strategic National Stockpile 
or who makes decisions on those kinds of issues, I think you 
would be surprised by the answer. It is essential that someone 
be in charge, as Senator Burr has said. And it is essential 
that that person have the authority and powers within that 
position to do the necessary things.
    Senator Blumenthal asked a very insightful question, 
subject to the issue of DOD and I would add also VA in that 
respect. We have huge health assets that should be mobilized, 
on call to support the response to a major catastrophic event 
in our country and yet we don't have that necessarily in place.
    The second issue is about the State and local public health 
infrastructure and you will hear from others about the parties 
around that, other than much of the progress that has been made 
in the last decade could be lost based on the attrition, based 
on the tremendous physical pressures, as well as the aging 
population of the workforce as we go forward.
    And the third element here, as quite a bit of the 
discussion has already really been around the Medical 
Countermeasures Enterprise, but the notion that is, and this is 
extraordinary and a credit to the people at BARDA, that they 
have been able to basically produce a number of products, get 
them in the stockpile and basically operate at a budget that 
has been somewhere between 20 percent to 40 percent of their 
actual authorization. I wouldn't expect that our SEALS would do 
as well against Osama bin Laden or any of our forces would do 
as well if we only funded them at 40 percent of their funding 
level.
    I think with that, I am just left with the great awe and 
appreciation for what this Congress has done, this committee 
has done in the past. If there is any group in Congress that 
gets this problem and knows how to get it done, it is the HELP 
Committee. And I think under the leadership of the Chairman and 
the Ranking Member, as well as you, Senator Casey and Senator 
Burr, I am convinced that we will have further success and make 
further progress. Thank you.
    [The prepared statement of Dr. Kadlec follows:]
                 Prepared Statement of Robert P. Kadlec
                                summary
    Reauthorizing the Pandemic and All Hazards Preparedness (P.L. 109-
417) and Project BioShield (P.L. 108-276) Acts is a timely and urgent 
national security issue. Much progress has been achieved through the 
implementation of both laws. It is a priority to further refine and 
improve the overall state of all hazard public health and medical 
preparedness and response.
    Despite the death of Bin Laden, the threat of domestic terrorist 
attacks using Chemical, Biological and Radio-Nuclear (CBRN) agents 
remains a serious concern. In February 2011, the Directors of CIA and 
NCTC both testified that Al Qaeda and Al Qaeda of the Arabian Peninsula 
are intent on conducting attacks using CBRN agents. The head of the 
FBI's WMD Directorate stated that there is a 100 percent probability of 
a terrorist WMD attack on the United States. Both Senators Harkin and 
Lugar publicly expressed their concern about the risk of bioterrorism 
following the death of Bin Laden.
    The challenge associated with deliberate CBRN attacks particularly 
involving biological agents should not be confused with natural disease 
outbreaks. Insights learned from the former U.S.-offensive biological 
weapons program indicate that biological attacks can have the lethal 
equivalence of a thermo-nuclear weapon. Unlike Mother Nature, a 
deliberate thinking enemy could employ multiple biological agents in 
overwhelming doses that are resistant to common treatments. Responding 
to bioterrorism requires a speed and complexity of effort that is 
greater than what would be likely needed in natural disease outbreak.
    There are 3 areas that should receive consideration as part of this 
reauthorization process:

    1. Strengthen the role and responsibilities of the HHS Assistant 
Secretary of Preparedness and Response (ASPR). The original intent 
creating the ASPR was to put ``someone in charge'' of public health and 
medical preparedness and response. As in military or special 
operations, unity of command is essential to ensure an effective 
response to protect and save American lives during an attack or 
influenza pandemic. Despite efforts to date, the lines of operational 
command and policy oversight within HHS and across the relevant 
Interagency remain unclear.
    2. Maintain a capable public health and medical infrastructure to 
respond to catastrophic events. Recent fiscal crises at the State and 
local levels have severely impacted that state of preparedness and 
response with the loss of highly trained and qualified personnel. 
Continuation of Public Health Emergency Preparedness and Hospital 
Preparedness Grant programs is essential to maintain needed 
capabilities.
    3. Promoting a robust medical countermeasure (MCM) development, 
manufacturing and distribution and dispensing enterprise. HHS should be 
required to submit multi-year budget plans for MCM development and 
procurement and authorized to accelerate MCM development. Further 
measures should be enacted to support companies developing CBRN MCM 
that have no or limited commercial market overcome the funding and 
regulatory challenges. Efforts underway to improve the speed of 
dispensing MCM to augment existing modalities should be accelerated to 
improve preparedness and response. These should include utilizing 
approaches such as the U.S. Postal Service home delivery; development 
of FDA approved medkits and first responder pre-event anthrax 
vaccination.
                                 ______
                                 
    Chairman Harkin and Senator Enzi, it is a distinct privilege and 
pleasure to appear before you today. The reauthorization of the 
Pandemic All-Hazard Preparedness Act (PAHPA) is a timely and urgent 
issue. In the course of the intervening 5 years since its passage; many 
of this law's provisions have been implemented and in many cases 
resulted in improvements in our overall preparedness and response for 
all-hazard incidents. No doubt, there are some provisions that have not 
resulted in what Congress envisioned and deserve reconsideration.
    Further, the recent review conducted by the Obama administration 
following the H1N1 Influenza Pandemic evaluating the status of the 
medical countermeasure enterprise, has identified opportunities for 
further improvements to the advanced development, regulatory support 
and manufacture of certain medical countermeasures. The results of this 
review are also worthy of consideration during this process. This 
hearing and reauthorization process is also timely in light of the 
anticipated expenditure of the $5.6 billion advanced appropriations 
contained in the Project BioShield Special Reserve Fund. Hopefully your 
deliberations will seriously consider reauthorizing this important act 
as well.
    There is urgency to these efforts as well. The death of Bin Laden 
is an important inflection point in the war against Al Qaeda and 
Islamic extremism. As President Obama has explicitly stated, the threat 
from terrorism has not abated. Mr. Chairman, you and Senator Lugar 
recently highlighted the potential increased risk of bioterrorism 
following Bin Laden's death.
    I note other recent authoritative statements by key Intelligence 
and FBI officials as reason for continued concern that should lead to 
urgency to improve our preparedness and response for a range of 
possible conventional and unconventional attacks. In February of this 
year, both the Central Intelligence Agency (CIA) Director Leon Panetta 
and National Counter-Terrorism Center (NCTC) Director Michael Leiter 
highlighted their concern about continued high interest by both Al 
Qaeda and Al Qaeda of the Arabian Peninsula to obtain and use 
radiological materials in dirty bombs, or chemical or biological 
agents, particularly anthrax, in attacks. Dr. Vahid Majidi of the FBI 
WMD Directorate rated the probability of a WMD attack in the United 
States at 100 percent, either from a known terrorist group or an 
unknown ``lone wolf '' actor. In light of Bin Laden's demise, there 
should be a greater urgency about correcting deficiencies. In some 
cases, as in the development or manufacture of certain medical 
countermeasures (MCM) or addressing manpower shortages in critical 
public health or medical professions; there is a significant lead time 
to rectify shortfalls.
    While we have recently experienced significant natural disasters or 
accidents, they do not reflect the risk of a catastrophe from a 
deliberate WMD attack by a thinking enemy. Insights learned from the 
former U.S.-offensive biological weapons program highlight several 
important considerations. The impact of an aerosolized biological agent 
attack can have the lethal equivalence of a nuclear weapon. 
Adversaries, States, groups or even individuals, who are intent to use 
such weapons will do so with the specific intent to defeat one's 
defenses through the potential delivery of multiple virulent agents, 
overwhelming infectious doses, antibiotic resistant strains or all the 
above. The belief that deliberate attacks are similar to or less 
challenging than natural emerging disease pandemics is not only false 
but dangerous.
    Though the title of this Committee on Health, Education, Labor, and 
Pensions, doesn't reflect it; the issue of preparedness and response is 
vital to national and homeland security. Unfortunately, your efforts 
don't receive the press or notoriety of your colleagues on the Armed 
Services, Homeland Security and Intelligence Committees. I suggest that 
your efforts here today and the weeks and months ahead can build on 
PAHPA's achievements and advance preparedness and response. I suggest 
that there are three areas that should receive your particular 
attention, consideration and effort.

    1. Strengthen the role and authorities of the Assistant Secretary 
of Preparedness and Response (ASPR) in the Department of Health and 
Human Services (HHS). The original intent of legislation was to put 
``someone'' in charge of medical and public health preparedness and 
response. Second only to protecting and defending the Constitution, 
protecting and saving Americans whose lives are threatened from 
potentially catastrophic attacks or natural disasters is a sacred 
obligation. The model used to create the ASPR was the one used to 
create the military Regional Combatant Commanders. In advance of a 
contingency, they set the requirements for the forces that would be 
committed in the event of hostilities. Should a contingency occur, that 
regional combatant commander would assume operational control of those 
assets and prosecute the mission under a unified command structure. 
This doesn't mean that units are physically moved, it means the 
operational scheme is pre-determined and that those capabilities are 
trained and equipped to ensure success.
    Prior to the creation of the ASPR, no one was in charge and no one 
was accountable for public health or medical preparedness and response. 
That is what the ASPR was created to do. It is a tall order in a non-
national security Department like HHS to immediately embrace or 
transform itself in such a fashion. However, the ASPR was the result of 
careful and thoughtful consideration to consolidate these functions 
under one person who is presidentially appointed and confirmed by the 
Senate to ensure that American lives can be protected and saved should 
a catastrophe happen. As with any transformational change, progress 
comes haltingly. The objective should never be forgotten: Protecting 
and saving American lives from the threat of weapons of mass 
destruction or pandemics is the ASPR's sacred duty.
    The ASPR should have the necessary policy oversight and operational 
control in the event of or anticipation of a public health emergency of 
all the HHS elements, including CDC response and designated Inter-
agency assets under Emergency Support Function Eight of the National 
Response Framework during an anticipated or actual public health 
emergency. This goal has not been fully achieved but is essential to 
ensure the success of this mission.
    2. Maintaining a capable public health and medical infrastructure 
to respond to catastrophic events. Much progress has been achieved 
through the funds authorized and appropriated to the Public Health 
Emergency Preparedness and Hospital Preparedness Grant programs. Mr. 
Chairman, I particularly recall your vision of creating a national 
public health system that was similar to our national highway system: 
standardized, interconnected, and promoting not only public health but 
national security. You will hear from others concerning the incredible 
strain that the recent fiscal crisis has wreaked on State and local 
public health programs, particularly concerning the retention of 
qualified personnel. People are the cornerstone of public health 
preparedness and response.
    3. Promoting a robust medical countermeasure (MCM) development, 
manufacturing, distribution and dispensing enterprise. Much effort and 
attention was recently given to the issue of MCM development and 
manufacturing. During the H1N1 pandemic, deficiencies in our ability to 
rapidly produce vaccines were noted. The recently announced Medical 
Countermeasure Initiative by HHS highlights some important 
opportunities to improve the process by which the Government subsidizes 
the development and production of these necessary products. While there 
has been much focus on the threat of pandemic influenza, I am concerned 
that the challenges and risk around the development of national 
security MCM for chemical, biological and radio-nuclear threats remains 
high. Despite limited advanced development funding, BARDA has had 
several notable successes including developing and stockpiling Bavarian 
Nordic's smallpox vaccine, Human Genome Sciences anthrax monoclonal 
antibody and SIGA's and Chimerix's smallpox antiviral drugs. More 
should be done to assist companies who are attempting to navigate the 
difficult funding and regulatory pathways while developing vital 
national security MCM that have no or limited commercial market. Simply 
requiring HHS to develop and submit multi-year budget plans outlining 
their priorities and intended procurements would go a long way to 
assist both Congress and companies involved in this endeavor. Further, 
BARDA should have the resources necessary to conduct a robust advanced 
development portfolio and have the flexibility to accelerate advanced 
development of select products as required. BARDA's efforts and budget 
should reflect the priority of creating MCM for national security.
    There also needs to be clear requirements concerning what should be 
our policy in the event of either a credible threat of or actual 
biological attack. In response to the threat of smallpox, the United 
States has stockpiled enough vaccine for every American and now is 
stockpiling antiviral drugs. We will soon be able to take smallpox 
``off the table'' and go on to create a credible deterrent against this 
threat. We have not made similar policy determinations for other 
potential threats. The recent Fukushima disaster starkly highlights a 
policy decision as to whether we should pre-position potassium iodide 
in metropolitan areas at risk for nuclear or radiological attacks. 
These policy requirements are essential to guide decisions concerning 
not only procurement but building adequate capacity to produce the 
range of CBRN vaccines and biological products that may be needed in a 
crisis.
    The proposal to improve the FDA's ability to assist such companies 
and provide the necessary dedicated regulatory support is an important 
initiative that deserves congressional backing. Ensuring BARDA has the 
necessary means to conduct its support of and the ability to accelerate 
advanced development remains a serious shortfall in the overall U.S. 
Government approach in producing national security MCM.
    Significantly, there remain serious shortfalls in our capabilities 
to rapidly distribute and dispense MCM in the event a deliberate 
attack. I note that President Obama signed an Executive order in 
December 2009 instructing Federal Departments and Agencies to examine 
how they can assist State and local authorities to more rapidly 
dispense MCM to populations that may be affected by CBRN attacks. An 
essential measure that was identified is the forward deployment of MCM 
so they can be rapidly accessed by essential first responders, health 
care workers and the public. There are a range of options that should 
be aggressively pursued including development of medkits for use by 
first responders, their families and available to the public; utilizing 
existing distribution systems with the U.S. Postal Service and retail 
pharmacies; and options for vaccinating first responders against the 
most likely threat of anthrax. There is an urgent need to act now to 
prepare to prevent the potential significant loss of life, social chaos 
and loss of confidence in the U.S. Government in the event of an 
attack.
    I very much appreciate the opportunity to appear before you all 
today and look forward to your questions.

    Senator Casey. Doctor, thank you very much for your 
testimony and for your work on these important issues.
    I want to note for the record, I should have said this 
before, that of course all of the witnesses testimony, if you 
wanted to submit something in writing you can do that as well, 
that will be made a part of the record if you submit it, in 
addition to anything that you obviously say by way of summary.
    What I will do next is I will introduce our next three 
witnesses by way of biography and background and then we will 
start picking up the testimony again with Phyllis Arthur.
    Let me add as well, any panelist who wants to introduce 
members of your family, all of us realize that when someone 
serves in public office, appointed or elected, that the family 
serves as well, so they deserve recognition and commendation.
    Next, and I am moving from left to right here, next is 
Phyllis Arthur. Phyllis, we welcome you. Ms. Arthur is the 
senior director for vaccines of immunotherapeutics and 
diagnostic policy at the Biotechnology Industry Organization, 
known as BIO. And Ms. Arthur is a recognized expert in the 
field of vaccines. Before joining BIO she worked in marketing 
and sales in the vaccine division at Merck and Company. And 
through her career she has launched several new vaccines in the 
United States and abroad, most notably Gardasil, the first 
vaccine for HPV. We appreciate your presence here and your 
testimony, Phyllis Arthur.
    Next, Dr. Michael Anderson. Dr. Anderson is the vice 
president, associate chief medical officer at University 
Hospitals in Cleveland. In addition to his leadership position 
Dr. Anderson serves as the associate professor of pediatric 
critical care at Rainbow Babies & Children's Hospital. In 2008 
Dr. Anderson was appointed to the National Commission on 
Children and Disasters. And as a member of this commission, he 
was charged with analyzing our readiness to care for children 
in disasters and issuing recommendations to the President and 
to the Congress. Welcome, Doctor.
    And finally, Ms. Susan Cooper. Susan Cooper is the 
commissioner of Tennessee's Department of Health. She is the 
first nurse to serve in this capacity. Commissioner Cooper has 
a wealth of public health and emergency preparedness 
experience. She has helped develop Tennessee's healthcare 
safety net and programs addressing the threat of Type 2 
Diabetes. Commissioner Cooper also serves on the executive 
committee of the Board of Directors of the Association of State 
and Territorial Health Officials. Ms. Cooper, thank you very 
much--or Commissioner, I should say.
    I think we will go back to Ms. Arthur, if you wanted to 
provide your testimony. And again, if any of you want to 
introduce family, you have that option. Thank you.

    STATEMENT OF PHYLLIS ARTHUR, SENIOR DIRECTOR, VACCINES, 
   IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY 
             INDUSTRY ORGANIZATION, WASHINGTON, DC

    Ms. Arthur. Thank you. Good afternoon. Thank you for that 
nice introduction, Chairman Casey, Ranking Member Burr. I will 
say I am a graduate of the University of Pennsylvania, so I 
will give that shout out.
    Members of the committee, ladies and gentlemen, as stated, 
I am Phyllis Arthur, with BIO. BIO represents a broad mix of 
companies involved in the research, development and manufacture 
of biologicals, including products for the detection, 
diagnosis, treatment, prevention, and delivery of medical 
countermeasures, or MCMs, in response to chemical, biological, 
radiological and nuclear threats.
    These companies consider themselves integral partners with 
the U.S. Government in the development of these vital 
countermeasures that are needed to protect the American people. 
And therefore, BIO has focused its recommendations on changes 
that are essential to both attract and of course retain 
companies in the Enterprise. Over the last 10 years, as 
Assistant Secretary Lurie pointed out, bipartisan congressional 
efforts have created and funded an MCM Enterprise that has 
begun to show success.
    In partnership with industry the U.S. Government has 
responded to the 2009 H1N1 pandemic, prepared for a possible 
pandemic of bird flu, made numerous improvements to existing 
flu production and issued contracts on a host of different 
platforms for strategic treats, including delivering two key 
countermeasures for smallpox and anthrax to the Strategic 
National Stockpile. Presently there are more than 50 companies 
conducting research and development in influenza vaccines in 
over seven different platforms. In addition, there are 25 
companies, actually maybe more, that are currently working on 
new treatments, vaccines and diagnostic countermeasures related 
to CBRN threats.
    Developing CBRN countermeasures can be even more complex 
than influenza. First the targeted diseases are less well 
understood. Second, determining the best development pathway to 
demonstrate safety and efficacy requires a great deal of 
scientific collaboration between industry and the key Federal 
agencies, especially in special populations such as children 
and pregnant women. Third, many bio-threats are complex and 
unique and they may require specific diagnostic tools, vaccines 
and treatments requiring separate, detailed clinical plans.
    BIO has identified three key priorities to improve 
preparedness and reduce the time to develop and approve 
essential countermeasures. First, provide greater transparency 
and clarity in the MCM market, the contracting process and in 
advanced research and development activities. Second, improve 
the clarity, consistency and integration of the FDA in the 
development and approval of MCMs. And third, ensure the future 
of the Enterprise while simultaneously reauthorizing Project 
BioShield and Special Reserve Fund with PAHPA.
    The Project BioShield Act accomplished several important 
goals, including the creation of the Special Reserve Fund which 
is designed to guarantee companies that the government will 
purchase new, successfully developed countermeasures for the 
SNS. The existence of the SRF and the annual appropriations to 
BARDA define the marketplace for MCMs, because there is not a 
viable commercial market for these products. Company resources 
allocated to countermeasures divert R&D and manufacturing away 
from commercial products and they must be subjected to the same 
rates of return. In addition, private investors are wary of 
investing in this type of research.
    So BIO recommends that HHS be required to provide biannual 
reports outlining BARDA advanced development activities and the 
length of time to BioShield requirements and procurement 
awards. BIO also recommends greater transparency in BARDA and 
BioShield contact requirements, including the early 
establishment of required product characteristics.
    One of the most significant risks unique to countermeasures 
development is certainly the testing and the clinical trial 
design requirements. These are less well-established. Clinical 
trials often require the use of multiple animal models to prove 
human efficacy and this adds to the uncertainty. The most 
significant recommendation from the PHEMCE review was to invest 
in the FDA and its review and regulatory science processes. 
This would enable FDA to have an affirmative role in solving 
the scientific and regulatory hurdles of MCMs.
    BIO and its members strongly support this recommendation 
and encourage the FDA to work collaboratively with company 
sponsors throughout the entire MCM process to help design 
development plans and associated studies, especially those 
requiring the use of animal models. Implementation of new MCM 
initiatives should be coupled with specific measurements for 
success.
    The Project BioShield Act and PAHPA help to build processes 
to advance clinical and manufacturing infrastructure to protect 
against a multitude of biological threats. In addition to 
developing and stockpiling countermeasures, devices and 
diagnostics against currently anticipated threats, it is 
crucial that the United States build the capacity to respond to 
novel threats, such as newly emerging diseases and genetically 
modified pathogens. The reauthorization of PAHPA and BioShield 
SRF are critical to these efforts.
    Therefore, BIO strongly urges Congress to simultaneously 
reauthorize the SRF with PAHPA. The SRF should be funded at a 
level that incentivizes private industry to actively 
participate. Furthermore, Congress should clearly articulate 
that development of MCMs is a national security priority and 
that funding for these efforts be treated as national security 
spending.
    Since 2001 the Enterprise has had some successes. However, 
much remains to be done. Future planning and sustained 
investment in global surveillance networks, our public health 
infrastructure, MCM development and distribution systems is 
critical to adequately alert, prevent and recover from any 
future CBRN or natural biological event.
    BIO commends the committee for holding this hearing and we 
stand ready to work with Congress to implement these important 
issues. Thank you.
    [The prepared statement of Ms. Arthur follows:]
                  Prepared Statement of Phyllis Arthur
    BIO represents a broad mix of small, medium and large companies 
that develop and manufacture biological products for the detection, 
diagnosis, treatment, prevention and delivery of countermeasures in 
response to chemical, biological, radiological and nuclear (CBRN) 
events.
    Over the last 10 years, bipartisan congressional efforts have 
created and funded a Public Health Emergency Medical Countermeasure 
Enterprise (PHEMCE) that has begun to show success. In partnership with 
industry the U.S. Government:

     Responded to the 2009 H1N1 pandemic;
     Invested in products to prepare for a possible bird flu 
pandemic;
     Completed a comprehensive review of influenza vaccine 
production issues;
     Issued contracts for novel platforms for seasonal and 
pandemic influenza vaccines, diagnostics and antivirals as well as the 
final development of novel treatments for smallpox, new antibiotics and 
innovative treatments for the side effects associated with acute 
radiation syndrome (ARS); and
     Acquired and delivered key countermeasures to vaccinate 
against smallpox and treat anthrax to the Strategic National Stockpile 
(SNS).

    Among the goals of the U.S. Government in conducting the medical 
countermeasure (MCM) review issued in August 2010 were identifying 
issues limiting companies of all sizes from successfully engaging in 
the countermeasures process and proposing solutions to increase 
engagement. BIO has identified three key priorities that will help 
achieve a greater degree of industry participation and urges the 
committee to consider incorporating them into the legislation to 
reauthorize the Pandemic All-Hazards and Preparedness Act (PAHPA) of 
2006. Priorities include: (1) providing greater transparency and 
clarity in the MCM market establishment, the contracting process, and 
in advanced research and development activities; (2) improving the 
clarity, consistency and integration of FDA in the development of MCMs; 
and (3) sustaining the MCM market by ensuring that Project Bioshield 
and the Special Reserve Fund (SRF) are simultaneously reauthorized with 
PAHPA.
              (1) defining a viable market value for mcms
    Project BioShield was designed to serve as a symbol of the U.S. 
Government's commitment to purchase new, successfully developed 
countermeasures for placement in the SNS. The acquisition and 
contracting processes at HHS to acquire new countermeasures are viewed 
by industry partners of all sizes as lengthy, opaque, and 
unpredictable. BIO recommends greater transparency in BARDA/BioShield 
contract requirements including the early establishment of product 
characteristics required. BIO also recommends that HHS be required to 
provide bi-annual reports outlining BARDA advanced development 
timelines/activities and the length of time to BioShield procurement 
award and that appropriate action be taken if timelines are not met.
  (2) management of cost and risk and the regulatory process for mcms
    The development of countermeasures is a unique, resource-intensive 
and complex process that can be costly and fraught with risk. One of 
the most significant risks is that countermeasures are approved via a 
convoluted regulatory pathway. Testing and clinical trial design 
requirements are not well-established, requiring the use of multiple 
animal models to prove efficacy, which adds an extra dimension of risk 
and uncertainty to this process.
    BIO and its members strongly support making significant investments 
in FDA review and regulatory science initiatives related to medical 
countermeasures. FDA should play an affirmative role in solving the 
scientific and regulatory hurdles that exist, not just the review and 
approval, of MCMs. This can best be accomplished by encouraging the FDA 
to work collaboratively with company sponsors throughout the entire MCM 
development process to design development plans and associated studies, 
especially those requiring use of animal models.
    BIO recommends that the FDA become more involved in the development 
of MCMs through a combination of planning and coordination activities 
and implementation of specific measurements for MCM initiatives.
                  (3) sustainability of the mcm market
    The Project BioShield Act and PAHPA helped to build processes to 
advance clinical and manufacturing infrastructure to protect against a 
multitude of biological threats. While there have been successes in 
several strategic portfolios, currently the United States is decades 
away from having an adequate arsenal of countermeasures to safeguard 
our citizens. The reauthorization of PAHPA and the replenishment of the 
BioShield SRF are critical to these efforts.
    Therefore BIO strongly urges Congress to reauthorize the Special 
Reserve Fund simultaneously with the reauthorization of PAHPA. The SRF 
should be funded at a level that incentivizes private industry to 
actively participate in the MCM process and should be designated as a 
national security or homeland security priority.
                                 ______
                                 
    Good morning Chairman Harkin, Ranking Member Enzi, members of the 
committee, ladies and gentleman. I am Phyllis Arthur, senior director 
for Vaccines, Immunotherapeutics and Diagnostics Policy at the 
Biotechnology Industry Organization (BIO). BIO represents more than 
1,100 companies, academic institutions, State biotechnology centers and 
related organizations in all 50 States.
    In the area of biodefense, BIO represents a broad mix of small, 
medium and large companies involved in the research, development and 
manufacture of medical countermeasures or MCMs. These companies develop 
and manufacture biological products for the detection, diagnosis, 
treatment, prevention and delivery of countermeasures in response to 
chemical, biological, radiological and nuclear (CBRN) events.
    One of the goals of the Department of Health and Human Services' 
(HHS) review of the Public Health and Emergency Medical Countermeasures 
Enterprise (PHEMCE) was to identify and solve those issues limiting 
companies of all sizes from successfully engaging in the countermeasure 
process. In its input on both the HHS PHEMCE review and reauthorization 
of the Pandemic and All-Hazards Preparedness Act (PAHPA) of 2006, BIO 
has stressed one overarching principle: the biopharmaceutical industry 
wants to be an integral partner with the U.S. Government in the 
development and stockpile delivery of these vitally important 
countermeasures to protect the American people. Therefore BIO has 
focused its recommendations on changes that are essential to both 
attract and retain companies of all sizes to the Enterprise. 
Maintaining the skills and know-how of companies that have already 
weathered the complicated MCM development and contracting process must 
be as important to the U.S. Government as attracting new companies to 
the MCM development space.
    BIO has identified three key priorities to improve preparedness, 
accelerate approvals and reduce the time needed to develop essential 
MCMs. We urge the committee to address these areas in the 
reauthorization of PAHPA. These include: (1) providing greater 
transparency and clarity in the MCM market establishment, the 
contracting process, and in advanced research and development 
activities; (2) improving the clarity, consistency and integration of 
FDA in the development and approval of MCMs; and (3) ensuring that the 
future of the PHEMCE is adequately funded by simultaneously 
reauthorizing Project Bioshield and the Special Reserve Fund (SRF) with 
PAHPA.
                    investments have yielded success
    Over the last 10 years, bipartisan congressional efforts have 
created and funded an Enterprise that has begun to show success. Some 
of the most important accomplishments involve pandemic influenza 
preparedness. Not only did government agencies and industry partners 
mount a well-thought out response to the 2009 H1N1 pandemic, they also 
invested in products to prepare for a possible avian/bird (H5N1) 
pandemic and conducted a comprehensive review of influenza vaccine 
production issues. This review resulted in the President's Council of 
Advisors on Science and Technology (PCAST) report in August of 2010.\1\ 
This report made important and attainable recommendations for both 
existing and future technology to meet the challenges of responding to 
future pandemics. Some of these are currently being implemented, but 
all should be fully considered and supported with adequate resources.
---------------------------------------------------------------------------
    \1\ Executive Office of the President, President's Council of 
Advisors on Science and Technology, Report to the President on Re-
engineering the Influenza Vaccine Production Enterprise to Meet the 
Challenges of Pandemic Influenza, August 2010.
---------------------------------------------------------------------------
    Currently, there are more than 50 biotechnology companies 
conducting research and development in new seasonal and pandemic 
influenza vaccines in over seven different novel technologies and 
platforms. Other companies are developing new antivirals and diagnostic 
tools as well. While the Biomedical Advanced Research and Development 
Authority (BARDA) has invested in new manufacturing facilities and 
issued new contracts for several of these innovative platforms, more 
investment at every phase of development is vital from both the public 
and private sectors if America wants to realize our full potential.
    Developing countermeasures to respond to bioterrorism threats is 
even more complex than influenza. First, the targeted diseases are less 
well-characterized and studied, especially in special populations such 
as children and pregnant women, and the study of these diseases often 
relies on complicated animal models. Second, how the MCM will be used 
in response to an attack determines how it should be designed and 
clinically studied. Thus, determining the best development pathway to 
demonstrate safety and efficacy requires a great deal of scientific 
collaboration between industry and the key Federal agencies. Third, for 
each unique biothreat, the goal is to have a diagnostic tool to 
identify the threat as well as countermeasures to prevent illness and 
others to treat those who become infected. Lastly, many of the 
technologies being applied for medical countermeasures are relatively 
new themselves. They hold great promise as methods to solve the pivotal 
clinical issues that these threats pose, but they also require more 
significant investment at every research stage to help increase the 
probability of success.
    Despite these challenges there have been some successes in the 
development and procurement of MCMs for the treatment and prevention of 
lethal biothreats, such as anthrax, botulinum toxin and smallpox. In 
the past 2 years, key countermeasures to vaccinate against smallpox and 
treat exposure to anthrax have been delivered to the Strategic National 
Stockpile (SNS). Furthermore, several key procurement and advanced 
development contracts have been issued that will lead to the final 
development of novel technologies for smallpox, new broad spectrum 
antibiotics and innovative treatments for the side effects associated 
with acute radiation syndrome (ARS).
                          recommended actions
    BIO has identified three challenges that limit industry's 
participation in PHEMCE and we urge Congress to address them in the 
PAHPA reauthorization: (1) defining a viable market value for MCMs 
versus the opportunity cost of investing in alternative therapeutic 
areas; (2) management of cost and risk, especially in the regulatory 
process; and (3) the sustainability of the market over time.
              (1) defining a viable market value for mcms
    The Project BioShield Act of 2004 accomplished several important 
goals, but the most significant was the creation of the Special Reserve 
Fund. BioShield is designed to guarantee companies that the government 
will purchase new, successfully developed countermeasures for placement 
in the Strategic National Stockpile. The existence of the SRF and the 
annual appropriations to BARDA, which support MCM advanced development 
and CDC procurement funding, define the marketplace for MCMs. Companies 
consider the amount of resources available through BARDA and the SRF 
when comparing the opportunity cost of pursuing the development of a 
specific countermeasure. The time and company resources allocated for 
these products diverts R&D and manufacturing resources away from 
commercial products and must be subjected to the same rates of return 
analysis. In addition, private investors place little to no value on 
this type of research as the market is difficult to calculate, 
development and contract award projections are seldom met, and the 
guarantee of government purchase is not always clear. Therefore, there 
are very limited external private funds to support companies in the MCM 
space.
    Another part of the opportunity cost assessed by industry is the 
time required to achieve success. While industry, particularly small 
biotechnology companies, finds BARDA a good and effective partner, the 
acquisition and contracting functions to acquire new countermeasures 
are viewed as lengthy, opaque, and unpredictable. The trigger to 
transition a program from advanced development to procurement is 
unclear. Target dates to complete contract awards are typically not met 
and some acquisitions are delayed by months, years, or even canceled. 
The negotiation process is lengthy and the rationale and potential 
triggers for contract options are unclear. The signal to industry is 
that despite the enormous risks of development, new drugs and vaccines 
developed as countermeasures have far less value than commercial 
products.
    BIO recommends that HHS be required to provide bi-annual reports to 
Congress outlining BARDA advanced development activities and the status 
of achieving key milestones, the length of time to BioShield 
procurement award, and other BioShield procurement activities. BIO also 
recommends greater transparency in BARDA/BioShield contract 
requirements including the early establishment of required product 
characteristics.
  (2) management of cost and risk and the regulatory process for mcms
    The development of countermeasures is a unique, resource-intensive 
and complex process that is costly and fraught with risk. One of the 
most significant risks is that countermeasures are approved via a 
convoluted regulatory pathway. Similar to commercial biologicals, new 
countermeasures can take 8-12 years to develop at a cost of $800 
million to $1 billion, and failure is common at all stages of 
development. Yet in most other ways MCM development and approval is 
much more complicated. Testing and clinical trial design requirements 
are less well-established, requiring the use of multiple animal models 
to prove efficacy, which adds an extra dimension of risk and 
uncertainty to this process.
    One of the most significant recommendations from the PHEMCE review 
was to invest significantly in the FDA review and regulatory science 
processes. BIO and its members strongly support this recommendation, 
and have worked to ensure FDA was allowed a transfer of money for such 
purposes as part of the fiscal year 2011 FDA appropriation. The FDA has 
tremendous expertise in the science of drug development and the 
manufacturing of complex drugs, diagnostics and biologics. The lack of 
full integration across the Enterprise, especially as it pertains to 
the approval process for countermeasures, has in several instances, led 
to significant delays and the need for unexpected regulatory actions by 
companies in order to achieve licensure for a product. Effectively 
integrating FDA into the MCM development efforts will ensure that the 
government can have more rapid access to fully licensed medicines, 
devices and diagnostics for national security threats in a cost-
effective manner.
    To meet this goal FDA needs to be given an affirmative role in 
solving the scientific and regulatory hurdles, not just the review and 
approval, of MCMs. This can best be accomplished by encouraging the FDA 
to work collaboratively with company sponsors throughout the entire MCM 
development process to design development plans and associated studies, 
especially those requiring use of animal models. The current structure 
and resources provide a disincentive for FDA to spend time on these 
complex issues in partnership with industry. Additionally, BIO 
recommends that FDA funding targeted to improving MCM efforts should be 
linked to measurable metrics.
    BIO recommends that the FDA become more involved in the development 
of MCM's through a combination of planning and coordination activities 
and implementation of specific measurements for MCM initiatives.
                  (3) sustainability of the mcm market
    The Project BioShield Act and PAHPA helped to build processes to 
advance clinical and manufacturing infrastructure to protect against a 
multitude of biological threats. While there have been successes in 
several strategic portfolios within HHS, currently the United States is 
decades away from having an adequate arsenal of countermeasures to 
safeguard our citizens. In addition to developing and stockpiling 
countermeasures against currently anticipated threats, it is critical 
that the United States build the capability to respond to novel threats 
such as newly emerging diseases and genetically modified pathogens. The 
U.S. Government can help increase the Nation's preparedness by 
undertaking several other key actions.
    First, the reauthorization of PAHPA and the BioShield SRF are 
critical to these efforts. Therefore, BIO strongly urges Congress to 
reauthorize the Special Reserve Fund simultaneously with the 
reauthorization of PAHPA. The SRF should be funded at a level that 
incentivizes private industry to actively participate in the MCM 
process.
    Furthermore, Congress should clearly articulate that development of 
MCMs is a national security priority and that funding for these efforts 
be treated as national security and/or homeland security spending.
    Second, BIO recommends that Congress formally establish a process 
by which HHS and its relevant agencies (NIH, CDC, FDA and ASPR) develop 
an integrated 5-year plan that can be shared with all stakeholders. 
Ineffective coordination and collaboration between the various 
government agencies involved in the Enterprise adds to the overall 
uncertainty surrounding MCM's. The prioritization of threats is not 
transparent so it is not clear which pathogens, platforms, indications 
and target populations are the most important. Indeed one government 
agency may view these threats in different ways from the others, thus 
leading to conflicting, or overlapping, programs with differing 
priorities.
    The PHEMCE review highlighted the importance of a 5-year plan for 
the Enterprise with goals tied to measurable outputs and outcomes. Due 
to the long development timelines for biological products, industry 
partners need to be able to plan and communicate with their investors 
on the anticipated value and impact of MCM projects with some increased 
level of certainty. A systematic, transparent vision from the U.S. 
Government will help companies assess the viability of both their 
existing and future countermeasures' programs. This multi-year 
strategic plan, coupled with modifications to the contracting 
processes, would encourage increased industry participation.
    Third, BIO recommends the continued investment in distribution and 
public health infrastructure. Both the PHEMCE review and the PCAST 
report on Pandemic Influenza considered the breadth of the preparedness 
continuum--surveillance, rapid manufacturing of MCMs, diagnosis, and 
ultimate delivery to the public. In order to benefit the public, the 
U.S. Government must know when and how to deploy and administer 
countermeasures. Some of the PHEMCE and PCAST recommendations will 
require longer-term investments, such as training public health and 
medical first-responders, while others can be implemented in the near-
term through more effective planning and with modest resources. For 
example, stockpiling strategies for products that are applicable to 
many different emergencies--such as needles, syringes, and critical 
assay compounds, can ensure rapid availability and avoid supply chain 
disruptions.
    Lastly, one of the most critical elements of responsiveness 
involves the Nation's ability to detect and identify these threats to 
best mount a proper and timely response. BIO members are also concerned 
that the U.S. Government makes the right investments in global and U.S. 
surveillance testing and reporting networks. Efforts should be made to 
extend the network and to invest in and explore common platforms and 
design tools that can increase efficiency and reduce costs. Improving 
interagency coordination within the U.S. national network, while 
striving to modernize its technical and technological capabilities, 
would increase speed and accuracy in detecting emerging diseases and 
threats.
        improving the mcm process requires sustained partnership
    Because there is no viable commercial market for most MCMs, it is 
essential for Federal, State and local governments to be involved in 
the detection of threats and the development and dissemination of the 
products in the event of an emergency. As is true with typical 
biologics development, it takes many products in development to arrive 
at one successfully licensed vaccine, antimicrobial or diagnostic test. 
If our collective goal is to use innovative technology to help solve 
vital national security issues, then everyone must be willing to 
acknowledge the higher degree of risk and uncertainty inherent in MCM 
development. Future plans and investments are pivotal to sustain 
current successes and further strengthen and improve the Nation's 
preparedness.
    BIO commends the committee for holding this important hearing and 
stands ready to work with Congress on these important issues. BIO 
strongly encourages the committee to improve preparedness and 
accelerate development and approval of essential MCMs by: (1) providing 
greater transparency and clarity in the MCM market establishment, the 
contracting administration process, and in advanced research and 
development activities; (2) improving the clarity, consistency and 
integration of FDA in the development of MCMs; and (3) ensuring that 
Project Bioshield and the Special Reserve Fund are simultaneously 
reauthorized with PAHPA.
    Over the last 10 years, bipartisan congressional efforts have 
created and funded a public health emergency medical countermeasure 
enterprise (PHEMCE) that has begun to show success. It is critical that 
future plans and investments be made that will build upon this success.

    Senator Casey. Thanks, Ms. Arthur.
    Dr. Anderson.

 STATEMENT OF MICHAEL R. ANDERSON, M.D., FAAP, VICE PRESIDENT 
AND ASSOCIATE CHIEF MEDICAL OFFICER AT UNIVERSITY HOSPITALS AND 
   ASSOCIATE PROFESSOR OF PEDIATRIC CRITICAL CARE AT RAINBOW 
          BABIES & CHILDREN'S HOSPITAL, CLEVELAND, OH

    Dr. Anderson. Good afternoon, Mr. Chairman and members of 
the HELP Committee. I am Dr. Michael Anderson, a practicing 
pediatric intensive care physician at Rainbow Babies & 
Children's Hospital in Cleveland.
    None of my family members are here, although last week I 
was here with about a million eighth graders on a bus. So I 
feel that my family has been in town recently.
    Up until April I was also proud of serving as vice chairman 
of the National Commission on Children and Disasters, a 
commission created out of the strong leadership of this 
committee.
    On behalf of the American Academy of Pediatrics, I would 
like to thank you for holding today's hearing on such an 
important topic, strengthening our medical and public health 
preparedness and response.
    Recent events in Alabama, Mississippi, Louisiana and the 
Chairman's own State of Iowa, make today's hearing especially 
timely. These events and the tragedy in Japan are a stark 
reminder that disasters can and do strike, oftentimes obviously 
without warning. Therefore, as a Nation, as individuals and 
families and importantly as healthcare professionals we must 
plan ahead and we must be prepared.
    As a clinician and someone active at the State and local 
and national level on pediatric disaster readiness and 
response, I can tell you that our Nation's preparedness has 
improved dramatically with the legislation like PAHPA and the 
Emergency Medical Services Act for Children. Through the 
leadership of this committee we have made tremendous progress, 
but from what I see as a pediatrician and a former 
commissioner, we are not fully prepared to address the needs of 
25 percent of our population, our Nation's children.
    You have heard the saying that children are not little 
adults. My written testimony goes into detail about why this is 
the case, from a clinical standpoint. The reason it matters the 
most when it comes to medical and public health preparedness is 
that children live in every part of this country. When a 
disaster strikes, children will show up at hospitals, not just 
children's hospitals. They will need care by EMS professionals 
in the pre-hospital setting. They will be in shelters, live in 
temporary housing and may be separated from their parents and 
caregivers. If each and every one of these settings and others 
are not able to handle the unique physical and mental health 
needs of children, including children with disabilities, our 
work is far from finished.
    The Academy supports the efforts of this committee to 
reauthorize PAHPA and urges the committee to use this bill as 
an opportunity to redouble our efforts at the Federal level to 
prioritize the needs of children and including children with 
disabilities and other vulnerable populations.
    While I recognize this is a tough fiscal climate, I believe 
a significant step would be to remove children from the broader 
at-risk population category in the law and designate an office 
with the authority and funding necessary to adequately meet the 
needs of children during a disaster. This is especially 
critical now that our commission has been terminated. I 
appreciate the sensitivities around this recommendation, but I 
continue to believe it is vitally important.
    But there are many other ways that we can strengthen our 
preparedness. No. 1, when it comes to medical countermeasures 
for children, it would be very helpful for the Federal 
Government to set a goal to achieve parity between adult and 
pediatric medical countermeasures developed and included in the 
SNS and other federally funded caches. Among the recent 
advancement for children is the approval of pediatric labeling 
for Pollodoxin for the treatment of nerve agent poisoning 
meaning it can now be stockpiled in the SNS for that 
indication. However, that labeling took 7 years to get 
approval, with no new data. We must figure out how to 
streamline that process.
    Two programs this committee is very familiar with, BPCA and 
the Pediatric Research Equity Act have resulted in the labeling 
or re-labeling of 400 new drugs for children with new safety, 
efficacy and dosing information and this is a huge advance in 
the field of pediatrics. The Academy looks forward to working 
with this committee to reauthorize these two vital programs and 
maximize their potential to improve pediatric labeling of MCM 
so that they can be stockpiled.
    No. 2, volunteerism. I am proud to be a member of the 
National Disaster Medical System. But the NDMS and the Medical 
Reserve Corps need more clinicians. Thought should be given to 
how we might make it easier for clinicians to participate and 
how we might tailor pre-certification or training programs to 
reach clinicians on a broader scale all while ensuring 
recruitment of clinicians for specific populations such as 
geriatrics, pediatrics and individuals with disabilities or 
medical conditions.
    Third, among the lessons learned from H1N1 is that hospital 
preparedness is critical. HHS has recently announced that 76 
percent of hospitals participating in the HPP program meet 90 
percent of their core measures. However, a 2008 CDC study 
showed that only a third of hospitals had guidelines for 
pediatric surge capacity, only 34 percent had plans for 
reunification of children with their families and 40 percent 
had a tracking system for unaccompanied children. The 
disparities in these findings is striking and I have included 
several recommendations in my written testimony of how we could 
deal with this.
    I want to thank the committee for this opportunity. I look 
forward to your questions. America's children represent the 
future of our Nation and our more precious resource, they must 
not be an afterthought in medical and public healthcare 
preparedness and response. Thank you.
    [The prepared statement of Dr. Anderson follows:]
         Prepared Statement of Michael R. Anderson, M.D., FAAP
    Chairman Harkin and Ranking Member Enzi, thank you for holding 
today's hearing on such an important topic, strengthening our medical 
and public health preparedness and response. My name is Mike Anderson, 
M.D., FAAP, and I am representing the American Academy of Pediatrics, a 
non-profit professional organization of more than 60,000 primary care 
pediatricians, pediatric medical sub-specialists, and pediatric 
surgical specialists dedicated to the health, safety, and well-being of 
infants, children, adolescents, and young adults. For more than a 
decade, the Academy has engaged in a broad range of activities related 
to disaster preparedness, including policy statements on clinical care 
and tools for pediatricians before, during, and after disaster 
situations.
    I am vice president and associate chief medical officer at 
University Hospitals Case Medical Center and associate professor of 
pediatrics at the Case Western Reserve School of Medicine in Cleveland, 
OH. I am also a practicing pediatric critical care specialist at 
Rainbow Babies & Children's Hospital. In my capacity as a practicing 
clinician, I have been active at the local, State, and national level 
in pediatric disaster readiness and response. In 2008, I was appointed 
by President George W. Bush to the National Commission on Children and 
Disasters (the Commission) which was created by Congress under the 
strong leadership of Chairman Harkin, former Senator Chris Dodd, and 
many others. I had the distinct honor of serving as the Commission's 
vice chair until its termination in early April 2011.
    Recent events in Alabama, Mississippi, and in the Chairman's home 
State of Iowa make today's hearing especially timely and critical. 
These events and the tragedy in Japan are a stark reminder that 
disasters can and do strike, and oftentimes without warning. Therefore, 
as a nation and as individuals and families, we must plan ahead and we 
must be prepared.
    The recovery and relief efforts here in the United States from 
tornadoes and flooding and from the earthquake and tsunami in Japan 
will take time and for countless families, especially those who lost 
loved ones, life will never be the same. Recovery for the most 
vulnerable of our population, children, may present several unique 
challenges and it is important that we, as Americans, assess whether 
the planning and exercises our government and communities engage in; 
whether our medical capabilities and the training of our first 
responders; and whether the preparedness of our Nation's hospitals, 
Federal, State and local governments, and families, adequately account 
for the needs of children and other populations in the event of a 
disaster.
    Unfortunately, today, the reality is that none of those systems are 
fully prepared to address the needs of nearly 25 percent of the 
population, children. We need to work to change this reality. The 
Academy supports the efforts of this committee to reauthorize the 
Pandemic and All-Hazards Preparedness Act (PAHPA) and urges the 
committee to use the reauthorization bill as an opportunity to redouble 
our efforts at the Federal level to prioritize the needs of children, 
including children with special heath care needs.
    The most significant step Congress could take to achieve this goal 
would be to remove children from the broader at-risk population 
category and designate an office with the authority and funding 
necessary to adequately meet the needs of children during a disaster. 
This is especially critical now that the National Commission on 
Children and Disasters has terminated. The Commission provided the 
needed, and previously lacking, focus and attention to children's needs 
in disaster planning and preparedness within Federal agencies. 
Additionally, removing children from the broader at-risk population 
category would allow Federal agencies to better direct resources and 
attention to populations such as individuals with disabilities, senior 
citizens, and pregnant women.
                children are more vulnerable than adults
    You've heard the saying that children are not little adults. Why is 
that and, more importantly, why does that matter when it comes to 
medical and public health preparedness and response?

     Children are particularly vulnerable to aerosolized 
biological or chemical agents because they normally breathe more times 
per minute than do adults, meaning they would be exposed to larger 
doses of an aerosolized substance in the same period of time. Also, 
because such agents (e.g. sarin and chlorine) are heavier than air, 
they accumulate close to the ground--right in the breathing zone of 
children.
     Children are also much more vulnerable to agents that act 
on or are absorbed through the skin because their skin is thinner and 
they have a much larger skin surface-to-body mass ratio than adults.
     Children are more vulnerable to the effects of agents that 
produce vomiting or diarrhea because they have smaller body fluid 
reserves than adults, increasing the risk of rapid progression to 
dehydration or shock.\1\
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    \1\ Committee on Environmental Health and Committee on Infectious 
Diseases. Chemical-Biological Terrorism and Its Impact on Children. 
Pediatrics, Vol. 118, No. 3 September 2006. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;118/3/1267.pdf.
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     Children have much smaller circulating blood volumes than 
adults, so without timely intervention, relatively small amounts of 
blood loss can quickly tip the physiological scale from reversible 
shock to profound, irreversible shock or death. An infant or small 
child can literally bleed to death from a large scalp laceration.
     Children have significant developmental vulnerabilities 
not shared by adults. Infants, toddlers and young children may not have 
the motor skills to escape from the site of a hazard or disaster. Even 
if they are able to walk, young children may not have the cognitive 
ability to know when to flee from danger, or when to follow directions 
from strangers such as in an evacuation, or to cooperate with 
decontamination.\2\ As we all learned from Hurricane Katrina, children 
are also notably vulnerable when they are separated from their parents 
or guardians.
---------------------------------------------------------------------------
    \2\ American Academy of Pediatrics. Children, Terrorism & Disasters 
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's 
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf.
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     Children have immature immune systems that make them more 
susceptible to biological, chemical, radiological agents.
     Children are also more vulnerable to radiological agents 
due to their more rapid metabolic and cellular growth rates.
                  children have unique treatment needs
    When children are critically ill or injured, their bodies respond 
differently than adults exposed to similar insults. Consequently, 
pediatric treatment needs are unique in a number of ways:

     Children need different dosages and formulations of 
medicine than adults--not only because they are smaller, but also 
because certain drugs and biological agents may have adverse effects in 
developing children that are not of concern for adults.
     Children need different sized equipment and other medical 
devices than adults. In fact, our day-to-day emergency readiness 
requires the presence of many different sizes of key resuscitation 
equipment for infants, pre-school and school-aged children, and 
adolescents. From needles and tubing, to oxygen masks and ventilators, 
to imaging equipment and laboratory technology, children need equipment 
that has been specifically designed for their size.
     Children demand special consideration during 
decontamination efforts. Because children lose body heat more quickly 
than adults, mass decontamination systems that may be safe for adults 
can cause hypothermia in young children unless special heating 
precautions or other warming equipment is provided.\3\ Hypothermia can 
have a profoundly detrimental impact on a child's survival from illness 
or injury. Additionally, a first responder wearing a Hazmat suit can be 
scary for a child so decontamination systems should ideally be designed 
so that parents can remain with their children and help them through 
the decontamination process.
---------------------------------------------------------------------------
    \3\ American Academy of Pediatrics. Children, Terrorism & Disasters 
Toolkit. The Youngest Victims: Disaster Preparedness to Meet Children's 
Needs. http://www.aap.org/terrorism/topics/PhysiciansSheet.pdf.
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     Children display unique developmental and psychological 
responses to acute illness and injury, as well as to mass casualty 
events. Compared to adults, children appear to be at greater risk for 
acute- and post-traumatic stress disorders. The identification and 
optimal management of these disorders in children requires 
professionals with expertise in pediatric mental health.\4\ When 
disaster strikes and these professionals are not readily available, it 
may fall to the responsibility of first responders who need to be 
adequately prepared, trained and equipped for children.
---------------------------------------------------------------------------
    \4\ Hagan, J and the Committee on Psychosocial Aspects of Child and 
Family Health and the Task Force on Terrorism. Psychosocial 
Implications of Disaster or Terrorism on Children: A Guide for the 
Pediatrician. Pediatrics, Vol. 116, No. 3, September 2005.
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     Children may be developmentally unable to communicate 
their needs with health care providers. The medical treatment of 
children is optimized with the presence of parents and/or family 
members. Timely reunification of children with parents and family-
centered care should be a priority for all levels of emergency care.
  children need care from providers trained to meet their unique needs
    Because children respond differently than adults in a medical 
crisis, it is critical that all health care workers be able to 
recognize the unique signs and symptoms in children that may indicate a 
life-threatening situation, and then possess the experience and skill 
to intervene accordingly.\5\ As already noted, a child's condition can 
rapidly deteriorate from stable to life-threatening as they have less 
blood and fluid reserves, are more sensitive to changes in body 
temperature, and have faster metabolisms. Once cardio-pulmonary arrest 
has occurred, the prognosis is particularly dismal in children, with 
less than 20 percent surviving the event, and with 75 percent of the 
survivors sustaining permanent disability.
---------------------------------------------------------------------------
    \5\ Markenson D, Reynolds S, Committee on Pediatric Emergency and 
Medicine and Task Force on Terrorism. The Pediatrician and Disaster 
Preparedness. Pediatrics, Vol. 117 No. 2 February 2006.
---------------------------------------------------------------------------
    Therefore, the goal in pediatric emergency care is to recognize 
pre-cardiopulmo-
nary arrest conditions and intervene before they occur. While children 
represent 25 to 30 percent of all emergency department visits in the 
United States, and 5 to 10 percent of all EMS ambulance patients, the 
number of these children who require this advanced level of emergency 
and critical care, and use of the associated cognitive and technical 
abilities, is quite small. This creates a special problem for pre-
hospital and hospital-based emergency care providers, as they have 
limited exposure and opportunities to maintain their pediatric 
assessment and resuscitation skills. Fifty percent of U.S. Emergency 
Departments (EDs) provide care for fewer than 10 children per day.\6\ 
The Academy, jointly with the American College of Emergency Physicians, 
and the Emergency Nurses Association, issued guidelines to help 
hospitals with identifying and training a pediatric advocate within 
their institutions to implement certain protocols and help improve 
hospital preparedness.\7\
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    \6\ Gausche-Hill M, Schmitz C, Lewis RJ. Pediatric preparedness of 
United States emergency departments: a 2003 survey. Pediatrics. 
2007;120(6):1229-37.
    \7\ American Academy of Pediatrics, American College of Emergency 
Physicians, and Emergency Nurses Association. Joint Policy Statement: 
Guidelines for Care in the Emergency Department. Pediatrics, Vol. 124, 
No. 4 (2009): 1233-43. http://aappolicy.aappublications.org/cgi/
reprint/pediatrics;124/4/1233.pdf.
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    Children with special health care needs represent 13.9 percent of 
U.S. children, and 21.8 percent of households with children include at 
least one child with a special health care need.\8\ Children with 
chronic medical conditions, including children with special health care 
needs, rely on multiple medications, medical devices, and complex 
management plans, which can cause them to be at increased risk of acute 
deterioration, medical errors, and suboptimal outcomes, especially in 
emergency situations.\9\ These children pose unique emergency and 
disaster care challenges well beyond those of otherwise healthy 
children. Our emergency medical services systems and our disaster 
response plans must consider and meet the needs of this group of 
children.
---------------------------------------------------------------------------
    \8\ U.S. Department of Health and Human Services, Health Resources 
and Services Administration, Maternal and Child Health Bureau. The 
National Survey of Children with Special Health Care Needs Chartbook 
2005-6. Rockville, MD: U.S. Department of Health and Human Services, 
2007.
    \9\ American Academy of Pediatrics. Policy Statement--Emergency 
Information Forms and Emergency Preparedness for Children with Special 
Health Care Needs. Pediatrics, Vol. 125, No. 4 April 2010. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;125/4/829.pdf.
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         clinicians' role before, during, and after a disaster
    Clinicians, including pediatricians, play an integral role in 
disaster preparedness. From my personal experience, families view 
pediatricians as their expert and trusted source of information. As 
part of the network of health responders, pediatricians need to be able 
to answer concerns of patients and families, recognize signs of 
possible exposure to a weapon of terror, understand first-line response 
to such attacks, and sufficiently participate in disaster planning to 
ensure that the unique needs of children are addressed satisfactorily 
in the overall process.\10\ However, the challenges that face 
pediatricians and other clinicians in their daily practices are 
heightened during a disaster situation.
---------------------------------------------------------------------------
    \10\ American Academy of Pediatrics. Policy Statement--The 
Pediatrician and Disaster Preparedness. Pediatrics, Vol. 117, No. 2 
February 2006. http://aappolicy.aappublications.org/cgi/reprint/
pediatrics;117/2/560.pdf.
---------------------------------------------------------------------------
    It is important to point out that more than 95 percent of office-
based pediatricians practice in settings defined as ``small 
businesses'' by the U.S. Small Business Administration. Fifty percent 
of private office-based pediatricians work in practices of 3 or fewer 
physicians with 8 or fewer non-physician staff; 70 percent work in 
practices of no more than 5 physicians and no more than 15 non-
physician staff. Children live in every part of the country and, as 
such, pediatricians are part of the recovery effort in all communities 
after a disaster. When disaster strikes, pediatricians may become 
displaced, losing their workplaces and/or their homes. During the 
immediate aftermath of a disaster, they may be unable to practice, 
leaving children without access to care within their medical home. 
Every effort should be made at the Federal, State, and local level to 
help pediatricians with assistance relocating or rebuilding within 
their communities.
    Many clinicians, myself included, are volunteers with the National 
Disaster Medical System (NDMS). The NDMS plays a vital role in our 
Nation's preparedness but the NDMS and the Volunteer Medical Reserve 
Corps (MRC) need more clinicians. Thought should be given to how we 
might make it easier on clinicians to volunteer and how we might tailor 
pre-certification or training programs to reach clinicians on a broader 
scale. Special attention should be paid to the recruitment of 
clinicians for specific populations such as geriatrics, pediatrics, and 
individuals with disabilities or chronic medical conditions.
    Disaster preparedness starts at home with one's own preparedness. 
The Academy has provided guidance to pediatricians about preparedness 
in their own offices and communities.\11\ For clinicians, there may be 
great value in reviewing what type of education, if any, they are 
receiving during medical school and subsequent training around disaster 
preparedness. A core curriculum around disaster preparedness, including 
at-risk population such as children, may be helpful.
---------------------------------------------------------------------------
    \11\ Markenson D, Reynolds S, Committee on Pediatric Emergency and 
Medicine and Task Force on Terrorism. The Pediatrician and Disaster 
Preparedness. Pediatrics, Vol. 117, No. 2 February 2006. http://
aappolicy.aappublications.org/cgi/reprint/pediatrics;117/2/e340.pdf.
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                   hospital preparedness for children
    This committee is no doubt familiar with ED overcrowding as a day-
to-day reality for many, if not most, hospitals. Imagine layering on 
top of the current situation, a widespread mass care or mass casualty 
event involving children. This scenario played out in hospitals across 
the country in 2009 during the H1N1 pandemic. Large volumes of patients 
and their families sought medical care; pharmacies had to be educated 
on how to constitute Oseltamivir for the pediatric populations; 
hospitals had to create innovative strategies to address the surge of 
patients on top of the baseline patients; physicians and other health 
care providers worked to engage their communities and demystify vaccine 
safety concerns; physician groups like the AAP partnered with the 
government to ensure that media messages were consistent and accurate 
with medically sound and timely information. While children were 
disproportionately affected by this strain of influenza virus, 
fortunately the overall morbidity of this strain was less than 
expected.
    The experience of H1N1 taught us many lessons. Among them is the 
fact that the science of ED surge remains relatively undeveloped.\12\ 
In a 2008 survey of hospital preparedness by the Centers for Disease 
Control and Prevention (CDC), less than one-third (32.4 percent) of 
hospitals had guidelines for increasing pediatric surge capacity. About 
one-third (34 percent) of hospitals had plans for reunification of 
children with families, and only 42.6 percent of hospitals had a 
tracking system for accompanied and unaccompanied children.\13\
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    \12\ Nager AL, Khanna K. Emergency department surge: models and 
practical implications. J Trauma. 2009;67(2 Suppl):S96-99.
    \13\ Niska R and Shimizu I. Hospital Preparedness for Emergency 
Response: United States, 2008. National Health Statistics Reports, No. 
37, March 24, 2011.
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    In the face of a disaster, all hospitals will need to increase 
their capacity. The vital clinical ability to recognize and respond to 
the needs of an ill or injured child must be present at all levels of 
care--from the pre-hospital setting, to emergency department care, to 
definitive inpatient medical and surgical care. The outcome for the 
most severely ill or injured children, and for the rapidly growing 
number of special needs children with chronic medical conditions, is 
optimized in centers that offer pediatric critical care and trauma 
services as well as pediatric medical and surgical subspecialty care. 
As it is not feasible to provide this level of expertise in all 
hospital settings, existing emergency and trauma care systems and State 
and Federal disaster plans need to address regionalization of pediatric 
emergency and critical care within and across State lines, leveraging 
inter-facility transport as a means to maximize the outcome of the most 
severely ill and injured children.
    This committee has helped hospitals make notable progress with 
their disaster preparedness upon the creation of the Hospital 
Preparedness Program, formerly the National Bioterrorism Hospital 
Preparedness Program, under PAHPA. The Assistant Secretary for 
Preparedness and Response (ASPR) at the Department of Health and Human 
Services recently announced that more than 76 percent of hospitals 
participating in the National Hospital Preparedness Program (HPP) met 
90 percent or more of all program measures for all-hazards preparedness 
in 2009.\14\ Without question, the leadership of the ASPR and the 
congressional support through appropriations for the Hospital 
Preparedness Program has made our Nation better prepared.
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    \14\ http://www.hhs.gov/news/press/2011pres/05/20110505a.html.
---------------------------------------------------------------------------
    The disparity between the CDC's 2008 data on hospital preparedness 
and ASPR's recent announcement is striking. As Congress looks ahead to 
the reauthorization of PAHPA and the ASPR develops grant guidance for 
the HPP program for fiscal year 2012, attention should be paid to what 
criteria hospitals are being asked to meet for children, including 
children with special health care needs, through the Hospital 
Preparedness Program. A ``Whole Community'' approach to the HPP program 
and other grant programs may be very beneficial for children and other 
at-risk populations. The AAP commends the HPP program for prioritizing 
the ``Needs of At-Risk Populations,'' including children, as one of 
four overarching requirements that must be incorporated into the 
development and maintenance of all program sub-capabilities but we feel 
that specific requirements and performance measures pertaining to 
pediatric preparedness in the HPP program are currently lacking and 
should be included in the future.
    To ensure the needs of children, including children with special 
health care needs, are integrated into hospital planning, the AAP 
recommends the following:

     All hospital emergency departments should stand ready to 
care for ill or injured children through the adoption of the AAP's 
Joint Guidelines for Care of Children in the Emergency Department.\15\
---------------------------------------------------------------------------
    \15\ American Academy of Pediatrics, American College of Emergency 
Physicians, and Emergency Nurses Association. Joint Policy Statement: 
Guidelines for Care in the Emergency Department. Pediatrics, Vol. 124, 
No. 4 (2009): 1233-43, http://aappolicy.aappublications.org/cgi/
reprint/pediatrics;124/4/1233.pdf.
---------------------------------------------------------------------------
     All health care professionals who may treat children 
during an emergency should have adequate pediatric disaster clinical 
and psychosocial support training and equipment.
     The creation of guidelines for addressing pediatric surge 
capacity and a formal regionalized pediatric system of care including 
written transfer protocols and memoranda of understandings (MOUs) with 
other hospitals.
     The needs of children should be specifically addressed in 
exercises and drills including the National Level Exercise.
     The inclusion of a focus on mental and behavioral health 
for children in disaster planning activities and the enhancement of 
pre-disaster preparedness and just-in-time training in pediatric 
disaster mental and behavioral health, including psychological first 
aid, and bereavement support.
     The creation of tracking systems for accompanied and 
unaccompanied children and establishment of plans for reunification of 
children with families and protocols to identify and protect displaced 
children.
                emergency medical services for children
    The Academy commends the work of the HELP Committee to reauthorize 
the Emergency Medical Services for Children (EMSC) program in the 
Patient Protection and Affordable Care Act and urges Congress to fully 
fund the EMSC program at its authorized level of $27,562,500 in fiscal 
year 2012. It is fitting that this hearing is being held 1 day before 
national EMSC Day. The EMSC program has played a crucial role in 
driving significant improvements in pediatric emergency care, including 
disaster preparedness. Despite a modest appropriation of slightly more 
than $20 million, EMSC has managed to effect these changes despite the 
lack of pediatric emphasis in other related government programs. EMSC 
has funded pediatric emergency care improvement initiatives in every 
State, territory and the District of Columbia, as well as national 
improvement programs. These include the development of equipment lists 
for ambulances, guidelines for hospital emergency preparedness, 
pediatric treatment protocols, and handbooks for school nurses and 
other providers that would be critical in the event of an emergency. 
EMSC supports training for emergency medical technicians and paramedics 
who often have little background in caring for children, and has 
underwritten the development of vital educational materials and 
treatment guidelines. In the 27 years since the program was 
established, child injury death rates have dropped by 40 percent.
             national commission on children and disasters
    Recognizing how far children lagged behind in disaster 
preparedness, response, and recovery, Congress, led by this committee, 
saw fit to create the National Commission on Children and Disasters in 
2008. The Commission produced two reports, the most recent in October 
2010, in which it makes comprehensive recommendations aimed at the 
Federal Government and policymakers. The Commission also called on the 
President to develop and present to Congress a National Strategy on 
Children and Disasters. Such a national strategy from the President 
would serve as a clarion call to government, the private sector, 
communities and families to engage one another in setting and achieving 
goals and priorities for children.
    Of note to this committee, the Commission recommended that 
Congress, HHS, and the Department of Homeland Security/Federal 
Emergency Management Agency should ensure availability of and access to 
pediatric medical countermeasures at the Federal, State, and local 
levels for chemical, biological, radiological, nuclear, and explosive 
threats.\16\ The Commission offered several proposals to carry out this 
recommendation which include amendments to the Emergency Use 
Authorization authority to allow the FDA to authorize pediatric 
indications of medical countermeasures for emergency use before an 
emergency is known or imminent as well as funding and grant guidance 
for the development, acquisition, and stockpiling of medical 
countermeasures for children. The Academy strongly supports these 
recommendations.
---------------------------------------------------------------------------
    \16\ National Commission on Children and Disasters. 2010 Report to 
the President and Congress. AHRQ Publication No. 10-M037. Rockville, 
MD: Agency for Healthcare Research and Quality. October 2010.
---------------------------------------------------------------------------
    The Commission, through the leadership of its Chair Mark Shriver 
and my fellow Commissioners, made great progress within the Federal 
agencies to improve our Nation's preparedness for children. The 
Commission also raised public awareness of the many gaps that exist for 
children. Despite the efforts of many on this committee, the Commission 
terminated last month as was required by the authorizing language that 
created it. The Academy opposes the termination of the Commission and 
urges Congress to move quickly to reconstitute it. It is unacceptable 
to us, and it should be to Congress as well, to allow the Commission's 
recommendations to simply sit on a shelf and gather dust.
                     medical products for children
    In 1977, AAP experts first published a policy statement saying that 
not only was it ethical to study drugs in children, it was unethical 
not to. Since that time, the Academy has advocated strongly that 
children deserve the same standards of therapeutic evidence as adults.
    The first step forward in public policy solutions to the lack of 
pediatric drug research came in 1997 when Congress, under this 
committee's leadership, passed the Food and Drug Administration 
Modernization Act. This law contained the first authorization of 
pediatric exclusivity, an incentive to study drugs in children. This 
program was reauthorized as the Best Pharmaceuticals for Children Act 
(BPCA) in 2002. In 2003, the Pediatric Research Equity Act (PREA), a 
requirement for pediatric studies, was passed after the Pediatric Rule 
was struck down. Finally in 2007, BPCA and PREA were reauthorized 
together, creating an integrated system for pediatric research 
incentives and requirements. These vital programs for children will 
expire on September 30, 2012 and the AAP looks forward to working with 
the committee to reauthorize them.
    The uniqueness of pediatric therapeutics has been proven over and 
over again by surprising and unexpected results. BPCA and PREA studies 
have revealed safety issues, altered dosing, led to new indications, 
and have shown some drugs to lack efficacy in children. In total, 
nearly 400 drugs have been labeled for children as a result of BPCA and 
PREA. These laws have also served as a model for international advances 
in pediatric therapeutics, including the development of a parallel 
pediatric program used by the European Medicines Agency (EMEA). We can 
say unequivocally that BPCA and PREA have dramatically improved 
pediatric practice.
    There are real opportunities to harness the experience of these 
programs and the strong leadership of the Food and Drug Administration 
(FDA) with Biomedical Advanced Research and Development Authority 
(BARDA) and their industry partners to improve pediatric labeling for 
medical countermeasures. There are opportunities for collaborations 
with the National Institutes of Health (NIH) as well. Within the last 
month, NIH released the 2011 BPCA Priority List of Needs in Pediatric 
Therapeutics and among the drugs identified by the NIH are several in 
the biodefense arena. The Academy looks forward to working with 
Congress to maximize the potential of BPCA and PREA in the medical 
countermeasures enterprise.
            medical countermeasures for at-risk populations
    Progress has been made to improve the availability of pediatric 
countermeasures but much more work needs to be done. Most recently, 
pediatric labeling was added to pralidoxime for the treatment of nerve 
agent poisoning meaning it can now be stockpiled for that indication in 
children. However, that labeling took 7 years during which time no new 
data was presented. It is hard to understand why it took that long. 
Pediatric labeling was the first step. HHS and BARDA need to support 
the manufacture and purchase of a child-specific auto-injector so that 
pralidoxime can be forward deployed and administered in the field.
    In the event of a radioactive release much like we saw in Japan, 
children must be administered potassium iodide as quickly as possible, 
ideally within 2 hours, and in an appropriate form and dosage to 
prevent long-term health effects.\17\ The liquid formulation of 
potassium iodide exists and is safe and effective but if Federal and 
State Governments do not purchase it to be stockpiled in the event of 
radiation exposure and in sufficient quantities to treat all of our 
Nation's children, how secure are we really?
---------------------------------------------------------------------------
    \17\ Committee on Environmental Health. Radiation Disasters and 
Children. Pediatrics, Vol. 111, No. 6, June 2003.
---------------------------------------------------------------------------
    The Academy looks forward to the approval of pediatric labeling for 
midazolam to treat nerve gas exposure. Those studies are well underway 
at NIH and the Academy hopes that NIH and FDA are closely coordinating 
their efforts in order to expedite the approval of pediatric labeling.
                   additional policy recommendations
    The American Academy of Pediatrics has specific recommendations for 
all policymakers regarding children and medical countermeasures:

     The medical countermeasure enterprise, led by the Federal 
Government, should set a goal to achieve parity between adult and child 
medical countermeasures developed and included in the Strategic 
National Stockpile (SNS) and all other federally funded caches.
     PAHPA should be amended to require that the Secretary, 
acting through BARDA, prioritize children.
     The Federal Government should conduct a comprehensive 
review of the contents of the SNS and all other federally funded caches 
to assess how many products have pediatric labeling and, for those that 
don't, the government should create a plan by which pediatric labeling 
can be added.
     The Emergency Use Authorization process should be amended 
to allow the FDA to authorize pediatric indications of medical 
countermeasures for emergency use before an emergency is known or 
imminent.
     The Federal Government must give guidance to States that 
ensures they purchase adequate supplies of countermeasures for 
children, especially liquid potassium iodide in States with or near 
nuclear facilities. And, there must be accountability for States' plans 
for maintenance and distribution of medical countermeasures for 
children.
     Prepositioning of medical countermeasures is critical. All 
prepositioning strategies must include locations where children gather, 
e.g., schools, child care facilities, and camps, and they must include 
plans for children with special healthcare needs.
     Because ``children'' encompass individuals from birth 
through adolescence, it is often insufficient to have a single size 
device to serve all children. In the case of respiratory masks, for 
example, different sizes are needed for infants, young children, and 
adolescents. Both individual facilities and the SNS must take this into 
account and provide for these needs. Similarly, drugs must be available 
in appropriate formulations and dosages for children. Infants cannot be 
expected to take pills. Needles must be provided in smaller sizes. In 
many cases, dosages for children should be determined not by age but by 
weight.
     Utilize pediatric subject matter expertise in identifying 
gaps, setting priorities, planning, and exercising all-hazard disaster 
response capabilities.
     Federal agencies such as FDA, BARDA, and NIH must 
coordinate their efforts with the goal of prioritizing pediatric 
medical countermeasures.
                               conclusion
    The American Academy of Pediatrics thanks the committee for this 
opportunity to testify on the important issue of medical and public 
health preparedness and response. America's children represent the 
future of our Nation, our most precious national resource. Children 
must not be an afterthought in disaster planning and medical 
countermeasures. The Academy looks forward to working with you to 
protect and promote the health and well-being of all children, 
especially in emergency and disaster preparedness. We would like to 
offer the children and disasters Web site of the Academy as a resource 
to you as you work on disaster preparedness issues. It can be found at 
www.aap.org/disasters.
    Finally, we would like to leave you with the findings of recent 
public opinion polling released by the AAP in partnership with 
Children's Health Fund on the use of resources related to disaster 
planning and response specific to children's issues. The poll found:

     76 percent of Americans agree that if resources are 
limited, children should be given a higher priority for life-saving 
treatments;
     75 percent believe that if tough decisions must be made, 
life-saving treatments should be provided to children rather than 
adults with the same medical condition; and
     92 percent agree that if there were a terrorist attack, 
our country should have the same medical treatments readily available 
for children as are now available for adults.

    You represent fathers, mothers, grandparents, uncles and aunts, our 
children deserve better. When disaster strikes, we as a nation must be 
adequately prepared so that our children will be protected and can 
achieve their full potential. As a pediatrician and a father, I look 
forward to your questions and to working with you to address the 
preparedness needs of all children.

    Senator Casey. Thank you, Doctor.
    Commissioner Cooper.

STATEMENT OF SUSAN R. COOPER, MSN, RN, COMMISSIONER, TENNESSEE 
              DEPARTMENT OF HEALTH, NASHVILLE, TN

    Ms. Cooper. Thank you. I don't have any family here either 
and so I will just say thanks to all the public health folks in 
Tennessee who work every day to protect, promote and improve 
the health of those that live in, work in and travel through 
our great State.
    Mr. Chairman and distinguished committee members, it is 
truly a special privilege today to be before you to discuss an 
issue of such great importance to our Nation, public health and 
medical preparedness and response. The thoughts I will share 
with you today are my own, but they are shared with so many 
public health professionals at the State and local levels 
across this country who devote considerable time, attention and 
resources preparing to most effectively manage the consequences 
of an array of emerging and evolving threats such as disease 
outbreaks and disasters in order to prevent or reduce illness, 
injury and death.
    You know, as we sit here today we are just 4 months away 
from the 10th anniversary of the attacks of September 11th, 
which were followed 1 month later by the anthrax attacks. These 
two acts of terrorism were seminal events that made it evident 
to all Americans and all Tennesseans of the dangers that we can 
expect to face. By everyone's account here there is no question 
that tremendous progress has been made over the past 10 years. 
We are much better prepared now than we were on that memorable 
Tuesday morning.
    You have heard of several reports that are out. The Centers 
for Disease Control and Prevention in September 2010 reported 
that they reviewed preparedness activities of the States and 
territories and in our four largest cities. And they concluded 
that much progress has been made to build and strengthen 
national public health preparedness and response capabilities. 
This report provided that a national snapshot that shows that 
all States have reporting capacity systems that can receive 
urgent disease reports at any time of the day or night, 7 days 
a week. They have capabilities to receive, distribute and 
dispense strategic national stockpile assets and nearly all 
States can rapidly respond within 30 minutes to a health alert 
network message, which provides information to State and local 
public health practitioners, clinicians and public health labs 
about urgent health events.
    We know that every State has developed and continues to 
refine the pandemic planning as required by PAHPA. The Trust 
for America's Health Annual Ready or Not Report acknowledges 
again that the country has made great strides. It showed that 
last year all but one State has increased or maintained its lab 
response network.
    One more illustration. Just last month, released from ASPR, 
was the report that talked about hospital preparedness. And we 
can show now what the numerous ways, including planning for all 
hazards, increasing search capacity and tracking the 
availability of beds and other resources and developing 
communication systems that are interoperable with partners.
    We still have work to do, though. It is really great to see 
how well we are doing in writing, from all these respected 
authorities, but I am where the rubber hits the road and I am 
here to tell you that the progress is palpable but this system 
is fragile and it is the point that I will come back to in just 
a few moments.
    Our decade-long commitment in investing and strengthening 
the Nation's public health enterprise has and continues to pay 
off. But we see, every single day, examples where these systems 
are being put into practice. If you just look back over the 
past year, there is no doubt in my mind that my colleagues in 
Alabama and Louisiana who have faced disasters with the Gulf 
oil spill, you think about the flooding in North Dakota, you 
think about the effects of the tsunami in Hawaii and Washington 
State and Oregon and then you think about my State of Tennessee 
who has just suffered through the super cell tornados, terrible 
devastation in many of our rural counties and significant 
flooding in Memphis. We have signs of the emergency 
preparedness system working well every single day. When we look 
at preparedness though, we need to consider that public health 
preparedness is not an endpoint it is a process and it cannot 
remain static. We have to continuously rigorously review what 
we are doing and revise our State plans.
    One additional point is the critical importance role that 
our partners play. When you look at our experience with H1N1 
and our ability to work with retail pharmacies across our 
State, this added to our public health response capacity and I 
think we need to take a stronger look in that direction as 
well.
    I want to conclude with just a few points. First of all, I 
think there is a need to reauthorize PAHPA with a few minor 
adjustments. Second, is that we face very difficult times and 
hard budget decisions must be made. But when it comes to our 
preparedness programs I will tell you in Tennessee alone our 
base preparedness funding has decreased by 37 percent from 2004 
to 2011 with an additional cut in just an announcement that 
came out. Our Nation's State and local public health system is 
seriously frayed. We have seen budget cuts at all levels of 
government that have resulted in more than 44,000 State and 
local public health jobs, staffs, FTEs, going away. These job 
losses represent 14 percent of State health workforce and 20 
percent of local health workforce. In the midst of a crisis is 
not the time to find your staff. You have to be prepared to 
respond.
    The last point is about community resilience. One of the 
best ways to help a community become more resilient is to 
improve their overall health. No State or community is ever 
completely prepared to address the health and medical 
consequences of a major disaster, terrorist event or pandemic. 
We have improved since 2001 but we still have a way to go.
    If you think about the reports I cited earlier that 
demonstrated progress, they also identified that more needs to 
be done. Protecting the public from threats is a matter of 
national security and protecting the public's health is no 
exception.
    Thank you. We will be happy to answer any questions.
    [The prepared statement of Ms. Cooper follows:]
             Prepared Statement of Susan R. Cooper, MSN, RN
    Preparedness Approach--Our approach to preparedness follows two 
main principles:

    (1) build capacity and capabilities that can effectively address 
all hazards, both for everyday emergencies, as well as for catastrophic 
events; and
    (2) preparedness is not an end point, it's a process that must 
continually be developed, maintained, refined, and improved.

    Capabilities--While the birth of our modern day preparedness and 
response efforts was appropriately centered on bioterrorism, we quickly 
learned that the most effective and efficient way to protect the public 
was to know all of your vulnerabilities, anticipate those threats, and 
build systems, programs, and services that are flexible and agile 
enough to handle anything that may come our way. Building and 
maintaining capabilities in such areas as: (1) incident management; (2) 
information sharing and public warning; (3) biosurveillance 
(epidemiology and laboratory services); (4) countermeasures 
distribution and dispensing; (5) surge management for mass health care 
delivery, mass fatalities, and the coordination of volunteers; and (6) 
community resilience are in so many ways universal in their application 
to any and all hazards.
    Disaster Threats--Emergencies and disasters impact the health of 
Americans every day. Public health responds to all hazards, be it a 
disease outbreak, a pandemic, the health consequences of natural 
disasters, or a man-made incident, like a terrorist attack. And these 
events happen in big cities, rural and suburban communities, and in 
every State. Not only last year at this time, but even as we speak 
today, in Tennessee, we have and are experiencing episodes of severe 
weather and flooding (2010/2011). Even as this is occurring, we must 
concurrently plan for the continuing threat of a New Madrid Seismic 
Zone earthquake and the catastrophic impact it would have on the State. 
Other threats that have manifested in emergency response include: white 
powder incidents (ongoing since 2002), sheltering of hurricane evacuees 
from partner States (2005/2008), TVA coal fly ash spill (2008), ice 
storms (2009), and the H1N1 influenza pandemic (2009). As each unique 
disaster is evaluated for areas of improvement, the lessons learned are 
carried forward to improve future response efforts.
    Priorities--Engagement with partners, effective communications, and 
building community resilience are at the heart of every public health 
agency's goals in emergency preparedness and response. In Tennessee, 
we've focused on these priorities as follows:

    (1) Partner collaboration--Community partners from healthcare (H1N1 
retail pharmacy), business, media, State and local governmental 
agencies and bordering States have all been at the table to contribute 
to planning and response efforts. This is especially valuable as we 
continually strive to improve our medical countermeasures distribution 
and administration operations.
    (2) Information Sharing and Situational Awareness--With the 
assistance of preparedness funding, the Tennessee Emergency Medical, 
Awareness, Response, and Resources suite of information systems has 
been developed and includes the Hospital Resource Tracking System, 
Tennessee Health Alert Network, Tennessee Volunteer Mobilizer, and the 
Tennessee Countermeasure Response Network. We also established Regional 
Medical Communication Centers to improve interoperable communications 
among EMS agencies, emergency management, hospitals, and public health 
to support a medical response. Interoperability initiatives are 
paramount to the success of data exchange between response partners.
    (3) Community resilience--To ensure comprehensive community 
resilience and preparedness, Tennessee has adopted an all-hazard 
planning approach. This approach must include prevention strategies 
that are innovative and aggressively outreach to multiple population 
groups. Some of these initiatives include the annually high rates of 
childhood immunizations, collaborations with mental health providers 
for disaster response, child care center preparedness planning, 
vulnerable population outreach and information sharing, ongoing 
dialogue with professional associations, and a proactive training and 
exercises.
                                 ______
                                 
    Chairman Harkin, Ranking Member Enzi, and distinguished committee 
members, it is my special privilege to appear before you today to 
discuss an issue of great importance to our Nation, public health and 
medical preparedness and response. The thoughts I will be sharing with 
you today, while my own, are also embraced by my many State and local 
public health colleagues across the country that devote considerable 
time, attention, and resources preparing to most effectively manage the 
consequences of an array of emerging and evolving threats, such as 
disease outbreaks and disasters, in order to prevent or reduce illness, 
injury, and death. In the few minutes I have for opening remarks, I 
would like to talk about how far we have come and what more we must do 
to maintain our state of readiness.
    We sit here today just 4 months away from the 10th anniversary of 
the attacks of September 11, which were followed just 1 month later by 
the anthrax attacks. These two acts of terrorism were seminal events 
that made it very evident to all Americans of the dangers we can expect 
to face in the future and the need to rapidly escalate our bioterrorism 
preparedness efforts that began in earnest just 2 years earlier in 
1999.
    By everyone's account, there is no question that tremendous 
progress has been made over the last 10 years. We are so much better 
prepared now than we were on that memorable sunny Tuesday morning in 
mid-September 2001.
    In the Centers for Disease Control and Prevention (CDC) September 
2010 report where they reviewed the preparedness activities of the 
States, territories, and the four largest U.S. cities, CDC concluded 
that, ``much progress has been made to build and strengthen national 
public health preparedness and response capabilities.'' This report 
provides a national snapshot that shows that all States have a 
reporting capacity system that can receive urgent disease reports at 
any time of the day, seven days a week; have capabilities to receive, 
distribute, and dispense Strategic National Stockpile assets; and 
nearly all States can rapidly respond within 30 minutes to Health Alert 
Network messages, which provide information to State and local public 
health practitioners, clinicians, and public health laboratories about 
urgent health events. We also know that every State has developed and 
continues to refine its pandemic planning, as required by the Pandemic 
and All Hazards Preparedness Act (PAHPA).
    The Trust for America's Health annual Ready or Not Report in 
December 2010 acknowledges that, ``over the past decade, the country 
has made great strides in preparing for public health emergencies.'' 
This report shows that last year all but one State increased or 
maintained its Laboratory Response Network capability for chemical 
threats and 43 States and DC can currently send and receive important 
electronic health information with health care providers in their 
jurisdiction.
    One more illustration, just last month, in April 2011, the HHS 
Office of the Assistant Secretary for Preparedness and Response (ASPR) 
reported that we have advanced the preparedness of hospitals and 
communities in numerous ways, including through planning for all-
hazards, increasing surge capacity, tracking the availability of beds 
and other resources using electronic systems, and developing 
communication systems that are interoperable with other response 
partners. We can now also work with greater speed and improved response 
time since so often time is of the essence when it comes to information 
sharing, laboratory detection of biological threats, and getting 
vaccines and antibiotics to the public who may be in harm's way.
    While it is great to see this in writing from respected 
authorities, for those of us on the job and in the communities doing 
this work, this progress is very palpable, but yet fragile, a point I 
will come back to in a few moments.
    Our decade-long commitment of investing in and strengthening the 
Nation's public health enterprise has and continues to pay off in so 
many ways. Congress, and especially this committee, should be applauded 
for its work on laws like PAHPA that give States, territories, 
localities, and tribes the resources and tools needed to get the job 
done.
    Our approach to preparedness follows two main principles: (1) build 
capacity and capabilities that can effectively address all hazards, 
both for everyday emergencies, as well as for catastrophic events, and 
(2) preparedness is not an end point, it's a process that must 
continually be developed, maintained, refined, and improved. Allow me 
to elaborate.
    While the birth of our modern day preparedness and response efforts 
was appropriately centered on bioterrorism, we quickly learned that the 
most effective and efficient way to protect the public was to know all 
of your vulnerabilities, anticipate those threats, and build systems, 
programs, and services that are flexible and agile enough to handle 
anything that may come our way. Building and maintaining capabilities 
in such areas as: (1) incident management; (2) information sharing and 
public warning; (3) biosurveillance (epidemiology and laboratory 
services); (4) countermeasures distribution and dispensing; (5) surge 
management for mass health care delivery, mass fatalities, and the 
coordination of volunteers; and (6) community resilience are in so many 
ways universal in their application to any and all hazards.
    Just thinking back over the last year, there is no doubt in my mind 
that my colleagues--like Don Williamson, the State health officer in 
Alabama, and Jimmy Guidry, the medical director and State health 
officer in Louisiana, in their handling of the Gulf Coast Deepwater 
Horizon Oil Rig Disaster; or Terry Dwelle, the State health officer in 
North Dakota, dealing with the flooding of the Red River; or Loretta 
Fuddy, the director of health in Hawaii, and Mary Selecky, the 
secretary of health in Washington State, as they work hand in glove 
with their emergency management and environmental protection 
counterparts on the Japanese Earthquake/Tsunami and nuclear reactor 
radiation release crisis--they all will tell you that the strength and 
success of their response can be directly attributed to years of 
planning and preparedness following an all hazards model. Even as we 
sit here today, there are multiple States still recovering from the 
severe weather of late April/early May that included severe super-cell 
tornado outbreaks and repeated rounds of severe rain that have now 
resulted in raging flood waters in the Mississippi River valley.
    And in my State of Tennessee, we live in the New Madrid Seismic 
Zone, which includes the States of Tennessee, Kentucky, Missouri, 
Arkansas, and Illinois. The planning assumptions for a catastrophic 
earthquake of a magnitude seven or greater in this area could impact 50 
percent of Tennessee's population. Such an earthquake would overload 
response capabilities and cripple local and State government. Tennessee 
projections include: 33,000 injuries, 3,000 fatalities and 7,000 
seriously injured; 342,000 in need of shelter; 2.1 million without 
food, water, or ice; 107,000 structures totally destroyed; 265,000 
structures with major damage; 1,000 damaged bridges, 330 collapsed; 608 
schools collapsed and unusable; 54 hospitals damaged; and 50 percent of 
all emergency vehicles destroyed. Up to seven other States may 
experience similar levels of loss of life, damage and destruction.
    We have been engaged in a wide array of public health emergency 
responses including multiple white powder incidents (ongoing since 
2002), sheltering of hurricane evacuees from partner States (2005/
2008), TVA coal fly ash spill (2008), ice storm (2009), and the H1N1 
influenza pandemic (2009). More recently, the response activities 
associated with the severe flooding in both May of 2010 and 2011 
included shelter staffing and support, vaccinations, water sampling, 
community assessments, vector control, prescription assistance, the use 
of emergency response information systems, and the creation of public 
information messages and fact sheets that were posted to the State's 
Web site and disseminated to the public and response partners. Of note, 
our previous work in 2010 was leveraged during our 2011 flood response 
allowing us to be ready, agile, and fully engaged. As a result of 
planning, exercising, frequent communications, and improvements in 
community health, Tennesseans responded to assist their neighbors and 
their communities. The results of these efforts represented a visual 
picture of the successes of the preparedness interventions. The 
successful public health response and recovery was made possible by 
preparedness funding.
    Regarding my second point about preparedness being a process, not 
an end point, the main thought here is that plans cannot remain static, 
they must be periodically and rigorously reviewed and revised based on 
experience, lessons learned, and evolving information; sophisticated 
laboratory and field equipment must be properly maintained and 
serviced; the public health workforce must remain sharp and skilled 
requiring ongoing training; and our plans and people must go through 
regular drills and exercises to reinforce our strengths and identify 
gaps and weaknesses where we need to improve on a continuous basis. 
This takes not only ongoing commitment, but resources.
    Before I share with you my final thoughts, one additional point I 
want to make is the critical importance and value of partner 
collaboration, information sharing and situational awareness, and 
community resilience. In Tennessee, community partners from healthcare, 
business, media, State and local governmental agencies and bordering 
States have all been at the table to contribute to planning and 
response efforts. One example includes the partnership with retail 
pharmacies and their ability to participate in both the H1N1 
vaccination campaign and antiviral medication distribution to the 
under-insured. These partners equate to public health force multipliers 
and can have a significant impact on prevention of disease. These 
relationships will continue to be fostered to ensure all-hazards 
response capabilities exist. This is especially valuable as we 
continually strive to improve our medical countermeasures distribution 
and administration operations.
    With the assistance of preparedness funding, the Tennessee 
Emergency Medical, Awareness, Response, and Resources (TEMARR) suite of 
information systems has been developed. TEMARR integrates numerous 
systems, technologies, programs, and leadership from across the State 
to respond to emergencies. Collectively, the TEMARR systems provide a 
broad picture of situational awareness and are used to more effectively 
manage and monitor Tennessee Department of Health (TDH) responses to 
disasters using national and international data exchange standards. We 
now have the capacity to better understand the disaster itself, alert 
key response agencies, identify and contact pre-credentialed first 
responders, allocate resource needs in terms of people and equipment, 
apply all required resources to the disaster, quickly triage and track 
all persons impacted, and transport them to the correct healthcare 
facility. Using ASPR funds, the State established eight Regional 
Medical Communication Centers as a joint venture between hospitals and 
TDH. Prior to the centers, limited interoperable communications existed 
among EMS agencies, emergency management, hospitals, and public health 
across the State to support a medical response.
    The above information systems could not have been developed without 
preparedness funding and will quickly disappear without sustained 
funding. By developing and delivering the TEMARR systems to the State 
we eliminated the need for multiple agencies to construct or procure 
like capabilities. The use of statewide solutions, that meet the needs 
of system users, provides for the sustainability of information 
technology infrastructure. The innovative use of interoperability 
standards supported by the U.S. Department of Homeland Security Office 
of Interoperability and Compatibility has promoted data exchange and 
collaboration at the Federal, State, and local level. Other critically 
needed efforts beyond pure requirements and standards development are 
to continue collaboration with the HHS Office of the National 
Coordinator (ONC) for Health Information Technology and ASPR, and to 
merge, integrate or support the transparent movement of message traffic 
across health information exchanges.
    To ensure comprehensive community resilience and preparedness, 
Tennessee has adopted an all-hazard planning approach. This approach 
must include prevention strategies that are innovative and aggressively 
outreach to multiple population groups. Some of these initiatives 
include the annually high rates of childhood immunizations, 
collaborations with mental health providers for disaster response, 
child care center preparedness planning, vulnerable population outreach 
and information sharing, ongoing dialogue with professional 
associations, and proactive training and exercises.
    As we look toward the future, with your permission, I would like to 
respectfully share with you three recommendations for your 
consideration:

     First is the need to reauthorize PAHPA. The Pandemic and 
All Hazards Preparedness Act is a well-designed and effective law that 
served us well. That being said, over the 5 years of it being in 
existence and in working with and using PAHPA, a short list of 
potential revisions and additions have been identified that would make 
a reauthorized PAHPA even stronger and more effective. I know your 
staff have been in contact with ASTHO leadership and discussed our 
suggestions for consideration.
     Next, even during these very difficult fiscal times when 
hard budget decisions have to be made, adequate funding through the CDC 
Public Health Emergency Preparedness (PHEP) and ASPR Hospital 
Preparedness Program (HPP) cooperative agreements to States must be 
maintained. We cannot let our progress erode. Tennessee-base 
preparedness funding has decreased by 37 percent from 2004 to 2011.
    The Nation's State and local public health system is already 
seriously frayed due to the adverse impact of the recession on State 
and local governments. Budget cuts at all levels of government are 
jeopardizing the significant gains that State, territorial, and local 
health departments made in prevention and preparedness programs during 
the past decade. From 2008-10, more than 44,000 jobs were lost in State 
and local health departments, reducing staff such as public health 
physicians and nurses, laboratory specialists, and epidemiologists. 
These job losses represent 14 percent of the State health workforce and 
20 percent of the local health workforce. Recent reports from both the 
Association of State and Territorial Health Officials (ASTHO) and the 
National Association of County and City Health Officials (NACCHO), on 
the impact of budget cuts on the health of Americans indicate that, 
since 2008, State and local health agencies have been forced to reduce 
critical public health programs, such as immunizations, HIV/AIDS 
prevention and treatment activities, and all-hazards preparedness and 
response efforts.
     My last point is that of community resilience. One of the 
best ways to help a community become more resilient is to improve their 
overall health through prevention. A healthier community and a 
healthier individual will fare far better in an emergency than a 
community or individual that is coping with underlying preventable 
health conditions, such as obesity, heart disease, or diabetes. 
Ensuring that adequate resources and attention is paid to addressing 
America's major health problems and common risk factors will have a 
major impact on the overall preparedness and response capacity of 
public health, and all other, emergency responders. These can be 
addressed through other Public Health Service Act programs authorized 
by this committee, such as the Prevention and Public Health Fund, 
Community Transformation Grants, and the Preventive Health and Health 
Services Block Grant, just to name a few.
    No State or community is ever completely prepared to address the 
health and medical consequences of a major disaster, terrorist event, 
or pandemic. However, since 2001, States have significantly improved 
and demonstrated their ability to prevent, respond to, recover from, 
and reduce the effects of a full range of threats and hazards. Through 
planning, training, education, drills, exercises, and building 
partnerships, State public health agencies have improved disease 
surveillance and laboratory testing, patient care surge capacity, 
decontamination capacity, and availability and deployment of 
pharmaceutical and other medical supplies. If you recall the reports I 
cited earlier that demonstrated progress, they also identify more that 
needs to be done, which requires our collective attention. Protecting 
the public from threats is a matter of national security, and 
protecting the public's health is no exception.
    Thank you for this opportunity and I would gladly address any of 
your questions.

    Senator Casey. Commissioner, thank you. And thanks for 
reminding us of some of the challenges people are experiencing 
right now, horrific tragedies.
    Dr. Anderson, I wanted to start with you with regard to 
children. And I know you spoke to this in your statement. I 
wanted to turn to your prepared statement and ask you to 
amplify or maybe reiterate some of what you said. You say, and 
I'm looking at page 5 and page 6, you say in that third 
paragraph under the general heading, ``Hospital Preparedness 
for Children'': ``In the face of a disaster all hospitals will 
need to increase their capacity.'' And then you go on to talk 
about pre-hospital setting, emergency, surgical.
    Then on page 7 you say, in the second full paragraph,

          ``As Congress looks ahead to the reauthorization of 
        PAHPA and the ASPR develops grant guidance for the HPP 
        program for this fiscal year coming up, attention 
        should be paid to what criteria hospitals are being 
        asked to meet for children, including children with 
        special healthcare needs.''

    And it goes on from there. And you referred to some 
recommendations that the Academy has. Can you go through those 
and highlight--I am not saying you have to go through all of 
them, it is in your testimony, but just highlight why you are 
making those recommendations.
    Dr. Anderson. Excellent question, Senator. What we look to 
at the American Academy of Pediatrics and the world of 
children's hospitals is really helping non-children's hospitals 
prepare for the needs of kids. And it really starts with day-in 
and day-out preparedness. We are talking about big disasters, 
mass casualty events--hospitals that aren't used to seeing a 
lot of kids have to be prepared every day, because parents are 
going to see emergency room and think, OK, I now have my child 
at a place that is going to give wonderful care. We need to 
assure that as best we can.
    The AAP has put out several statements. Here is the stuff 
you need, and it starts with equipment because the equipment 
for children is very, very different. Here is the training you 
need, there are wonderful courses if you don't take care of 
kids a lot, to sort of dust off the memory. And by the way, one 
of the most important recommendations are to have a coordinator 
at each and every hospital in this country, each and every ER 
that is that pediatric person, that is always that sort of 
annoying, clanging person. Have we thought about the kids? Do 
we have the right stuff? Hey, beautiful new decontamination 
chamber. How are you going to do kids? How are you going to 
decontaminate kids in wheelchairs? So we have to start from a 
day-in and day-out preparedness and then figure out when the 
big one hits how are we going to surge up.
    Several of my co-panelists and Dr. Lurie mentioned we 
learned a lot of lessons from H1N1. We were reaching out to 
community hospitals in northeast Ohio saying,

          ``If this gets really big and our children's 
        hospitals are closed or only taking the sickest of the 
        sick, are you prepared, community hospital, to keep 
        kids overnight, to admit children, when you haven't 
        done that in 20 years?''

    We also have some recommendations, if we hit that sort of 
surge capacity, how do you reach out and find physicians to 
come help you staff it. How do you find the right equipment? 
How do you work with your local children's hospital in a 
regionalized approach to sort of figure out what children need 
the children's hospital and what kids could stay locally.
    So, to make a long story as short as I can, it starts with 
day-in and day-out preparedness. Are you ready for what we call 
``the disaster of one,'' that really sick kid you are not used 
to taking care of and then how do you ramp up if you've got 
more and more of those kids.
    Senator Casey. How prepared do you think we are just as it 
relates to this particular issue? Hospitals preparing for 
treating children and caring for children in the aftermath of a 
disaster?
    Dr. Anderson. As a practicing ICU or PICU doctor, I think 
we are better prepared than we have been. There were some very 
disconcerting studies in the early 2000's that showed only 6 
percent, repeat 6 percent, of ERs had the right equipment. I 
think that number is a lot better now. I think we are seeing 
people really take these recommendations seriously.
    I think unfortunately we are learning lessons from Katrina, 
from tornados, etc. But I still think there is a lot of work to 
be done. It is important to celebrate our successes but it is 
much more important to advocate for getting better prepared.
    Senator Casey. And based upon your experience and based 
upon your interfacing with folks who are the real world of 
running hospitals and delivering healthcare, often when someone 
in that real world hears government say the following words, 
``thou shalt'' and then gives the directive that folks running 
a hospital or running a business say, ``that is easy for you to 
say, let me tell you the impediments to compliance.'' What do 
you hear in terms of hospitals saying, ``we would love to do 
all this but we can't?'' Is it mostly access to capital?
    Or is it something more significant?
    Dr. Anderson. It is a great question, because we have heard 
some push back. It is another unfunded mandate. I have to come 
up with this list of stuff and this list of--we are not asking 
for a $2 million suite off of your ER that has all the latest 
technology. The basics are the basics, and that is training, 
very readily available courses, the basics of equipment. The 
basics, if you are going to have a drill, which disaster drills 
are part of Joint Commission accreditation, why not include 
kids? The chances are 22 percent of our population are 
children, why not just include them in the drill.
    We do occasionally hear, as advocates for kids, a little 
push back, this is another unfunded mandate, but we are not 
asking for big stuff here. This is a coordinator, equipment, 
training and drills and I think that is pretty straightforward, 
quite frankly.
    Senator Casey. I will come back to some of our others, but 
Senator Burr.
    Senator Burr. Thank you, Mr. Chairman. I had high hopes 
that when the average age on the dais today got below 60 the 
air conditioning would come back on and it would get cooler in 
here.
    [Laughter.]
    I think we are making progress, but it is a slow process.
    Let me also just make a comment and I will be as diplomatic 
as I can. I always find it amazing that we could be at a point 
in time talking about the reauthorization of PAHPA, the 
importance of it and that the key individuals that work within 
the framework of it, who came here to testify didn't find it 
interesting enough to stay and listen to the second panel where 
we talked about how it is working within BIO, within hospitals, 
within the community health network and from somebody who was 
one of the most instrumental architects of the original bill.
    I say that to the whole cadre of HHS folks and I hope 
whoever was assigned the responsibility to stay in the room and 
take notes, that you take pretty darn good ones, because I find 
it appalling that those officials who ask to serve in this 
capacity and carry this out don't find any significance in 
staying and hearing what this panel has to say, but more 
importantly, what the questions are of the members for the 
second panel.
    With that, Commissioner Cooper, let me just ask you. What 
do you see as the key challenges for the public health 
departments regarding bio-surveillance and the capacity to 
detect novel and unknown viruses?
    Ms. Cooper. It is a great question. There are several 
challenges. One is just the technology to do so. It would be 
nice to be able to pull up a screen on a computer, any given 
day, and be able to track any outbreak in any hospital or any 
physician's office in our State. We can't do that right now.
    The second thing is workforce capacity is a struggle for 
us. If you look at the challenges we face, I talked a little 
bit about the number of folks that have gotten out of the 
public health field, if you just look at my health department, 
our State health department, by December 2012, 42 percent of 
the State public health workforce is eligible for retirement. 
And when you look at those jobs that have been eliminated you 
are talking about public health physicians, nurses, 
epidemiologists, laboratorians, that is a workforce that needs 
to be replenished. And we have significant challenges in 
drawing people into the field of public health.
    Also, we have had great support from our Federal partners 
along the way, but as Admiral Lurie said, there is much more to 
be done. We need some real-time detection devices that can give 
an isolate right where you find it, whether it is in a 
community, in a hospital instead of having to vet it through 
multiple laboratories.
    Senator Burr. I am sure I am not telling you anything that 
you don't know, but if today the CDC were to provide access--if 
they contracted with one of a couple of companies that monitor 
prescriptions that were written yesterday, and they allowed 
local health departments access to that, you could look by zip 
code all the way down to the four digit additional, meaning you 
could detect, almost in a city block, individuals who had seen 
different doctors or gone to different hospitals and were 
treated for similar things, cluing you in to a problem. We 
don't, today, make that available.
    It is not a technological breakthrough, this is something 
that is at our fingertips today where right and left hands 
don't understand the capabilities that we can provide in real-
time, in a 24-hour period we could know, regardless of where in 
Tennessee, there had been exposure to anthrax because of what 
was determined from a diagnostic standpoint, what was 
prescribed from a pharmaceutical standpoint and you could start 
looking at, did this happen at the workplace or did it happen 
at the home based upon what those area codes or zip codes in 
fact told us.
    I am going to run out of time. I want to go to Dr. Bob real 
quick and just say, are we prepared? And if not, what do we 
need to do?
    Dr. Kadlec. Sir, I will go back to an occasion on June 30, 
2008 when I told the last president, after 8 years and $50 
billion, that we weren't prepared for a modest-size anthrax 
attack. And basically said, the difficulty we have, is that 
when you look end to end we have some of the pieces in place, 
but not all the pieces in place. So if you look at that one 
particular problem alone, you raise the issue of detection, we 
have some capabilities in that space, but still we don't have 
point-of-care diagnostics for clinicians to be able to rapidly 
make that diagnosis in any major metropolitan emergency room. 
Along the chain of that we have 60 million 60-day courses of 
antibiotics and we have no guarantee that we can get them to 
the people who need them when they need them. That the 
distribution mechanisms we have in place may be too slow to 
deal with the kind of event that we would anticipate in that 
way. In some ways we lack a little bit of imagination of how to 
address that problem. In many ways, some of the challenges 
there are logistics.
    The third one is, we just have to basically make a 
commitment to do this. We have a stockpile of anthrax vaccine 
that quite frankly sits in a nice cool place and at some point 
in time will expire and will be thrown away. And yet we could 
basically use that material today and have volunteers, first 
responders, members of the National Guard, members of different 
first responder communities basically use that product.
    And the last one is, then why don't we have antibiotics if 
people want to store them in their home and there is a way to 
do this responsibly so to prevent abuse, potentially avoid 
antibiotic resistance in populations to basically develop these 
med kits? Again, an FDA issue that could be readily done.
    So there are a variety of things that could be done along 
this whole chain, but quite frankly we haven't just made a 
commitment to get it done. And so in some ways we study the 
problem to death, but we just don't act on the things that we 
know that we could do to effectively change that equation 
today.
    Senator Burr. I thank you for that and hope that all of you 
will make yourselves available for additional questions from me 
and from all the members. But more importantly, if there are 
details that you have, as we go through the reauthorization, 
that you will share those ideas with us no matter how around 
the edges they might be. It is important that we try to 
incorporate it.
    I had a conversation several weeks ago with somebody that 
had inquired about the BARDA process and a particular 
countermeasure for a known threat. And as I understand it, the 
response they got was, ``well that is not an imminent threat, 
therefore that is sort of on the back burner.'' When this was 
created we didn't ask DHS to list whether threats were 
imminent, we just asked them to list if they were real.
    I think it was our belief, that if that could happen, then 
we need to be prepared. None of us have the foresight to know 
who or when somebody might use it or whether Mother Nature 
herself will present us a curve ball. That is one of the 
reasons that we set it up the way we did where another agency 
establishes that threat and, from within HHS, their mission is 
to bring a countermeasure or a vaccine to the stockpile or 
capabilities of having it to offset it. We never envisioned 
that there were threats that were not imminent. They are all 
imminent if in fact they fall into the category that we have 
resolved.
    So I thank all of you and I look forward to working with my 
colleagues on this panel. I believe that reauthorization is 
absolutely essential. I think we can do it better than we did 
it before. It will not be easy and we will have some push back 
from people within the government simply because we are going 
to have to challenge the culture that is out there right now.
    I thank the Chair.
    Senator Casey. Thank you, Senator Burr and thanks for your 
work on these issues.
    I want to move to Senator Whitehouse.
    Senator Whitehouse. Thank you, Mr. Chairman. It has been a 
very good hearing so I haven't been patient at all, I have been 
very interested and I appreciate that the witnesses have come 
here and shared their expertise with us.
    Dr. Kadlec, could you evaluate for me the--I don't--they 
are not exactly different strategies, but they are sort of more 
like opposite ends of the spectrum on strategy. One is prepare 
in advance, build your medical countermeasures in advance, 
stockpile them in vast numbers and develop a rapid development 
and deployment strategy so that when something, to use Senator 
Burr's description, a curve ball comes down the road that you 
haven't stockpiled for, you are in a place where you can move 
rapidly to protect the public health in that circumstance.
    And if it is appropriate, if you could distinguish between 
the two strategies or the two ends of the spectrum strategy in 
the light of known threats, like flu and anthrax versus the 
unknowns that might be coming at us or the modified biologics 
that might be coming at us.
    Dr. Kadlec. The best way to look at it, is as book ends. So 
if you had to look at a book end of the policy and capabilities 
that were developed for smallpox, for example, it was a clear 
policy decision to basically take smallpox off the table, for 
which we basically procured or had in our possession 300 
million doses of the smallpox vaccine. And we are looking now 
to basically expand that stockpile by ensuring that 
particularly for people with compromised immune systems that 
you could have a product that wouldn't be harmful to them if 
you had to prospectively immunize them in advance of a threat, 
credible threat, or if there were an outbreak that you could 
reasonably protect them to ensure that the vaccine itself 
wouldn't harm them. So that is one end of it.
    The other end of it is, this idea of stockpiling 300 
million. In between, is their 12 other potential agents of 
concern that we have. If you look at the list, for me anthrax 
on down through rickettsia or typhus. The point is we haven't 
made the same determination what we would need there. So in 
some cases we have looked at anthrax and basically said, 
``well, we need 80 million doses,'' 75 million doses in the 
stockpile, but we haven't made the affirmative decision, well 
what would happen if it would be used against us, do we want to 
immunize everyone in the United States? What is our ability to 
do that? So there's the flexibility within the known.
    Then there is the issue of the unknown, as you say. And 
what I am concerned about is basically the idea that if you 
basically take this as a one off of pandemic influenza, which 
in some ways I think is the strategic choice to date, that you 
would somehow use a variety of different platforms to make a 
pandemic influenza vaccine, well that may be appropriate. You 
need 600 million, theoretically, for the whole country. The 
question is, what happens if you are attacked by multiple 
biological agents.
    And maybe only one platform is capable of doing that.
    So one of the things that I think is necessary in 
evaluating this is a little bit of, if you will red team it, 
also evaluating the platforms that you have to maximize that 
your depth, your capacities that are available go beyond what 
just exists maybe in one or two facilities, but really would be 
able to mobilize what is in the private sector.
    Also looking for the technology innovations, and I think 
there has been some work in that space, to see what may be out 
there. Again, not FDA approved yet, but something that may be a 
decade away to do so, but yet could be leveraged in this case 
as well.
    So the answer is, there is no clear strategy. There are 
some strategic options that are out there. We have made some 
partial decisions but we haven't, what I would say, made a 
holistic, comprehensive one, which I think is kind of the worse 
place of all to be.
    Senator Whitehouse. With respect to my questions earlier 
about the state of our capability for developing rapid response 
in the event of an attack using unknown biological agent and 
the BARDA process that is our sort of first venture into 
developing that capability, how are we doing?
    Dr. Kadlec. I think one of the things, and the name was 
supposed to give it away, a kind of BARDA sounded like DARPA. 
Again, it was Senator Burr's concept. But, really it was to 
provoke the notion that somehow we would give all the 
authorities, as DARPA has, other transactional authorities, to 
really give it the maximum flexibility to basically engage to 
look for innovative technologies and rapidly bring and 
accelerate development of these products as we need to, whether 
it be platform technologies or specific countermeasures.
    Senator Whitehouse. Is it working?
    Dr. Kadlec. It hasn't quite--it hasn't worked that way. I 
think part of it has been a resource issue. I alluded to 
earlier, if you only give them 40 percent of the budget that 
they theoretically need or they have identified they needed, 
you have to wonder whether they can effectively do their 
mission.
    But I think part of it is, again pushing the envelope as to 
what you are willing to do. And it is a very difficult thing to 
suggest, particularly given all the regulatory issues around 
it. And now I think one of the vital pieces that have been laid 
on the table by a number of people is this idea of improving 
regulatory support, bringing the FDA into the tent and having 
them more as an active participant in this thing can alleviate 
some of the challenges.
    But quite frankly, I think it does take a bigger push, and 
again, a bit of imagination to say, ``how can we do this 
better, faster.'' Originally we even said a bit cheaper if you 
could, to basically work in a program that was competitive in 
nature, that you would highlight a number of potential 
candidates, bring them down the pipeline, making critical 
decisions, as a pharmaceutical company would do, to basically 
identify which, at the end, is the investment that you have to 
put your money on to basically ensure you have an FDA licensed 
product.
    But I don't think it is where we need to be. Part of it is 
I think some of it is authority, part of it is the regulatory 
involvement and part of it is a resource issue.
    Senator Whitehouse. Thank you, Chairman. I appreciate the 
hearing and I look forward to working with you and Senator Burr 
on the reauthorization.
    Senator Casey. Thanks, Senator Whitehouse.
    I know we are running low, we are pretty much at the end of 
our time. But I wanted to maybe ask two more questions and then 
we will say something about leaving the record open.
    Ms. Arthur, I wanted to ask you about this issue that I 
know you have had a concern about. The particular challenge you 
face with regard to developing countermeasures for at-risk 
populations. We have heard a good bit today about children. Can 
you highlight those, from the perspective of whether they are 
just bureaucratic or other challenges or whether they are 
scientific hurdles. But you are looking at it from the private 
sector, from the nongovernmental sector, we will call it. Can 
you outline some of those challenges?
    Ms. Arthur. Absolutely. Thank you for the question.
    Actually I think that the--looking at special populations 
adds an extra dimension of complexity. So, as we were talking 
about before, a lot of the products, the countermeasures need 
to be researched, generally using the animal model guidance and 
the animal model rule, because you really can't do the key 
testing on efficacy in humans, you have to do it in these 
animals. The problem is, it is not always clear which animal is 
the right model to use. And add to that, not necessarily surety 
about which animal is the right animal to use to exemplify 
children.
    So you add a layer of scientific complexity that needs to 
be solved in concert with the FDA. So a lot of the companies 
that are trying to not just license a countermeasure for use in 
healthy adults, but in all of the population, need to really be 
able to work in concert with the FDA on how to answer the key 
question. If the goal is to have a product that you can use 
after exposure and you want to be able to use across all 
populations, you need to really think through which models to 
use and what questions you are going to answer and what 
scientific rigor you are going to have to apply to that. That 
is really one of the key problems that we would like to have 
solved through the FDA review.
    So, the reason why we are supporting the FDA process so 
strongly is precisely because they really want to put resources 
toward those key scientific questions that all countermeasure 
sponsors have.
    Senator Casey. Thank you very much.
    I just have one more question. Commissioner Cooper, are 
there, and I am assuming there are, particular challenges in 
rural communities? Can you outline some of those, because often 
when we turn on the news and we see some of these horrific 
images, they invariably seem to be in smaller communities and 
often communities that are, at least by demographics, rural. 
Any insights or--it may be better to say any concerns that you 
have or any suggestions you have as to how we can better 
prepare for those communities?
    Ms. Cooper. Certainly Tennessee is a very rural State. We 
are about 42,000 square miles, touching about eight other 
States. And we have worked in a very strategic fashion to put 
counties into regions across the State, because similar rural 
counties had similar issues, whether it is lack of resources. 
You think about community hospitals, or you may have a single 
healthcare provider, if you have one in that community. You 
think about the emergency medical system, it is more 
sophisticated in urban areas than it is in a rural community. 
All of these are key players and key partners in the public 
health response.
    Even when I talked about earlier, the pharmacies, when you 
think back to H1N1 we had a very aggressive program with 
Tamiflu, making it available to all persons across the State. 
But we had two counties in our State that don't have a pharmacy 
in it, so you had to come up with a redundant system to address 
those needs.
    I think our regional strategy has worked very well. I think 
there are some lessons to be learned from that. But again, it 
is really about the capacity of not just the public health but 
the medical system in place to respond to these emerging 
disasters.
    Senator Casey. I know we are wrapping up. I just wanted to 
make sure that I put on the record that we will keep the record 
open for 10 days for members of the committee to submit 
statements for the record and for testimony.
    And unless there is something any of you would want to add, 
we will conclude. But certainly the record will be open, not 
only for more questions that will be presented, due to answer 
in writing, but of course if you feel the need to supplement 
your testimony or provide other information that is certainly 
an option available to you.
    Thanks for your help and thanks for enlightening us as we 
begin this process of reauthorization.
    We are adjourned. Thank you.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                 Prepared Statement of Senator Mikulski

    Chairman Harkin, thank you for organizing today's hearing 
on public health, medical, and bioterrorism preparedness. Also, 
I appreciate Senator Enzi and Senator Burr's long-standing 
efforts to improve our Nation's ability to respond to public 
health emergencies.
    Terrorism is a danger to us on many fronts. We must prepare 
ourselves to respond to all hazards that impact our Nation's 
security. Every day, Americans are faced with natural disasters 
in our communities--floods, hurricanes, earthquakes, and food 
safety outbreaks. These incidences challenge our Federal 
ability to assist those in harm's way and the States' 
capabilities to respond to local needs.
    Today as we scrutinize every dollar spent, this hearing 
will be important in showing how our past investments have made 
us more prepared for the unexpected, and how future investments 
and resources can be utilized more efficiently.
    I also hope this hearing will demonstrate how Congress can 
come together in a bipartisan fashion, and bridge the all-too-
common partisan divisions, when it comes to protecting our 
citizens.
    As I have said before, the key question we must address 
today is readiness. Are we ready to respond to all hazards? We 
are better prepared than we ever have been before, yet the 
distressing answer to the question is No.
    If a major catastrophic health event occurs in the United 
States--such as the earthquake and tsunami in Japan, or another 
Hurricane Katrina, or a severe pandemic, or bioterrorism 
attack--our infrastructure for the response will be stretched 
to the breaking point. And our Nation's most vulnerable 
populations--children, the elderly, and Americans with 
disabilities--will be the ones most at risk.
    Fortunately we do have efforts underway that must continue. 
We have newly developed countermeasures that we did not have a 
decade ago. The Strategic National Stockpile contains medicines 
to protect Americans against smallpox, anthrax, and nerve 
agents.
    Maryland has been a leader in our national and public 
health security. Fort Detrick in Maryland is on the frontlines 
of bioweapons research to develop our best defense against 
these weapons. I am proud of these Federal employees. Also, 
Maryland's biopharmaceutical manufacturers are working closely 
with Dr. Lurie and the Biomedical Advanced Research and 
Development Authority to develop novel countermeasures for our 
Nation's Strategic National Stockpile.
    Marylanders at Emergent Biosolutions, PharmAthene, Human 
Genome Sciences, Cangene, and Medimmune are developing the next 
generation anthrax vaccine; improving our manufacturing 
platforms for influenza vaccines; creating better medications 
to treat people exposed to nerve agents; and working to conquer 
infectious diseases like tuberculosis and typhoid.
    I am also proud of the work we have done in Congress to 
assist our biotech companies, our pharmaceutical companies, and 
our local, State, and Federal agencies in preparing for some of 
the most common threats we face.
    I remember last time I worked with Senator Burr on this 
legislation, and I look forward to improving upon the law in a 
bipartisan fashion in order to deliver the most protection for 
our country. I look forward to hearing from all of our 
witnesses today about the accomplishments and challenges we 
face with developing medical countermeasures and sustaining our 
public health infrastructure so that health agencies are able 
to respond to all hazards. We must ensure our Nation is secure 
when national disasters strike and terrorists try to attack us.
    These are national problems that require national solutions 
and national leadership from the Federal Government. We must 
not wait for the disaster to occur. We must have a plan of 
defense and have a plan of offense.
    I look forward to working with my colleagues to make sure 
we are ready to combat tomorrow's threats!

                  Prepared Statement of Senator Hagan

    I would like to thank Chairman Harkin for holding this 
hearing today. I would also like to thank the Assistant 
Secretary for Preparedness and Response at HHS, Dr. Lurie, and 
all the witnesses for coming before the committee to discuss 
strengthening our Nation's medical and public health 
preparedness and response.
    Our experiences during the September 11 terrorist attacks, 
the 2001 anthrax attacks, Hurricane Katrina, the 2009 H1N1 
influenza pandemic, and the 2010 Deepwater Horizon oil 
disaster, clearly show how important it is for our Nation to 
continually improve our public health emergency preparedness 
and response activities.
    Earlier this month, the long hunt ended for the terrorist 
leader, Osama bin Laden. I am extremely proud of the U.S. 
Special Forces and our intelligence community that finally 
brought down this mass murderer. I am pleased that justice was 
served and I hope this event can bring some peace to our 9/11 
families and the country.
    However, the terrorist threat to our Nation remains. The 
Commission on the Prevention of Weapons of Mass Destruction 
Proliferation and Terrorism has repeatedly warned of the near-
term threat of a biological attack and the need to enhance our 
capabilities to rapidly respond to such threats and potential 
attacks. Just a few months ago, the Directors of the Central 
Intelligence Agency and the National Counterterrorism Center 
testified to Congress that Al Qaeda is still intent on 
developing chemical, biological, radiological, and nuclear 
attack capabilities. Our Nation must be prepared for any such 
attacks and we must consider our public health preparedness as 
a national security objective.
    The Pandemic and All-Hazards Preparedness Act of 2006 
(PAHPA) reauthorization is timely and urgent. In addition to 
making preparedness a national security priority, we need to 
focus on: interagency coordination; addressing real-time 
detection and biosurveillance capabilities; ensuring that 
hospitals and clinicians are equipped in the event of a 
pandemic; ensuring that special populations, like children and 
the elderly, have access to appropriate countermeasures; and 
finally, establishing a prospective multi-year plan for 
preparedness including research, development, and stockpiling. 
I look forward to hearing from our witnesses today as we 
discuss the reauthorization of this important legislation.

  Prepared Statement of Governor Lowell P. Weicker, President of the 
             Board of Directors, Trust for America's Health
    My name is Lowell P. Weicker, and I am president of the board of 
directors of Trust for America's Health (TFAH), a nonprofit, 
nonpartisan organization dedicated to saving lives by protecting the 
health of every community and working to make disease prevention a 
National priority. I am grateful for the opportunity to submit 
testimony to the committee on reauthorization of a groundbreaking piece 
of legislation, the Pandemic and All-Hazards Preparedness Act (PAHPA).
    PAHPA represented a major step in acknowledging and developing the 
role of America's public health system in preparing for and responding 
to major emergencies, whether natural or man-made. The reauthorization 
of PAHPA is an opportunity to build more prepared and resilient 
communities, able to weather a storm, contain its impact, and return to 
normal as quickly as possible. I applaud the committee for 
demonstrating its commitment to better preparing our Nation for 
disasters.
    I have two major points to make in my testimony today:

    First, our Nation faces continuing natural and man-made threats 
that require an ongoing commitment to public health preparedness. This 
is a national security threat--as direct as any we face abroad. The 
death of Osama Bin-Laden does not erase that threat; there are still 
very creative terrorists out there and our guard cannot be let down.
    Second, we must fund public health preparedness with the same level 
of commitment as we have made to other national security priorities. 
This means: (a) we must assure reliable, predictable funding for public 
health preparedness, in contrast to the 27 percent decline faced over 
the last several years; (b) we must assure that State and local health 
departments are given flexibility to use all employees supported with 
Federal funds during an emergency and not be hamstrung by categorical 
restrictions; (c) and we must fully embrace the spirit of ``all 
hazards'' in PAHPA by recognizing that almost every public health 
program contributes to preparedness. As our health care system 
modernizes--especially with regard to health information technology--we 
must be sure public health programs, such as biosurveillance, adapt as 
well, including by leveraging existing resources in more creative ways.

    The public health system has always been integral in our response 
to natural disasters and terrorist attacks. Public health was on the 
frontlines of the response to 9-11 and to the anthrax attacks. It is as 
fundamental to the Nation's security as our military and as fundamental 
to local protection as fire and rescue. Passage of PAHPA codified and 
expanded the Federal Government's support for this role. As a result of 
this legislation, and the investments that followed, our Nation is more 
prepared than ever. We saw this in the response to the H1N1 outbreak in 
2009, when nearly every State and jurisdiction implemented its pandemic 
influenza plan in response to the H1N1 outbreak, with activities 
including disease surveillance, ongoing communication updates, carrying 
out vaccination campaigns and the coordination of response efforts with 
partners.\1\
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    \1\ Centers for Disease Control and Prevention, Public Health 
Preparedness: Strengthening the Nation's Emergency Response State by 
State, September 2010. Available from: http://emergency.cdc.gov/
publications/2010phprep/pdf/complete_PHPREP_report.pdf.
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    In TFAH's 2010 report, Ready or Not?, we found that States had made 
enormous progress since the events of 2001 in planning for and 
responding to disasters. The Public Health Emergency Preparedness 
(PHEP) cooperative agreement and Hospital Preparedness Program (HPP), 
Federal, State, and local attention to the role of public health in 
emergency preparedness, and real-world experiences such as the H1N1 
outbreak have helped us bring preparedness to the next level. However, 
the report also found that the economic crisis is putting almost a 
decade of gains at serious risk. While emergency H1N1 and stimulus 
funds may have helped States weather the storm of the pandemic, we 
cannot continue to fund preparedness on a disaster-by-disaster basis. 
Our report found that 33 States and DC cut public health funding from 
fiscal years 2008-9 to 2009-10, with 18 of these States cutting funding 
for the second year in a row. In addition, Federal support for public 
health preparedness was cut by 27 percent between fiscal year 2005 and 
fiscal year 2010 (adjusted for inflation). We expect to see major cuts 
to Federal public health preparedness programs in both fiscal year 2011 
and 2012. These inconsistencies represent the greatest threats to our 
ability to respond to a public health catastrophe on the level of the 
Japan earthquake and tsunami.
    We believe a modernized, prepared public health system must address 
several remaining gaps:

     A Workforce Gap: The National Association of County and 
City Health Officials reports that we have lost roughly 19 percent of 
the local health department workforce since 2008. This loss of 
experience has a staggering impact on preparedness, as workers cannot 
simply be hired and trained once a disaster strikes.
     A Surge Capacity Gap: Surge capacity, the ability of the 
medical system to care for a massive influx of patients, requires 
ongoing planning, funding, and coordination across healthcare, public 
health, first responder, and private sectors.
     A Surveillance Gap: The Nation still lacks an integrated, 
national approach to biosurveillance, which could significantly improve 
response capabilities for emergencies.
     Gaps in Medical Countermeasure Development: The research 
and development of vaccines, antivirals, diagnostics, and other 
countermeasures is years ahead of where we were during the 2001 anthrax 
outbreak; yet our ability to spur innovation in these limited-use 
technologies has been hampered by a lack of stable funding and some 
breakdowns in program administration.

    PAHPA reauthorization represents an opportunity to fill some of 
these critical gaps. As you begin consideration of amending the law, 
TFAH would like to offer the following recommendations:
    1. Strengthen Public Health Preparedness Infrastructure: The 
economic recession has led to cuts in public health staffing and eroded 
the basic capabilities of State and local health departments. 
Strengthening the public health preparedness workforce and 
infrastructure is critical to ensuring the health protection of our 
Nation. It also requires adequate funding and human resources to 
recruit and train personnel, stockpile life saving countermeasures, 
develop and exercise plans, and identify and engage partners to support 
the public health mission. The resources required to truly modernize 
public health systems must be made available to bring public health 
into the 21st century and improve preparedness.
    The PHEP cooperative agreements and HPP are two key grant programs 
that support the development and sustainability of State and local 
public health preparedness infrastructure. Since their inception, these 
programs have increased the capacity of State and local health 
departments and health systems to prepare for and respond to a 
disaster.\2\ \3\ Our 2010 report found that these funding streams have 
contributed to major progress in workforce training, epidemiology and 
laboratory capacity, surveillance, and planning and exercising at the 
State and local level.
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    \2\ Centers for Disease Control and Prevention, Public Health 
Preparedness: Strengthening the Nation's Emergency Response State by 
State, Sept 2010. http://emergency.cdc.gov/publications/2010phprep/
index.asp.
    \3\ Center for Biosecurity, Hospitals Rising to the Challenge: HPP 
Evaluation Report, March 2009. http://www.upmc-biosecurity.org/website/
resources/publications/2009/2009-04-16-hpp
report.html.
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    During the 2009-10 H1N1 influenza outbreak, State and local health 
departments were on the front lines responding to the pandemic, though 
many were limited in their efforts as a result of Federal and State 
budget cuts, particularly those that have occurred over the past 5 
years. These budget crises demonstrated, among other things, the need 
to build in mechanisms to allow more flexibility in how staff, funded 
by Federal grant programs, are used during emergencies. In the H1N1 
influenza response, the ability to re-assign staff from other federally 
funded projects in health departments could have improved the financial 
and human resource efficiencies of that agency's response to the 
influenza pandemic, especially during the earlier response phases when 
additional funding was not yet available and jurisdictions needed to 
mobilize ``all hands on deck.'' To address these concerns, we recommend 
language that would:

     Establish multi-year grant cycles with greater flexibility 
in States' retention and use of carry forward and unexpended funds;
     Create a mechanism to fast track the awarding and 
programming of emergency supplemental funds into existing grant 
mechanisms without additional match or maintenance of funding 
requirements; and
     Grant authority to the Secretary to allow States to also 
use personnel that are part of other Federal programs in response to a 
public health emergency (e.g. an ``all hands on deck'' scenario).
     We understand that HHS and the Department of Homeland 
Security (DHS) have begun working to align grant programs that aim to 
build our Nation's emergency preparedness capacity, including PHEP, 
HPP, and FEMA grants. Currently the PHEP and HPP grants, both of which 
are often distributed through public health departments, have separate 
application and reporting requirements, overarching goals, and in some 
cases conflicting performance metrics. We believe the alignment process 
should include coordinating grant priorities and goals, grant cycles, 
and streamlining application and reporting mechanisms to achieve 
maximum efficiency. I urge you to use PAHPA to ensure oversight and 
proper implementation of this alignment process.

    2. Modernize Biosurveillance: Situational awareness--knowing what 
the threats are, and knowing what our capacity to respond is, at any 
given moment--is critical to responding to any emergency and we need to 
make sure we are building capacity using 21st century technology and 
approaches. We have built our disease surveillance system one disease 
at a time and one crisis at a time, rather than as a unified, 
interoperable unit. Rather than continuing these silos, we have the 
opportunity to think across diseases (infectious and chronic) and 
emergency situations, because health information technology is 
advancing at a rapid pace and the health care system is becoming 
electronic.
    It is time for public health to do the same. Imagine a system where 
a provider inputs data into an electronic health record, the health 
department is rapidly informed of a cluster of unusual symptoms 
(indicating an outbreak), and the health department then communicates 
with the provider and responds quickly with the appropriate 
intervention. Right now, the ability of health departments to receive 
and analyze electronic data varies widely from jurisdiction to 
jurisdiction. Because the Federal Government is in the process of 
catalyzing adoption of electronic health records, now is the time to 
think about how to incorporate public health into the system. PAHPA can 
help fill this gap:

     PAHPA should call for a new national strategy, led by HHS 
and CDC, that would examine means to achieve interoperability and 
transparency among various surveillance systems.\4\ The United States 
lacks an integrated, national approach to biosurveillance, and there 
are major variations in how quickly States collect and report data 
which hamper bioterrorism and disease outbreak response capabilities. 
The lack of an overarching Federal biosurveillance strategy has led to 
fragmentation, multiple separate surveillance systems, and barriers to 
relevant agencies prioritizing and synthesizing data.\5\ \6\ And 
according to a December 2010 GAO report, HHS had not provided a 
strategic plan for electronic situational awareness, as required by 
PAHPA.\7\
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    \4\ Nuzzo, Jennifer, Center for Biosecurity of UPMC. ``Developing a 
National Biosurveillance Program,'' Biosecurity and Bioterrorism. 
Volume 7, Number 1, 2009. http://www.upmc-biosecurity.org/website/
resources/publications/2009/biomemo/2009-03-27-
develop_natl_biosurveill-
ance.html.
    \5\ Nuzzo, 2009.
    \6\ Vinter, S. et al., Trust for America's Health, Ready or Not? 
2009: Protecting the Public's Health from Diseases, Disasters, and 
Bioterrorism. December, 2009. http://healthyamericans
.org/reports/bioterror09/pdf/TFAHReadyorNot200906.pdf.
    \7\ U.S. Government Accountability Office, Public Health 
Information Technology: Additional Strategic Planning Needed to Guide 
HHS's Efforts to Establish Electronic Situational Awareness 
Capabilities. http://www.gao.gov/products/GAO-11-99.
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     The national strategy should also call for leveraging of 
new epidemiological data that may become available as a result of the 
development of health information technology (IT) and electronic health 
records (EHRs). There is no overarching coordination between public 
health surveillance efforts at HHS and the work of the Office of the 
National Coordinator for Health Information Technology (ONC). The ONC 
should work closely with a designated person at CDC and with State/
local/tribal/territorial partners, with PAHPA mandating this 
synchronization and collaboration. For example, as ONC develops new 
standards for meaningful use of health IT, it should incorporate the 
preparedness and biosurveillance implications of such technologies. 
Interoperability between public health and EHRs could not only help 
with early detection of an emerging disease outbreak or bioterror 
attack, but could also help with identification of targeted populations 
or geographic regions to receive medical countermeasures and tracking 
the post-dispensing impact of medical interventions.

    3. Improve Vaccine and Pharmaceutical Research, Development, and 
Manufacturing: The United States is falling behind in its research and 
development of medical countermeasures to fight public health threats. 
As the Nation revamps its approach to research and development of 
vaccines, medicines, diagnostics and equipment to respond to emerging 
public health threats, policymakers must ensure public health is 
involved throughout the process, from initial investment through 
distribution and dispensing. PAHPA can advance the Nation's MCM 
enterprise through the following activities:

     Congress should consider authorizing President's requests 
for MCM advancement: building an MCM Strategic Investor to leverage 
private capital for promising technologies; using unspent H1N1 money to 
establish Centers for Innovation in Advanced Development and 
Manufacturing; and developing end-to-end leadership to see products 
through from initial research through dispensing. However, bill 
language should request additional detail from HHS on how these 
programs would be implemented, including multiyear professional 
judgment budgets for implementation of the PHEMCE strategy.
     Report language in PAHPA should urge: (1) increased 
coordination between FDA, BARDA, NIH, and CDC from initial investment 
through dispensing; (2) improved transparency of the development 
process, including regulatory pathways by FDA and contracting process 
with BARDA and Bioshield; and (3) MCM strategy should be end-to-end--
not just focused on initial investments, but on advance development, 
procurement, distribution, and surveillance.
     Improving SNS Management: There should be a plan for 
stocking the Strategic National Stockpile (SNS) and for ongoing 
replacement of expiring product, especially vaccines,\8\ pediatric 
doses of antimicrobials, antivirals and other products, and restocking 
materiel used as a result of the H1N1 outbreak. This plan should also 
include a professional judgment budget for replacing product expiring 
over the next several years. The legislation should also call for 
increased coordination between CDC and BARDA on SNS procurement and 
management.
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    \8\ Testimony of Robert Kadlec Before House Homeland Security 
Subcommittee on Emerging Threats, Cybersecurity, and Science and 
Technology. June 15, 2010. http://hsc.house.gov/SiteDocuments/
20100615131640-79968.pdf.
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     Authorize extension of the Shelf-Life Extension Program 
(SLEP) to State stockpiles of medical materiel. Currently, only 
federally held stockpiles are eligible for the SLEP, which can be a 
cost-effective way to maintain State and local supplies.
    4. Enhance Surge Capacity: In the event of a major disease outbreak 
or attack, the public health and health care systems would be severely 
overstretched. Policymakers must address the ability of the health care 
system to quickly expand beyond normal services during a major 
emergency. Investments in research and development, stockpiling, and 
practice in drills and tabletop exercises will aid in the timely 
distribution of antivirals and other equipment during an outbreak. 
PAHPA should facilitate health care preparedness by:

     Encouraging enhancements in the Hospital Preparedness 
Program (HPP). The HPP, administered by the Assistant Secretary for 
Preparedness and Response (ASPR), aims to prepare the Nation's health 
system for the medical and logistical impacts of a disaster. Rather 
than continuing to fund individual hospitals for preparing for a 
crisis, HPP has played a role in spurring creation of regional 
healthcare coalitions, alliances between hospitals, public health, and 
emergency management.\9\ These coalitions allow for a shared burden and 
reduce surge to any single facility. However, in many regions, this is 
still a nascent process.\10\ Building and developing these coalitions 
should be an explicit goal of HPP, including expanding coalitions to 
every city and linking them into a national system.
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    \9\ Toner, Eric, et al., Center for Biosecurity of UPMC. Hospitals 
Rising to the Challenge: The First Five Years of the U.S. Hospital 
Preparedness Program and Priorities Going Forward, March, 2009. http://
www.upmc-biosecurity.org/website/resources/publications/2009/pdf/2009-
04-16-hppreport.pdf.
    \10\ Toner, Eric. Expert perspective in Ready or Not? 2009. http://
healthyamericans.org/assets/files/TFAH2010ReadyorNot%20FINAL.pdf.
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     Clarifying crisis standards of care. The Federal 
Government should provide a national framework to guide States and 
local entities in developing crisis standards for use during a mass 
casualty event. Leaving this process up to the States has not led to 
enough progress in developing a better understanding of the kind of 
care that would be available in a disaster.
     Clarifying Federal volunteer liability laws to implement 
one, blanket liability that applies to all volunteer health 
professionals and entities volunteering under a nationally declared 
public health emergency or disaster. HHS has acknowledged that a 
patchwork of Federal liability laws is confusing and frustrating to 
providers.\11\ There should also be Federal Tort Claims Act protection 
for Medical Reserve Corps volunteers year-round, as these personnel 
participate in public health drills and training during times of non-
disaster.
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    \11\ DHHS, Office of the General Counsel, ``Public Health 
Emergencies and Federal Health Law.'' Presentation at 2010 Public 
Health Preparedness Summit, February 2010. http://www.phprep.org/2010/
Agenda/upload/Interactive-145.pdf.

    Thank you for this opportunity to weigh in as the committee 
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considers reauthorization of PAHPA. I look forward to your questions.

    [Whereupon, at 4:26 a.m., the hearing was adjourned.]

                              

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