[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 
                   TAKING MEASURE OF COUNTERMEASURES
                              PARTS I & II

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

                                HEARING

                               before the

                       SUBCOMMITTEE ON EMERGENCY

                        PREPAREDNESS, RESPONSE,

                           AND COMMUNICATIONS

                                 of the

                     COMMITTEE ON HOMELAND SECURITY

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                    APRIL 13, 2011 and MAY 12, 2011

                               __________

                           Serial No. 112-18

                               __________

       Printed for the use of the Committee on Homeland Security
                                     

[GRAPHIC] [TIFF OMITTED] 


                                     

      Available via the World Wide Web: http://www.gpo.gov/fdsys/

                               __________




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                     COMMITTEE ON HOMELAND SECURITY

                   Peter T. King, New York, Chairman
Lamar Smith, Texas                   Bennie G. Thompson, Mississippi
Daniel E. Lungren, California        Loretta Sanchez, California
Mike Rogers, Alabama                 Sheila Jackson Lee, Texas
Michael T. McCaul, Texas             Henry Cuellar, Texas
Gus M. Bilirakis, Florida            Yvette D. Clarke, New York
Paul C. Broun, Georgia               Laura Richardson, California
Candice S. Miller, Michigan          Danny K. Davis, Illinois
Tim Walberg, Michigan                Brian Higgins, New York
Chip Cravaack, Minnesota             Jackie Speier, California
Joe Walsh, Illinois                  Cedric L. Richmond, Louisiana
Patrick Meehan, Pennsylvania         Hansen Clarke, Michigan
Ben Quayle, Arizona                  William R. Keating, Massachusetts
Scott Rigell, Virginia               Vacancy
Billy Long, Missouri                 Vacancy
Jeff Duncan, South Carolina
Tom Marino, Pennsylvania
Blake Farenthold, Texas
Mo Brooks, Alabama
            Michael J. Russell, Staff Director/Chief Counsel
                    Michael S. Twinchek, Chief Clerk
                I. Lanier Avant, Minority Staff Director
                                 ------                                

  SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS

                  Gus M. Bilirakis, Florida, Chairman
Joe Walsh, Illinois                  Laura Richardson, California
Scott Rigell, Virginia               Hansen Clarke, Michigan
Tom Marino, Pennsylvania, Vice       Vacancy
    Chair                            Bennie G. Thompson, Mississippi 
Blake Farenthold, Texas                  (Ex Officio)
Peter T. King, New York (Ex 
    Officio)
                   Kerry A. Kinirons, Staff Director
                   Natalie Nixon, Deputy Chief Clerk
            Curtis Brown, Minority Professional Staff Member


                            C O N T E N T S

                              ----------                              
                                                                   Page

                               STATEMENTS

                             APRIL 13, 2011

The Honorable Gus M. Bilirakis, a Representative in Congress From 
  the State of Florida, and Chairman, Subcommittee on Emergency 
  Preparedness, Response, and Communications.....................     1
The Honorable Laura Richardson, a Representative in Congress From 
  the State of California, and Ranking Member, Subcommittee on 
  Emergency Preparedness, Response, and Communications...........     2

                               WITNESSES
                                Panel I

Ms. Cynthia A. Bascetta, Managing Director, Health Care, 
  Government Accountability Office:
  Oral Statement.................................................     4
  Prepared Statement.............................................     6
Dr. Segaran P. Pillai, Chief Medical and Science Advisor, 
  Chemical and Biological Division, Science and Technology 
  Directorate, Department of Homeland Security:
  Oral Statement.................................................    14
  Prepared Statement.............................................    16
Dr. Richard J. Hatchett, Chief Medical Officer and Deputy 
  Director, Strategic Sciences and Management, Department of 
  Health and Human Services:
  Oral Statement.................................................    21
  Prepared Statement.............................................    23
Dr. Gerald W. Parker, Jr., Deputy Assistant to the Secretary of 
  Defense, Chemical and Biological Defense, Department of 
  Defense:
  Oral Statement.................................................    29
  Prepared Statement.............................................    30

                                Panel II

Ms. Phyllis Arthur, Senior Director, Vaccines, 
  Immunotherapeutics, and Diagnostics Policy, Biotechnology 
  Industry Organization:
  Oral Statement.................................................    44
  Prepared Statement.............................................    45
Mr. John M. Clerici, Principal, Tiber Creek Partners, LLC:
  Oral Statement.................................................    48
  Prepared Statement.............................................    50
Dr. Daniel B. Fagbuyi, Medical Director, Disaster Preparedness 
  and Emergency Management, Children's National Medical Center:
  Oral Statement.................................................    55
  Prepared Statement.............................................    57

                                APPENDIX

Questions From Chairman Gus M. Bilirakis for Cynthia A. Bascetta.    69
Questions From Ranking Member Laura Richardson for Richard J. 
  Hatchett.......................................................    69
Questions From Chairman Gus M. Bilirakis for Gerald W. Parker....    72

                              MAY 12, 2011

The Honorable Gus M. Bilirakis, a Representative in Congress From 
  the State of Florida, and Chairman, Subcommittee on Emergency 
  Preparedness, Response, and Communications.....................    75
The Honorable Laura Richardson, a Representative in Congress From 
  the State of California, and Ranking Member, Subcommittee on 
  Emergency Preparedness, Response, and Communications...........    76

                               WITNESSES
                                Panel I

Dr. Alexander G. Garza, MD, MPH, Assistant Secretary for Health 
  Affairs, Chief Medical Officer, Department of Homeland 
  Security:
  Oral Statement.................................................    80
  Prepared Statement.............................................    82
Dr. Ali S. Khan, MD, MPH, Director, Officer of Public Health 
  Preparedness and Response, Centers for Disease Control and 
  Prevention:
  Oral Statement.................................................    85
  Prepared Statement.............................................    87

                                Panel II

Mr. Mike McHargue, Director of Emergency Operations, Division of 
  Emergency Medical Operations, Florida Department of Health:
  Oral Statement.................................................    92
  Prepared Statement.............................................    94
Mr. David Starr, Director, Countermeasures Response Unit, 
  Emergency Preparedness and Response, New York City Department 
  of Health and Mental Hygiene:
  Oral Statement.................................................    98
  Prepared Statement.............................................   100
Mr. Lawrence E. Tan, Emergency Medical Services Division, 
  Department of Public Safety, New Castle County, Delaware:
  Oral Statement.................................................   102
  Prepared Statement.............................................   105
Mr. Jeffrey Levi, PhD, Executive Director, Trust for America's 
  Health:
  Oral Statement.................................................   107
  Prepared Statement.............................................   109

                             FOR THE RECORD

The Honorable Gus M. Bilirakis, a Representative in Congress From 
  the State of Florida, and Chairman, Subcommittee on Emergency 
  Preparedness, Response, and Communications:
  Statement of The National Association of Chain Drug Stores.....    78

                                APPENDIX

Questions From Chairman Gus M. Bilirakis for Alexander G. Garza..   119
Questions From Chairman Gus M. Bilirakis for Mike McHargue.......   121
Questions From Chairman Gus M. Bilirakis for Ali S. Khan.........   122


TAKING MEASURE OF COUNTERMEASURES (PART I): A REVIEW OF GOVERNMENT AND 
INDUSTRY EFFORTS TO PROTECT THE HOMELAND THROUGH ACCELERATED RESEARCH, 
DEVELOPMENT, AND ACQUISITION OF CHEMICAL, BIOLOGICAL, RADIOLOGICAL, AND 
                    NUCLEAR MEDICAL COUNTERMEASURES

                              ----------                              


                       Wednesday, April 13, 2011

             U.S. House of Representatives,
 Subcommittee on Emergency Preparedness, Response, 
                                and Communications,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 2:10 p.m., in 
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis 
[Chairman of the subcommittee] presiding.
    Present: Representatives Bilirakis, Marino, and Richardson.
    Mr. Bilirakis [presiding]. The Subcommittee on Emergency 
Preparedness, Response, and Communications will come to order. 
The subcommittee is meeting today to receive testimony on the 
efforts of Federal agencies to work with each other and with 
industry to research, develop, and procure vital medical 
countermeasures.
    I now recognize myself for an opening statement.
    I would like to welcome all of our witnesses here today and 
thank you for your dedication to making our Nation more secure 
from terrorist threats. The events of October 2001, when our 
Nation was attacked through the mail with anthrax letters, 
changed the face of medical preparedness. These tragic events 
instilled an urgency to prepare for bioterror threats in a way 
that we had never done before.
    The 2009 H1N1 influenza pandemic similarly caused us to 
turn inward and review the successes of our public health 
response as well as our failures. The catastrophic events in 
Japan--two natural disasters and a subsequent industrial 
disaster, an entirely unforeseen combination of events--once 
again force us to assess our preparedness capacity, this time 
for radiological and nuclear threats.
    This hearing was planned well before Japan was hit with an 
unimaginable crisis. We are here today to discuss the ways we 
can and must be proactive, not just reactive, to chemical, 
biological, radiological, and nuclear threats, both nature and 
manmade.
    The responsibility begins with the Department of Homeland 
Security. The threats must be recognized, defined, and 
prioritized.
    The DHS threat and risk assessments are central to this 
effort. These tools have become instrumental in providing an 
awareness of the threat. They are designed not to instill fear, 
but rather to provide a healthy recognition of reality and an 
effective means by which to prioritize limited resources.
    I look forward to hearing from our DHS witnesses today on 
how these assessments have grown, surpassed criticism, and are 
providing their customers with an indispensible tool.
    One of those customers is the Department of Health and 
Human Services and its Biomedical Advanced Research and 
Development Authority. BARDA is responsible for advanced 
development and procurement of CBRN medical countermeasures. We 
look forward to learning from the witnesses about BARDA 
successes that must be supported as well as continued 
challenges to forging an effective and fruitful relationship 
with the private sector.
    We know that BARDA has the authorities it needs to develop 
and acquire countermeasures. What is less clear is why it has 
not made use of those authorities.
    Of particular concern are the contracting delays. These 
delays seem to have increased in the past, since the 
contracting and procurement functions were taken out of BARDA 
and placed under the assistant secretary for preparedness and 
response.
    What is the strategic direction that BARDA is looking to 
take to allow development and procurement of the best 
countermeasures and in the most expedient, transparent, and 
industry-friendly way possible? What are the countermeasures 
that are missing from our stockpile? Do we need vaccines for 
hemorrhagic fevers or rapid diagnostics to know who has been 
exposed? How the material threat determinations are informing 
HHS investments and meeting the needs laid out by DHS is a 
central question.
    The contributions of the Department of Defense to the 
health of our Nation through medical countermeasure development 
go back decades. DOD was a pioneer in this area. I look forward 
to hearing today how DOD's program has matured and how its best 
practices and expertise are leveraged by DHS and HHS.
    DOD and HHS have a unique relationship--that of a shared 
stockpile. The shared anthrax stockpile, for example, allows 
fewer vaccines to expire and therefore better resource 
efficiencies.
    Of course, we would also like to see a next-generation 
anthrax vaccine developed, and I am aware of considerable 
delays on the part of BARDA to procure that, pushing this until 
at least 2018, from what I understand. I look forward to 
hearing from DOD and HHS on how we can meet these and other 
pressing countermeasure needs.
    So once again, I thank our witnesses for being here and for 
working to protect our health, protect our homeland, and foster 
more jobs and a healthier economy in the process.
    I now recognize the Ranking Minority Member, Ms. 
Richardson, from California, for any statement she may have.
    Ms. Richardson. That timing wasn't planned.
    [Laughter.]
    Ms. Richardson. Good afternoon to all of you. Actually, I 
am going to hold most of my comments since I just walked in, 
but it would suffice to say that I am glad we have the 
witnesses before us. I am very concerned in light of some of 
the things that have occurred.
    I concur with Mr. Bilirakis in terms of my concern with the 
timing of the anthrax. I think that all the delegates probably 
have some questions about that.
    Then I would also like to talk about this potassium iodide. 
I have some concerns in those areas, so I will hold the rest of 
my comments and submit my full statement into the record. Thank 
you.
    Mr. Bilirakis. Thank you. Appreciate it.
    Other Members of the subcommittee are reminded that opening 
statements may be submitted for the record. Before I introduce 
our first panel I would ask unanimous consent to insert in the 
record a statement from Mr. Morris, of Anbex, Inc. If there are 
no objections, so ordered.
    I am pleased to welcome our witnesses. I will note, 
however, that I am disappointed that Dr. O'Toole, Dr. Lurie, 
and Mr. Weber declined to attend today's hearing. I certainly 
hope their failure to attend does not indicate a lack of 
attention or commitment to this very important issue.
    That being said, I look forward to hearing from our 
witnesses. Our first witness is Ms. Cynthia Bascetta. Ms. 
Bascetta is the managing director of the Government 
Accountability's Office, GAO, health care team. She has led the 
programs designed to protect and enhance public health.
    She is currently leading GAO's public health work with its 
focus on quality of care and disaster preparedness and 
response. Ms. Bascetta joined GAO in 1983 after conducting 
regulatory impact analysis of major occupational health rules 
at the U.S. Department of Labor.
    In 2008 Ms. Bascetta was a finalist for the Service to 
America Medical for career achievement. She has a Bachelor's 
Degree in government from Smith College, a Master's in applied 
economics from the University of Michigan, a Master's in public 
health from the University of Michigan.
    Our next witness is Dr. Segaran Pillai. Dr. Pillai serves 
as the chief medical and scientific officer in the division of 
chem bio and Department of Homeland Security's science and 
technology directorate. In this role he serves as an advisor 
for all DHS S&T initiatives to deter, detect, or mitigate a 
biological attack on the Nation.
    Prior to joining S&T, Dr. Pillai served as director of the 
Florida Department of Health State Public Health Laboratory in 
Miami and as the clinical services director for the Miami-Dade 
County Health Department. Dr. Pillai is board certified by the 
American Academy of Microbiology and the American Society for 
Clinical Pathology.
    He received a Bachelor's Degree with honors in microbiology 
and a Master's of Science Degree with honors in medical 
physiology from the Pittsburgh State University. He also 
received his Ph.D. in molecular genetics and biochemistry from 
the University of Kansas.
    Following Dr. Pillai, we will hear from Dr. Richard 
Hatchett. Dr. Hatchett is chief medical officer and deputy 
director for strategic sciences and management at the 
Biomedical Advanced Research and Development Authority, of 
course, BARDA, within the Department of Health and Human 
Services office of the assistant secretary for preparedness and 
response.
    Prior to joining BARDA, Dr. Hatchett served as director for 
medical preparedness policy on the White House National 
security staff, where he worked on issues related to the 
development of medical countermeasures. Dr. Hatchett received 
his undergraduate and medical degrees from Vanderbilt 
University.
    Finally, we will hear testimony from Dr. Gerald Parker. Dr. 
Parker serves as the deputy assistant to the Secretary of 
defense for chemical and biological defense. In this role Dr. 
Parker is responsible for chemical and biological defense 
program oversight throughout the Department of Defense and 
integration with interagencies and international partners.
    Prior to joining DOD, Dr. Parker served as the principal 
deputy assistant secretary in the office of the assistant 
secretary for preparedness and response at the Department of 
Health and Human Services. Dr. Parker also served in the United 
States Army for 26 years.
    Dr. Parker graduated from Texas A&M University with a 
Bachelor's of Science in veterinary medicine and with a degree 
of Doctor of Veterinarian Medicine. He holds a Doctorate in 
psychology from Baylor College of Medicine in Houston, Texas, 
and a Master's of Science in resourcing the National strategy 
from the Industrial College of the Armed Forces.
    I want to welcome all our witnesses. Your entire written 
statements will appear in the record. I ask that you each 
summarize your testimony for 5 minutes, and we will begin with 
Ms. Bascetta.
    Welcome.

  STATEMENT OF CYNTHIA A. BASCETTA, MANAGING DIRECTOR, HEALTH 
             CARE, GOVERNMENT ACCOUNTABILITY OFFICE

    Ms. Bascetta. Thank you very much.
    Mr. Bilirakis. Thank you. Is the microphone on?
    Ms. Bascetta. Now it is.
    Mr. Chairman, Ranking Member Richardson, and Representative 
Marino, I am pleased to be here to discuss the acquisition and 
development of medical countermeasures to protect the public 
health in the event of exposure to chemical, radiological, 
biological, and nuclear threats, whether intentional or 
accidental. The 2001 anthrax attacks and the on-going nuclear 
disaster in Japan are just two reminders of the need for CBRN 
countermeasures to mitigate the potentially devastating effects 
of exposure. Members of Congress, Federal commissions, and 
other experts have all noted the need for acquiring available 
countermeasures as well as developing new ones.
    Today my remarks will focus on HHS, which leads Federal 
efforts to determine countermeasure priorities as well as to 
develop and acquire them. HHS coordinates these efforts through 
the interagency public health emergency medical countermeasures 
enterprise, known as PHEMCE, which is responsible for all 
hazards, from bioterrorism to naturally occurring epidemics.
    PHEMCE was established in 2006 and it includes several HHS 
components as well as DHS, DOD, VA, Department of Agriculture, 
and the Executive Office of the President. Through PHEMCE, DOD 
and HHS also coordinate an integrated portfolio to identify 
common civilian and military medical countermeasure priorities.
    HHS's acquisition strategy is based on a four-step process, 
as shown on the dark blue side of our graphic, shown overhead. 
With input from HHS in Step No. 1, DHS identifies and assesses 
CBRN agents to determine which ones pose a material threat to 
National security, as required by the Project BioShield Act.
    DHS develops material threat assessments using plausible, 
high-consequence scenarios to provide estimates of the number 
of people likely to be exposed to an agent. Since 2004 DHS has 
determined that 13 CBRN agents pose a material threat.
    In Step No. 2, PHEMCE assesses medical and public health 
consequences of attacks with CBRN agents. HHS and its PHEMCE 
partners use the DHS material threat assessment scenarios along 
with other scientific data and expert consultation to model the 
public health and medical consequences of a CBRN event. This 
modeling estimates the number of individuals who may become 
ill, be hospitalized, or die after exposure to CBRN agents with 
or without medical intervention.
    In Step No. 3, PHEMCE establishes medical countermeasure 
requirements. PHEMCE uses the consequence modeling results to 
determine how much of a countermeasure is needed, how it would 
be administered, and how it would need to be stored. Preferred 
characteristics, such as oral administration instead of 
injection and room temperature storage instead of 
refrigeration, are an important part of this step.
    In Step No. 4, PHEMCE prioritizes development and 
acquisition of medical countermeasures needed for the Strategic 
National Stockpile. Its acquisition priorities include 
diagnostic devices in drugs or vaccines to mitigate the health 
effects of exposure to all of the agents that DHS deemed to be 
material threats.
    PHEMCE acquires any countermeasures that are immediately 
available and it also supports research and development for the 
many countermeasures that are not immediately available. This 
occurs in four additional stages led by NIH and BARDA, as shown 
in the light blue areas of our graphic.
    First, basic research is geared to better understand the 
health effects of CBRN agents. Next, applied research validates 
and tests concepts to identify the potential countermeasures 
and scientific or practical limitations of any products 
produced.
    Early development demonstrates basic safety, 
reproducibility, and ability to use the countermeasures in 
humans. Advanced development further evaluates the safety and 
effectiveness of countermeasures. In addition, in this stage 
HHS determines whether manufacturing, scale-up production, and 
licensing can be achieved in a timely and reliable manner.
    I would like to take just another minute to highlight 
several development challenges that serve to temper what we can 
expect from this process no matter how well it is implemented. 
One challenge is that the failure rate in research and 
development of CBRN medical countermeasures can be high; HHS 
estimates it may exceed 80 percent for products in early 
development.
    Another is the difficulty of attracting large 
pharmaceutical companies who have the experience needed to meet 
complex requirements but little incentive to participate. Other 
challenges can be addressed through process or management 
improvements, such as regulatory challenges with the Animal 
Rule, regulatory challenges in determining appropriate 
countermeasure doses for children, and logistical challenges 
that HHS faces in managing the Strategic National Stockpile.
    That concludes my remarks and I would be happy to answer 
your questions or those of the other committee Members.
    [The statement of Ms. Bascetta follows:]
               Prepared Statement of Cynthia A. Bascetta
                             April 13, 2011
                             gao highlights
    Highlights of GAO-11-567T, a testimony before the Subcommittee on 
Emergency Preparedness, Response, and Communications, Committee on 
Homeland Security, House of Representatives.
Why GAO Did This Study
    The anthrax attacks of 2001 and a radiation leak after the recent 
natural disaster in Japan highlighted concerns that the United States 
is vulnerable to threats from chemical, biological, radiological, and 
nuclear (CBRN) agents, which can cause widespread illness and death. 
Medical countermeasures--such as drugs, vaccines, and diagnostic 
devices--can prevent or treat the health effects of exposure, but few 
are currently available for many of these CBRN agents.
    GAO was asked to testify on the Department of Health and Human 
Services' (HHS) CBRN medical countermeasure development and acquisition 
activities. This statement focuses on: (1) How HHS determines needed 
CBRN medical countermeasures and priorities for development and 
acquisition and (2) selected challenges to medical countermeasure 
development and acquisition. This statement of preliminary findings is 
based on on-going work. To do this work, GAO examined relevant laws and 
Presidential directives, analyzed Federal agency documents and reports 
from advisory boards and expert groups, and interviewed officials from 
HHS and the Department of Homeland Security (DHS) about the processes 
for developing and acquiring CBRN medical countermeasures and the 
challenges related to those efforts. GAO shared the information in this 
statement with HHS. HHS provided technical comments, which GAO 
incorporated as appropriate.
     public health preparedness.--developing and acquiring medical 
countermeasures against chemical, biological, radiological, and nuclear 
                                 agents
What GAO Found
    HHS coordinates and leads Federal efforts to determine CBRN medical 
countermeasure priorities and develop and acquire CBRN medical 
countermeasures, primarily through an interagency body that includes 
other Federal agencies with related responsibilities, such as DHS and 
the Department of Defense. HHS's medical countermeasure acquisition 
strategy is based on a four-step process: (1) Identify and assess the 
threat of CBRN agents, (2) assess medical and public health 
consequences of attacks with these agents, (3) establish medical 
countermeasure requirements, and (4) identify and prioritize near-, 
mid-, and long-term development and acquisition. Through these 
processes, HHS determines which countermeasures to buy for specific 
CBRN agents, including the desired characteristics of these 
countermeasures--such as how many doses a vaccine requires to confer 
immunity--the needed quantity of certain medical countermeasures, and 
the acquisition priorities. While a few CBRN countermeasures can be 
immediately acquired, most have not yet been developed. Therefore, HHS 
and the interagency body support and oversee several stages of research 
and development to try to obtain usable countermeasures. These include 
basic cellular and biological research to understand the effects of 
these agents on humans; applied research to validate approaches, such 
as testing the effectiveness of treatment in animals; early development 
to assess the safety of potential countermeasures; and advanced 
development, in which the products are more fully evaluated for safety 
and effectiveness, including their formulation and manufacturing 
processes.
    The Federal Government faces a variety of challenges in developing 
and acquiring medical countermeasures, such as the high failure rate in 
research and development and difficulties meeting regulatory 
requirements. For example, the failure rate for development and 
licensure of most drugs, vaccines, and diagnostic devices can be more 
than 80 percent, depending on the stage of scientific research and 
development. Given this risk, as well as a lack of a commercial market 
for most medical countermeasures, attracting large, experienced 
pharmaceutical firms to research and develop them is challenging. 
Smaller biotechnology companies are more likely to be developing 
medical countermeasures, but HHS must provide more guidance to these 
less experienced small companies than might be typical with larger 
companies. In addition, several challenges exist related to regulatory 
processes for evaluating promising medical countermeasures. These 
challenges include: (1) Proving a countermeasure's effectiveness using 
animals as proxies for humans, because humans cannot ethically be used 
in studies involving CBRN agents; (2) determining appropriate doses of 
countermeasures for children, who may be more vulnerable to exposure to 
CBRN agents; and (3) evaluating the safety and effectiveness of medical 
countermeasures for use in a public health emergency if they have not 
yet been approved or licensed. Finally, HHS faces the logistical 
challenge of on-going replenishment of expiring medical countermeasures 
in the U.S. Strategic National Stockpile, the National repository of 
medications, medical supplies, and equipment for public health 
emergencies.
    Chairman Bilirakis, Ranking Member Richardson, and Members of the 
subcommittee: I am pleased to be here today to discuss the Department 
of Health and Human Services' (HHS) chemical, biological, radiological, 
and nuclear (CBRN) medical countermeasure development and acquisition 
activities and associated challenges.\1\ The anthrax attacks of 2001 
raised concerns that the United States is vulnerable to intentional 
threats from CBRN agents. In addition, the recent earthquake and 
resulting tsunami in Japan that caused a nuclear reactor to rupture 
highlighted a population's vulnerability to unintentional CBRN 
exposure, such as to radiation. CBRN agents have the potential to cause 
widespread illness and death, which can be partially mitigated through 
the use of medical countermeasures. Medical countermeasures for CBRN 
agents include drugs, vaccines, and devices to diagnose, treat, 
prevent, or mitigate potential effects of exposure. Members of 
Congress, Federal commissions, and other experts have noted the need 
for the United States to acquire available medical countermeasures and 
develop new ones to protect the public from attacks with CBRN agents. 
While rapid diagnosis, treatment, and prevention may minimize the 
public health impact of a release of these agents, there are currently 
few countermeasures available for many CBRN agents, and research and 
development to create usable countermeasures is a lengthy and complex 
process.
---------------------------------------------------------------------------
    \1\ See appendix I for a list of abbreviations used in this 
statement.
---------------------------------------------------------------------------
    You asked us to provide information about HHS's CBRN medical 
countermeasure development and acquisition activities. My statement 
today addresses: (1) How HHS determines needed CBRN medical 
countermeasures and priorities for development and acquisition, and (2) 
selected challenges to Federal CBRN medical countermeasure development 
and acquisition.
    To develop preliminary findings based on our on-going work on HHS's 
CBRN medical countermeasure development and acquisition activities and 
selected challenges of these activities, we reviewed relevant laws and 
agency documents and interviewed Federal officials. Specifically, to 
understand how HHS determines needed CBRN medical countermeasures and 
priorities for developing and acquiring them, we examined relevant laws 
and reviewed Presidential directives that guide HHS's CBRN medical 
countermeasure development and acquisition activities. We obtained and 
analyzed HHS planning documents for medical countermeasure development 
and acquisition, such as public health and medical consequence modeling 
reports and strategy and implementation plans for medical 
countermeasure development and acquisition priorities. We interviewed 
officials from the Department of Homeland Security (DHS) about their 
activities related to CBRN agents and medical countermeasures. We also 
interviewed officials from HHS offices and agencies, including the 
Biomedical Advanced Research and Development Authority (BARDA) within 
the Office of the Assistant Secretary for Preparedness and Response 
(ASPR), the Centers for Disease Control and Prevention (CDC), the Food 
and Drug Administration (FDA), and the National Institutes of Health 
(NIH), to obtain information on their activities related to medical 
countermeasure development and acquisition. These officials participate 
in the Public Health Emergency Medical Countermeasures Enterprise 
(PHEMCE), HHS's interagency decision-making body responsible for 
providing recommendations to the Secretary of HHS regarding CBRN 
medical countermeasure development and acquisition. To identify 
selected challenges that the Federal Government faces in developing and 
acquiring CBRN medical countermeasures, we reviewed reports from 
Federal agencies, advisory boards, and nongovernmental organizations 
and interviewed Federal officials from the agencies identified above 
and other experts. We included selected challenges that were discussed 
in multiple reports published by Federal agencies or other expert 
groups, such as the Institute of Medicine, or those mentioned to us by 
officials from multiple Federal agencies or organizations. We did not 
include any challenges that related to interagency coordination and 
agency investments in medical countermeasure development and 
acquisition because we are currently examining these issues for on-
going audit work. In addition, because it was not the focus of this 
hearing, we excluded HHS processes for and challenges in distributing 
CBRN medical countermeasures from the scope of this statement. We 
shared the information in this statement with HHS. HHS provided 
technical comments, which we incorporated as appropriate.
    We are conducting this performance audit in accordance with 
generally accepted Government auditing standards. This statement is 
based on work conducted from March 2011 to April 2011. The performance 
audit standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives.
                               background
    Several Federal departments and agencies have responsibilities for 
assessing the threat of CBRN agents and determining requirements and 
priorities for developing and acquiring medical countermeasures for 
these agents, as part of their mission and, in some cases, as 
specifically required by law.
    DHS leads Federal interagency coordination and planning for 
emergency response to catastrophic CBRN incidents. Under the Project 
BioShield Act of 2004, DHS is required, in consultation with HHS, to 
assess the threat of CBRN agents.\2\
---------------------------------------------------------------------------
    \2\ 42 U.S.C.  247d-6b(c)(2)(A).
---------------------------------------------------------------------------
    HHS leads the Federal medical and public health response to 
potential CBRN incidents.
   HHS established PHEMCE in 2006. PHEMCE is a Federal 
        interagency decision-making body responsible for providing 
        recommendations to the Secretary of HHS on: (1) Prioritized 
        requirements for CBRN medical countermeasures, (2) coordination 
        of medical countermeasure development and acquisition 
        activities to address the requirements, and (3) strategies for 
        distributing medical countermeasures held in the U.S. Strategic 
        National Stockpile (SNS), the National repository of 
        medications, medical supplies, and equipment for use in a 
        public health emergency. As required by the Pandemic and All-
        Hazards Preparedness Act of 2006, PHEMCE also conducts annual 
        reviews of the SNS, the results of which are used to make 
        necessary additions or modifications to its contents.\3\ PHEMCE 
        is composed primarily of officials from HHS's ASPR, BARDA, CDC, 
        FDA, and NIH, which also have specific agency responsibilities 
        for countermeasure development and acquisition. In addition, 
        PHEMCE includes officials from DHS, the Department of Defense 
        (DOD), the Department of Veterans Affairs, the Department of 
        Agriculture, and the Executive Office of the President.
---------------------------------------------------------------------------
    \3\ 42 U.S.C.  247d-6b(a)(1).
---------------------------------------------------------------------------
   Within HHS, ASPR is responsible for leading Federal 
        Government efforts to research, develop, evaluate, and acquire 
        public health emergency medical countermeasures to prevent, 
        treat, or mitigate the potential health effects from exposure 
        to CBRN agents. Under the Project BioShield Act, HHS is 
        responsible for arranging for the acquisition of certain 
        medical countermeasures, some of which may not yet be FDA-
        approved or licensed.\4\ These countermeasures also include 
        those for children and other vulnerable populations, such as 
        those for the elderly and immunocompromised individuals. The 
        Project BioShield Act authorized the Special Reserve Fund for 
        acquisition of these countermeasures.\5\
---------------------------------------------------------------------------
    \4\ 42 U.S.C.  247b(c)(7)(C)(i).
    \5\ 42 U.S.C.  247d-6b(c)(1)(A). The Department of Homeland 
Security Appropriations Act of 2004 appropriated over $5.5 billion to 
the Special Reserve Fund to be available for obligation from fiscal 
year 2004 through fiscal year 2013. Pub. L. No. 108-90, 117 Stat. 1137, 
1148 (2003). The Project BioShield Act also authorizes the Federal 
Government to use specific contracting authorities to procure certain 
medical countermeasures for these agents and requires HHS to report on 
these contracting authorities and procurements using the Special 
Reserve Fund, among other information. 42 U.S.C.  247d-6b, 247d-6c.
---------------------------------------------------------------------------
   Within ASPR, BARDA--established by the Pandemic and All-
        Hazards Preparedness Act of 2006--is responsible for overseeing 
        and funding advanced development and acquisition of CBRN 
        medical countermeasures.\6\
---------------------------------------------------------------------------
    \6\ 42 U.S.C.  247d-7e. The act also gave BARDA the authority to 
make advance and milestone-based payments to vendors prior to product 
delivery to the SNS. 42 U.S.C.  247d-7e(c)(5)(C), (D).
---------------------------------------------------------------------------
   CDC is responsible for maintaining the SNS. CDC also 
        supports State and local public health departments in their 
        efforts to detect and respond to public health emergencies such 
        as CBRN incidents, including providing guidance and 
        recommendations for the mass distribution and use of medical 
        countermeasures.
   FDA is responsible for assessing the safety and 
        effectiveness of CBRN medical countermeasures and regulates 
        their development, approval and licensure, and postmarket 
        surveillance.\7\ FDA also provides technical support for the 
        development of tools to support medical countermeasure 
        development. Under the Project BioShield Act, as delegated by 
        the HHS Secretary, FDA may temporarily authorize the emergency 
        use of unapproved or unlicensed medical products in certain 
        circumstances through emergency use authorizations (EUA).\8\
---------------------------------------------------------------------------
    \7\ In FDA regulations, drugs are ``approved,'' vaccines and other 
biologics are ``licensed,'' and devices may either be ``approved'' or 
``cleared.'' For this statement, we use the term ``approve'' to refer 
to both approval and clearance.
    \8\ 21 U.S.C.  360bbb-3. FDA can issue EUAs only after the HHS 
Secretary declares a public health emergency and under certain 
circumstances. For example, FDA can issue EUAs in declared emergencies 
only if the agent specified in the emergency declaration can cause a 
serious or life-threatening disease or condition; the known and 
potential benefits outweigh the known and potential risks of the 
countermeasure to diagnose, prevent, or treat the condition; and there 
is no adequate, approved, and available alternative to the product, 
among other requirements. FDA has issued 19 EUAs since 2004. In 2005, 
FDA issued an EUA for an anthrax vaccine to allow vaccination of DOD 
personnel. FDA has also issued several EUAs for medical countermeasures 
to diagnose and treat pandemic strains of influenza. The only currently 
active EUA is for anthrax antibiotics in home kits for postal workers 
to be used in the event of an anthrax attack.
---------------------------------------------------------------------------
   The National Institutes of Health (NIH) is responsible for 
        conducting and coordinating basic and applied research to 
        develop new or enhanced medical countermeasures and related 
        medical tools for CBRN agents.
   The National Biodefense Science Board (NBSB), established by 
        the Pandemic and All-Hazards Preparedness Act, provides the HHS 
        Secretary with expert advice and guidance on scientific and 
        technical matters related to current and future CBRN agents, 
        including those that occur naturally.\9\
---------------------------------------------------------------------------
    \9\ 42 U.S.C.  247d-7f.
---------------------------------------------------------------------------
    DOD has exclusive responsibility for research, development, 
acquisition, and deployment of medical countermeasures to prevent or 
mitigate the health effects of CBRN agents and naturally occurring 
diseases on Armed Forces personnel. Under the PHEMCE structure, DOD 
also coordinates with HHS on the Integrated Portfolio to identify 
common medical countermeasure priorities.\10\
---------------------------------------------------------------------------
    \10\ The Integrated Portfolio is intended to reduce duplication of 
effort and provide a mechanism for HHS and DOD to share information and 
resources for common CBRN medical countermeasure priorities.
---------------------------------------------------------------------------
hhs, through phemce, uses a four-step process to determine acquisition 
 priorities for medical countermeasures and oversees their development
    HHS coordinates and leads Federal efforts to determine CBRN medical 
countermeasure priorities and develop and acquire CBRN medical 
countermeasures, primarily through PHEMCE. HHS's medical countermeasure 
acquisition strategy is based on a four-step process: (1) Identify and 
assess the threat of CBRN agents, (2) assess medical and public health 
consequences of attacks with these agents, (3) establish medical 
countermeasure requirements, and (4) identify and prioritize 
near-, mid-, and long-term development and acquisition programs.\11\ 
Because desired CBRN medical countermeasures may not be immediately 
available for acquisition, HHS oversees and supports the various stages 
of research and development of these countermeasures, also under 
PHEMCE. (See figure 1.)
---------------------------------------------------------------------------
    \11\ PHEMCE's near-term development and acquisition period is 
fiscal years 2007 and 2008; the mid-term period is fiscal year 2009 
through fiscal year 2013, and the long-term period is beyond fiscal 
year 2013. PHEMCE established these development and acquisition periods 
to correspond with appropriations for the Special Reserve Fund. The 
Department of Homeland Security Appropriations Act appropriated over 
$5.5 billion for the Special Reserve Fund to be available for 
obligation through fiscal year 2013 but provided that no more than $3.4 
billion may be obligated through fiscal year 2008.


    With input from HHS, DHS leads the first step in the process to 
assess, on an on-going basis, the threat of CBRN agents and determine 
which of these agents pose a material threat to National security, as 
required by the Project BioShield Act.\12\ The material threat 
assessments (MTA) that DHS issues examine the threat posed by given 
CBRN agents or classes of agents for plausible, high-consequence 
scenarios and provide estimates of the number of people exposed to 
different dose levels of an agent in the scenarios. Since 2004, DHS has 
determined that 13 of these CBRN agents pose a material threat, based 
on the MTAs.\13\
---------------------------------------------------------------------------
    \12\ Pub. L. No. 108-276,  3(a), 118 Stat. 835, 842 (2004) 
(codified as amended at 42 U.S.C.  247d-6b(c)(2)(A)(B)).
    \13\ The 13 agents that DHS determined pose a material threat to 
National security and public health are Bacillus anthracis (anthrax), 
Burkholderia mallei (glanders), Burkholderia pseudomallei 
(melioidosis), Clostridium botulinum (botulism toxin), Ebola virus 
(hemorrhagic fever), Francisella tularensis (tularemia), Junin virus 
(hemorrhagic fever), Marburg virus (hemorrhagic fever), multidrug-
resistant Bacillus anthracis (MDR anthrax), Rickettsia prowazekii 
(typhus), Variola major (smallpox), Yersinia pestis (plague), and 
radiological and nuclear materials.
---------------------------------------------------------------------------
    In the second step, HHS and its PHEMCE partners use the data from 
the MTA scenarios to assess the public health and medical consequences 
of an attack using these agents.\14\ Public health consequence modeling 
estimates the number of individuals who may become ill, be 
hospitalized, or die from exposure to and infection with CBRN agents, 
with or without medical intervention. To develop these estimates from 
the MTA exposure data, HHS consults with experts and uses available 
scientific data, such as data on how much of an agent is needed to 
cause infection and how long it takes to develop symptoms of disease 
after exposure. In addition, HHS assesses the status of current 
countermeasure development and availability, including applicable 
countermeasures that DOD may be developing. Through consequence 
modeling, HHS determines the public health impact on the affected 
population in terms of the potential health effects throughout the 
course of disease based on different time frames for medical 
countermeasure delivery and treatment. According to HHS officials, 
consequence modeling allows PHEMCE to consider public health 
preparedness needs, such as whether a particular countermeasure is 
plausible or feasible for a certain CBRN agent and the amount that 
would be needed.
---------------------------------------------------------------------------
    \14\ To date, DHS has not issued determinations that any of the 
assessed chemical agents pose a material threat to the United States. 
Nevertheless, HHS has assessed the public health consequences of 
chemical agents for which DHS has developed MTAs.
---------------------------------------------------------------------------
    In the third step, PHEMCE uses the consequence modeling results to 
determine requirements for needed medical countermeasures, including 
the needed quantity and the desired characteristics, such as how they 
would be used and stored. HHS officials told us that these requirements 
would include the preferred method of administration, such as oral 
administration of a medicine that can be stored at room temperature. 
PHEMCE partners consult with experts and incorporate intelligence 
information and information on State and local response capabilities to 
determine ideal countermeasure characteristics. If countermeasures that 
meet these characteristics are not immediately available, HHS may 
acquire countermeasures that are currently available and work with 
manufacturers over time to develop countermeasures that better meet the 
ideal characteristics.\15\
---------------------------------------------------------------------------
    \15\ For example, HHS officials said that they would like to 
acquire an anthrax vaccine that confers immunity in a single dose, but 
because no such vaccine was available when HHS set the requirements, 
the Department initially acquired a vaccine that could provide immunity 
in six doses. Through further research, HHS was able to determine that 
this vaccine could be administered in fewer doses.
---------------------------------------------------------------------------
    In the fourth step, the established medical countermeasure 
requirements help HHS assess and prioritize its countermeasure 
investments, and, according to HHS officials, form the basis for 
development and acquisition solicitations and contracts. Based on the 
requirements, in 2007, PHEMCE set its medical countermeasure 
acquisition priorities to focus on spending the remainder of the 
Project BioShield Special Reserve Fund for certain CBRN agents that DHS 
determined posed a material threat to National security. In addition, 
PHEMCE priorities focus on obtaining medical countermeasures for 
postexposure prevention or treatment of disease caused by those CBRN 
agents. HHS grouped these priorities in time frames for the near term 
(fiscal year 2007 through fiscal year 2008), midterm (fiscal year 2009 
through fiscal year 2013), and long term (beyond fiscal year 2013). 
PHEMCE's stated priorities include acquiring diagnostics for each 
biological agent deemed a material threat, smallpox vaccine, medical 
countermeasures for Ebola and Marburg viruses, and medications to treat 
the acute and delayed effects of radiation. PHEMCE also uses the 
results of its annual SNS review to reassess prioritization of CBRN 
medical countermeasures, based on any SNS acquisitions made after the 
initial 2007 prioritizations.
    BARDA oversees the acquisition and delivery of medical 
countermeasures into the SNS. If a medical countermeasure is not FDA-
approved or licensed, its acquisition is funded by BARDA using the 
Project BioShield Special Reserve Fund. If a medical countermeasure is 
FDA-approved or licensed for use in treating the health effects of a 
CBRN agent, CDC purchases the countermeasure for the SNS. HHS officials 
told us that once FDA approves or licenses a countermeasure acquired 
with the Special Reserve Fund, BARDA is still responsible for 
overseeing its acquisition through the end of the Project BioShield 
contract. BARDA is also responsible for negotiating with the 
manufacturer to obtain additional quantities of the countermeasure in 
the event of a CBRN attack. CDC officials told us that they develop a 
5-year project plan for each countermeasure in the SNS upon acquisition 
to evaluate specific needs over time--such as shelf life, replacement 
costs of expiring products, and storage and space requirements--and 
update the plan every year, or more frequently if conditions change.
    HHS officials told us that of the few available medical 
countermeasures for CBRN agents, some are FDA-approved or licensed 
specifically for CBRN use. Other countermeasures that HHS has acquired 
for CBRN use have been approved or licensed for other uses only. For 
example, there are no currently available rapid diagnostic tools for 
any of the biological agents that DHS deemed material threats other 
than anthrax, nor are there any available medical countermeasures for 
postexposure prevention of disease for Ebola and Marburg viruses.
    NIH and BARDA oversee and support CBRN medical countermeasure 
research and development, which is conducted in several stages.\16\ 
(See figure 1.)
---------------------------------------------------------------------------
    \16\ FDA works with researchers throughout the development stages, 
to review safety and effectiveness test results, ensure that research 
meets FDA's regulatory requirements, and approve successful products 
for licensure.
---------------------------------------------------------------------------
   Early research.--Early, or basic, research seeks to better 
        understand CBRN agents and the response of the host organism to 
        the agents through the study of the cellular and molecular 
        biology of agents and hosts, their physiologic processes, and 
        their genome sequences and structures. According to NIH 
        officials, individual researchers typically initiate research 
        in this stage. NIH assesses these research projects and their 
        application for specific CBRN agents.
   Applied research.--Applied, or translational, research 
        builds on basic research by validating and testing concepts in 
        practical settings to identify potential products. NIH 
        officials told us that the agency funds applied research to 
        identify scientific or practical limitations that may affect 
        the potential of a scientific concept to develop into a medical 
        countermeasure product.
   Early development.--NIH moves successful concepts from the 
        applied research stage into the early development stage, in 
        which it funds research to demonstrate basic safety, 
        reproducibility, and ability to be used in humans. In its 
        requests for research proposals for early development, NIH 
        officials told us that the agency specifies its needs by 
        product modes and categories, such as therapeutics, 
        diagnostics, and vaccines; NIH can further specify the 
        characteristics of a medical countermeasure, and companies 
        agree to the terms of the contract up front.
   Advanced development.--BARDA oversees and funds CBRN 
        advanced research and development. In this stage, potential 
        medical countermeasures are further evaluated in animal studies 
        to demonstrate safety and effectiveness for preventing, 
        diagnosing, or treating disease in humans. Successful products 
        are then available for development and acquisition. In 
        addition, in this stage, BARDA determines that manufacturing, 
        scale-up production, and licensing of countermeasures can be 
        achieved in a timely and reliable manner. BARDA also awards 
        contracts using the Project BioShield Special Reserve Fund to 
        acquire medical countermeasures for the SNS that are reasonably 
        expected to qualify for FDA approval or licensure within 8 
        years.
 challenges to development and acquisition of medical countermeasures 
    include high failure rates in research and difficulties meeting 
                        regulatory requirements
    The Federal Government faces a variety of challenges in developing 
and acquiring medical countermeasures, such as the high failure rate in 
research and development and difficulties meeting regulatory 
requirements. One scientific challenge is that, as with other medical 
products, the failure rate for development of certain CBRN medical 
countermeasures can be high, depending on the stage of scientific 
research and development. HHS estimates that the failure rate for 
development and licensure of most drugs, vaccines, and diagnostic 
devices in the early development stage can be more than 80 percent, 
with an increasing probability of success as the product moves further 
through development. Because most CBRN research does not result in 
viable medical countermeasures, HHS officials told us that they try to 
fund a larger set of candidates in earlier stages of research in order 
to increase the likelihood that at least one candidate countermeasure 
may be successful. HHS officials noted that they would ideally prefer 
to have at least two successfully developed medical countermeasures 
from different manufacturers available for a particular CBRN agent for 
several reasons, such as if certain segments of the population are 
resistant to one of the countermeasures or if one of the companies 
experiences manufacturing problems.
    Given the high risk of failure in research, as well as a lack of a 
commercial market for most CBRN countermeasures, attracting companies 
experienced in meeting the complex requirements necessary to develop a 
new product is also challenging. The private sector--especially large 
pharmaceutical companies--has little incentive to invest millions of 
dollars to develop a potential new medical countermeasure because the 
lack of a commercial market makes a return on investment less likely or 
less lucrative. The Project BioShield Act facilitates the creation of a 
Government market by authorizing the Government to commit to make the 
Special Reserve Fund available to acquire certain medical 
countermeasures, including those that are not yet licensed or approved, 
provided they meet certain conditions.\17\ In addition, the Pandemic 
and All-Hazards Preparedness Act established BARDA to support advanced 
research and development by, for example, awarding contracts and grants 
for countermeasure advanced research and development.\18\ BARDA 
provides funding for advanced research and development for those 
countermeasures that are not eligible for the Special Reserve Fund. 
Nevertheless, despite the Special Reserve Fund and BARDA support, HHS 
and others have noted that engaging large pharmaceutical companies 
remains a challenge. In addition, smaller biotechnology companies 
conducting much of the research and development for medical 
countermeasures generally have less experience with drug development. 
As a result, FDA officials told us that they have to provide more 
regulatory and scientific guidance to these companies than they might 
provide to larger pharmaceutical companies, which generally have more 
experience with bringing products through the regulatory process.
---------------------------------------------------------------------------
    \17\ 42 U.S.C.  247d-6b(c)(4)(A).
    \18\ 42 U.S.C.  247d-7e(c)(4)(B).
---------------------------------------------------------------------------
    There are also several challenges related to the regulatory 
processes for evaluating the development of promising medical 
countermeasures. For example, researchers face challenges proving the 
effectiveness of potential countermeasures because they cannot 
ethically or feasibly test the effectiveness of countermeasures on 
humans due to the dangers posed by CBRN agents. However, because FDA 
requires evidence of a countermeasure's effectiveness for approval or 
licensure, researchers can submit evidence of effectiveness obtained 
from appropriate studies in animals in accordance with FDA's Animal 
Rule. The Animal Rule states that in selected circumstances, when it is 
neither ethical nor feasible to conduct human efficacy studies, FDA may 
grant marketing approval based on adequate and well-controlled animal 
studies when the results of those studies establish that the drug or 
biological product is reasonably likely to produce clinical benefit in 
humans.\19\ Under this rule, researchers can demonstrate effectiveness 
of medical countermeasures if the way a disease occurs in the animal 
being studied adequately mimics the way the disease occurs in humans. 
However, animals that manifest the disease in the same way as humans 
may not always exist for a given CBRN agent. For example, according to 
FDA officials, smallpox occurs only in humans, and related viruses that 
occur in animals, such as monkey pox, may not be similar enough to 
mimic smallpox in humans. Because of the complexities of using animal 
studies as models for human reactions to agents and potential 
countermeasures, FDA would prefer to meet with researchers earlier and 
more frequently, and FDA takes longer to evaluate product applications 
for CBRN medical countermeasures than to evaluate other medical 
products. In addition, the NBSB and others have reported that 
researchers face difficulty in applying FDA's draft guidance on the 
Animal Rule, which is currently under revision. According to the 
guidance, the agent tested in the animal must be identical to the agent 
that causes human disease. However, as discussed above, some animal 
studies may not meet that criterion and therefore cannot be used to 
demonstrate a countermeasure's effectiveness. To date, FDA has not 
approved any newly developed CBRN medical countermeasures based on 
animal model testing.\20\
---------------------------------------------------------------------------
    \19\ 21 C.F.R.  314.600-.650; 601.90-.95.
    \20\ Under the Animal Rule, FDA has approved existing products for 
CBRN use, such as drugs to treat the effects of nerve gas and cyanide 
exposure.
---------------------------------------------------------------------------
    Determining appropriate doses of CBRN countermeasures for children, 
who may be more vulnerable to the adverse effects of a CBRN agent, also 
involves regulatory challenges.\21\ Most approved or licensed CBRN 
medical countermeasures have been approved for use in adults only and 
lack pediatric dosing information. In addition, several candidate 
medical countermeasures currently in development lack or have limited 
pediatric dosing information. Regulations restrict children's 
participation in clinical trials when they do not benefit from 
them;\22\ therefore, developing pediatric dosing information relies on 
existing adult data or data from animal studies.
---------------------------------------------------------------------------
    \21\ See National Commission on Children and Disasters, 2010 Report 
to the President and Congress (Rockville, MD: October 2010). According 
to the report, in a CBRN incident children may be more vulnerable to 
exposure than adults because children inhale more air and consume more 
water in comparison to their body weight than adults.
    \22\ 21 C.F.R.  50.50-.56.
---------------------------------------------------------------------------
    There are also challenges in the processes for evaluating the 
emergency use of a promising medical countermeasure that has not been 
FDA-approved or licensed for treatment or postexposure prevention of 
disease for a given CBRN agent. In order for the Government to use an 
unapproved countermeasure to respond to a CBRN event, FDA must issue an 
EUA. FDA can issue EUAs only after the HHS Secretary declares a public 
health emergency. In order for FDA to issue an EUA, CDC, or another 
Government or private entity has to submit detailed information for FDA 
to evaluate, such as available safety and effectiveness information, a 
discussion of risks and benefits of using the unapproved 
countermeasure, draft fact sheets for health care providers and 
patients, and instructions for using the countermeasure. While CDC or 
other entities may submit all available data for FDA review in advance, 
such as when CDC acquires a countermeasure for the SNS, the agency must 
formally submit the EUA request at the time of the declared emergency. 
In the event of an attack with a CBRN agent that can cause disease 
within hours or days after exposure, CDC and FDA would have to process 
the final documents quickly in order for FDA to issue EUAs for 
appropriate medical countermeasures. Further, the Project BioShield Act 
precludes the use of data collected during the emergency use of an 
unapproved product to constitute a clinical investigation to support 
later product approval.\23\
---------------------------------------------------------------------------
    \23\ 21 U.S.C.  360bbb-3(k).
---------------------------------------------------------------------------
    Finally, CDC faces the logistical challenge of on-going 
replenishment of expiring medical countermeasures in the SNS. CDC can 
work with FDA to extend the expiration date of certain drugs in the 
stockpile, and thereby defer the cost of replacing the countermeasure 
and extend its availability for use in a potential CBRN event. In such 
cases, however, FDA has to conduct studies to ensure stability and 
quality of each drug. In addition, CDC faces the cost of relabeling the 
products to reflect the new expiration date. If the shelf life of an 
expiring countermeasure cannot be extended, CDC must replace it. For 
some countermeasures in the SNS, CDC may not face this challenge. For 
example, CDC officials told us that anthrax vaccine is moved out of the 
SNS before expiration because CDC rotates it out to DOD facilities for 
routine use.\24\ In addition, other countermeasures may be held for the 
SNS by private vendors and can be used commercially, provided that the 
vendors hold a certain amount for use in the event of a public health 
emergency.
---------------------------------------------------------------------------
    \24\ CDC and DOD have an agreement to share anthrax vaccine, which 
CDC holds in the SNS for DOD use.
---------------------------------------------------------------------------
    Chairman Bilirakis, this concludes my prepared statement. I would 
be happy to answer any questions that you, Ranking Member Richardson, 
or other Members of the subcommittee may have.
                       Appendix I: Abbreviations
ASPR: Office of the Assistant Secretary for Preparedness and Response
BARDA: Biomedical Advanced Research and Development Authority
CBRN: Chemical, Biological, Radiological, and Nuclear
CDC: Centers for Disease Control and Prevention
DHS: Department of Homeland Security
DOD: Department of Defense
EUA: Emergency Use Authorization
FDA: Food and Drug Administration
HHS: Department of Health and Human Services
MTA: Material Threat Assessment
NBSB: National Biodefense Science Board
NIH: National Institutes of Health
PHEMCE: Public Health Emergency Medical Countermeasures Enterprise
SNS: U.S. Strategic National Stockpile

    Mr. Bilirakis. Thank you very much.
    Dr. Pillai, you are recognized for 5 minutes.

   STATEMENT OF SEGARAN P. PILLAI, CHIEF MEDICAL AND SCIENCE 
    ADVISOR, CHEMICAL AND BIOLOGICAL DIVISION, SCIENCE AND 
    TECHNOLOGY DIRECTORATE, DEPARTMENT OF HOMELAND SECURITY

    Dr. Pillai. Good afternoon, Chairman Bilirakis, Ranking 
Member Richardson, and distinguished Members of the 
subcommittee. It is an honor to appear before you today.
    In fulfilling the Department of Homeland Security's mission 
to protect the American people the Science and Technology 
Directorate strives to equip the decision-makers with tools for 
better assessing the significant risk that chemical, 
biological, radiological, and nuclear threats pose to the 
Nation. In my statement today I intend to discuss the 
utilization of DHS S&T's Risk Assessment and Material Threat 
Assessment products which support the issuance of the Material 
Threat Determinations (MTD) that inform the Federal 
Government's medical countermeasures position.
    On July 21, 2004 President George W. Bush signed into law 
the Project BioShield Act of 2004. The purpose of BioShield is 
to celebrate and encourage the research, development, 
acquisition, and availability of safe and effective medical 
countermeasures to protect the United States from CBRN threats. 
It requires the Secretary of Homeland Security, in consultation 
with the Secretary of Health and Human Services and the heads 
of other agencies as appropriate, to make determinations of 
CBRN agents that are material threats to the U.S. population.
    It also authorizes the Secretary of Health and Human 
Services to determine the public health consequence and 
recommend countermeasures to such threats. If suitable 
countermeasures do not already exist this process can result in 
a joint DHS-HHS recommendation to the President or his 
delegate, the director of the Office of Management and Budget, 
to authorize the use of BioShield special reserve funds.
    The BioShield medical countermeasure acquisition strategy 
must be driven by many factors, including threat agents' 
potential cause to public health emergencies sufficient to 
affect National security and the potential for effective, 
feasible, and pragmatic medical interventions to counter their 
effects. Thus, the first step in the BioShield process is to 
determine the relative risks and threat of specific CBRN 
agents.
    To support this, DHS S&T conducts quantitative Terrorism 
Risk Assessments of CBRN agents as mandated under HSPD 10, 18, 
and 22, which provide the combined understanding of the 
likelihood and the specific consequence of a broad range of 
possible CBRN terrorist attacks. These assessments inform the 
relative risk associated with specific CBRN agents and assist 
the understanding as to which agents pose a relatively higher 
or lower threat to the American public.
    These risk assessments support Federal, State, and local 
agencies to guide their--defense and preparations and 
preparedness-related investments, as well as the direct HHS 
planning requirements by identifying the top-tier CBRN agents 
that poses a high risk to the Nation. In addition, DHS 
leverages the risk assessments to conduct the material threat 
assessments on high-risk agents.
    Specific to the material threat assessment process, DHS 
develops and models the possible high-consequence scenario 
taking into account acquisition, production, examination 
efficacy--conditions. This model is used to derive an estimate 
of the number of potentially exposed individuals. These 
estimates are then provided to HHS to conduct its public health 
consequence model studies, which serves as the basis for 
determining public health impacts.
    At the conclusion of these studies, a meeting within DHS 
and HHS takes place to collectively determine the public health 
impact of an agent and its potential to affect National 
security. If the material threat assessments results indicate 
that a significant number of fatalities will result from the 
possible high-consequence scenario it is deemed a threat and 
the under secretary for science and technology, in 
collaboration and coordination with the office of health 
effects, infrastructure protection, intelligence analysis, and 
policy recommends to the DHS Secretary for consideration to 
issue an NPD. To date, DHS has issued 12 NPDs for biological 
agents, one for radiological materials, and one for nuclear 
detonation impacts.
    Correct provision of CBRN agents and terrorism risk is an 
inherently dynamic and challenging problem. As the threat space 
evolves so do the technical approaches. Continually updating 
and gathering new data and feedback ensures that the 
assessments are backed by state-of-the-art science.
    DHS is committed to continual improvement of the risk and 
threat assessments, as it is vital to appropriately capture the 
CBRN landscape to help prioritize resources.
    In conclusion, I would like to thank you for the 
opportunity to discuss DHS S&T's risk assessment and material 
threat assessment products, which supports the material threat 
determinations that informs medical countermeasures decisions. 
I look forward to answering any questions you may ask and 
working with you to solve the homeland security challenges of 
our time.
    [The statement of Mr. Pillai follows:]
                Prepared Statement of Segaran P. Pillai
                             April 13, 2011
                              introduction
    Good afternoon, Chairman Bilirakis, Ranking Member Richardson and 
distinguished Members of the subcommittee. It is an honor to appear 
before you today. In fulfilling the Department of Homeland Security's 
(DHS) mission to protect the American people, the Science and 
Technology Directorate (S&T) strives to equip decisionmakers with tools 
for better assessing the significant risks that chemical, biological, 
radiological, and nuclear (CBRN) threats pose to the Nation. In my 
statement today, I intend to discuss the utilization of the DHS S&T's 
Risk Assessment and Material Threat Assessment products which support 
the issuance of the Material Threat Determinations (MTD) that inform 
the Federal Government's medical countermeasure decisions.
    On July 21, 2004, President George W. Bush signed into law the 
Project BioShield Act of 2004 (Pub. L. 108-276) (BioShield). The 
purpose of BioShield is to accelerate and encourage the research, 
development, acquisition, and availability of safe and effective 
medical countermeasures to protect the United States from CBRN threats. 
In 2004 Congress appropriated $5.6 billion for a Special Reserve Fund 
for use over 10 years (fiscal year 2004-fiscal year 2013) to acquire 
those medical countermeasures. Section 3(a)(2) of BioShield, adding 
section 319F-2(c)(2) to the Public Health Service Act, requires the 
Secretary of Homeland Security, in consultation with the Secretary of 
Health and Human Services (HHS) and the heads of other agencies as 
appropriate, to make determinations of CBRN agents that are material 
threats to the U.S. population. Section 319F-2(c)(2)(B) authorizes the 
Secretary of HHS to determine the public health consequences and 
recommend countermeasures to such threats. If suitable countermeasures 
do not already exist, this process can culminate in a joint DHS-HHS 
recommendation to the President or his delegate, the Director of the 
Office of Management and Budget, to authorize the use of BioShield 
special reserve funds.
    To determine the most effective ways to mitigate the effects of 
CBRN threats or incidents, it is essential to understand that the 
threat classes (i.e., chemical, biological, radiological, and nuclear) 
are distinct in their feasibility, likelihood of use, and potential 
public health consequences. The BioShield medical countermeasure 
acquisition strategy must be driven by many factors, including threat 
agents' potential to cause a public health emergency affecting National 
security and the potential for effective, feasible, and pragmatic 
medical intervention to counter their effects. Thus, the first step in 
the BioShield process is determining the relative risks of specific 
CBRN agents. DHS conducts quantitative Terrorism Risk Assessments 
(TRAs) of biological, chemical, radiological, and nuclear attacks to 
better understand the likelihood and associated consequences of 
specific types of CBRN terrorist attacks. The TRAs accomplish this by 
integrating the information derived from the intelligence and law 
enforcement communities with input from the scientific, medical, and 
public health communities. The assessments establish the relative risk 
associated with specific chemical, biological, radiological, and 
nuclear agents and assist with understanding which agents pose 
relatively higher or lower threats to the American public. ``High 
risk'' agents are then subjected to a secondary, detailed analysis 
called the Material Threat Assessment (MTA) to support DHS issuance of 
MTDs in collaboration with HHS.
              summary of terrorism risk assessment process
    Under Homeland Security Presidential Directives (HSPD) 10, 22, and 
18, DHS is mandated to conduct the Biological Terrorism Risk 
Assessment, the Chemical Terrorism Risk Assessment, the Radiological 
and Nuclear Terrorism Risk Assessment, and the Integrated CBRN 
Terrorism Risk Assessment.
    Federal agency stakeholders provide input on the scope of each TRA 
by participating in the Terrorism Risk Assessment Working Groups. These 
recommendations form the basis of each assessment's models, 
methodology, and improvements. DHS has conducted biennial TRAs since 
2006 and each updated assessment includes refinements to the 
methodology and technical approach that are guided by input obtained 
from HHS, DoD, EPA, the intelligence agencies and other Federal 
agencies and stakeholders, as well as the National Academy of Sciences.
    Once Federal agency stakeholder inputs are established, the next 
phase of the process involves refining the assessments through 
stakeholder coordination. This phase begins with the elicitation of 
intelligence from the law enforcement community on threats, including 
adversary group types and weaponization preferences. Each assessment 
incorporates a broad set of scenarios that consider multiple routes of 
exposure, multiple targets, different dissemination approaches and 
scales of attack, and modeling data from sources across Government, 
academic, and private sectors. These results are then shared with the 
inter- and intra-agency stakeholders in a draft report for review and 
comment.
    After inter- and intra-agency reviews have been conducted and input 
incorporated, the final TRA reports are released to the National 
Security Staff and interagency stakeholders. The Risk Assessments 
address HHS planning requirements by identifying top-tier CBRN agents 
(i.e. relative risk ranking where risk is the likelihood of an attack 
combined with the associated consequences) that pose a high risk to the 
Nation. These Risk Assessments are then leveraged to support the 
conduct of MTAs on high-risk agents. Results of the MTAs are a critical 
element of consideration in issuing an MTD.
                 dhs terrorism risk assessment products
    Biological Terrorism Risk Assessment (BTRA).--To inform decisions 
about biodefense investments, DHS S&T performs the BTRA every 2 years. 
The BTRA is a comprehensive, probabilistic risk assessment that 
integrates the judgments of the intelligence and law enforcement 
communities with input from the scientific, medical, and public health 
communities. The BTRA is a strategic level assessment designed to: (1) 
Aide in identifying and prioritizing credible, high-impact threats, (2) 
aid in identifying and prioritizing vulnerabilities and knowledge gaps, 
and (3) provide a systematic, science-based, common framework for 
``what if'' analyses. 


    The probabilistic risk assessment methodology captures the 
scenarios in an event tree format allowing the model to address 
different classes of agents, including a full spectrum of attack 
scenarios, beginning with the relevant characteristics of the adversary 
groups under consideration, and ending with the effectiveness of the 
response. In the simple example above, the terrorist enters the event 
tree on the left-hand side with attack conception. The first branch in 
this simple binary example is the selection of the bioagent. The tree 
then splits and the second event is the selection of the target, 
followed by production and dissemination, etc. The accumulation of all 
steps in the sequence defines a scenario, with a total relative 
probability defined by the product of the all of the branch 
probabilities. For each scenario, an estimate of the overall 
consequence is made. The risk from each branch is then determined as 
the probability times the consequences, and the total risk is the sum 
of the risks of all of the branches. Of course, for the branches in 
which the terrorist fails, there are no consequences and therefore the 
risk is zero.
    The event tree in the 2010 BTRA has 21 events and multiple branches 
at each event level. The 2010 study scope considers four terrorist 
types (international, state-sponsored, domestic, lone wolf) exploiting 
43 different bioagents (38 human, five livestock pathogens) that may be 
obtained from two locations (foreign and domestic) by five routes of 
acquisition (among them theft and environmental isolation). The 
adversary may use multiple methods of production and weaponization to 
attack any of 20 different targets (including a subway, stadium, 
transportation, or outdoor events) using eight modes of dissemination 
(food, aerosol, etc.). Human health and economic consequences are then 
calculated for each scenario path in the event tree and combined with 
probabilities to estimate the risk associated with millions of 
enumerated scenarios. This enables a comprehensive evaluation of not 
only what is possible but also probable in bioterrorism. The study 
model allows for risk data visualization by agent, target, adversary 
group and other factors to inform understanding. The probabilistic risk 
assessment methodology also supports an evaluation of the impact of 
knowledge gaps and incorporates explicit consideration of the inherent 
uncertainty in bioterrorism modeling.
    Chemical Terrorism Risk Assessment (CTRA).--The CTRA provides a 
comprehensive analysis of the homeland security risks from a broad 
range of chemical threat agent materials, including toxic industrial 
chemicals, traditional chemical warfare agents, and emerging threats. 
The CTRA, developed by S&T's Chemical Security Analysis Center (CSAC), 
uses information from across the intelligence community, the law 
enforcement community, and technical experts from the Government and 
chemical industries to assess the capabilities and intentions of 
different types of terrorist groups, and the feasibility of acquiring a 
given chemical threat material. Multiple Federal agencies are involved 
in providing information on medical consequences of these attacks, and 
the capabilities that are available to mitigate the effects of an 
attack. Using scientific information and advanced modeling 
capabilities, the consequences of possible chemical attack scenarios 
are calculated, providing information on the numbers of people likely 
to be killed or injured in the attacks.
    The final estimates of overall risk produced by the assessment 
combine the likelihood of each attack scenario, the possibility of law 
enforcement interdiction, and the magnitude of the consequences for 
each attack. The 2010 CTRA provides a relative risk assessment of 100 
representative chemicals for three routes of exposure (inhalation, 
dermal, ingestion) over 30 different scenario types. This relative 
assessment of the chemical risk captures the broad range of threats 
posed by a number of classes of chemical compounds.
    CSAC is applying the same probabilistic methodology to assess the 
risks of chemicals regulated under the Chemical Facility Antiterrorism 
Standards. This assessment, termed the Chemical Infrastructure Risk 
Assessment, provides DHS with tools to understand the risk of a 
chemical release from chemical facilities or while in transport, and to 
determine the impact of current threat reduction activities.
    Radiological and Nuclear Terrorism Risk Assessment (RNTRA).--A 
collaborative effort led by S&T and Domestic Nuclear Detection Office 
(DNDO), the RNTRA assessment is updated biennially with information 
from the intelligence community, coordinated by the DHS Office of 
Intelligence and Analysis, and the interagency contributions from the 
Department of Energy, Nuclear Regulatory Commission, HHS, the 
Department of Defense (DoD), the Environmental Protection Agency (EPA), 
and many other Federal agencies. The RNTRA includes over 2 million 
attack scenarios from the highest consequence to most plausible. These 
scenarios consider: International and domestic terrorist groups as well 
as lone wolf scenarios; 11 radiological agents and three sizes of 
improvised nuclear devices; multiple modes of radiological agent 
dissemination; and many plausible targets such as public entertainment 
venues, transportation targets, and supply chain networks. The 
scenarios are coupled with analyzing the public health response, 
management and distribution of medical countermeasures and resultant 
fatalities, illnesses and economic consequences using integrated 
dispersion modeling and National laboratory nuclear effects modeling. 
This assessment provides decision-makers with an understanding of 
radiological and nuclear terrorism risks as they relate to illnesses 
and injuries, fatalities, latent cancer morbidities and mortalities and 
economic cost from both regional and National perspectives.
    Integrated CBRN Terrorism Risk Assessment (ITRA).--The ITRA is the 
only Federal report that provides an assessment of the relative risks 
associated with chemical, biological, radiological, and nuclear 
terrorism in the homeland. The assessment is conducted biennially and 
provided to the Executive Office of the President's National Security 
Staff as mandated by HSPD-18. While the purpose of the ITRA intended by 
HSPD-18 is to inform resource allocation for medical countermeasures, 
the assessment can be leveraged by a broader range of Federal decision-
makers to support development of risk management strategies that have 
tangible operational impact on WMD terrorism risk such as prevention, 
protection, surveillance and detection, response and recovery 
activities. The ITRA capability is based on integration and 
harmonization of each of the threat agent specific assessments (BTRA, 
CTRA and RNTRA) augmented with intelligence information that 
establishes the relative likelihood that a terrorist will select a 
biological, chemical, radiological, or nuclear weapon. The ITRA 
encompasses more than 10 million attack scenarios across broad ranges 
of consequence and likelihood. They include various terrorist 
organizations, more than 150 specific agents, multiple modes of agent 
dissemination, and many potential targets such as public entertainment 
venues, transportation targets, and certain supply chain networks. 
These types of scenarios are coupled with modeling of the public health 
response, management and distribution of medical countermeasures to 
arrive at an estimated risk of fatalities, illnesses, and economic 
consequences associated with attack scenarios.
    Federal, State, and local agencies can leverage these assessments 
to guide their WMD defense-related investments focused on prevention, 
protection, surveillance, detection, response and recovery-related 
preparedness efforts. This includes guiding prioritization, 
development, acquisition, and maintenance of medical countermeasures. 
The assessments are accomplished through formal DHS working groups, 
where DHS engages with HHS, DoD, the National intelligence agencies, 
and several other Federal agencies such as EPA and NRC. This approach 
includes several steps in which working group members engage with DHS 
to develop requirements, provide technical input, and conduct a 
critical review of the TRAs.
                   material threat assessment process
    The first step in the BioShield process is threat identification 
and prioritization in order to inform medical countermeasure 
development and acquisition. DHS has the lead in threat identification 
and leverages the DHS Integrated Terrorism Risk Assessment findings to 
determine which CBRN agents present a greater risk based on the 
relative risk ranking against the U.S. population sufficient to affect 
National security. Specifically, for the highest-ranked agents in the 
TRA, DHS evaluates the intelligence and threat information and develops 
and models a highly plausible consequence scenario taking into account 
acquisition, production, dissemination efficacy, source strength, and 
meteorological conditions. This model is used to derive an estimate of 
the number of potentially exposed individuals at various levels of 
exposure, which becomes part of the MTA. The estimates are provided to 
HHS, which conducts its Public Health Consequence Modeling (PHCM) as 
the basis for determining public health impacts. At the conclusion of 
these studies, a meeting between DHS and HHS takes place to 
collectively determine the potential impact on public health and its 
potential to affect National security. If the PHCM results indicate 
that a significant number of fatalities will result from the highly 
plausible scenario with a particular agent, it is deemed a ``threat'' 
and the DHS Under Secretary of Science and Technology recommends to the 
DHS Secretary the issuance of an MTD, as outlined in Figure 2. Although 
the predominant role of DHS in the initial stages of the BioShield 
process is in conducting the MTAs, assessing the findings of the PHCM 
and issuing MTDs, DHS is actively involved in the subsequent 
interagency process and has the joint statutory responsibility with HHS 
in recommending to the Office of Management and Budget (OMB) to release 
the BioShield Special Reserve Funds.
    For agents considered to be a material threat, HHS determines 
whether these agents lack an existing, effective countermeasure and 
whether a countermeasure should be procured using BioShield reserve 
funds. If so, then HHS uses the interagency Public Health Emergency 
Medical Countermeasure Enterprise (PHEMCE), created by HHS in 2006, to 
define countermeasure requirements and acquisition options. The PHEMCE 
is overseen by an Enterprise Senior Council (ESC), previously known as 
the Enterprise Governance Board, to take a more integrated, systematic, 
end-to-end approach to the medical countermeasure mission, including 
research, development, acquisition, storage, maintenance, deployment, 
and guidance for utilization. Currently, the ESC serves as the primary 
conduit for communication among entities involved in the medical 
countermeasure mission and coordinates the implementation not only of 
BioShield, but also: HSPDs 18 and 22; the National Pandemic Influenza 
Strategy; the Strategic Plan for Countermeasure Research, Development, 
and Procurement required by the Pandemic and All-Hazards Preparedness 
Act; and other strategic planning documents. The DHS Office of Health 
Affairs and S&T are both members of the ESC. To date, DHS has issued 12 
MTDs for biological agents, one MTD for radiological materials, and one 
MTD for nuclear detonation effects. 




   tra improvement on process and methodology limitations identified 
     through the national academies report and stakeholder feedback
    Since their origin, the DHS Risk Assessment Programs have been very 
proactive in soliciting internal and external expert review of 
methodology, data inputs, outputs, and findings. Characterization of 
the biothreat and bioterrorism risk is an inherently dynamic problem. 
DHS is committed to continual improvement of the Terrorism Risk 
Assessments to support stakeholder decision-making. The main challenges 
we face in evaluating the WMD terrorism risk are that we must rely on 
historical data and information about our adversaries' future plans--
both of which are limited. DHS continues to work closely with HHS, DoD, 
EPA, and other stakeholders to provide transparency and to address, 
document, codify, and implement requirements aimed to improve the 
technical quality and utility of the TRAs.
    As the first Biological Terrorism Risk Assessment represented the 
pioneer of the TRAs, it garnered much attention. In response to the 
DHS-commissioned 2008 National Academy of Sciences (NAS) Report: 
``Department of Homeland Security Bioterrorism Risk Assessment: A Call 
for Change,'' the National Research Council provided 13 
recommendations. S&T was able to take action on several NAS 
recommendations in 2008, addressed others in the 2010 BTRA, and has 
research dollars invested to address the longer-term challenges, such 
as modeling the intelligent, adaptive adversary. Since 2006, BTRA has 
improved in its lexicon, transparency, and external peer review; the 
scope of consequences considered; platform flexibility; validation and 
verification; normalization methodology; communication strategy; and 
overall approach.
    The BTRA program has been pushing forward on improvements as 
quickly as science allows, and the process remains committed to 
addressing any and all deficiencies noted in the report. Meanwhile, the 
scientific community continues to debate the evolving new science of 
terrorism risk assessment and S&T continues to research new approaches. 
It is clear that providing sound risk-informed guidance to our 
leadership is a job that is too important not to get right. The models 
are continually reviewed, updated, and exercised to support partner 
decision making, and by doing so, DHS adds significant value to the 
biodefense decision and policy development National dialog.
    informing current biological defense research and the value of 
                           knowledge products
    In order to enable our TRAs and MTAs to achieve greater fidelity, 
the National Biodefense Analysis and Countermeasures Center (NBACC) 
supports S&T by providing knowledge and understanding of biological 
agents, closing the knowledge gaps on those known agents, and 
supporting attribution. The direction and prioritization of NBACC's 
scientific research are informed by DHS in coordination with 
interagency partners who serve on our science advisory groups. Reducing 
the uncertainty in the BTRA is an important target outcome of NBACC's 
work.
    In the current fiscal year, DHS's priority for the National 
Biological Threat Characterization Center (NBTCC) within NBACC is to 
develop plans for assessing and reducing knowledge gaps for 
traditional/nontraditional threat agents. These include specific and/or 
general properties associated with acquisition, production, 
dissemination, stability, virulence and pathogenesis, and medical 
countermeasure efficacy.
                               conclusion
    Thank you for the opportunity to discuss DHS's S&T Risk Assessment 
products and the Material Threat Assessment products which support the 
Material Threat Determinations that inform medical countermeasure 
decisions.
    Characterizing CBRN agents and terrorism risk is an inherently 
dynamic and challenging problem. As the threat space evolves, so do 
technical approaches; by continually updating and gathering new data 
and feedback on the TRAs and MTAs, we ensure that the assessments are 
backed by the best available science, and that risk reduction 
strategies are continually re-evaluated to support program 
effectiveness. DHS is committed to the continual improvement of risk 
assessments to support stakeholder decision making, investments, and 
strategic planning initiatives. It is vital to appropriately capture 
the CBRN terrorism landscape to help prioritize resources and indicate 
areas which may need additional focus.
    Thank you for inviting me to appear before you today. I look 
forward to answering any questions you may have.

    Mr. Bilirakis. Thank you, Dr. Pillai.
    Dr. Hatchett, you are recognized for 5 minutes.

  STATEMENT OF RICHARD J. HATCHETT, CHIEF MEDICAL OFFICER AND 
DEPUTY DIRECTOR, STRATEGIC SCIENCES AND MANAGEMENT, DEPARTMENT 
                  OF HEALTH AND HUMAN SERVICES

    Dr. Hatchett. Thank you.
    Good afternoon, Chairman Bilirakis, Ranking Member 
Richardson, Representative Marino. I am pleased to discuss our 
efforts to develop medical countermeasures against chemical, 
biological, radiological, and nuclear threats. The drugs, 
vaccines, and biological therapeutics, and diagnostic and non-
pharmaceutical devices we use to prevent, mitigate, and treat 
the health consequences of CBRN agents are one of our chief 
bulwarks against such threats.
    The Department of Health and Human Services has invested 
more than a decade and billions of dollars in developing such 
products to protect civilian populations. Within the 
interagency PHEMCE, BARDA works closely with the NIH, CDC, and 
FDA, as well as the Departments of Homeland Security, Defense, 
Veterans Affairs, and Agriculture, to define and prioritize 
requirements, coordinate research, product development and 
procurement, and establish strategies for the deployment and 
use of products held in the Strategic National Stockpile, or 
SNS.
    Requirements answer the question of: What do we need and 
how much should we buy? Dr. Pillai described DHS's role in 
establishing material threat determinations and developing 
material threat assessments of the number of people who might 
be exposed in a given event. These, in turn, inform public 
health consequence assessments of how many people would benefit 
from a given medical countermeasure.
    DHS also provides the integrated terrorism risk assessment, 
which helps us determine program priorities. Collectively, 
these assessments help us to align and prioritize our 
investments while coordinating our efforts with those of our 
Federal partners.
    A prime example of our commitment to such coordination is 
the integrated portfolio for CBRN medical countermeasures 
managed by HHS and the Department of Defense. Through the 
integrated portfolio, HHS and DOD leverage each other's efforts 
to address a broad range of common threats and requirements 
with greater efficiency and economy.
    The enterprise has notable successes to its credit. We have 
procured eight countermeasures for the SNS using Project 
BioShield funds, reducing our vulnerability to anthrax, 
smallpox, botulism, and radiation threats in the process. The 
SNS has an adequate supply of smallpox vaccine for the entire 
country and we have met our requirement for heptavalent 
botulinum antitoxin.
    But our efforts to support the development of medical 
countermeasures have faced and continue to face many 
challenges. Eight years ago Congress envisioned that the 
authorities and funding provided through Project BioShield 
would solve our medical countermeasures problem.
    The important authorities and funding from Project 
BioShield have been necessary but not sufficient conditions for 
success. We have spent the years since Project BioShield was 
established coming to better understand our private sector 
partners and the challenges they face, and in making 
improvements--not least through Congress' passage of the 
Pandemic and All-Hazards Preparedness Act--to our model for 
partnering with them.
    Under the form of last year's PHEMCE review we stepped back 
and took a systems approach to addressing these challenges. The 
result of the review is that we have undertaken an ambitious 
and important initiative involving multiple components to 
fundamentally alter the environment within which medical 
countermeasures development occurs. The goal is to shape a 
tightly integrated end-to-end enterprise in which promising 
concepts and discoveries are readily translated into candidate 
countermeasures and moved through the development pipeline with 
the Government coming to the table at every stage as a full and 
active partner.
    The four major initiatives proposed by the review--the 
creation of, first, a concept acceleration program at the 
National Institute of Allergy and Infectious Diseases; second, 
a nonprofit, independent medical countermeasures strategic 
investor; third, centers for innovation in advanced development 
and manufacturing; and fourth, a robust medical countermeasures 
regulatory science program at the FDA--will create a more 
complete arch of support across the entire chain of 
development.
    Collectively, these initiatives will mitigate the 
technical, regulatory, business, and Governmental risks that 
companies face in undertaking medical countermeasures 
development while simultaneously reducing their opportunity 
costs for working in this area. In parallel, we are also 
restructuring the way we do business, with all of the HHS 
components working together and seamlessly from the beginning 
with a focus on continual quality improvement.
    Let me be clear about one thing: These initiatives are not 
substitutes for the market guarantee provided by Project 
BioShield. By altering the environment within which medical 
countermeasures development occurs and by increasing the speed 
and rapidity with which products enter and move through the 
pipeline we believe these initiatives will help Project 
BioShield realize its full potential.
    Thank you, again, for inviting me to testify, and I would 
certainly be happy to answer any questions that you may have in 
this----
    [The statement of Dr. Hatchett follows:]
               Prepared Statement of Richard J. Hatchett
                             April 13, 2011
    Good afternoon Chairman Bilirakis, Ranking Member Richardson, and 
distinguished Members of the subcommittee. Thank you for inviting me 
here today to testify on the Department of Health and Human Services' 
(HHS) efforts to prepare for and protect against chemical, biological, 
radiological, and nuclear (CBRN) threats. My name is Richard Hatchett 
and I serve as the Chief Medical Officer and Deputy Director for 
Strategic Sciences and Management at the HHS Biomedical Advanced 
Research and Development Authority. I am pleased to join my Department 
of Homeland Security and Department of Defense colleagues, as well as 
the Government Accountability Office, to discuss these very important 
issues. The threats that our Nation faces continue to evolve, and we 
know that we cannot identify and characterize them all in advance. It 
is critical that we have the capability, as a Nation, to be resilient 
when disaster strikes--and to be resilient, we must be able to respond 
quickly and effectively to all disasters with the appropriate resources 
necessary to limit casualties and disruptions to communities.
                    introduction--aspr/barda mission
    The HHS Assistant Secretary for Preparedness and Response, Dr. 
Nicole Lurie, serves as the principal advisor to the Secretary on all 
matters related to Federal public health and medical preparedness and 
response for public health emergencies. The Office of the ASPR (or 
ASPR) promotes community preparedness and resilience; builds public 
health partnerships with Federal departments and agencies, State and 
local governments, non-governmental organizations, academic 
institutions and private sector partners; and coordinates Federal 
public health and medical response capabilities.
    Within ASPR, the Biomedical Advanced Research and Development 
Authority (BARDA) is responsible for developing and procuring safe and 
effective medical countermeasures (MCMs) against CBRN threats, pandemic 
influenza, and emerging infectious diseases. A principal BARDA 
responsibility is to help bring promising MCMs through the so-called 
``valley of death.'' The ``valley of death'' describes a period of time 
during MCM research and development when promising innovative 
technologies fail to advance to a marketable product due to 
entrepreneurial capital shortage or other similar cause. Left to their 
own devices and resources, most of our small biotech partners would 
find that the ``valley of death'' poses a nearly insuperable set of 
financial, technical, and regulatory challenges. BARDA provides the 
financial and technical resources our partners need to address these 
challenges. BARDA supports medical countermeasure activities such as 
industrialization, non-clinical and clinical testing, development of 
manufacturing technologies and scale-up, submissions for FDA regulatory 
review, and procurement for the Strategic National Stockpile (SNS). 
BARDA works closely with its HHS partners at the National Institutes of 
Health (NIH), the Centers for Disease Control and Prevention (CDC), the 
U.S. Food and Drug Administration (FDA), as well as at the Department 
of Defense (DoD) and the Department of Homeland Security (DHS) to 
ensure the Nation has appropriate MCMs to save lives during a CBRN 
event.
    As the BARDA Chief Medical Officer and Deputy Director for 
Strategic Sciences and Management, one of my primary responsibilities 
is to ensure we have safe and effective medical countermeasures 
available for our response efforts. One of the key avenues BARDA uses 
to align its work with that of our HHS and interagency partners is the 
HHS Public Health Emergency Medical Countermeasures Enterprise, or 
PHEMCE, which encompasses the development, manufacturing, production, 
stockpiling, and deployment and use strategies of products deemed 
critical to protecting or treating our population against a variety of 
CBRN threats, as well as against pandemic influenza and other emerging 
infectious diseases. My written testimony discusses the PHEMCE MCM 
requirements setting process; BARDA's MCM procurement and advanced 
research and development efforts; our collaboration with Federal 
partners and outreach efforts to industry; and identified gaps and 
challenges related to MCM development and procurement and how we are 
addressing these challenges.
     the public health emergency medical countermeasure enterprise
    In July 2006, HHS established the Public Health Emergency Medical 
Countermeasures Enterprise to improve the Federal coordination of 
Government policy, investments, and activities related to the 
development and procurement of medical countermeasures for CBRN 
threats. The overarching mission of the 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 SNS.
    ASPR leads the PHEMCE, which includes the CDC, the FDA, and the 
NIH. The PHEMCE also includes key interagency partners from DHS, DoD, 
the VA, and the USDA. The PHEMCE uses a decision forum named the 
Enterprise Senior Council (ESC) for MCM policy and implementation 
development. The ESC is chaired by the ASPR and is comprised of the 
senior leadership of the Enterprise. Together, the PHEMCE organizations 
and agencies work to improve our preparedness for public health 
emergencies with respect to the development, stockpiling, and use of 
medical countermeasures.
PHEMCE MCM Requirement-Setting Process
    Simply stated, medical countermeasure requirements answer the 
questions of ``What do we need, and how much should we buy?'' For CBRN 
threats, these MCM requirements serve two critical functions:
   to improve the outcome of public health emergencies by 
        focusing MCM activities across a wide range of key 
        stakeholders, and
   to align the multibillion-dollar investments of the NIH, 
        BARDA, and CDC in the discovery, advanced development, 
        acquisition, deployment, and use of MCMs; and
   to coordinate programs effectively with interagency partners 
        at USDA, VA, DoD and DHS.
    The current PHEMCE MCM requirements process includes the following 
activities:
   Threat Assessments.--DHS develops Material Threat 
        Assessments (MTAs) to support use of Project BioShield Special 
        Reserve Fund acquisitions based on ``plausible, high-
        consequence'' scenarios. To date, CBRN medical countermeasure 
        requirements have derived from these scenarios. The classified 
        MTAs prepared by DHS estimate the number of people in the 
        population exposed to specified levels of a given threat agent. 
        Issuance by DHS of a Material Threat Determination (MTD) based 
        on the information in the MTA and on risk assessments is a 
        requirement for use of Project BioShield Special Reserve Funds.
   Medical and Public Health Consequence Assessments.--ASPR 
        modeling staff collaborate with threat-specific Requirement 
        Working Groups (including Subject Matter Experts) to develop 
        medical and public health consequence assessments using 
        epidemiological modeling tools that estimate the number of 
        people who would benefit from a particular medical 
        countermeasure using the population exposure numbers derived 
        from the MTA. Subject Matter Experts review and discuss the 
        appropriate disease-related parameters that should be included 
        in the modeling and what those values should be. They review 
        the modeling outputs and provide feedback on the model and the 
        results in an iterative and highly collaborative process.
   Consultation with Subject Matter Experts.--ASPR staff 
        consult with a wide range of Federal subject matter experts 
        (with expertise in areas including, but not limited to, 
        microbiology, health physics, chemistry, toxicology, medical 
        care, and diagnostics) through the PHEMCE Requirements Working 
        Groups and Integrated Program Teams. Expertise from non-Federal 
        personnel is sought as needed and appropriate.
   Consultation with End-Users.--Through one-on-one, small, and 
        large group settings, PHEMCE partners work with emergency 
        planners as well as public health, first responder, and 
        hospital-based end-users of medical countermeasures at the 
        local, State, regional, and National levels to understand the 
        concept of operations (CONOPs) under which the medical 
        countermeasures will actually be used. Examples of past 
        interactions include roundtable settings, one-on-one interviews 
        supporting interactive design methodologies, and the annual 
        PHEMCE Stakeholders Workshop. Of note, there is an Institute of 
        Medicine Study Committee presently looking at issues related to 
        pre-deployment of MCMs in community settings.
   Leadership Approval.--CBRN medical countermeasure 
        requirements are approved through a formal governance process 
        within the PHEMCE. Following concurrence by the appropriate 
        PHEMCE Requirements Working Group and Integrated Program Team, 
        the draft requirements are briefed to the interagency 
        Enterprise Executive Committee and to interagency leadership at 
        the Enterprise Senior Council.
   Requirement Revision.--ASPR leads re-examination and update 
        of requirements at the request of the PHEMCE leadership or as 
        needed as response capabilities and CONOPs evolve or new 
        technological or threat information is gained, or as real 
        events present new information through lessons learned (e.g. 
        2009 H1N1, or the Japan nuclear crisis).
    MCM requirements fall into two major classes: (1) Scenario-based 
requirements, and (2) product-specific requirements.
    (1) Scenario-Based Requirements establish the classes and 
        quantities of MCMs necessary to effectively respond to 
        plausible, high-consequence scenarios for each threat agent. 
        Medical and public health consequence assessments are used to 
        inform these requirements.
    (2) Product-Specific Requirements determine the acceptable 
        (threshold) and ideal (objective) characteristics for 
        individual MCM product types. These are set through 
        consideration of existing research and development technologies 
        and response capabilities, and are communicated in the form of 
        a Target Product Profile that calls out minimal qualities 
        acceptable and goal characteristics for medical countermeasures 
        HHS will pursue. Product-Specific Requirements also specify the 
        quantity of a product with ideal characteristics that might be 
        acquired to meet the specified needs, along with an indication 
        of how variations in product characteristics might affect the 
        quantity sought. Final acquisition quantities are determined 
        based on product-specific characteristics and other 
        considerations in the acquisition strategy and plans developed 
        by program staff.
 mcm procurements, advanced research and development, and outreach to 
                                industry
    Once the requirements setting process is complete, and the PHEMCE 
determines that advanced development or acquisition of unlicensed 
medical countermeasures is appropriate to meet these requirements, 
BARDA funds these activities to protect the American civilian 
population against CBRN and naturally occurring threats to public 
health. Further, BARDA collaborates with intra- and inter-agency 
partners in MCM research that may be a precursor need for meeting these 
requirements and has a robust process for screening new technologies 
and interacting with the private sector on novel MCM technologies and 
products.
Project BioShield MCM Procurements
    Project BioShield, authorized by the Project BioShield Act of 2004 
(Pub. L. 108-276), established the Special Reserve Fund, a market 
signal, a guarantee, and a secure funding source for the procurement of 
critical medical countermeasures, such as vaccines, therapeutics, and 
diagnostics that are close to licensure. It provides a tangible 
guarantee to industry that a market will exist for these products. The 
Project BioShield Act also provides additional and more flexible 
authorities and funding to support and expedite the development and 
procurement of CBRN MCMs. Finally, the Project BioShield Act provides 
the Secretary with the authority to authorize the use of unapproved 
products or the unapproved use of approved products during emergencies.
    In 2003, Congress appropriated $5.593 billion to support Project 
BioShield over a 10-year period. Since its inception, ASPR has used 
Project BioShield funds to procure:
   anthrax therapeutics and vaccines;
   heptavalent botulinum antitoxin;
   smallpox vaccine; and
   a number of MCM products intended for use after radiological 
        and/or nuclear events.
    Of the $5.593 billion originally appropriated, $2.348 billion 
remains available. The difference includes $2.130 billion directed 
towards the procurement of MCMs and $1.114 billion transferred, 
rescinded, or spent on ARD contracts.
Advanced Research and Development
    Using its Advanced Research and Development (ARD) authority, BARDA 
bridges the ``valley of death'' funding gap that exists between the 
early stages of product development and the procurement of approved or 
approvable medical countermeasures under Project BioShield. Given that 
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 a 
substantial pipeline of products to diagnose and treat illness with, or 
prevent the effects of CBRN agents. The fiscal year 2011 budget 
includes a request that $476 million be made available from Project 
BioShield balances to support such ARD projects. 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 budget requests another $765 million from Project BioShield 
balances to support these priorities.
Integrated Portfolio for CBRN Medical Countermeasures
    The DoD and HHS each identify medical countermeasure requirements 
to address their different missions and focus. Historically, DoD has 
prioritized the development of MCMs to protect our military prior to 
exposure to CBRN agents, whereas HHS's focus has been on responding to 
threats to the civilian population once exposure has occurred. However, 
there are areas of common requirements or interest where medical 
countermeasure candidates, resources, and information can be 
appropriately shared to maximize opportunities for success in the 
development of medical countermeasures for the highest priority 
threats. BARDA, in partnership with other HHS and DoD partners, is 
leading an Integrated Portfolio for CBRN Medical Countermeasures to 
leverage resources and programs across the agencies that develop and 
acquire CBRN medical countermeasures to more effectively address the 
broad range of common threats and requirements. Members of the 
Integrated Portfolio working to integrate HHS and DoD efforts include 
BARDA, biodefense programs at NIH, and multiple elements of the DoD 
Chemical and Biological Defense Program.
BARDA TechWatch Program
    BARDA has developed an active TechWatch program, which provides an 
opportunity for external organizations to meet with the Federal 
Government to discuss their new and innovative medical countermeasure 
technologies. Companies may request meetings with Government subject 
matter experts to discuss their products and plans for submitting 
proposals in response to BARDA's Broad Agency Announcements (BAAs) 
through the PHEMCE portal website www.medicalcountermeasures.gov. These 
meetings provide the Federal Government with the latest information 
about emerging technology and inform strategic and programmatic 
planning for effective public health emergency response. The TechWatch 
program has been highly successful in improving communication with 
potential partners. Those companies who utilize TechWatch prior to 
submitting a white paper in response to a BAA are three times more 
likely to be invited to submit a full proposal than companies that 
proceed directly to the white paper without the benefit of a TechWatch 
meeting.
                medical countermeasure enterprise review
    Recently, our department undertook an effort to address gaps and 
challenges in MCM development and procurement by improving the 
efficiency of our translational efforts, enhancing the advanced 
development and manufacturing services we provide our partners, 
clarifying regulatory pathways, and building a strong base for MCM 
regulatory science at the FDA. These initiatives, once implemented, 
will provide the capability to speed MCM development and respond faster 
and more effectively to rapidly evolving public health threats. In 
December 2009, on the heels of the 2009-H1N1 pandemic, HHS Secretary 
Kathleen Sebelius requested a complete review of the MCM enterprise and 
assigned this responsibility to ASPR. The goal of the review was the 
end-to-end transformation of the enterprise: To improve its 
performance, enhance collaborations with the private sector, and 
prepare the Nation for the threats of the 21st Century--those we can 
predict as well as those we cannot. The MCM Enterprise Review, released 
in August 2010, identifies ``processes, policies, and infrastructure 
required to take a product concept derived from a national requirement 
through research, early and advanced development, manufacturing, 
regulatory approval, procurement, and stockpiling.'' Specifically, this 
review looked across the entire arc of product development, from early 
discovery through regulatory approval, and identified the chokepoints 
where product development was stalling or failing. To address these 
chokepoints, which create technical, business, and regulatory risks for 
small innovator companies and form the basis of the MCM ``valley of 
death,'' the Review proposes a series of initiatives:
   The establishment of a Concept Acceleration Program at the 
        NIH National Institute of Allergy and Infectious Diseases to 
        work with partner agencies, academic researches, biotech 
        companies, and large pharmaceutical companies to identify 
        promising scientific discoveries and expedite their 
        transformation into practical, usable products.
   The establishment of a nonprofit [501(c)3 or equivalent] 
        Strategic Investor firm to spur innovation by supporting 
        companies that possess strategic technologies that 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.
   A major investment in regulatory sciences and review 
        capabilities at the FDA focused on CBRN MCMs.
    The Concept Acceleration Program will leverage existing intramural 
and extramural research programs as well as applied and translational 
resources throughout NIH, CDC, FDA, and DOD to speed the translation of 
promising concepts into candidate MCMs.
    The Strategic Investor initiative would spur innovation and provide 
the kinds of business and financial services and support that venture 
capital firms typically provide, mitigating the risk that funded 
pharmaceutical manufacturing firms will fail because of poor 
management, an inadequate business model, or lack of financial 
expertise. The Strategic Investor initiative is critical to 
transitioning MCM development and procurement from a ``one bug, one 
drug'' approach to an enterprise capable of responding to any threat at 
any time.
    The Centers for Innovation will be created to reduce risk, increase 
product yields, 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 that include advanced 
development and manufacturing capabilities of USG-supported developers 
of medical countermeasures for chemical, biological, radiological, and 
nuclear MCMs to address National preparedness and response priorities 
and needs. In the event of a pandemic, the Centers will also be 
available to assist in the manufacture of influenza vaccine and other 
biologics. The Request for Proposals for this latter initiative was 
published on March 30, 2011, and we have been working closely with our 
colleagues at DoD, who are preparing a complementary initiative for 
release in the near future.
    Finally, expanding regulatory science and review capabilities at 
the FDA will strengthen and clarify the MCM regulatory process, which 
will expedite MCM development.
    Collectively, these initiatives, once implemented, will help us 
establish a more nimble and diversified approach in preparing for and 
responding to CBRN and other threats.
                mcm distribution--executive order 13527
    Finally, Mr. Chairman and Members of the subcommittee, I must 
address the importance of the entire MCM continuum--from research and 
development to procurement to distribution and dispensing. The MCM 
enterprise is one component of a broader response strategy to mitigate 
the effects of a CBRN event. To be resilient in the face of CBRN 
disasters, we need a fully integrated and coordinated strategy to 
address how the various sectors of our health care system will work 
together to respond and save lives. We need an integrated health care 
system that can address patients' needs when and where necessary. After 
we work to procure valuable CBRN medical countermeasures, we need 
adaptable distribution and dispensing plans in place capable of quickly 
delivering these countermeasures to every American who needs them.
    On December 30, 2009, the President issued Executive Order 13527 
establishing the Federal Government policy, in the event of a 
biological attack, to plan and prepare for the timely provision of 
medical countermeasures to the American people through a rapid Federal 
response in coordination with State, local, territorial, and Tribal 
governments. Section 2 of the Executive Order tasks HHS and DHS, in 
coordination with the USPS to develop a national USPS medical 
countermeasures dispensing model for U.S. cities to respond to a large-
scale biological attack, with anthrax as the primary threat 
consideration. This dispensing model was delivered to the President on 
June 30, 2010 and was included in a recent grant announcement issued 
through ASPR. The President's fiscal year 2011 budget requested $10 
million to fund this initiative. However, these funds were eliminated 
in the previous, current, and proposed continuing resolutions to fund 
Government operations in fiscal year 2011. The President's fiscal year 
2012 budget requests $5 million for this initiative.
                               conclusion
    In closing, I want to reiterate that as the threats we face evolve, 
we will continue to work closely with our colleagues at DHS, DoD, and 
across Government to ensure that our investments are rational and 
sustainable. We understand the importance of thorough surveillance and 
early detection to limit the impact of a CBRN event and will continue 
to work closely with our partners to build upon existing infrastructure 
and align supporting investments and capabilities. We continue to face 
significant challenges in the realm of MCM research and development and 
hope that through implementation of the priorities established in the 
MCM Enterprise Review, we can transform the way we collaborate with our 
industry partners while demonstrating our sustained commitment to 
developing new and promising MCMs. Medical countermeasures are a 
bulwark against the deliberate and natural threats we face, a critical 
link in the chain of preparedness.
    I speak for all my colleagues throughout HHS in saying that we look 
forward to working with you on the matters I have raised this 
afternoon. With the leadership and support of Congress, and in 
collaboration with our agency partners, we have made substantial 
progress in MCM development and procurements. We have accumulated a 
great deal of practical experience over the last decade and have a deep 
understanding of the challenges our private sector and academic 
partners face. To meet these challenges, we have made changes in our 
governance--continual improvements in our processes and institutions, 
our standard operating procedures, and our collaborations with our DHS 
and DoD partners. We are in the process of transforming the MCM 
Enterprise to ensure its sustainability while meeting the threats of 
the future.
    Let me assure you that we take our mission of preparing the Nation 
against these threats with the utmost seriousness and that we know how 
much we still have left to do.
    Thank you again for inviting me to testify. At this time I would be 
happy to address any questions you may have.

    Mr. Bilirakis. Thank you, Dr. Hatchett.
    Dr. Parker, you are recognized for 5 minutes and then we 
will recess because we have four votes. Then we will come back 
as soon as the last vote is completed.
    So you are recognized, sir, for 5 minutes.

  STATEMENT OF GERALD W. PARKER, JR., DEPUTY ASSISTANT TO THE 
    SECRETARY OF DEFENSE, CHEMICAL AND BIOLOGICAL DEFENSE, 
                     DEPARTMENT OF DEFENSE

    Dr. Parker. Thank you.
    Chairman Bilirakis, Ranking Member Richardson, and 
Representative Marino, I am honored to be here to discuss the 
Department of Defense efforts to develop medical 
countermeasures to protect the warfighter and the Nation. First 
I would like to briefly describe the DOD chemical and 
biological defense enterprise. We have a process in place to 
analyze threats and gaps in our capabilities so we provide our 
warfighters the protection they need to carry out their 
mission, protect our country, and come home safe and healthy.
    The joint staff works with the services and combatant 
commands through the joint requirements office to establish 
requirements. Our joint science and technology office manages 
research and development to fill our S&T product development 
pipeline. As medical countermeasure candidates mature, products 
transition to the joint holding executive office for advanced 
development, manufacturing, and testing to address all 
regulatory requirements leading to FDA approval.
    From research to acquisition our efforts are product-
focused, with target product profiles developed early to guide 
countermeasure development.
    The DOD works in close partnership with HHS and DHS through 
the integrated National portfolio to ensure we are not 
duplicating efforts and to leverage capabilities. It is a great 
partnership.
    I have a unique perspective of having worked on biodefense 
with each of the agencies represented here today, and I would 
also like, though, to emphasize the exceptional DOD outcome-
based, product-focused contributions. We have a rich history in 
infectious disease and medical biological defense R&D, with DOD 
playing a significant role in developing eight of the 15 adult 
vaccines licensed in the United States since 1962. Since 2000 
our efforts have led to eight more FDA approvals for 
diagnostics and licensed medical countermeasures for anthrax, 
smallpox, and nerve agents.
    However, we recognize that we must develop new ways to 
confront the growing and evolving risk of chemical, biological, 
radiological, and nuclear threats as well as emerging 
infectious disease. The average 12 to 15 years to develop a 
medical countermeasure against a single threat is too long and 
too costly.
    This National security challenge demands new approaches. 
The Department's needs for specific medical countermeasures are 
variable in number, ranging from tens of thousands of doses to 
a few million doses, owing to unique operational requirements 
and our global presence.
    The potential spectrum of threats and the many diseases we 
confront globally are diverse. Yet, today we have numerous 
unmet requirements for medical countermeasures. It is crucial 
that we close these gaps.
    DOD is responding to this challenge by building an 
integrated capability to respond to the threat through enhanced 
diagnostics, detection, and global biosurveillance and through 
innovative industrial capacity for advanced development and 
adaptive manufacturing capabilities that will capitalize on 
multi-use platform technologies. DOD pioneered this approach 
beginning in 2006 when we initiated the Transformational 
Medical Technologies Initiative, or TMT, to change the approach 
to medical countermeasures development and the science base and 
to invigorate the S&T pipeline.
    TMT has made exceptional progress in our ability to 
identify, characterize, and discover new drug candidates 
rapidly. But we need to apply similar innovative approaches to 
establish new development, regulatory sciences, and 
manufacturing capabilities.
    We are preparing to implement the Medical Countermeasures 
Initiative through our cooperative partnership with industry to 
establish industrial capacity and expertise for the rapid 
development agile manufacturing of medical countermeasures. To 
this end, we are collaborating closely with the Department of 
Health and Human Services to create and integrate National 
capability to produce medical countermeasures in a more cost-
effective manner and rapidly in the face of any attack or 
threat.
    The DOD is looking to address the operational needs of the 
military while HHS must address the large-scale production 
needed to meet the needs of the U.S. population. Both efforts 
are integrated and complementary.
    During fiscal year 2012 the DOD plans to award a long-term 
contract to establish an advanced development and agile 
manufacturing capability. The Department of Defense must have 
the ability to fight and win in an environment that might be 
compromised by threats of a bioattack or endemic diseases. This 
includes the timely provision of safe and effective vaccines 
and treatments for our military and our coalition partners.
    These threats on our troops and citizens are very real and 
ever-changing in the 21st Century. I appreciate the strong 
leadership from the White House and the Congress on this 
critical issue and the opportunity to testify today. I will be 
pleased to answer your questions.
    Thank you.
    [The statement of Dr. Parker follows:]
              Prepared Statement of Gerald W. Parker, Jr.
                             April 13, 2011
                              introduction
    Chairman Bilirakis, Ranking Member Richardson, and Members of the 
subcommittee, thank you for giving me this opportunity to discuss 
Department of Defense efforts to develop medical countermeasures to 
protect the Warfighter and the Nation.
    DoD has to confront the growing and evolving risk of chemical, 
biological, radiological, and nuclear threats, and emerging infectious 
disease. Our National security is challenged to both accurately 
identify and rapidly respond to an attack or naturally occurring 
outbreak with countermeasures that limit impacts and loss of life. DoD 
is responding to this challenge by building an end-to-end, integrated 
capability to respond to the threat through enhanced diagnostics, 
detection, and biosurveillance; and through innovative industrial 
capacity for advanced development and adaptive manufacture of medical 
countermeasures for rapid response.
    The potential threats today are much more difficult to plan 
against. We face a broad array of both natural and man-made challenges. 
The world is smaller so global pandemics come to our shores faster, and 
DoD personnel are deployed around the world coming into contact with 
endemic diseases unlikely to be seen in North America. The emergence 
and rapid advance of synthetic biology will make it easier over time 
for an adversary, whether state or non-state, to develop modified 
pathogens. These challenges will only increase with the exponential 
growth in the field of biotechnology, global industrialization, and the 
wealth of scientific information becomes even more available through 
mass communications.
    Our over-arching goal, of course, is to prevent an attack or 
infectious disease outbreak in the first place. The Department has 
expanded prevention efforts underway that include international 
scientific engagements to promote a culture of laboratory 
responsibility, enhance scientific collaboration, and to secure 
dangerous pathogens. Should a crisis occur, however, we will have to 
act swiftly and decisively with the capability to rapidly indentify and 
characterize the threat, activate response plans, and rapidly 
distribute and disseminate medical countermeasures in sufficient 
quantities.
    Before addressing medical countermeasure development challenges and 
solutions, I want to take the opportunity to emphasize the strong and 
productive collaboration we share with the Department of Health and 
Human Services and the Department of Homeland Security on many levels, 
and particularly through the Public Health Emergency Medical 
Countermeasures Enterprise. Through this Medical Countermeasures 
Enterprise, we have developed the Integrated Portfolio for CBRN Medical 
Countermeasures to develop medical countermeasures required for 
National and Homeland Security. Our relationship with HHS and DHS 
through the Enterprise is synergy at its best--we team our expertise, 
avoid duplicating efforts, and participate in joint acquisition and 
stockpiling when possible.
    As a former laboratory director, I want to mention that the 
Department of Defense has an incomparable set of laboratory assets and 
scientific expertise based throughout the United States and around the 
globe engaging in basic and applied research, advanced technology 
development to prove concepts for medical products and information, and 
response to threats against health and performance. These include 
medical research and technology aimed at endemic disease threats, 
chemical and biological warfare threats, environmental hazards, battle 
sequelae, systems hazards, operational stressors, and combat injuries.
    Our overseas laboratories are National assets that advance U.S. 
diplomacy through the study of infectious diseases of critical regional 
public health importance. By contributing to the health infrastructure 
of another country, we contribute to that country's security and by 
extension to U.S. security as well. The laboratory missions also 
include the evaluation of vaccines, therapeutic agents, diagnostic 
assays, and vector control measures. New international collaborations 
include the Republic of Georgia-U.S. Biosurveillance and Research 
Center which engages scientists in diagnostic and epidemiological 
studies, and medical countermeasures research. DoD endeavors with 
coalition partners are exemplified by the work in the Republic of South 
Korea where diagnostic, detection, biosurveillance, and laboratory 
capabilities to protect U.S. forces are tested and deployed. This work 
is done in collaboration with the Republic of Korea Defense, Health, 
and other Ministries to improve our collective preparedness and 
response posture to emerging infectious disease threats of any origin 
in this critical geographic region.
           challenges to progress on medical countermeasures
    The December 2010 National Strategy for Countering Biological 
Threats highlighted the significant threat posed by especially 
dangerous pathogens to our people, forces, and coalition partners. The 
Department of Defense must have the ability to fight and win in an 
environment that might be compromised by diseases or threat of a 
bioattack. This includes the timely provision of safe and effective 
vaccines and treatments for our Joint Service Members and our coalition 
partners.
    The events of the 2009 H1N1 pandemic, along with the on-going 
challenges and costs associated with development of chemical, 
biological, radiological, and nuclear medical countermeasures, revealed 
major gaps in advanced development and access to domestic surge 
manufacturing capacity. These and other challenges underscored by the 
Public Health Emergency Medical Countermeasures Enterprise Review in 
August 2010, revealed the need for a whole-of-government approach.
    Factors that have limited progress for developing biodefense 
vaccines include the inability to leverage the expertise and 
capabilities of larger, experienced biopharmaceutical companies due to 
the high opportunity costs of entering the limited chemical, 
biological, radiological, and nuclear medical countermeasure market. 
The result is a reliance on small biotechnology firms that are engines 
of innovation and critical for discovery and early development of 
medical countermeasure candidates, but they have limited advanced 
development and regulatory experience and limited manufacturing 
capabilities. This is a costly, inefficient, and risky approach to meet 
critical biodefense and public health needs.
    The cost and time required to develop and obtain Food and Drug 
Administration approval to market a new biologic and/or drug is costly, 
takes years, and is a risky endeavor even for large, experienced 
pharmaceutical companies or for medical countermeasure candidates that 
have well-established regulatory and development pathways and a 
commercial market.
    The Department's needs for medical countermeasures are variable in 
number, ranging from tens of thousands to a few million doses, owing to 
unique operational vaccine and treatment requirements due to our global 
presence. The potential spectrum of CBRN threats and emerging 
infectious diseases is diverse, and we have too many gaps and unmet 
requirements for medical countermeasure vaccines and treatments.
    It is crucial that we close the vaccine, antimicrobial, and 
antiviral drug gaps. We cannot afford to take the average 12 to 15 
years to develop a medical countermeasure against a single threat, nor 
can we afford to use the traditional and costly ``one bug-one drug'' 
development paradigm. This National security challenge requires new 
approaches for medical countermeasure advanced development and 
manufacturing to counter anticipated and unanticipated threats from an 
attack or naturally occurring infectious disease threats. The DoD 
approach to overcome some of these challenges is to bring innovation to 
manufacturing processes in an analogous way that the Transformational 
Medical Technology program brought innovation to discovery and early 
development. The approach will capitalize on platform technologies that 
can be multi-use and give us an ability to quickly characterize the 
pathogen and promptly develop a countermeasure.
                     integrated biodefense approach
    The Department will address these gaps holistically and as an 
integrated set of capabilities including establishment of critical 
industrial capacity to respond swiftly and effectively to these 
evolving threats. These capabilities focus on the need to quickly and 
precisely detect, diagnose, and identify the threat, develop, or refine 
a medical countermeasure, and manufacture quickly those countermeasures 
in useful quantities.
Detection and Initial Response
    The first step in this integrated set of functions is detection, 
and includes the entire system and processes that can quickly determine 
the nature of the infectious disease or emerging threat. Our ability to 
obtain early warning about the emergence and progression of new and/or 
particularly dangerous threats feeds directly into our ability to 
prepare effective vaccines and therapeutics.
    Detection capabilities are a priority for DoD and include pursuit 
of research, development, and acquisition of medical diagnostics, 
environmental detection, and data fusion, management, and decision 
tools.
    One diagnostic capability currently fielded with our forces in over 
300 locations worldwide is the Joint Biological Agent Identification 
and Diagnostic System. It is capable of rapidly identifying multiple 
biological agents, such as anthrax, plague, and avian influenza. In 
response to the 2009 H1N1 pandemic, genomic signatures and assays 
obtained from the CDC were quickly ported to the JBAID system under FDA 
Emergency Use Authorization enabling use of this deployed platform for 
both military and public health needs. The utility of this genomic 
based diagnostic system has been very successful, enough to warrant 
investments and a new development thrust in next-generation 
diagnostics.
    We are also working closely with the Department of Homeland 
Security and the Department of Health and Human Services on 
biosurveillance, diagnostics, environmental detection, laboratory 
capabilities, integrating operations, and data systems, and 
participating in joint exercises in support of a National biomonitoring 
architecture. In BioWatch cities, for example, military installations 
are included in the local emergency management and public health 
incident command centers enabling shared situational awareness through 
local, State, and National operations centers. We are also integrated 
through the National Biosurveillance Integration System, which serves 
as the platform for information exchange between agencies and 
facilitates the early recognition of biological events, including 
natural disease outbreaks, accidental or intentional use of biological 
agents, and emergent biohazards. DoD also collaborates with the DHS 
National Biodefense Analysis and Countermeasures Center for biological 
risk assessments and bioforensic analysis to support attribution.
    DoD global biosurveillance activities are enhanced by establishing 
strategic research partnerships and scientific cooperation efforts with 
partner nations. Global biosurveillance initiatives and medical 
diplomacy through overseas labs foster on-going communication, 
collaboration, and information networks among the U.S. Government 
agencies, non-governmental organizations, academia, and international 
partners. The Armed Forces Health Surveillance Center Global Emerging 
Infections Surveillance and Response System is a centralized 
communication hub to help coordinate DoD resources and link with other 
U.S. and international disease surveillance efforts. This center links 
DoD laboratories, research facilities, and the military health system 
to facilitate rapid recognition and response to protect the health of 
the forces and National security. Within DoD, a new laboratory 
information and communications system, the Electronic Integrated 
Disease Surveillance System, can link together the different levels of 
a National disease surveillance network within a country providing 
near-real-time information flow that can be disseminated to the 
appropriate organizations in a timely manner. DoD's overarching 
interest is to improve the capability for international surveillance, 
countering biological threats, and responding to emerging infectious 
diseases of intentional or natural origins. This is done in close 
collaboration with CDC global disease detection efforts.
    DoD supports civil authorities in chemical, biological, 
radiological, and nuclear consequence management operations to save 
lives and reduce the effects of a weapon of mass destruction attack. We 
recognize the importance of maintaining a force that is ready and able 
to respond to these special threats and is prepared to rapidly support 
civil authorities in response to an event. The Department has 
established elements to provide forces as soon as possible to support 
any consequence management scenario that may occur. This includes 
command and control, decontamination of personnel and equipment, 
hazardous material handling and disposal, air and land transportation, 
aerial evacuation, emergency medical treatment, and sustainment. Other 
units provide casualty/patient decontamination, emergency medical 
support, and casualty search and extraction. We are continually looking 
for ways to improve support to civil authorities, increasing life-
saving capabilities and reducing response times. By the end of 2012 
there will be 10 Homeland Response Force units capable of responding 
within hours in each of the FEMA regions to provide more life-saving 
capabilities faster using the same approximately 18,000 personnel 
assigned to this mission.
Medical Countermeasures Discovery and Development
    The second step of our integrated biodefense enterprise includes 
the entire scope of efforts to discover and develop a medical 
countermeasure candidate to a chemical, biological, radiological, and 
nuclear threat or new pathogen. These countermeasures must be rapidly 
demonstrated to be safe and effective through streamlined, but still 
rigorous, techniques. The Transformational Medical Technologies 
program, established as a DoD Initiative in 2006, focuses on the 
discovery and refinement of medical countermeasures in response to 
emerging threats and has been so successful it is now becoming the base 
approach for the entire medical discovery program.
    The Transformational Medical Technologies program addresses novel 
threats, biologically engineered pathogens, or emerging infectious 
diseases by developing new detection and therapeutic capabilities. The 
goal is to provide a rapid response capability to identify and 
characterize an unknown, and then apply a broad spectrum medical 
countermeasure. If none exist, a therapeutic platform will discover and 
develop medical countermeasure candidates quickly.
    For example, in 2009 we redirected a therapeutic platform focused 
on developing therapeutics for hemorrhagic fever viruses to discover 
and refine medical countermeasures against an outbreak of an unknown 
pathogen. Our systems quickly identified the unknown sample as the H1N1 
virus, and a new antiviral was synthesized within 14 days. This is a 
revolutionary change from traditional discovery methods which can take 
years. However, traditional advanced development and manufacturing is 
not rapid, and will require further innovation. Even so, the H1N1 
antiviral showed great promise in animal studies and is now entering 
clinical trials. Still, we must bring innovation to advanced 
development and manufacturing as well.
Advanced Development and Manufacturing
    The essential third step is access to critical industrial capacity 
and expertise for the agile development and manufacturing of medical 
countermeasures in quantities to treat affected populations rapidly. We 
are preparing to implement the Medical Countermeasures Initiative 
through a cooperative partnership with industry. One of the innovation 
drivers will be the ability to manufacture medical countermeasures in a 
flexible fashion to include ``on-demand'' surge capacity for specific 
products in the event of a National security emergency or change 
manufacturing runs on different products as the need arises. The 
Medical Countermeasures Initiative encompasses two components: Science 
and technology, and advanced development and manufacturing. A related 
component is the planned National test and evaluation facility for 
animal studies necessary for FDA approval. The science and technology 
component will concentrate on three areas: Novel platform/expression 
systems, advancement of regulatory science, and advancements in 
flexible manufacturing technologies. The advanced development component 
will concentrate on integrating novel platform/expression systems into 
a production process and establishing a Technical Center of Excellence 
to provide advanced development core services and a flexible 
manufacturing capability for DoD and National security needs. 
Ultimately, the Medical Countermeasures Initiative will coalesce to 
provide a ``one-stop'' shop for all future DoD medical countermeasure 
development.
    Although platform and new manufacturing technologies coupled with 
new facility design make this approach technically feasible, it is not 
without risks and challenges. The technologies are new and the 
underpinning regulatory science will have to be developed in parallel 
as the products develop.
    DoD intends to engage the most capable performer(s) to integrate 
innovative manufacturing technologies and to perform advanced 
development using scalable commercial manufacturing processes for 
meeting the Department's medical countermeasure requirements. 
Developing the right industry partnerships, small biotechnology 
endeavors generating new innovations needed for the revolutionary 
breakthroughs and larger companies with advanced development and 
licensure experience, will require the right incentives. We anticipate 
the need to motivate entry into the MCM niche, possibly cost-sharing, 
intellectual property rights, indemnification, or other attributes 
deemed necessary to generate interest.
                       interagency collaboration
    The FDA has already started promoting regulatory innovation and 
investment in regulatory science in order to provide private sector 
partners with more access to regulators and greater clarity about the 
pathways to product approval. We are collaborating with the FDA and our 
other interagency, private sector, and academic partners to explore 
solutions to complex scientific regulatory problems and to identify 
situations in which the application of new science could simplify or 
speed product development and streamline the FDA regulatory approval 
process for medical countermeasures. Regulatory science is a critical 
enabling factor, particularly for unique challenges of developing 
biological defense medical countermeasures where pivotal efficacy 
studies must be done in animal model systems. Together, we will develop 
strategies and assemble new tools for mutual success. Whether it is a 
member of our Armed Forces in the field or a fellow citizen in our 
neighborhood, safe and effective FDA approved medical countermeasures 
are needed when an event occurs.
    Collaboration with the Department of Health and Human Services is 
essential to the successful implementation of the DoD Medical 
Countermeasures Initiative. Not only does this include the FDA, but the 
DoD advanced development and manufacturing capability must complement 
the parallel, but distinct, Biomedical Advanced Research and 
Development Authority work to establish Centers of Excellence for 
Advanced Development and Manufacturing. Leveraging the regulatory 
sciences component of the DoD's Medical Countermeasures Initiative will 
aid in surmounting these challenges by supporting the FDA in developing 
new methods for regulatory assessments so those assessments will not 
hamper moving advanced development programs forward. By working closely 
with HHS, we expect to provide one part of a National advanced 
development and manufacturing capability to support National security 
and meet unique DoD operational requirements.
    Our Nation must have the nimble, flexible capability to produce 
medical countermeasures in a more cost-effective manner and rapidly in 
the face of any attack or threat, whether known or unknown, novel or 
reemerging, natural or intentional. President Obama called for this in 
last year's State of the Union Address. Our effort, along with the 
complementary manufacturing efforts within the Department of Health and 
Human Services, will provide surge production when necessary and will 
address the science and technology efforts to develop the next 
generation medical countermeasure platform technologies, critical 
industrial manufacturing systems and regulatory science technologies. 
DoD has to commit to flexible manufacturing technologies because of the 
breadth of medical countermeasures we need to protect our troops and 
support global operations, and because of the varying numbers of doses 
required for each of these. We do not need to give every service member 
every vaccine, but we do need to be prepared to provide the levels of 
protection required.
    There is no way to draw a line between National security and public 
health so we coordinate closely with our public health colleagues. We 
have a great partnership with other U.S. agencies and are careful to 
maintain our focus on National security to avoid overlap with 
established U.S. public health efforts.
    The Department of Defense has a long and proud history in 
infectious disease medical research and development. The DoD played a 
significant role in developing eight of the 15 adult vaccines licensed 
in the United States since 1962. Currently used worldwide, these 
include vaccines for influenza, meningococcal disease, hepatitis, 
rubella, adenovirus, typhoid, and Japanese encephalitis. In the high-
risk business of vaccine production, experience breeds proficiency and 
efficiency, curbing the scientific, regulatory, and financial risk that 
can stifle product development. Since 2000, biodefense efforts have 
resulted in eight FDA approvals for diagnostics and medical 
countermeasures (including licensed medical countermeasures for 
anthrax, smallpox, and nerve agents) generated in our pipeline. Still 
in the advanced development pipeline are 14 candidates for next-
generation countermeasures against anthrax, smallpox, botulism, 
alphaviruses, plague, influenza, and other emerging infectious 
diseases; chemical agents; and radiological threats. We anticipate more 
FDA approvals in the next 5 years.
    DoD brings a unique capability to the National biodefense 
portfolio: Detection and diagnostics sound the alarm, the 
Transformational Medical Technologies program or similar rapid response 
efforts generate new medical countermeasure candidates, and the Medical 
Countermeasures Initiative will establish the critical industrial 
capacity and expertise for advanced development and manufacture of 
medical countermeasure.
                               conclusion
    We are putting more emphasis on biodefense, particularly medical 
biodefense, leveraging the rapid growth in new technologies for our 
purposes. These threats on our troops or citizens are very real and 
ever-changing in the 21st Century. The Department of Defense must 
develop a nimble and agile program to respond. My organization is 
working to strengthen our capabilities to effectively prevent, deter, 
and defeat these threats. We are working with interagency partners, to 
include the Departments of Homeland Security and Health and Human 
Services, to better detect threats and protect the Nation from harm 
before an event occurs: We are changing the way we address research and 
development so we can be better stewards of the pipeline that we share 
with HHS, and we are becoming more responsive and proactive. I 
appreciate the opportunity to testify today and would be pleased to 
answer your questions.

    Mr. Bilirakis. Thank you very much. Appreciate it, Dr. 
Parker.
    Again, the subcommittee will stand in recess until the 
conclusion of the votes. We will reconvene immediately 
following the last vote as soon as I get a quorum.
    So thank you very much and thanks for your understanding. 
We will see you in a few minutes. We have four votes.
    [Recess.]
    Mr. Bilirakis. Okay. We will go ahead and continue. 
Appreciate you waiting for us. Appreciate your patience.
    The Ranking Member is ready, so I will ask--I will 
recognize myself for 5 minutes to ask questions.
    The first question will be for Dr. Pillai and Dr. Hatchett. 
In what ways does DHS work with HHS on the threat assessments 
so as to ensure that, as a customer, HHS is getting what it 
needs out of the assessments?
    Dr. Pillai. We from DHS are responsible for conducting the 
threat assessments and risk assessments. Based on the products 
that we develop is the support of customers at HHS as well as 
interagencies. With that said, we have actually held multiple 
working group meetings as well as multiple durations of the 
product in the draft stage.
    In the working group meetings we have participation from 
HHS, ask for members from BARDA, members from CDC, FDA, NIH, 
and AID, a factor, as well as members from DOD, the intel 
community, as well as EPA and others. So collectively we try to 
leverage all of the information and knowledge from all of the 
subject matter experts to develop the material threat 
assessments and the risk assessment products to support HHS in 
the process.
    Basically, it is very collectively, collaborative 
architecture to support this effort. With that said, that we 
have been very proactive in soliciting comments and 
recommendations and suggestions from HHS to better improve the 
product over the period of time.
    We continue to receive comments from them, and we continue 
to address them as appropriate, and we continue to refine these 
models and these tools to support HHS to the best of our 
ability.
    Mr. Bilirakis. Dr. Hatchett.
    Dr. Hatchett. Yes, sir. Just to reiterate what Dr. Pillai 
said, we felt we have contributed subject matter experts in the 
early stages of the development of the various assessments. We, 
through the PHEMCE--I should underscore the public health 
emergency medical countermeasures enterprise incorporates DHS 
subject matter experts in our on-going assessments once we 
receive the material threat assessments in performing our 
public health consequence modeling and in making subsequent 
determinations about requirements as they relate to medical 
countermeasures, per se.
    The integrated terrorism risk assessment has been an 
integrated process since that process was initiated several 
years ago. There have been multiple iterations--of course, the 
National Academy of Science's report, and it is a process of 
continual improvement towards our goal of an integrated threat 
assessment and we work closely with our colleagues at DHS.
    Mr. Bilirakis. Thank you.
    Next question for Dr. Pillai: Are you confident that your 
single high-consequence scenario is the best approach for 
setting medical countermeasure requirements? If not, what are 
the plans for revisiting the material threat assessments to 
increase their reliability and utility?
    Dr. Pillai. There are many approaches that one can take to 
support medical countermeasures requirements. One of these 
approaches is basically taking a look at the high possible 
consequence scenario and then utilizing that particular 
scenario to drive the medical countermeasures requirement.
    The benefit of doing that is basically you are capturing 
all of the threat space and potentially, if you develop 
countermeasure requirements, supposedly addressing the high-
consequence scenario, basically captured all of the potential 
low-consequence scenarios that might take place. With that 
said, originally when we started developing our material threat 
assessments at DHS the intent of the material threat 
assessments were basically to support material threat 
determination in support of the Secretary at DHS. With that 
said, there is on-going discussions and collaborations at the 
current time between HHS and DHS to better refine the product 
so that we can support HHS in their medical countermeasures 
requirement generation process.
    With that said, one of the ideas and suggestions we ask is 
potentially redefining the MTAs, or refining the MTAs in such a 
fashion that it will take a look at multiple scenarios so that 
it has got much broader application in terms of supporting HHS 
in their MCM requirements. The other alternate approach is 
basically leveraging the integrated CBNR risk assessment with 
some minor refinement along with some risk mitigation 
strategies to support HHS in their needs in terms of medical 
countermeasures requirement.
    Mr. Bilirakis. One last question for Ms. Bascetta.
    Your office is undertaking a look at DHS's threat and risk 
assessments to try to understand how this work informs HHS 
investments. I understand that your analysis is still underway, 
but have you formed any initial impressions about how this 
process between the two departments is working? Similarly, can 
you speak to relationships within HHS, such as between BARDA 
and CDC for the setting the requirements and priorities?
    Ms. Bascetta. You are correct that our work is underway, 
and we are actually not at the point where we have findings or 
conclusions that I could share. But I am happy to say that, in 
fact, I believe that since 2004 and especially since PHEMCE was 
established in 2006 there has been a significant amount of 
progress and we have a lot of documentation about constructive 
meetings that have gone on between HHS and DHS.
    Within HHS we haven't looked at how well the components are 
working together, but I can say that in other work that we have 
done we have noted that HHS is a large department and many of 
their components are set up with different specific missions. 
You know, in the spirit of maximizing their resources we would 
encourage them to continue to look for ways to reduce 
fragmentation and to ensure that there isn't overlap that, you 
know, isn't--to ensure that there is, you know, better traction 
from the resources that they have. But we don't have evidence, 
at this point, that there is a problem that we would point to.
    Mr. Bilirakis. Okay. Thank you very much.
    I now recognize our Ranking Member, Ms. Richardson, for 5 
minutes or so.
    You are recognized.
    Ms. Richardson. Thank you, Mr. Chairman. My questions are 
for Mr. Hatchett.
    Mr. Hatchett, with regard to the potassium iodide, the 
scientific need for this particular countermeasure is obviously 
well-established over many years. Congress, in fact, has done 
its part by providing the financial mechanisms to stockpile KI 
with the Project BioShield Act of 2004, which funds 
countermeasures against biological and chemical, radiological, 
and nuclear agents, roughly some $5.6 billion through fiscal 
year 2013.
    Could you please explain to this subcommittee why KI has 
not been stockpiled as directed by Congress? What specific 
countermeasures have been done? Where has the money been spent 
thus far?
    Dr. Hatchett. Representative Richardson, with respect to 
potassium iodide, it actually was procured for the Strategic 
National Stockpile. ThyroShield, the liquid formulation of 
potassium iodide, was procured and offered to States in 
compliance with the 2002 Bioterrorism Act.
    The current domestic requirements for potassium iodide have 
been met through the existing program that is administered by 
the Nuclear Regulatory Commission in conjunction with FEMA and 
State and local authorities in States that have nuclear power 
plants or are adjacent to nuclear power plants. So----
    Ms. Richardson. So, have you--the various State agencies to 
see if, in fact, they have sufficient stockpile that is 
required?
    Dr. Hatchett. Well, as I said, this is a long-standing 
program between Nuclear Regulatory Commission and FEMA 
specifically for the procurement, distribution, and dispensing 
of potassium iodide, so I would defer the question to my 
colleagues at NRC. I will say that when we had ThyroShield in 
the Strategic National Stockpile and we offered it to States 
there were some States that accepted the offer of the liquid 
potassium iodide solutions.
    Ms. Richardson. So, could you give this committee an update 
of where the States are regarding this issue?
    Dr. Hatchett. Yes, ma'am. I will need to get back to you 
for the record, if that is acceptable.
    Ms. Richardson. So----
    Dr. Hatchett. HHS administers the Project BioShield funds. 
We have used Project BioShield, actually, for the procurement 
of the ThyroShield product as well as for the procurement of 
another radiation countermeasure, calcium-DTPA, and its--zinc-
DTPA.
    Ms. Richardson. So can you provide for this committee where 
the $5.6 billion has gone?
    Dr. Hatchett. Yes. A detailed explanation would be easier 
to submit in writing, but I would be happy to do that.
    Ms. Richardson. Okay. If you say that States are ready, I 
don't know if you know much about--but I come by way of 
California, and of the more recent situation with Japan where 
there is quite an outcry for potassium iodide, and in fact, it 
was not available. So how is it that you can say that it is 
supposed to be available when in my State it wasn't and we 
were, you know, one of the States along the pathway of the 
potential radiation?
    Dr. Hatchett. Couple of answers. The Nuclear Regulatory 
Commission program focuses on the emergency protection zones 
around nuclear power plants, and so its focus, in terms of 
purchasing and distributing the potassium iodide focuses on the 
EPZs around the nuclear power plants. Potassium iodide is an 
over-the-counter medication. It is available.
    I will say, with respect to the demand for potassium iodide 
in California, public health officials had a great deal of 
concern about that demand because there was not an indication 
for people to take potassium iodide, and potassium iodide, if 
taken inappropriately, can be associated with toxic events.
    Ms. Richardson. Okay. So whether folks were supposed to 
have taken it or not, it is my understanding that KI is 
currently only required to be stockpiled within the 10-mile 
radius. In light of what happened at Chernobyl or Fukushima and 
the Pacifica tolls in Nevada and Utah they are testing, and 
radioactive iodine has traveled 100 miles, which is far beyond 
the 10-mile area.
    Dr. Hatchett. Yes, ma'am. We are actively initiating a 
process to review our requirement for potassium iodide in the 
Strategic National Stockpile. This was initiated as a response 
to the Fukushima Daiichi catastrophe.
    We will certainly take the lessons learned from that in 
reassessing our requirement.
    Ms. Richardson. So, to your knowledge, are you saying that 
you are not aware that the administration is still concurring 
that 10 miles is sufficient? Is that not correct?
    Dr. Hatchett. The current policy is that 10 miles is 
sufficient. That would----
    Ms. Richardson. You are currently reviewing that--is that 
what you said?
    Dr. Hatchett. What we will be reviewing at HHS is the role 
of potassium iodide in a centralized Strategic National 
Stockpile. I am certain that there will be an interagency 
broader review that will look at the zero-to-10-mile issue, but 
that would involve other interagency partners such as DHS, 
FEMA, and the Nuclear Regulatory Commission.
    Ms. Richardson. So, will you supply this committee that 
information and then also supply us the information regarding 
the stockpile, verifying whether, in fact, that is happening 
within the States?
    Dr. Hatchett. Yes, ma'am.
    Ms. Richardson. Okay. Then I do have a second round of 
questions----
    Mr. Bilirakis. Yes. We are going to do a second round, yes. 
I am interested in that issue too, as you are.
    So please supply that information to us. I would really 
appreciate it.
    Dr. Hatchett, by the way of reorganization the assistant 
secretary for preparedness and response directed that the 
activities of BARDA's contracts office be separated from those 
of BARDA's technical group, yet the contracts office has 
contracting officers, not the scientific expertise needed to 
determine whether or not companies have met their scientific 
milestones. We have heard from many avenues that this model is 
ineffective.
    Can you explain to the committee why this action was taken? 
How do you explain the substantial complaints about 
contracting, that contracts take too long, that streamlining 
authorities are not being taken advantage of, and that 
contracting officers are making decisions that should be made 
by policy or technical staff? This is no small question and it 
appears to be the source of serious development and procurement 
problems at BARDA. So that is my first question and I have a 
second question.
    Dr. Hatchett. Okay. I think you have actually asked 
multiple questions and----let me take them in sequence.
    The change in reporting for the head of the contracting 
office--the head of the contracting office used to report to 
Dr. Robinson, the director of BARDA. He now reports to Dr. 
Lurie, the assistant secretary for preparedness and response. 
Physically, the contracting office is physically still in its 
same location, which is in an office that is shared with BARDA 
staff, so there has been no disruption of the relationships 
between BARDA program staff and BARDA contracting staff.
    The idea that technical decisions are being made by 
contracting officers actually is not correct. BARDA and the 
contracting staff and their office of finance within ASPR has 
created a decision gate process that is modeled on other 
substantial acquisition programs at the Department of Defense, 
Department of Energy, NASA, et cetera, and as well as--it 
included a review of similar cost estimates in private sector 
pharmaceutical companies.
    That decision gate process provides for milestone-based 
decisions about moving forward with specific projects, and 
those milestone-based decisions are--they use an in-process 
review, which brings in subject matter experts from across HHS 
and the interagency to review the progress of specific projects 
and to make appropriate decisions about whether they should 
move forward or whether sufficient concerns have arisen that 
adjustments need to be made.
    Is that a sufficient answer to your question, sir?
    Mr. Bilirakis. I think that is it, but I would like to 
speak with you, again, follow up on this.
    Then the next question is, why hasn't HHS ever exercised 
its other transaction authority?
    Dr. Hatchett. I think certainly we have not identified, to 
date, a specific requirement for using the other transaction 
authority. We actually do anticipate that we will be using it 
in the relatively near term, particularly in support of our 
broad spectrum antimicrobial program. The other transaction 
authority will help facilitate public-private partnerships for 
the development of multiuse countermeasures, particularly where 
some of those uses for which the products are being developed 
fall outside the CBRN sphere. So I would ask you to standby and 
we hope to be----
    Mr. Bilirakis. All right. Thank you.
    Dr. Parker, I am pleased to hear from your testimony that 
DOD works in tandem with DHS and HHS to leverage your efforts 
and expertise. Unfortunately, for the civilian medical 
countermeasures enterprise some will argue that much of 
industry has already been lost, that the barriers to effective 
partnership with the Federal Government for developing CBRN 
medical countermeasures are too high.
    But yet, DOD made the public-private development 
partnership work for stealth bombers. Why can't we do the same 
for medical countermeasures?
    Dr. Parker. Well, actually in medical countermeasures DOD 
shares some of the very similar challenges that HHS shares in 
this arena, and we are both--we are working together to--
actually have worked together to much better understand what 
those challenges are. The collective approaches we are taking 
now are trying to address those barriers so we can create much 
more effective partnerships and real-time communication between 
the Government at all levels, our industry partners, and also 
to encourage and promote the gleaning together with our 
industry partners the right looks of what we need from 
innovation, particularly from small biotechnology companies.
    But also we need to leverage and take advantage of some of 
the experience base of some of the larger pharmaceutical 
companies that have more demonstrated experience navigating the 
regulatory pathway, the scale-up manufacturing, and so forth, 
and trying to calibrate, you know, the exact-like index of 
Government partners, the experience of folks in industry, and 
our innovators from biotechnology, including coming in from 
academia.
    The experiences, you know, in Chernobyl and just in the 
last 5 to 6 years in this area, we have learned a lot, I think, 
both in Government and both industry about the challenges. 
Biodefense is a hard area. It really is--does demand a very 
multidisciplinary approach and an interagency approach. 
Collectively, I think, with our Government partners and our 
industry partners I think today we have a much better 
understanding and we are trying to work on those and reduce 
those barriers so we can deliver those needed medical 
countermeasures for our citizens and our troops.
    Mr. Bilirakis. Thank you, Dr. Parker.
    Now I will recognize Ms. Richardson for 5 minutes.
    Ms. Richardson. Thank you, Mr. Chairman.
    First of all, for Dr. Pillai--I apologize if I pronounced 
that wrong--several weeks ago this committee had a hearing 
featuring the head of DHS office of health affairs. Questions 
remain regarding how OHA fits inside the DHS enterprise. This 
committee wants to ensure that the roles are clearly defined in 
order to prevent an overlap and a duplication of efforts.
    What role will the science and technology S&T directorate 
play in the biodefense in DHS and how does that role differ 
from or overlap with the statutory responsibilities of the 
chief medical officer who is statutorily required to coordinate 
the biodefense at DHS?
    Dr. Pillai. Thank you, ma'am for the question. From DHS 
science and technology perspective we are focused, really, on 
the R&D aspects. We conduct research and development-related 
activities as well as threat assessments, risk assessments to 
support the director as well as the Department as a whole.
    The office of health affairs has the responsibility to 
oversee the--such as Biowatch and--in addition to that, they 
also serve as the chief medical advisor to the Secretary of DHS 
in terms of medical countermeasures procurement-related 
activities as well as our requirements-related activities.
    Ms. Richardson. Okay.
    Mr. Hatchett, could you describe for me what is the process 
regarding anthrax vaccine, what is available?
    Dr. Hatchett. Yes, ma'am. Thank you for the question.
    We, as you are probably aware, do currently stockpile 
anthrax vaccine, the AVA, Anthrax Vaccine Adsorbed, in the 
Strategic National Stockpile. We are supporting, through 
advanced development contracts, the development of recombinant 
protective energy vaccines, which are considered to be next-
generation vaccines.
    We are also supporting----
    Ms. Richardson. When you say supporting what do you mean by 
supporting? Because it is my understanding we have had some 
problems in that area.
    Dr. Hatchett. We are funding the advanced development of 
the RPA vaccines. We have funded the procurement of the AVA 
vaccine for the Strategic National Stockpile.
    I would say that the technical challenges have certainly 
been profound in terms of developing the next-generation 
vaccine. We have been supporting these vaccines for many years 
and we continue to support them.
    Ms. Richardson. Okay. It is my understanding that--
opportunity to--companies, and it is my understanding that we 
are using a 40-year-old vaccine, other products are potentially 
available, that there has been much delay in terms of--well, 
first of all, confusion in terms of whether a product should be 
developed in the United Kingdom, whether it should be done here 
in the United States, and once companies make a commitment and 
they come here then it is on and on with multiple changes.
    So have you had an opportunity or who within your 
organization has been working on this project?
    Dr. Hatchett. We have an anthrax vaccine group within the 
CBRN division of BARDA that superintends our contracts in this 
area. The AVA vaccine has been licensed for some time. I don't 
know the length of time.
    But we are actually working--our colleagues at the National 
Institutes of Health are currently funding studies to improve 
and optimize the existing vaccine. We are funding a number of 
contracts, as I said, to develop the next-generation vaccines. 
I can't, in this forum, speak to the commercial and proprietary 
details of the individual contracts but would be happy to get 
back to you for the record.
    Ms. Richardson. So would you be willing to discuss some of 
the problems that we are having? I might have pronounced it 
improperly, but I can supply you with the details if you need 
it.
    Dr. Hatchett. Yes, ma'am. I think you mean----
    Ms. Richardson. Yes. Thank you.
    Dr. Hatchett. We are currently working with them. I mean, 
they are receiving funding from us currently.
    Ms. Richardson. But I don't know if you are aware of some 
of the difficulties that have been brought to this committee's 
attention.
    Dr. Hatchett. I am aware of them, but this isn't the 
appropriate forum to discuss them for proprietary reasons.
    Ms. Richardson. Okay. But it is the appropriate forum if it 
is not being done correctly and the American public is at risk 
because--have been delayed. This is actually the forum. So I am 
going to suffice to say, do we have a commitment from you that 
you will meet with them and get an understanding of what the 
problems are and then give an update to the committee?
    Dr. Hatchett. Yes, ma'am.
    Ms. Richardson. Okay. Thank you.
    I would also like to acknowledge we have the CEO, Mr. Alan 
Morris, who is with Anbex Corporation, and they work with 
potassium iodide. Similarly, as I said, coming from California, 
it is my understanding some of these companies who actually 
work with the Government, who supply to the Government, don't 
seem to have some of the same communication open levels to be 
able to get us where we need to be.
    Because if in the event something happens then it is not 
probably--we need to make sure it is going to be our 
responsibility, as a part of being on this committee, that we 
didn't sit idly by knowing that you are not ready. I am not 
convinced at this point that we are properly ready.
    Dr. Hatchett. Yes, ma'am. Thank you for the comment.
    With respect to potassium iodide and the manufacturers, we 
have been in frequent contact both with Anbex, with their U.S. 
distributor--I believe their U.S. distributor, Heyltex, and 
with Fleming, which is the manufacturer of ThyroShield--to 
understand the current demand for the products, to understand 
their production capacity and how long it would take to 
manufacture additional potassium iodide should there be a 
requirement for immediate procurement. So we have battled very 
aggressively to stay on top of those issues.
    Ms. Richardson. Will you follow up with them as well?
    Dr. Hatchett. We are in at least weekly touch with them 
already, but yes, we will continue to do that.
    Ms. Richardson. Give a report to the committee?
    Dr. Hatchett. Yes, ma'am.
    Ms. Richardson. Thank you.
    Mr. Bilirakis. Thank you very much.
    I believe that we will finish with this panel. I thank you 
very much for your patience. Thanks for your testimony, and you 
are dismissed.
    We will call up the second panel.
    Good afternoon. Thanks for your patience.
    I welcome our second panel. Our first witness is Ms. 
Phyllis Arthur. Ms. Arthur is senior director for vaccines, 
immunotherapeutics--I am sorry, that is a mouthful--and 
diagnostics policy at the Biotechnology Industry Organization. 
In this role Ms. Arthur is responsible for working with member 
companies on vaccines, molecular diagnostics, and biodefense 
policy on policy, legislative, and regulatory issues.
    Ms. Arthur joined BIO in July 2009. Prior to joining BIO 
she held numerous positions with Merck. Ms. Arthur received her 
Bachelor's in economic and international politics from Goucher 
College and her MBA from the University of Pennsylvania Wharton 
School of Business.
    Our next witness is Mr. John Clerici. Mr. Clerici is a 
founding principal of Tiber Creek Partners and a partner in the 
Government contracts practice at McKenna Long & Aldridge, where 
he assists companies developing biotechnology for emerging 
disease and engineer threats.
    Mr. Clerici was instrumental in the passage of the Public 
Readiness and Emergency Preparedness Act as well as the 
creation of BARDA. Mr. Clerici has also served as a judge 
advocate in the United States Air Force. He received his 
undergraduate degree from Catholic University and his Juris 
Doctor from the University of North Carolina at Chapel Hill.
    Welcome.
    Finally, we will receive testimony from Dr. Daniel Fagbuyi. 
Dr. Fagbuyi is the medical director of disaster preparedness 
and emergency management at Children's National Medical Center 
in Washington, DC. He is an assistant professor of pediatrics 
and emergency medicine at George Washington University School 
of Medicine with board certification in pediatrics and 
pediatric emergency medicine.
    Dr. Fagbuyi was recently appointed to the National 
Biodefense Science Board by Secretary Sebelius. Dr. Fagbuyi 
served in the United States Army where he served as a battalion 
surgeon during Operation Iraqi Freedom. Dr. Fagbuyi received 
his medical degree from George Washington University School of 
Medicine.
    Welcome to all the panelists, and we look forward to your 
testimony.
    Ms. Arthur, you are recognized to testify for 5 minutes. 
Thank you, and welcome.

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

    Ms. Arthur. Thank you.
    Good afternoon, Chairman Bilirakis, Ranking Member 
Richardson, other Members, and ladies and gentlemen. As you may 
know, BIO represents more than 1,100 companies, academic 
institutions, State biotechnology centers and related 
organizations in all 50 States.
    BIO members include a broad mix of small, medium, and large 
companies involved in medical countermeasures, or MCMs. These 
companies develop and manufacture products for the detection, 
diagnosis, treatment, prevention, and delivery of 
countermeasures in the response to CBRN threats.
    Ensuring the availability of MCMs that will save lives 
during a public health crisis or man-made attack is the 
responsibility of the U.S. Government. The lack of a viable 
commercial market for countermeasures necessitates the active 
engagement of the Government in their development.
    Bipartisan Congressional efforts have created and funded an 
enterprise that has begun to show success, leading to the 
stockpiling of several new countermeasures in the areas of 
smallpox and anthrax as well as the awarding of new procurement 
contracts for other countermeasures. Future investments are 
pivotal to continue that success and further strengthen and 
improve our responsiveness.
    BIO has identified three core areas that have limited 
industry's participation in the countermeasures enterprise: 
First, defining a viable market value for MCMs versus the 
opportunity cost of investing in a different area; second, 
management of cost and risk, especially in the regulatory 
process; and third, sustainability of this market over time.
    The Project BioShield Act of 2004 accomplished several 
important goals, including the creation of a special reserve 
fund, or SRF. BioShield was designed to guarantee companies 
that the Government will purchase new successfully developed 
countermeasures for placing in the Strategic National 
Stockpile.
    Annual appropriations to BARDA and the existence of the SRF 
define the marketplace for MCMs. Companies can save these funds 
when comparing the opportunity costs of developing--of pursuing 
the development of specific countermeasures. Company time and 
funds spend on developing these products devotes scarce 
resources away from commercial products and must be subjected 
to the same rate of return analysis.
    In addition, private investors place little value on this 
type of research as the market is difficult to calculate and a 
guarantee of product success is not certain. Therefore, there 
are limited private sector funds.
    Part of the opportunity costs assessed by industry is the 
time required to achieve success. While the industry finds 
BARDA an effective partner in advanced development, the 
acquisition and contracting functions to acquire new 
countermeasures are viewed as lengthy, opaque, and 
unpredictable.
    The development of countermeasures is a unique, resource-
intensive, complex process that can impact the opportunity 
costs. Countermeasures are approved via a convoluted regulatory 
pathway requiring use of animal models to prove efficacy, which 
adds an extra dimension of risk and uncertainty.
    BIO strongly supports the recommendations to invest 
significantly in FDA review and regulatory science processes. 
FDA needs to be given an affirmative role in solving the 
scientific and regulatory hurdles--of solving the regulatory 
hurdles of MCMs. BIO recommends that the FDA be strongly 
encouraged to work collaboratively with company sponsors to 
design development plans and associated studies, especially 
those requiring the use of animal models.
    Due to the long development timelines for biological 
products, industry partners need to be able to plan and 
communicate with their investors. BIO recommends that Congress 
formally establish a process by which HHS and all its relevant 
agencies develop an integrated 5-year plan that can be shared 
with all stakeholders, and specifically industry.
    Lastly, it is critical the United States build capability 
to detect and identify new threats, such as emerging diseases 
or genetically modified pathogens. To increase speed and 
accuracy in detecting emerging diseases and threats BIO 
recommends that efforts be made to extend the surveillance 
network and invest in new platforms and design tools that can 
increase efficiency and reduce costs.
    The reauthorization of PAHPA and the replenishment of the 
BioShield SRF are critical to these efforts. Therefore, BIO 
strongly urges Congress to replenish the SRF 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.
    BIO commends the committee for holding this important 
hearing and stands ready to work with Congress on these 
important issues. Congress has the opportunity to implement 
changes to the PHEMCE that will improve preparedness, 
accelerate approvals, and reduce the cost of developing 
essential medical countermeasures, and we look forward to 
working together with you on these efforts.
    Thank you.
    [The statement of Ms. Arthur follows:]
                  Prepared Statement of Phyllis Arthur
                             April 13, 2011
    Good morning Chairman Bilirakis, Ranking Member Richardson, 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 
manufacturing of medical countermeasures or MCM's. 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 events.
    Ensuring the availability of MCM's that will save lives during a 
public health crisis (such as pandemic influenza) or weapons of mass 
destruction attack (such as anthrax) is the responsibility of the U.S. 
Government. BIO and its members were therefore encouraged when 
Secretary Sebelius engaged the Department of Health and Human Services 
(HHS) in an intense review of the Public Health and Emergency 
Preparedness Enterprise (PHEMCE). BIO actively engaged in this process, 
participating in stakeholder meetings related to most facets of the 
Enterprise. Some of the recommendations from industry were incorporated 
into the final review and still others can be included in the upcoming 
reauthorization of the Pandemic and All-Hazards Preparedness Act 
(PAHPA) or other biodefense-related vehicles moving through Congress.
    The lack of a viable commercial market for most of these products 
necessitates the active engagement of the Government in the development 
of these essential products. Over the last 10 years, bipartisan 
Congressional efforts have created and funded an Enterprise that has 
begun to show success. In the past 2 years, several key countermeasures 
in the area of smallpox and anthrax have been delivered to the 
Strategic National Stockpile. Furthermore several key procurement 
contracts have been issued that will lead to the final development of 
other countermeasures. Future plans and investments are pivotal to 
continue that success and further strengthen and improve the 
responsiveness of the United States.
    One of the goals of the U.S. Government in conducting the MCM 
review was to identify and solve those issues limiting companies of all 
sizes from successfully engaging in the countermeasures process. BIO 
identified three core issues that have limited industry's participation 
in PHEMCE. These issues fall into three categories: (1) Defining a 
viable market value for MCMs versus the opportunity cost of investing 
in a different area; (2) management of cost and risk, especially in the 
regulatory process; and (3) 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 part was the creation of the Special 
Reserve Fund (SRF). BioShield is designed to guarantee companies that 
the Government will purchase new, successfully developed 
countermeasures for placement in the Strategic National Stockpile 
(SNS). Annual appropriations to the Biomedical Advanced Research and 
Development Authority (BARDA), which was created in 2006 and manages 
Project Bioshield and PHEMCE, and the existence of the SRF, define the 
marketplace for MCM's. 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 funds, spent on 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 and the guarantee of Government purchase is uncertain. 
Therefore, there are very limited private sector funds to support 
companies in the MCM space.
    Part of the opportunity cost assessed by industry is the time 
required to achieve success. While industry, particularly small 
biotechnology companies, finds BARDA an increasingly desirable and 
effective partner in advanced development, 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, some acquisitions are 
delayed by years or canceled. The negotiation process is needlessly 
lengthy with technical and security issues resolved prior to pricing 
discussions. The rationale and potential triggers for contract options 
are unclear. Lastly, while Federal Acquisition Regulations (FAR  
12.102(f)(1)) states that contracting officers ``may treat any 
acquisition of supplies or services that, as determined by the head of 
the agency, are to be used to facilitate defense against or recovery 
from nuclear, biological, chemical, or radiological attack, as an 
acquisition of commercial items,'' not a single novel countermeasure 
has been designated as a commercial item. The signal to industry is 
that despite the enormous risks of development of novel 
countermeasures, pricing of new drugs and vaccines developed as 
countermeasures, is far below that in commercial markets.
  (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. In many respects the regulatory process 
for MCM's is no different from commercial biologicals. Products 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 other ways MCM 
development and approval is much more complicated. The required use of 
animal models to prove efficacy adds an extra dimension of risk and 
uncertainty to this process.
    The coordination and collaboration between the various Government 
agencies involved in the Enterprise can add 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. While 
BARDA and its Department of Defense counterparts have been working more 
collaboratively to coordinate their requirements, the FDA has not been 
as involved in the discussion of threats or in the early development of 
these requirements. 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 new regulatory 
actions by companies in order to achieve licensure for a product.
    One of the most significant recommendations from the PHEMCE review 
was the recommendation to invest significantly in the FDA review and 
regulatory science processes. This is a recommendation that is strongly 
supported by BIO and its members. The FDA has tremendous expertise in 
the science of drug development and the manufacturing of complex drugs, 
diagnostics, and biologics. 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 MCM's. This can best be accomplished by encouraging the 
FDA to work collaboratively with company sponsors 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, 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 builds capability to respond to new threats such 
as newly emerging diseases and genetically-modified pathogens.
    The reauthorization of PAHPA and the replenishment of the BioShield 
SRF are critical to these efforts. Therefore BIO strongly urges 
Congress to replenish 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.
    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 its MCM projects with some 
increased level of certainty. 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. 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, could encourage increased industry participation.
    Lastly, one of the most critical parts of responsiveness involves 
the Nation's ability to detect and identify these threats to best mount 
the proper and timely response. BIO members are also concerned that the 
U.S. Government make the right investments in global and U.S. 
surveillance testing and reporting networks. Efforts should be made to 
extend the network and invest 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.
    BIO commends the committee for holding this important hearing and 
stands ready to work with Congress on these important issues. Ensuring 
the availability of MCMs is a critical responsibility of the U.S. 
Government. The lack of viable commercial markets for these products 
necessitates the active engagement of Government in supporting the 
development of these essential products. 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. Future plans and investments are essential to 
this effort.
    Congress has the opportunity to implement changes to the PHEMCE 
that will improve preparedness, accelerate approvals and reduce the 
cost of developing essential medical countermeasures, including medical 
devices, and we look forward to working together with you in these 
efforts.

    Mr. Bilirakis. Thank you, Ms. Arthur. Appreciate it.
    Mr. Clerici, you are recognized for 5 minutes.

STATEMENT OF JOHN M. CLERICI, PRINCIPAL, TIBER CREEK PARTNERS, 
                              LLC

    Mr. Clerici. Thank you.
    Good afternoon Mr. Chairman and Congresswoman Richardson. 
For the last decade my colleagues and I have had the 
opportunity to work with dozens of companies pursuing medical 
countermeasures targeting CBRN and emerging infectious disease. 
From this vantage point I have personally seen both the good 
and the bad of the process and am delighted to share those 
observations with you today.
    As the subcommittee is aware, in the last decade Congress 
has passed several pieces of legislation to address public 
health preparedness, including the PAHPA legislation. In 
addition, Congress has provided billions in appropriation.
    The PAHPA legislation created BARDA, and it has achieved 
its goals of providing BARDA with the toolbox it needs to do 
its job. PAHPA should be reauthorized this year by Congress 
without need for significant modification.
    However, the toolbox provided to BARDA through PAHPA has 
been locked away while the organization is subjected to 
persistent internal and external reviews as well as constant 
shifts in strategic direction. Following what was generally 
viewed by the informed public health community as a very 
successful response to the 2009 influenza pandemic, BARDA 
underwent no less than three internal and external reviews 
during the course of 2010 to analyze its effectiveness. These 
reviews resulted in near standstill activity for almost a year 
and culminated in yet another shift of priorities for the 
organization.
    The solution here is simple. There must be a clear 
statement of priorities, including the allocation of resources 
and funding, with a realistic and achievable schedule for 
implementation that will actually be followed without delay. 
This does not require legislative change or even a future 
appropriation.
    Turning to my second observation, there have been several 
recent examples where a public health emergency has presented a 
situation that allows public health officials to 
retrospectively and proactively examine what could be done 
better or learned from the event. I am concerned that several 
of these situations have passed without proactive action. Let 
me offer an example to make this point.
    In March 2009 there was a widely reported incident in San 
Diego where a young Marine developed progressive vaccinia, a 
disease that closely resembles smallpox, after he received a 
smallpox vaccination. There was a tremendous response by 
military doctors, the CDC, and the FDA to respond to this 
incident. However, curiously, neither ASPR nor its parent 
organization ASPR--pardon me, neither BARDA nor its parent 
organization, ASPR, was part of this response.
    There were multiple products used to treat this patient, 
including products currently in the Strategic National 
Stockpile, as well as experimental products in late-stage 
development for a smallpox incident. The lessons learned from 
this case are extremely valuable for understanding what a mass 
casualty event involving smallpox would look like and 
determining effective therapeutics.
    Based on my understanding, there has been no affirmative 
outreach by either BARDA or ASPR to debrief the industry 
responders to understand what they learned about this incident. 
To the opposite, when BARDA was asked during the course of an 
active procurement by a prospective offerer to affirmatively 
consider the experience of human use of these products in 
evaluating which products were most appropriate for stockpile 
that request was declined.
    My strong belief is this failure to be proactive is not a 
result of inaction or lack of forethought by the BARDA 
leadership. Rather, the likely cause is unnecessary 
interference with the BARDA leadership and program managers by 
the contracting officers based upon perceived restrictions of 
Federal acquisition regulations.
    I emphasize the word perceived given that there is 
absolutely nothing that prevents these interactions from taking 
place. Yet, it has been my experience that communications from 
the BARDA leadership have been unnecessarily constrained by 
contracting officers to the significant detriment of BARDA's 
mission.
    My final observation is the need to be a greater focus on 
the sustainability of the overall public health enterprise. 
Reauthorization of Project BioShield and replenishment of the 
SRF is a key component in this sustainability. I strongly 
encourage Congress to do both in conjunction with the 
reauthorization of PAHPA.
    To ensure sustainability the first order of business must 
be to make sure that the products currently in the SNS are 
maintained at their current level. For products such as the 
licensed anthrax vaccine or smallpox vaccines that means 
ensuring CDC has both the funding and the processes it needs to 
ensure the levels of non-expired vaccine in the stockpile at a 
very minimum are maintained.
    The CDC must also stockpile adequate levels of 
countermeasures to match the material threat assessments 
conducted by the Department of Homeland Security. For products 
that have yet to achieve FDA approval, including the anthrax 
therapeutics and next-generation smallpox vaccines, that also 
means that BARDA must expeditiously exercise the options in 
those contracts to retain the supply of unexpired products at 
the level currently in the stockpile. This will also ensure the 
substantial investment BARDA has made in the manufacturing 
capacity to support these products is not lost.
    Next, the medical countermeasures review correctly placed 
significant importance upon the need to procure broad spectrum, 
dual-use products--that is, products that both have a CBRN and 
commercial use. Once approved by the FDA for commercial 
indication, the cost to the Government to sustain these 
products for CBRN use is far lower than the need to re-procure 
and stockpile products that are usable only for a public health 
emergency.
    Although the benefits of dual-use technologies are clear, 
it appears that products that lack this dual-use potential are 
still being favored for procurement under Project BioShield, 
although BARDA has funded these programs in advanced 
development. This lack of consistency with the clear mandate of 
medical countermeasure review is puzzling.
    Given the clear investment in creating and staffing the 
organization, BARDA should also have a clear role in the 
response to non-biodefense public threats, such as the rise of 
multi-drug resistant pathogens, the super bugs that are killing 
far more people at every--far more people every year than 9/11 
and even HIV. Emerging tropical diseases like dengue and global 
health diseases such as tuberculosis are impacting the United 
States, with a growing number of cases of dengue and TB in 
Florida, Hawaii, and elsewhere. BARDA should play a significant 
role in addressing these emerging diseases.
    This is one area where I believe Congress should 
affirmatively act to modify PAHPA legislation to explicitly 
give BARDA the mandate to address drug resistance as well as 
emerging infectious disease. This may require additional 
appropriations to support this expanded mission, but it is an 
area that needs to be addressed and BARDA is likely suited 
for--is ideally suited for this mission.
    In closing, I would like to go back to the discussion about 
Japan. If we look towards Japan, the lack of proactive 
decisions to inventory what drugs are currently available to 
respond to a nuclear emergency, of not ensuring that well-
conceived protocols are written in advance of these 
emergencies, and the failing to hear the wake-up call the 
events of the last month to prepare America for a nuclear 
incident could be devastating, as Congressman Richardson 
already pointed out.
    The decision made here--made today, or better yet, the 
decisions that are not being made today, will almost certainly 
result in leaving our homeland vulnerable.
    I thank you, Mr. Chairman and Congresswoman Richardson, for 
doing everything you can to protect our homeland. Thank you.
    [The statement of Mr. Clerici follows:]
                 Prepared Statement of John M. Clerici
                             April 13, 2011
    Good afternoon Mr. Chairman, Congresswoman Richardson, and Members 
of the subcommittee. My name is John Clerici and I am a principal of 
Tiber Creek Partners, a firm dedicated to assisting biotechnology 
companies throughout the world to ensure the development of the very 
best products that will have a positive impact upon public health and 
emerging infectious disease. For the last decade, my colleagues and I 
have had the opportunity to work with dozens of companies pursuing 
medical countermeasures targeting chemical, biological, radiological, 
and nuclear (CBRN) threats, many of which now sit in the U.S. Strategic 
National Stockpile and a number of which were deployed for use during 
the 2009 influenza pandemic. We have been involved in nearly every 
effort by the U.S. Government to support and purchase these products 
over the last 12 years, including working with many of your colleagues 
in Congress to support legislation to protect the American people from 
a variety of public health threats. From this vantage point, I 
personally have seen both the good and the bad of this process and I am 
delighted to share those observations with you in the hope that we can 
build upon the successes and learn from the challenges over the last 
decade with the mutual goal of ensuring our Nation is as prepared as 
possible.
    I have three main observations that I would like to share with the 
subcommittee this afternoon regarding the current efforts by what 
collectively is known as the ``Public Health Emergency Medical 
Countermeasures Enterprise'' in identifying and procuring medical 
countermeasures to address bioterrorism, nuclear preparedness, and 
emerging infectious disease.
    First, the current laws passed during the last decade have proved 
generally satisfactory to provide the relevant public health officials 
with the legal authorities, funding and structure necessary to carry 
out their mission. However, the implementation of these laws has been 
unnecessarily burdened by constant internal and external reviews, 
delayed action, bureaucracy, and a lack of transparency. This has had a 
devastating effect upon the willingness of the private sector to 
participate in these programs. Second, there have been several recent 
instances, to include the on-going crisis in Japan, where there has 
appeared to be a lack of proactive efforts to look toward an incident 
as a reminder that we need to bolster the knowledge base and 
understanding of what a mass casualty event in the United States would 
look like, and additionally demonstrates our need to more fully 
understand how medical countermeasures would be used, what resources 
are needed that are not currently available, and how best to reach 
those in need. I am concerned we are not being proactive to learn the 
proper lessons from these events. Last, there is a similar lack of 
proactive planning to address the sustainability of the medical 
countermeasures that have already been developed and purchased to 
maximize the value of the investments already made, as well to take 
full advantage of the benefits of sustainable, dual-use, broad-spectrum 
technologies.
    With your permission, I would like discuss each of these 
observations in greater detail and offer some thoughts on proposed 
solutions that I believe are easily achievable in the short term.
    As the subcommittee is aware, in the last decade, Congress has 
passed several key pieces of legislation to address public health 
preparedness, including the Bioterrorism Act of 2002, the Project 
BioShield Act of 2004, the PREP Act of 2005, and the Pandemic and All 
Hazards Preparedness Act of 2006 (known as PAHPA). In addition, 
Congress has provided billions in appropriations to support these 
programs. The PAHPA legislation, which created the Biomedical Advanced 
Research and Development Authority (BARDA), was meant to fill in the 
gaps in Project BioShield to help companies through the ``valley of 
death'' between advanced development and FDA approval, as well as 
streamline the procurement process. This bipartisan legislation, which 
earned the unanimous support of the House and Senate, was carefully 
crafted to provide the Executive branch all the authorities needed to 
carry out this important public health mission. I do not think it can 
be disputed that PAHPA achieved its goal of providing BARDA with the 
toolbox it needs to do its job. Thus PAHPA should be reauthorized by 
Congress this year without the need for significant modification.
    However, what was not anticipated by Congress in passing PAHPA, and 
what requires immediate attention, is the reality that the toolbox 
Congress provided to BARDA has been locked away while the organization 
is subjected to persistent internal and external reviews, as well as 
constant shifts in strategic direction, that have left industry 
confused and disheartened. Following what was generally viewed by the 
informed public health community as a very successful response to the 
2009 influenza pandemic, BARDA underwent no less than three internal 
and external reviews during the course of 2010 to analyze its 
effectiveness. These reviews resulted in a near stand-still of activity 
for almost a year and culminated in yet another shift in priorities for 
the organization. This included a transfer in critical human and 
financial resources away from implementing the Draft Strategic Plan 
announced in 2007, and toward implementation of the August 2010 
``Public Health Emergency Medical Countermeasures Enterprise Review.'' 
Although the Medical Countermeasures Review provides broad suggestions, 
it does not provide the necessary transparency to industry regarding 
what products are required, in what quantities, and paid for with what 
budgets, all of which had been outlined in the 2007 Draft Strategic 
Plan. This information is absolutely critical in order for industry to 
devote its scarce resources to the public health preparedness sector.
    This is not to say that all of the recommendations of the MCM 
review are flawed or that reviews are unwarranted. However, this 
constant shift in priorities and funding, along with delays, has 
presented considerable uncertainty that has directly impacted the 
ability of companies to participate in medical countermeasure 
initiatives. This lack of transparency is an enormous barrier to long-
term private sector interest in working the U.S. Government on medical 
countermeasures.
    Moreover, the continued delays in both issuing requests for 
proposal and awarding contracts have placed tremendous pressure upon 
industry to justify its continued participation in the U.S.-funded 
public health efforts. As you can imagine, in these financial times, 
when the management of a biotech, no matter the size, cannot tell its 
investors when an opportunity is coming and how much the opportunity 
will be potentially worth to the company, the resources dedicated in 
pursuit of that effort will be cut, plain and simple. The solution to 
this problem is not to make the function into a Government-run entity, 
as some have suggested, but rather to adjust the Government's 
performance to maximize private sector participation as envisioned by 
Project BioShield.
    To exemplify this point, consider that there are currently four 
FDA-approved products that have the immediate potential to benefit 
victims of a nuclear incident--regardless of whether it was caused by 
nature, as in what has happened in Japan, or detonation of a improvised 
nuclear device, an event the co-chairs of the 9/11 Commission described 
as ``certain'' to occur in their lifetime. Three of these products are 
made by the two of the largest of biotechnology companies in the world 
and have not only been on the market for over 10 years, but have been 
used in nuclear accidents in the past. The BARDA leadership is well 
aware of these products and is eager to see procurement of these 
products move forward. Yet after over 2 years of discussions, no 
Requests for Proposal have been issued to allow the Government to 
acquire these products, even though the funding is currently available 
in the Special Reserve Fund under Project BioShield to do so.
    I am aware that at least two of these companies are under extreme 
pressure from their management to justify any continued efforts in 
pursuing these projects due to these delays. One of those companies 
feeling this pressure is a small, yet well-funded, biotech, whose 
investors view efforts to try to assist BARDA as an unwarranted 
distraction, even though this company has an FDA-approved product that 
would have an immediate benefit to victims of a terrorist attack, as 
well as a natural disaster. Small biotechs are exactly the innovative 
engines the Government needs to address these public health problems. 
If these companies ultimately have to walk away due to these 
unwarranted delays, there is no question it will cost lives in the 
future.
    The solution here is simple. There must be a clear statement of 
priorities, including allocation of resources and funding, with a 
realistic and achievable schedule for implementation that will actually 
be followed without delay. This does not require legislative change or 
even future appropriations. But it is absolutely critical in order for 
industry's participation in public health preparedness efforts to 
continue.
    Turning to my second observation, there are several recent examples 
where a public health emergency has presented a situation that allows 
public officials to not only assess the ability of the United States to 
respond in a ``live fire'' exercise, but also to retrospectively, and 
proactively, examine what could be done better or could be learned from 
the event. I'm concerned that several of these situations have passed 
without proactive action to learn from the event. Let me offer three, 
specific examples to make this point.
    The subcommittee is well aware of the growing challenges facing 
Japan as well as the flurry of discussions these incidents have sparked 
regarding the state of U.S. preparedness for all three aspects--the 
earthquake, the tsunami, and the nuclear emergency--of the disaster. 
There are medical countermeasures currently available as well as 
products under development in the United States, many of which are 
funded by BARDA and DOD, which could play an important role in one or 
more the elements of the response in Japan.
    It is completely understandable that the United States cannot and 
should not act without being requested to do so by the Japanese 
government. It is equally understandable that BARDA cannot and should 
not be placed in the position of supporting the use of a non-FDA 
approved product outside of the authority provided by Project 
BioShield. However, it seems that it would be appropriate for BARDA to 
proactively reach out to its industry partners to: (1) Determine what 
products, if any, are currently available should they be requested by 
Japan and in what quantities and location; and (2) should these 
products be requested for use in Japan, what type of protocols, 
including Phase 4 and Emergency Use protocols, need to be in place to 
ensure the products are used as safely and effectively as possible. 
Having this information in hand today is key to being able to respond 
immediately if a request for assistance is received from Japan (or any 
other country facing a nuclear incident), rather than having to delay 
the response while this information is collected in a reactionary 
fashion. None of these actions require a request by Japan from 
assistance, nor do they require legislative action or additional 
funding. Yet, based upon discussions with several of the relevant 
companies, this proactive outreach has not occurred.
    In a similar vein, the subcommittee may be aware that there have 
been several recent incidents of anthrax infection in heroin users in 
Scotland. The U.K. public health officials have faced unique challenges 
with these patients and have gained considerable insights into how 
different therapeutics have contributed to and failed to contribute to 
the survival of these patients. I personally met with the lead U.K. 
officials handling this response in September of last year and, as you 
would imagine, they had a wealth of unique and valuable information 
regarding the course of the disease in these patients. I understand 
this information has been shared by the United Kingdom with their U.S. 
counterparts. But yet again, based upon, my discussions with industry 
and the U.K officials, there has yet to be a proactive effort by U.S. 
officials to share the information and data gleaned from these 
incidents with the companies developing anthrax treatments, nor has it 
been shared with researchers who are working to understand disease 
pathogenesis.
    Finally, in March 2009, there was a widely reported incident in San 
Diego where a young Marine developed Progressive Vaccinia, a virus that 
closely resembles smallpox, after having received a smallpox 
vaccination. There was a tremendous response by military doctors, the 
Centers for Disease Control and Prevention, and the FDA to respond to 
this incident. There were multiple products used to treat this patient, 
including products currently in the Strategic National Stockpile as 
well as experimental products in late stage development for use in a 
smallpox incident. The lessons learned from this case are extremely 
valuable for understanding what a mass casualty event involving 
smallpox would look like, and for determining effective deployment of 
therapeutics. But yet again, based upon my understanding, there has 
been no affirmative outreach by BARDA or DOD to debrief the industry 
responders to understand what they learned from this incident. To the 
opposite, when BARDA was asked during the course of an active 
procurement by a prospective offeror to affirmatively consider the 
experience of the human use of these products in evaluating which 
products were most appropriate for stockpile, the request was declined.
    These examples demonstrate a frustrating pattern where 
opportunities to learn are being lost and relevant information is not 
being even accumulated, much less considered. At the same time, 
companies that are being asked to propose to various procurement 
opportunities must develop a ``Target Product Profile,'' not only as 
part of their proposal, but more importantly, to guide the interactions 
with FDA. However, it is impossible to develop a TPP in the absence of 
an accurate understanding for how the product will be used in a public 
health emergency. This understanding can only be gained through a 
meaningful dialogue between industry and Government--incidents such as 
those I've outlined present a very unique situation for such a dialogue 
that is being utterly missed.
    My strong belief is this failure to be proactive is not a result of 
inaction or lack of forethought by the leadership at BARDA. Rather, the 
likely cause is an unnecessary and non-productive interference with the 
ability of the BARDA leadership and program managers to communicate 
with industry by the perceived restrictions of the Federal Acquisition 
Regulations (FAR). I emphasize the word ``perceived'' given that based 
on the clear language of the FAR and my over 16 years of experience in 
Government contracts law (both inside and outside the Government) there 
is absolutely nothing the prevents such interactions from taking place. 
To the contrary, as was recently made clear in a memorandum issued by 
Dan Gordon, President Obama's head of the Office of Federal Procurement 
Policy, transparent interactions with industry are an essential part of 
the procurement system and should not be inappropriately constrained by 
agency contracting officers. Despite this clear guidance from the top 
procurement officials in the administration, it has been my experience 
that communications from the BARDA leadership and program managers has 
been unnecessarily constrained by the contracting officials to the 
significant detriment of BARDA's mission.
    In the past, the procurement function and the contracting officers 
themselves were part of BARDA, and thus, the BARDA Director had greater 
influence to ensure both transparent communication as well as proper 
allocation of priorities by the contracting officers supporting the 
procurement process for medical countermeasures. Just over a year ago, 
this function was moved outside of the direct supervision of the BARDA 
Director, as was the requirement setting process. Since this has 
occurred, there has been a marked decline in the speed and efficiency 
of the contracting process. Reverting back to the prior organization, 
where the BARDA Director has responsibility and accountability for the 
contracting officers and requirements process supporting BARDA, would 
be a welcome change that would not require any change in legislation or 
additional costs to implement. Further, increased Congressional 
oversight to encourage greater proactive response from the Public 
Health Enterprise, as a whole, would most certainly be a benefit.
    The final observation I'd like to discuss today is the need for 
there to be greater focus on the sustainability of the overall Public 
Health Enterprise to ensure the investments made by BARDA are 
maximized. Reauthorization of Project BioShield and the replenishment 
of the soon-to-be exhausted Special Reserve Fund is a key component of 
sustainability. I strongly encourage Congress to do both in conjunction 
with the reauthorization of PAHPA. That said, even without any 
legislative action or additional funding, it is incumbent upon the 
Public Health Enterprise to make the best use possible of the remaining 
balance of BioShield funding and other resources to ensure 
sustainability.
    The first order of business must to be to ensure that the products 
currently in the SNS are maintained at their current level. For 
products such as the licensed anthrax and smallpox vaccines, that means 
ensuring the CDC has both the funding and processes it needs to ensure 
the levels of non-expired vaccine in the stockpile, at a very minimum, 
are maintained. However, it should be a top priority that we stockpile 
levels of countermeasures to match the Material Threat Assessments 
conducted by the Department of Homeland Security in order to protect 
the civilian population, our first responders, and our military men and 
women should an event occur. For example, we currently fall far short 
of having adequate stockpiles of licensed anthrax vaccine to meet the 
stated 75 million dose requirement set by the Material Threat 
Assessment. Addressing this should be a priority.
    For products that have yet to achieve FDA approval, including 
anthrax therapeutics and next-generation smallpox vaccines being 
procured under Project BioShield, that also means BARDA must exercise 
the options in those contracts to retain the supply of unexpired 
products at the levels currently in the stockpile, as well as to ensure 
that the substantial investment BARDA has made in the manufacturing 
capacity to support those products is not lost. Given that BARDA has 
recently undertaken an effort to create multiple ``Centers of 
Innovation for Advanced Development and Manufacturing'' to supplement 
the Nation's manufacturing capacity, an effort that is expected to take 
decades and cost billions to achieve, it seems the first, near-term 
step in maintaining a viable manufacturing capacity for medical 
countermeasures must begin with ensuring the investments made in the 
current capacity are not lost.
    Next, the Medical Countermeasures Review correctly placed 
significant importance upon the need to procure broad spectrum, dual-
use products--that is, products that have both a CBRN and commercial 
use. These products will be, by definition, more likely to achieve FDA 
approval given that the human data derived to support the commercial 
indication will supplement the animal data needed for approval under 
the Animal Efficacy Rule for the CBRN indication. Once approved by FDA 
for a commercial indication, the cost to the Government to sustain 
these products for CBRN use is also far lower than the need to re-
procure and stockpile products that are only usable in the event of a 
public health emergency. Although the benefits of dual-use technologies 
are clear, and are articulated in the 2010 Medical Countermeasures 
Review, it appears that products that lack this dual-use potential are 
still being favored for procurement under Project BioShield. This lack 
of consistency with the clear mandate of Medical Countermeasures Review 
is puzzling to say the least.
    Given the investment in creating and staffing the organization, 
BARDA should also have a clear role in the response to non-biodefense 
threats to public health such as the rise of multi-drug resistant 
pathogens--the ``super bugs'' that are killing far more people every 
year than the losses we suffered on 9/11. Emerging tropical diseases 
like dengue and global health diseases such as tuberculosis are also 
impacting the United States, with a growing number of cases of dengue 
and TB in Florida, Hawaii, and elsewhere. BARDA should play a 
significant role addressing these diseases. The investment in the 
infrastructure to create and support BARDA, as well as the obvious 
benefits and synergies of expanding the mission to include emerging 
infectious disease, make clear this is a worthy focus for BARDA. This 
is the one area where I believe Congress should affirmatively act to 
modify the PAHPA legislation to explicitly give BARDA the mandate to 
address drug resistance--both bacterial and viral--as well as emerging 
infectious disease as a whole. This may require additional 
appropriations to support this expanded mission, but it is an area that 
needs to be addressed and BARDA is ideally suited to take on this 
mission.
    In closing, I would like to return to both the 2009 influenza 
pandemic as well as the events in Japan.
    On the morning of September 11, 2001, a trusted advisor to the 
Secretary of HHS had a meeting scheduled with the Secretary to raise 
the issue of the emergence of the H5N1 virus in Asia and how the United 
States should prepare for an influenza pandemic like the one that 
devastated the world in 1918 as described in John Barry's book ``The 
Great Influenza.'' That meeting never occurred that day for obvious 
reasons, however, it was eventually rescheduled. HHS went on to make 
critical investments to secure the egg supply for flu vaccines, to 
bolster the U.S. vaccine base, stockpile millions of doses of flu 
antivirals, as well as diagnostics, and to support the passage of 
legislation to address liability issues that up-to-then had restrained 
our ability to prepare. That trusted advisor became the first Assistant 
Secretary for Preparedness, where, as the precursor to what is now 
BARDA, he made critical decisions regarding influenza vaccines and 
therapeutics, anthrax vaccine and therapeutics, smallpox vaccines, and 
radiation countermeasures. These decisions were implemented by a 
skeleton staff made up mostly of detailees from other parts of HHS and 
retired public health leaders who offered their time in order to help 
protect the Nation. The procurements were managed by a single 
contracting officer at the CDC, for which this was an extra duty. About 
half of those decisions, in retrospect, ultimately did not result in 
outcomes that immediately protected the homeland. However, about half 
of them did. The Assistant Secretary withstood enormous criticism for 
the decisions that did not appear to be immediately beneficial, and got 
little credit for the decisions that proved right, including those 
critical decisions that helped prepare the Nation for the 2009 
pandemic. Mr. Chairman, as the baseball teams that have Spring Training 
in your district are aware, a .500 batting average is something to be 
proud off. The bottom line is decisions were made then that clearly 
protected the United States. Yet, today, decision-making is ground to a 
halt by concerns about the perception that could result from a failure 
and overly bureaucratic procedures while the security of our homeland 
suffers.
    If we look toward to Japan, the lack of proactive decisions to 
inventory what drugs are currently available to respond to a nuclear 
emergency, of not ensuring that well-conceived protocols are written in 
advance to ensure their appropriate deployment if these products are 
ever used, and of failing to hear the wakeup call the events of the 
last month signal for the need to prepare in America could prove 
devastating. The decisions made to today--or better put, the decisions 
that are not being made today--will almost certainly result in leaving 
our Homeland vulnerable. I thank you Mr. Chairman and this committee 
for doing everything you can to ensure that our homeland remains 
secure.

    Mr. Bilirakis. Thank you, sir.
    I now recognize Dr. Fagbuyi for 5 minutes.
    Welcome, sir. Thank you.

  STATEMENT OF DANIEL B. FAGBUYI, MEDICAL DIRECTOR, DISASTER 
  PREPAREDNESS AND EMERGENCY MANAGEMENT, CHILDREN'S NATIONAL 
                         MEDICAL CENTER

    Dr. Fagbuyi. Good afternoon, Chairman Bilirakis and Ranking 
Member Richardson. Thank you for holding today's hearing on 
such an important topic, medical countermeasures.
    My name is Dan Fagbuyi. I am representing the Academy of 
Pediatrics, a nonprofit professional organization of more than 
60,000 primary care pediatricians, pediatric medical 
subspecialists, and pediatric subspecialists dedicated to the 
health, safety, and well-being of children of all races.
    I serve as the Academy Disaster Preparedness Advisory 
Council member, and you have heard the saying that children are 
not little adults. Why does this matter when it comes to 
medical countermeasures and disaster preparedness? Well, 
children are particularly vulnerable to aerosolized biological 
or chemical agents because they breathe more times per minute 
than do adults, meaning that they would be exposed to a larger 
dose of an aerosolized substance.
    Children are also more vulnerable to agents that act on or 
are absorbed through the skin because their skin is thinner and 
they have much larger skin-to-body surface ratio than adults. 
They have immature immune systems which put them at risk for 
CBRN-type agents and are more vulnerable to radiological agents 
due to their more rapid metabolic and cellular growth rates.
    So consider this: When children are critically ill or 
injured their bodies respond differently than adults to similar 
insults. Consequently, pediatric treatment needs are unique in 
a number of ways, and I will start with children actually need 
different doses and different formulizations of medicines than 
adults because certain drugs and biologic agents have certain 
safety and efficacy profiles that are different in developing 
children.
    Children also 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 in infants--for infants, for preschool 
children, school-aged children, and adolescents. From needles 
and tubing to oxygen and ventilator masks, all these are 
different in children. Children also display unique 
developmental and psychological responses to acute injury and 
illness, and also, as well, to mass casualty events, and are at 
greater risk for post-traumatic stress disorder and acute-
traumatic stress disorder.
    While we have a lot of work ahead of us to adequately plan 
and prepare for children in disastrous situations there are 
several programs that have really moved the needle, one of 
which is emergency medical services for children, EMSC, which 
has played a crucial role in driving a significant amount of 
improvement in pediatric emergency care, including disaster 
preparedness.
    Despite a modest appropriation of slightly more than $20 
million for EMSC, EMSC has managed to affect changes by 
providing pediatric emergency care initiatives in every State, 
territory, and the District of Columbia, as well as National 
improvement programs and protocols that will be critical in an 
event of National emergency.
    In the area of medical therapeutics there are two laws--the 
BPCA, Best Pharmaceuticals for Children Act, and PREA--have 
incentivized and required drugs to be studied in children. 
These studies have identified safety issues, altered dosing, 
have led to new indications and have shown some drugs even lack 
efficacy in children. Nearly 400 drugs have been labeled for 
children as a result.
    When it comes to medical countermeasures, 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. However, labeling took 7 years, during which 
time no new data was presented.
    It is hard to understand why that took so long. Pediatric 
labeling was the first step. HHS and BARDA need to support the 
manufacture and purchase of child-specific auto-injector so 
that pralidoxime can be forward deployed and administered in 
the field.
    In the event of a radioactive release such as what we 
experienced in--was experienced in Japan, children should be 
administered potassium iodide, as our Ranking Member had 
mentioned, as quickly as possible, and to be appropriate in 
dosage and treatment to prevent the long-term consequences. The 
big question, if a liquid formulation of potassium iodide 
exists and is safe and effective but if the Federal Government 
and State governments do not purchase this to be stockpiled in 
the Strategic National Stockpile in the event of a radiation 
exposure and in sufficient quantities to treat our Nation's 
children, how secure are we really?
    In other policy recommendations, the Academy of Pediatrics 
has specific recommendations for policymakers, and there are 
many that I listed in my written testimony but I will just 
highlight one. 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 and other Federally funded 
caches.
    This includes amending the PAHPA Act to require that the 
HHS Secretary, acting through BARDA, prioritize children. 
Children should be distinguished as a separate population from 
the broader at-risk category currently at the Health and Human 
Services.
    These also preposition medical countermeasures as a crucial 
piece and it needs to be in locations where children gather, 
such as schools and in child care facilities. They must not be 
an afterthought.
    In conclusion, the Academy of Pediatrics thanks this 
committee for the opportunity to testify on this important 
issue of medical countermeasures. Children are our future.
    Finally, I want to give you a recent poll which was 
conducted at the Academy of Pediatrics and the Children's 
Health Fund: 76 percent of Americans agree that if resources 
are limited children should be given a higher priority for 
lifesaving treatments; 75 percent believe that if tough 
decisions must be made lifesaving 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.
    When disaster strikes, we as a Nation must be prepared with 
the medical countermeasures to keep our children healthy and 
ensure that we have and they have an opportunity to achieve 
optimal health outcomes. As a pediatrician and a father of 
three, I look forward to your questions. Thank you.
    [The statement of Dr. Fagbuyi follows:]
                Prepared Statement of Daniel B. Fagbuyi
                             April 13, 2011
    Chairman Bilirakis and Ranking Member Richardson, thank you for 
holding today's hearing on such an important topic, medical 
countermeasures. My name is Dan Fagbuyi, MD 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 in crisis situations.
    I am currently the Medical Director of Disaster Preparedness and 
Emergency Management at Children's National Medical Center in 
Washington, DC. I am an Assistant Professor of Pediatrics and Emergency 
Medicine at The George Washington University School of Medicine with 
board certification in both Pediatrics and Pediatric Emergency 
Medicine. I have the distinct honor of recently being appointed by the 
U.S. Secretary of Health and Human Services, Kathleen Sebelius, to 
serve on the National Biodefense Science Board. As a Major in U.S. 
Army, I was involved in combat and civil military operations, serving 
as a battalion surgeon on the front lines and caring for more than 800 
soldiers while deployed for Operation Iraqi Freedom with the U.S. 
Army's 101st Airborne Division.
    Recent events in Japan make today's hearing especially timely and 
critical. The Academy strongly supports the Federal Government's 
response to the Japanese government and its people. We have been in 
touch with our pediatrician colleagues through the Japan Pediatric 
Society to offer the Academy's assistance and, as of today, we have 
raised $51,519 in gifts and pledges for Disaster Relief for Japan 
through the AAP Friends of Children Disaster Relief Fund.
    The recovery and relief efforts 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 citizens, children, 
may present several unique challenges and it is important that we as 
Americans look within our own borders to assess whether our planning 
and exercises our Government and communities engage in, our medical 
capabilities, the training of our first responders, and the 
preparedness of our Nation's hospitals, Federal, State, and local 
governments, and families, adequately account for the needs of children 
should a disaster strike.
    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 realty.
                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 countermeasures and disaster preparedness?
   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\
---------------------------------------------------------------------------
    \1\ Committee on Environmental Health and Committee on Infectious 
Disease. Chemical-Biological Terrorism and Its Impact on Children: A 
Subject Review. Pediatrics, Vol. 105 No. 3 March 2000. (update 
scheduled for publication in Pediatrics September 2006.)
---------------------------------------------------------------------------
   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 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
---------------------------------------------------------------------------
   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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
   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.
---------------------------------------------------------------------------
   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. In a 2008 survey of hospital preparedness by 
        the Centers for Disease Control and Prevention (CDC), only 42.6 
        percent of hospitals had a tracking system for accompanied and 
        unaccompanied children, about 34 percent of hospitals had plans 
        for reunification of children with families, and 31.1 percent 
        for protocols to identify and protect displaced children.\5\
---------------------------------------------------------------------------
    \5\ Niska R and Shimizu I. Hospital Preparedness for Emergency 
Response: United States, 2008. National Health Statistics Reports, No. 
37, March 24, 2011.
---------------------------------------------------------------------------
  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.\6\ 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% surviving the event, and with 75% of the survivors 
sustaining permanent disability.
---------------------------------------------------------------------------
    \6\ 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-cardiopulmonary arrest conditions and intervene before they occur. 
While children represent 25 to 30% of all emergency department visits 
in the United States, and 5 to 10% 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.\7\
---------------------------------------------------------------------------
    \7\ Gausche-Hill M, Schmitz C, Lewis RJ. Pediatric preparedness of 
United States emergency departments: a 2003 survey. Pediatrics. 
2007;120(6):1229-1237.
---------------------------------------------------------------------------
    This committee is no doubt familiar with ED overcrowding as a day-
to-day reality. Imagine layering on top of the current situation, a 
widespread mass care or mass casualty event involving children, 
including children with special health care needs. The experience is 
much like what my institution saw with H1N1.\8\ Large volumes of 
patients and their families seeking medical care; having to educate 
pharmacies on how to constitute Oseltamivir for the pediatric 
population with cherry syrup; creating innovative strategies to address 
the surge of patients on top of the baseline patients; engaging the 
community and demystifying vaccine concerns; ensuring that media 
message was consistent and accurate and medically sound, ensuring 
infection control and so on. Fortunately for all of us, the overall 
morbidity of H1N1 was less than expected, though children were 
disproportionately impacted by the pandemic.
---------------------------------------------------------------------------
    \8\ Fagbuyi DB, et al. A Rapid Medical Screening Process Improves 
Emergency Department Patient Flow During Surge Associated With Novel 
H1N1 Influenza Virus. Annals of Emergency Medicine, Vol. 57, No. 1, 
January 2011.
---------------------------------------------------------------------------
    The science of ED surge remains relatively undeveloped.\9\ What we 
do know is that when it comes to pediatrics, less than one-third (32.4 
percent) of hospitals have guidelines for increasing pediatric surge 
capacity. In the face of a disaster, all hospitals will need to 
increase their capacity.
---------------------------------------------------------------------------
    \9\ Nager AL, Khanna K. Emergency department surge: models and 
practical implications. J Trauma. 2009;67(2 Suppl):S96-99.
---------------------------------------------------------------------------
    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 and 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.
    Children with special health care needs\10\ are the fastest growing 
subset of children, representing 15 to 20% of the pediatric 
population.\11\ 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.
---------------------------------------------------------------------------
    \10\ MacPherson M et.al. A New Definition of Children with Special 
Health Care Needs. Pediatrics, Vol. 102, No. 1, July 1998.
    \11\ Van Dyck P et.al. Prevalence and Characteristics of Children 
With Special Health Care Needs. Arch Pediatr Adolesc Med, Vol. 158, No. 
9, September 2004.
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                emergency medical services for children
    The Emergency Medical Services for Children (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 21 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 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, some of whom are testifying at today's hearing. 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 given the subject of today's hearing, the 
Commission recommended that Congress, HHS, and DHS/FEMA 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.\12\ The Commission offers 
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 this recommendation.
---------------------------------------------------------------------------
    \12\ 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.
---------------------------------------------------------------------------
    I am saddened to report that the Commission officially terminated 
on April 4, pursuant to the statute that established it. The Academy 
opposes the termination of the Commission and will continue to urge 
Congress to move quickly to reconstitute the Commission. I had the 
pleasure of partaking in the discussions of the medical care 
subcommittee of the Commission and the achievements this Commission 
made with its Federal partners, professional organizations, and the 
public have been tremendous.
    The Academy supported the creation of the Commission and we are 
committed to helping carry on the work of implementing the Commission's 
outstanding recommendations. 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 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.
    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 
with BARDA and their industry partners to improve pediatric labeling 
for medical countermeasure. There are opportunities for collaborations 
with the National Institutes of Health (NIH) as well. Within the last 
week, 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 reauthorize and strengthen BPCA and PREA, two laws that 
have done so much to improve children's health.
                  medical countermeasures for children
    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. 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/BARDA needs 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.\13\ 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?
---------------------------------------------------------------------------
    \13\ 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.
                      other 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.
   The Pandemic and All-Hazards Preparedness Act should be 
        amended to require that the Secretary, acting through BARDA, 
        prioritize children.
   Children must be distinguished as a separate population from 
        the broader ``at-risk'' individuals' category and the HHS 
        Secretary should create an Office of Preparedness and Response 
        for Children to be headed by a Director who reports to the 
        Secretary.
   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 and child care facilities and they must 
        include plans for children with special health care 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 teenagers. 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 
countermeasures. America's children represent the future of our Nation, 
our most precious National resource. They must not be an afterthought 
in medical countermeasures and disaster planning. 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 website 
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 conducted 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% of Americans agree that if resources are limited, 
        children should be given a higher priority for life-saving 
        treatments;
   75% 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% 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 better prepared with the medical countermeasures to keep our 
children healthy and ensure they have the opportunity to achieve 
optimal health outcomes. As a pediatrician and a father of three, I 
look forward to your questions and to working with you to address the 
preparedness needs of all children.

    Mr. Bilirakis. Thank you, Doctor. Appreciate it very much.
    I recognize myself for 5 minutes.
    To the doctor, we appreciate your testimony describing how 
children are a particularly vulnerable population when it comes 
to CBRN threats. Many would argue that our preparedness and 
ability to deal with children and other vulnerable populations 
in a disaster lags behind our preparedness for adults. I know 
you mentioned this, so I am going to give you an opportunity to 
elaborate.
    Can you please elaborate on your comments about potassium 
iodide for children if you have more to say? That is my first 
question.
    Dr. Fagbuyi. Thank you.
    The issue with regards to potassium iodide, it is a 
countermeasure. It is safe and effective; the FDA has 
recommended it. It should be stockpiled. It should not be 
allowed to expire if it does exist in the stockpile.
    The stockpile actually should be evaluated to ensure that 
there are pediatric countermeasures in the stockpile sufficient 
enough to address the same needs that would be appropriate for 
a threat that would affect adults. That is something that is 
important and should be evaluated.
    With regards to KI, you can talk about amount, and what is 
the zone, and how far it should be deployed out, and who should 
have it, but if States and Federal Governments don't stockpile 
it and if we don't actually have enough in quantity then it 
doesn't matter if it is 10 miles, 20 miles, 30 miles. If you 
don't have enough you don't have enough.
    Mr. Bilirakis. Okay. I would like to follow up with you 
after the hearing as well on this issue.
    Mr. Clerici, your testimony indicates that the main 
challenge we face in this enterprise is not one of authority 
but one of culture. As a contracts lawyer it is your perception 
that many of the flaws in the system--in other words, is it 
your perception that many of the flaws in the system could be 
fixed if it would simply make better use of existing 
authorities, of the other transaction authority, of allowable 
transactions with industry under the FARR, of getting out RFPs 
and contracts quickly instead of waiting for years? So my 
question is: What needs to change to fix this and how can 
Congress help?
    Mr. Clerici. Thank you, Mr. Chairman. You clearly point 
out, it goes beyond just interactions with the procurement. It 
is the BioShield legislation itself.
    The vision of BioShield was actually to anticipate that 
Government has to act differently with respect to these non-
Governmental contractors, and there are special authorities in 
the BioShield legislation other than--beyond the other 
transactions authority that you mentioned on the last panel 
that have not been used at all, let alone to their fullest. It 
is a frustrating problem because here you have, in my view--the 
funding is available, which as we sit here today, as you vote 
on the continuing resolution of the budget, that is a rare 
benefit that you don't really see in these times.
    The leadership is actually very strong as well. I think Dr. 
Robinson and his team are very, very accessible to industry. It 
is what happens after that, after you have talked to that team 
down below where the problems seem to arise.
    The program has morphed into much more, at the Department 
of Defense, acquisition program based upon a very long timeline 
rather than the sense of urgency imparted upon the legislation 
with Project BioShield. The frustrating part, Mr. Chairman, is 
I am not sure what Congress can do. It has given them all the 
authority; it has given them all the tools and they actually do 
have strong leadership.
    You know, your oversight authority is certainly an 
important way to follow this, as well as kind of just reminding 
them that the legislation was meant to convey that sense of 
urgency of the events of 9/11 and after that has been somewhat 
lost as we move further and further away from the event.
    Mr. Bilirakis. Thank you.
    My next question is for Ms. Arthur. In your opinion is the 
Government working with industry to develop sufficient broad 
spectrum technologies thereby getting away from the one bug, 
one drug problem? This seems like just the type of challenge 
that biotechnology companies would be poised to tackle.
    Ms. Arthur. So actually, thank you for your question. I 
think that BARDA and the DOD both are working in concert with 
industry to try to maximize these multiplatform, multiuse 
opportunities. I think that one of the things that we face is 
actually what is the regulatory process for those products 
going forward?
    So in the end it is still true that the FDA approves a 
product for a specific indication. They don't approve the idea 
of how you might use this for multiple products, so it is very 
important, as we stress, that the agencies work together with 
the FDA to think through how we move these new platforms that 
have dual use through the regulatory process with clarity. 
Hopefully I answered your question.
    Mr. Bilirakis. Thank you.
    Mr. Clerici, can you please elaborate on your statement 
that HHS was unresponsive to industry offers to help provide 
products that would mitigate the radiological crisis in Japan? 
Why do you think that BARDA has not been proactive in this 
regard, second? Then the last question is, further, what needs 
to happen to ensure that the United States has stockpiled the 
countermeasures it would need to respond to a rad-nuc incident 
of its own?
    Mr. Clerici. Yes, Mr. Chairman. So in my experience there 
are three or four products out there that are licensed, FDA-
approved for other indications that are related to what would 
occur or what has occurred in Japan. Those companies are very 
well aware of BARDA and vice-versa. BARDA's leadership, again, 
has done, I think, an outstanding job of making an outreach to 
those teams.
    Based upon my understanding, since the events in Japan 
there has been very little interaction to understand how many 
of those products are on hand, what are the protocols that 
would be used during an event such as Japan if Japan asked for 
them, or what sort of file could be done to make sure the data 
that comes from where these products are actually used can go 
to license these products here in the United States for the 
nuclear indication.
    Why I think that has happened is a couple reasons, Mr. 
Chairman. First, I think that there is sensitivity to the 
Japanese. They have not asked for our help; we certainly can't 
offer it in the abstract. However, there is nothing wrong with 
being prepared for them to ask us those questions, and even 
that exercise alone I think would be very important.
    The second problem, I think, goes back to the procurement 
problem. I think that there is sensitivity among the program 
folks who very much want to have these exchanges with industry 
but they might be viewed as favoring industry or somehow 
endorsing them along the way. This is the time, essentially, to 
kind of act very proactively and I think we are missing it.
    The last one is a high level of sensitivity around 
endorsing a product for an unapproved use. We are very 
sensitive about offering a promotion and everything that goes 
along with that. But by definition these products that are FDA-
approved are a little bit different than a product that is 
earlier in development, and particularly those products that 
have already been used in nuclear events outside the country in 
South America and others.
    Seems there should be a little less sensitivity on that 
issue that I am not actually seeing.
    Mr. Bilirakis. One last question for Ms. Arthur.
    Ms. Arthur, you mentioned in the testimony that the Federal 
Government must provide an MCM market that is sustainable and 
therefore of interest to industry. Was the 10-year advance 
appropriation for BioShield a reasonable model? If not, what do 
you suggest now that the funds are nearing their expiration 
date?
    Ms. Arthur. Thank you. That is a good question.
    So, there have actually been several suggestions of what 
number would be the best number to put in BioShield to really 
serve as the right size for the marketplace that required all 
of these products--as the doctor pointed out, you don't just 
want products that treat adults; you want products to treat 
pediatrics, geriatrics, immunocompromised persons, and each of 
those indications is its own development process.
    So I think that the Weapons of Mass Destruction Commission 
actually suggested a number that was order of magnitude higher 
than $5.6 billion, and I would have to get back to the 
committee with the correct number, but there are some published 
data that show that the number would need to be bigger in order 
to actually prove a marketplace size big enough to give you all 
of the countermeasures that would be required for the--to 
fulfill all the needs. I hope I answered your question.
    Mr. Bilirakis. Get back to us on that.
    Ms. Arthur. We absolutely will.
    Mr. Bilirakis. I am sure the Ranking Member would be 
interested as well. Thank you.
    Okay, Ms. Richardson, you are recognized for 5 minutes or 
so.
    Ms. Richardson. Thank you, Mr. Chairman.
    Let me start off my first question with Mr. Clerici. From 
your perspective, which research and development works better, 
DOD's or HHS?
    Mr. Clerici. There are certain aspects of the DOD model, 
particularly in the program that Dr. Parker mentioned, the 
Transformation Medical Technologies program, that I think have 
been very strong. In fact, BARDA has actually adopted some of 
those practices--two-stage procurement, where you submit a very 
short white paper and then you are screened out and don't have 
to spend the time to go through a full proposal. That has been 
very positive.
    I have also seen examples that have been fairly public that 
DOD has been more aggressive. There is one example of a 
influenza therapeutic that was discussed in a recent 
publication after the H1N1 pandemic arose where DOD acted very 
aggressively. So in that respect I think that is a positive 
light.
    BARDA faces a lot greater challenges than DOD, quite 
frankly. You talked about the population differences. Generally 
speaking, the military is buying products for the warfighter, 
18- to, you know, 35-year-old healthy people. BARDA has to 
address the entire population.
    The other struggle that BARDA faces, which is kind of 
counterintuitive, is BARDA actually has the authority to use 
products that aren't FDA-approved; DOD does not. DOD must 
develop a product all the way through licensure before it can 
be used in a military setting. That creates challenges because 
of the Animal Rule and kind of the expectations around what 
BARDA's mission is.
    So I think I would have to say that in many respects DOD 
has been faster and better; in other respects I understand that 
BARDA has a much bigger challenge on its hands. But there are 
lessons that can be learned.
    Ms. Richardson. Okay.
    Ms. Arthur, will changes described in the August 2010 
PHEMCE review fix all of the problems with HHS's process in 
developing medical countermeasures? What is missing from those 
recommendations? Which of the recommendations should not be 
implemented?
    Ms. Arthur. Well, now, thank you.
    I think that a great--the review actually did touch on 
several of the most important issues that would go a long way 
to increasing industry involvement. Certainly the FDA 
investment is the most important and the most--the biggest 
hurdle that industry faces today.
    I think that in addition what might be missing is the 
opportunity to have more transparency of a longer-range plan. 
To discuss these products takes anywhere from 8 to 12 years to 
develop and that actually means that this annual procurement 
process and appropriations process does not necessarily allow 
companies to have their security that their investors are 
planning where they will be in the process and how they will be 
leveraging their funds and hitting their milestones over the 
long term.
    So the ability to do a more long-range plan that can be 
shared transparently with stakeholders would be added benefit 
to industry.
    I think there are several provisions inside the review that 
industry is still looking at--the strategic investor and the 
flexible manufacturing. I want to make sure that we work with 
BARDA and the DOD to understand exactly how those would be 
implemented and to make sure that there are no--or as few 
negative implications for commercialization of some of these 
dual-use products as possible.
    So while everything in the review was certainly meant to 
increase the incentive for industry to be involved, a few of 
the proposals might need to be finessed and worked on with 
industry and partnership.
    Ms. Richardson. Okay. Thank you.
    Doctor, since you are the director of disaster preparedness 
and emergency management at the Children's National Medical 
Center, to your knowledge--I don't know if you were in the room 
when I asked the question about stockpiling--to your knowledge 
is there an adequate stockpiling of children-related vaccines 
and so on?
    Dr. Fagbuyi. Thank you, ma'am. I do not know that. I am not 
privy to that.
    However, from the lessons that we learned from H1N1, for 
example, I will give--Oseltamivir is a drug we used that was 
the medical countermeasure at least that the population was--
was distributed to the population. That was a logistical 
nightmare trying to get that to different hospitals and other 
end-users, the patients themselves.
    In addition, pharmacies didn't even know how to constitute 
it right for a pediatric patient. There was an issue of cherry 
syrup shortage. What is going to happen with cherry syrup? What 
is that about? Well, that is how you mix it for it to be more 
palatable, and to constitute it right for the dosing for the 
pediatric patient.
    So that is a preview. That gives me an opportunity to say, 
well, I question the rest of the things then with that. That is 
where the Academy stands at. We need to actually look back into 
the stockpile, see what is actually there. What is in there? 
Does it have pediatric indications and can it be used in a 
patient? Does it have pediatric instructions that are clear so 
that people make sure they are using the right dose?
    People should engage with the pediatric experts who do this 
often to be able to make sure that that is changed. I hope that 
answers your question, ma'am.
    Ms. Richardson. Absolutely.
    Thank you. I yield back.
    Mr. Bilirakis. Thank you very much.
    I want to thank the witnesses for their valuable testimony, 
thank my Ranking Member for her great questions, and I am sure 
you will agree this is a very timely hearing and hopefully this 
will bring the issues to the forefront because these are so 
very important.
    The Members of the committee may have some additional 
questions for you and we ask you to respond in writing please. 
The hearing record will be held open for 10 days.
    Without objection, the subcommittee stands adjourned. Thank 
you.
    [Whereupon, at 4:31 p.m., the subcommittee was adjourned.]


                            A P P E N D I X

                              ----------                              

    Questions From Chairman Gus M. Bilirakis for Cynthia A. Bascetta
    Question 1. Medical countermeasures aren't just about vaccines and 
antibiotics, but also include appropriate diagnostic measures to 
determine who is actually exposed. We have no rapid diagnostic tools 
stockpiled for any of the material threats. In your opinion, is the 
civilian medical countermeasures program developing appropriate 
diagnostics to meet the material threat determinations?
    Answer. Our current work is examining HHS's chemical, biological, 
rediological, and nuclear (CBRN) medical countermeasure development and 
acquisition activities, and the Department has a stated interest in 
developing and acquiring vaccines, antibiotics, diagnostic devices, and 
other countermeasures. As we reported in our testimony, the Federal 
Government faces a variety of challenges in developing and acquiring 
these countermeasures, such as the high failure rate in research and 
development and difficulties meeting regulatory requirements. These 
challenges apply to diagnostic devices as well as vaccines and 
antibiotics. However, we have not reviewed issues specific to the 
development of diagnostics, but we agree that diagnostics are an 
important component of response to certain types of threats.
    Question 2. Do you believe that the distribution of funds for 
medical countermeasures is appropriate? That is, is the way the funds 
are spent actually resulting in enough and useful countermeasures?
    Answer. Our current work is examining how much HHS has invested in 
CBRN medical countermeasure research, development, and acquisition and 
its progress in these activities. However, we are unable to make a 
determination as to whether HHS is spending its funds appropriately. As 
we reported in our testimony, countermeasure research and development 
is a lengthy and complex process. In addition, given the high failure 
rates and other challenges, it is also an expensive process, especially 
in the advanced research and development stages. HHS is making some 
changes to its countermeasure enterprise and processes intended to 
improve countermeasure development and acquisition, which we are also 
examining in our current work. While it is too early to determine how 
some of these changes will affect countermeasure development and 
acquisition, our work will include a review of how investments in 
countermeasure development have been guided by threat and risk 
assessments.
 Questions From Ranking Member Laura Richardson for Richard J. Hatchett
    Question 1. Does HHS support the goal of achieving parity within 
the SNS between countermeasures for children and those available for 
adults?
    Answer. The Department of Health and Human Services (HHS) supports 
the goal of achieving parity within the Strategic National Stockpile 
(SNS) between medical countermeasures (MCMs) available for children and 
those for adults. HHS inventories the SNS on a yearly basis to assess 
and rectify MCM gaps, and there has been a specific focus on pediatric 
MCM requirements and gaps in the 2010 SNS Annual Review [relates to QFR 
No. 2 below] that will be reviewed and prioritized by the Enterprise 
Senior Council.
    In many cases, a gap exists because either a pediatric formulation 
of a countermeasure has not been developed or an existing 
countermeasure has not been approved by the Food and Drug 
Administration (FDA) for use in pediatric populations. HHS is working 
diligently to overcome the challenges to obtaining FDA approval for 
pediatric MCM. Because pediatric MCM research must be conducted in 
accordance with 21 CFR Part 50, Subpart D (50.50-50.56): ``Additional 
Safeguards for Children in Clinical Investigations,'' and with 45 CFR 
Part 46, Subpart D, ``Additional Protections for Children Involved as 
Subjects in Research,'' as relevant, the ability to conduct studies is 
limited and consequently the opportunity to collect sufficient data on 
the safety and efficacy of MCMs in pediatric populations is limited. 
Furthermore, the ethics and feasibility of collecting data on the use 
of MCMs against CBRN threats in children are particularly challenging.
    HHS is working to stimulate pediatric MCM development by 
integrating considerations for pediatric populations in every stage of 
development, including requirements setting, research, and program 
management. The National Institutes of Health (NIH) is spearheading 
clinical trials to obtain the data necessary for FDA approval of 
pediatric MCMs, such as midazolam to treat seizures resulting from 
nerve agent exposure. Since 2004, HHS's Biomedical Advanced Research 
and Development Authority (BARDA) has invested over $2 billion to 
support MCM development in healthy and special populations including 
pediatric populations. This includes MCMs for anthrax vaccines and 
therapeutics; heptavalent botulinum antitoxin; Smallpox vaccine for 
immunocompromised persons; and a number of products intended for use 
after radiological or nuclear events. Additionally, HHS is putting in 
place new mechanisms, such as a working group focused specifically on 
the issues of developing and dispensing MCMs to pediatric and obstetric 
populations, to improve the development and acquisition of safe and 
effective countermeasures for children.
    Question 2. Will the ASPR conduct a comprehensive review of the 
contents of the SNS and provide this committee and the public a report 
on how many have pediatric labeling?
    Answer. An annual review of the SNS formulary is mandated by 
Homeland Security Presidential Directive 21: Public Health and Medical 
Preparedness (HSPD-21) and Section 319F-2(a)(1) of the Public Health 
Service (PHS) Act, as added by Section 102(c) of the Pandemic and All 
Hazards Preparedness Act (PAHPA), Public Law 109-417.\1\
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    \1\ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
CFRSearch.cfm?CFRPart=50- &showFR=1&subpartNode=21:1.0.1.1.19.4.
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    PAHPA directs the SNS Annual Review to address medical 
countermeasure assets for at-risk individuals, including pediatric 
populations. To enhance preparedness planning for pediatric 
populations, the 2010 SNS Annual Review process specifically examined 
the medical countermeasure requirements needed to cover the U.S. 
pediatric population (defined as individuals aged 0-21 years).\2\ The 
HHS-led working groups that contribute input into formulary decisions 
have accounted for pediatric medications, formulations (some of which 
are also appropriate for persons unable to swallow pills), and dosages 
where available. This ensures that SNS requirements will include 
medical countermeasures appropriate for pediatrics wherever possible. 
The overall quantitative gaps were examined, while also pinpointing 
areas where existing medical countermeasures are insufficient to meet 
the specific needs of pediatric populations. The results of this Review 
will be available in 2012, as required under HSPD-21.
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    \2\ The 0-21 year age range is consistent with the definition 
generally used by the practicing community of pediatricians and 
pediatric stakeholder groups. An estimated 30% of the U.S. population 
is included in this age range. There are diverse medical countermeasure 
formulation requirements within this range however (e.g. suspension 
formulations are designated for children 0-9 years of age (14% of the 
U.S. population)).
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    The issue of pediatric labeling of MCMs is very important to HHS. 
This is a complex subject that presents challenges beyond its impact on 
medical countermeasures stockpiled in the SNS, as the majority of 
medications on the market today have not undergone clinical studies in 
children. The FDA maintains an informative web page that addresses the 
challenge of identifying safe pediatric uses for existing MCM that have 
not been tested and labeled for children (http://www.fda.gov/Drugs/
ResourcesForYou/Consumers/ucm143565.htm).
    The ability to use the medical countermeasures provided by SNS 
during an incident depends on necessary mechanisms that allow for 
deployment, dispensing, and utilization of those assets. In order to 
treat individuals at the State and local level with medical 
countermeasures that have not been approved, licensed, or cleared by 
FDA for their intended uses (e.g., off-label pediatric applications), 
Emergency Use Authorization (EUA) or Investigational New Drug protocols 
must be in place for each product for the intended purpose. CDC also 
continues to prepare for potential deployment and use of medical 
countermeasures by preparing pre-EUA documents and working with FDA to 
streamline the process for obtaining an EUA at the time of an incident.
    Question 3. In light of recent events in Japan, is the 
administration currently considering changing the policy to limit the 
availability of potassium iodide (KI) to just 10 miles around nuclear 
power plant facilities?
    Answer. The Nuclear Regulatory Commission (NRC) has principal 
Federal responsibility for policy recommendations regarding the use of 
potassium iodide (KI) in proximity to nuclear power plant facilities. 
Consequently, this question is more appropriately suited for the NRC to 
address. It should also be noted that the final authority to make any 
determinations regarding implementation of KI distribution beyond 10 
miles of nuclear power stations resides with States, which have to 
develop preparedness plans and submit them to the Federal Emergency 
Management Agency (FEMA), Department of Homeland Security, for review.
    Question 4a. At present, is there enough liquid KI in the SNS for 
all children, especially children living in States with or near nuclear 
facilities?
    Question 4b. If not, what is being done to ensure liquid 
formulation KI will be available for all children?
    Answer. The Nuclear Regulatory Commission currently implements the 
program for providing KI to the States that have populations living in 
the Emergency Planning Zones (EPZ) surrounding nuclear power plants in 
the United States. Following the decision not to distribute KI in the 
10-20 mile radius of nuclear power stations, the KI tablets originally 
purchased for the SNS to carry out this requirement were turned over to 
the NRC for the purpose of supporting these populations, and the KI 
liquid solution was offered to the States by HHS and SNS to address 
their childhood populations; however, it was declined by nearly all 
States due to the logistical issues and cost associated with accepting, 
stockpiling, and distributing this product to communities within 20 
miles of a nuclear power station.
    While KI liquid solution does reside in the SNS and could cover the 
childhood populations in many scenarios of potential radioiodine 
release from a nuclear power station, it is expiring and there is no 
operational requirement to maintain it in the SNS formulary. KI should 
be administered for risk of exposure, or within of 4-6 hours or less of 
exposure, to be effective, and thus National stockpiling of KI would 
not appear to be an effective strategy that allows for utilization in a 
timely manner.
    The quantities of bottles of liquid KI held in SNS inventory are 
treated as Controlled Unclassified Information, but HHS would be happy 
to provide this information in another manner that permits appropriate 
safeguards. Due to the packaging of KI liquid solution, it would be 
expected that one bottle would be provided per family with one or more 
children even though there are multiple doses in each bottle. Thus, the 
number of children that could be treated for prophylaxis with KI liquid 
solution following a release of radioactive iodine is, at a minimum, 
equal to the number of available bottles.
    The amount of excess KI liquid solution currently held in the SNS 
would be insufficient to treat the total pediatric population of the 
United States, if the entire Nation was at risk. HHS does not currently 
have information on the size and demographic breakdown of populations 
surrounding U.S. nuclear power plants to calculate the requirement for 
KI liquid solution to treat the entire pediatric population in those 
areas.
    The Office of the Assistant Secretary for Preparedness and Response 
is leading an interagency effort to evaluate the need for a National 
stockpile of KI that could include the liquid formulation of KI. We 
would welcome the opportunity to provide an update to the subcommittee 
when this review is complete.
    Question 5. Please describe how BARDA coordinates with 
pharmaceutical companies developing MCMs--specifically MCMs for 
anthrax.
    Answer. BARDA coordinates with large and small pharmaceutical and 
biotechnology companies through many different venues and mechanisms. 
Companies that have been awarded contracts by BARDA for the development 
of anthrax countermeasures are in constant communication with relevant 
program managers, project officers, and contracting officers and 
specialists. As warranted, companies with active contracts participate 
in interagency ``In-process Reviews'' to discuss progress toward 
project milestones or deviations of cost, schedule, or performance.
    BARDA senior leaders participate in and present BARDA plans and 
priorities at National and international biodefense, pharmaceutical, 
and biotechnology meetings. Subject matter experts from BARDA 
participate in a myriad of scientific and product development 
conferences throughout the world, broadening the understanding of 
BARDA's mission in the private sector.
    BARDA also supports public meetings that bring together scientists 
and pharmaceutical companies. BARDA, as mandated in PAHPA, convenes 
meetings with representatives from relevant industries, academia, other 
Federal agencies, international agencies as appropriate, and other 
interested persons at least once per year, providing an opportunity for 
the private sector to interact with USG staff and ask questions related 
to BARDA's mission, planning, priorities, and requirements. The next 
BARDA Industry Day will be conducted June 7-9 in San Diego, CA, with a 
similar meeting planned for Boston in October. Representatives of the 
Office of Acquisition Management, Contracts, and Grants within ASPR 
will also participate in and jointly sponsor both of these conferences.
    BARDA also has an open electronic portal 
(medicalcountermeasures.gov) for industry to request a meeting with the 
USG, and find information related to: (1) Procurement and grant 
opportunities, (2) public meetings and conferences, (3) specific 
product guidance, (4) available resources, and (5) PHEMCE and BARDA 
strategic and implementation plans and reports.
    Lastly, BARDA has a solicitation (Broad Agency Announcement; BAA) 
open year-round for product developers to engage BARDA through product 
development proposals. This solicitation allows private industry the 
ability to present ideas and projects to BARDA under an expedited 
review process. Although the solicitation calls for proposals based on 
all chemical, biological, radiological, and nuclear MCMs, BARDA has 
also issued Specific Instructions under the solicitation for anthrax 
countermeasures. Collectively, these activities are broadening BARDA's 
portfolio of anthrax medical countermeasure candidates and making it 
more feasible that these products will be available for future 
procurements.
     Questions From Chairman Gus M. Bilirakis for Gerald W. Parker
    Question 1. In your testimony, you indicated that DOD is integrated 
with other agencies through the National Biosurveillance Integration 
System (NBIS). Can you please expand on this comment, by describing the 
ways in which DOD participates (through information exchange, liaison 
officers, etc.)? Please also describe any memoranda of agreement, 
memoranda of understanding, etc. that have been signed, and how these 
have facilitated information sharing.
    Answer. Biosurveillance includes the process of data gathering and 
monitoring of potentially valuable information sources for tracking 
both naturally-occurring and man-made emerging epidemics. The ability 
to detect an outbreak early, investigate and verify the biological 
threat, and determine the extent of the outbreak all aid in responding 
to and mitigating the consequences of the outbreak. The Global Emerging 
Infections Surveillance and Response System (GEIS), operated by the 
Armed Forces Health Surveillance Center (AFHSC) through a network of 
U.S. and overseas laboratories, creates a centralized coordination and 
communication hub to help organize DoD resources and link U.S. and 
international efforts.
    DoD has entered into a Memorandum of Understanding (MOU) with the 
Department of Homeland Security, the Department of Agriculture, the 
Department of Health and Human Services, the Department of the 
Interior, the Department of State, and other agencies to participate in 
the establishment of the National Biological Integration System (NBIS). 
NBIS focuses on biosurveillance and early recognition and notification 
of hazards.
    This MOU has removed bureaucratic hurdles and clarified roles and 
requirements for DoD to share GEIS information with the Centers for 
Disease Control and Prevention and NBIS for integration into an overall 
National pattern. In particular, it allows DoD to participate in 
quarterly sessions of the NBIS Interagency Working Group and the NBIS 
Interagency Oversight Council. Moreover, DoD is involved in NBIS 
Protocol Activations, as needed (e.g., E. Coli outbreak in Germany). 
The NBIS representatives also participate in the DoD Joint 
Biosurveillance Working Group, contributing to discussions across the 
community that fields the necessary tools for operational users to 
gather data from environmental sensors, diagnostic results, or open 
source communications. The possibility exists for an MOU with DHS to 
allow DoD to place a military liaison with NBIS. In connection with the 
above, DoD's efforts are designed to capture all relevant 
biosurveillance information in a central location for better 
coordination with NBIS and other interagency and international 
partners.
    Question 2. The Department of Defense's Transformational Medical 
Technologies Initiative targets development of countermeasures that are 
broad spectrum, that is, effective against an array of threat agents. 
The civilian enterprise is also attempting a similar effort. Can you 
please provide the subcommittee with insights and best practices into 
how to advance this challenging, but necessary, endeavor in the 
civilian sector?
    Answer. Transformational Medical Technologies (TMT) investments are 
focused on broad-spectrum medical countermeasure (MCM) solutions, 
either individual MCMs that target conserved pathogen- or host-based 
targets or MCMs that are based on an adaptable platform technology that 
may be tailored to a new or emerging pathogen. These efforts attempt to 
mitigate the risk associated with both engineered and naturally evolved 
resistance in the pathogen.
    All medical countermeasure development toward licensure must adhere 
to Food and Drug Administration (FDA) regulations to demonstrate 
efficacy and to protect their respective populations, the general 
population and the warfighter, from unsafe drugs. The traditional FDA 
approval process presumes one indication per drug and one drug per 
target. The key breakthrough TMT seeks is a safe FDA approval process 
for a platform and not merely a product. In this regard, TMT has 
advanced further than the civilian sector. TMT New Drug Application 
submissions to FDA for approval consideration are the first examples 
under a new ``fast-track'' FDA process, still being developed.
    All products must comply with, and progress through, appropriate 
FDA regulatory processes governing their development and ultimate 
approval and use. Any civilian effort addressing MCMs should include 
working directly, and often, with the FDA and other organizations to 
promote and support new approaches to regulatory science.
    Civilian investments in broad-spectrum countermeasures should 
carefully consider the risks and benefits of a relabeling approach and 
assess whether relabeling or new discoveries will address their needs 
and gaps. Existing FDA-approved MCMs, and candidates under development 
by the civilian sector, are primarily pathogen-directed and well-
characterized. FDA-approved products could be (and are being) relabeled 
for additional indications. Consideration must include additional costs 
to license any subsequent indication necessary to reach broad-spectrum 
status with the FDA. The cost estimates should reflect the approximate 
cost to achieve FDA approval for the first indication, and the 
additional costs for new indications. Alternatives include designing 
MCMs against broadly conserved targets not easily subverted because 
they have a critical and necessary role in the pathogenesis of the 
infectious agent.
    To enable MCM discovery, TMT has invested in both in silico and in 
vitro platforms that enable rapid screening of candidates for off-
target effects, such as toxicity and drug-to-drug interactions. TMT 
supports development of computational tools that provide rapid analysis 
of potential targets, based on genomic sequence data. To enable MCM 
development under the FDA Animal Rule, TMT is investing in a range of 
tools to make drug testing in animals more predictive of the human 
experience. Collectively, these tools will improve the confidence for 
using data extrapolated from animal models for MCM evaluation. Broad-
spectrum investments should include enabling technologies to support 
this critical but original effort.


  TAKING MEASURE OF COUNTERMEASURES (PART II): A REVIEW OF EFFORTS TO 
 PROTECT THE HOMELAND THROUGH DISTRIBUTION AND DISPENSING OF CHEMICAL, 
     BIOLOGICAL, RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

                              ----------                              


                         Thursday, May 12, 2011

             U.S. House of Representatives,
 Subcommittee on Emergency Preparedness, Response, 
                                and Communications,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 1:00 p.m., in 
Room 311, Cannon House Office Building, Hon. Gus M. Bilirakis 
[Chairman of the subcommittee] presiding.
    Present: Representatives Bilirakis, Marino, and Richardson.
    Mr. Bilirakis. The Subcommittee on Emergency Preparedness, 
Response, and Communications will come to order.
    The subcommittee is meeting today to receive testimony on 
Federal, State, and local efforts to distribute and dispense 
medical countermeasures in the event of a CBRN attack, 
pandemic, or other emergency.
    I now recognize myself for an opening statement.
    At the outset, I would like to thank our witnesses for 
their flexibility on the timing of today's hearing. Thank you 
very much. Appreciate it.
    This hearing is the second in a series considering medical 
countermeasures. Last month, the subcommittee received 
testimony on Federal efforts to work with industry to research, 
develop, and acquire medical countermeasures. Today, the 
subcommittee will focus on efforts to get those medications, 
diagnostics, and other medical supplies to individuals who need 
them in the event of a CBRN attack, pandemic, or other 
emergency.
    Our enemies have made no secret of their desire to use 
weapons of mass destruction to attack the United States. Last 
year, the Committee on Homeland Security received testimony 
from former Senators Graham and Talent, the commissioners of 
the Commission on the Prevention of Weapons of Mass Destruction 
Proliferation and Terrorism.
    At the hearing, the commissioners noted that it is more 
likely than not that there will be a weapon of mass destruction 
used someplace on Earth by a terrorist group before the end of 
the year 2013 and that it is more likely that the weapons will 
be biological rather than nuclear.
    This assessment, along with the anthrax attacks in 2001, 
the H1N1 pandemic in 2009, and the disaster in Japan, 
highlights the need for robust plans for countermeasure 
distribution and dispensing.
    The WMD commission issued a report card on U.S. Government 
efforts to protect the Nation from WMD terrorism last year. 
Sadly, the Government received a grade of ``F'' on its efforts 
to enhance the Nation's capabilities for rapid response to 
prevent biological attacks from inflicting mass casualties. Of 
course we can and must do better.
    I look forward to hearing from our Federal witnesses about 
whether we have made strides in this area since January 2010, 
since the report card was issued. What lessons have we learned 
from the response to the H1N1 pandemic that can help us enhance 
our preparedness and response?
    I would also like their opinion on whether the Federal 
Government is investing adequate resources in the Strategic 
National Stockpile to ensure that we have appropriate 
quantities of the right drugs, diagnostics, and supplies. In 
light of the radiological emergency in Japan, we must not 
squander this opportunity to assess our own preparedness for a 
radiological or nuclear disaster, which I fear is, as I said, 
substantially inadequate.
    I am interested in hearing from all of our witnesses, 
especially our State and local witnesses on the second panel, 
on their view of the various distribution models and where we 
need to be today to respond to any event that may happen 
tomorrow. Which models are the most promising to reach the 
largest population as expeditiously as possible? What 
innovative efforts are being implemented at the local level to 
ensure prompt dispensing?
    Last, we must consider how effectively the Federal 
Government is interfacing with States and localities to ensure 
that resources and guidance are provided and that planning is 
coordinated. We must ensure that the public is appropriately 
informed of the threats they face and that the first responders 
who treat them have the guidance and opportunities for pre-
event vaccination that they deserve.
    With that, I welcome our witnesses, and I look forward to 
their testimony.
    Right on time, I will recognize the Ranking Member for her 
statement. Thank you. You are recognized.
    Ms. Richardson. Thank you, Mr. Chairman. Thank you for 
convening this very important hearing about our Nation's 
readiness for distributing and dispensing medical 
countermeasures.
    I would also like to express my gratitude to those of you 
who have served on our behalf. We are very grateful for that, 
and thank you.
    As a representative of the 37th Congressional District, I 
understand the critical importance of developing effective 
nuclear biological and radiological and chemical 
countermeasures. The Port of Long Beach and other critical 
infrastructure is throughout my entire district, not to mention 
the large population that Los Angeles County faces, us being 
the largest county in the entire United States.
    We must ensure that the Federal, State, and local efforts 
are coordinated to ensure a seamless and expeditious 
distribution and dispensing process to respond to bioterror, 
pandemic events, or emergencies caused by a natural disaster.
    There have been major improvements to the Nation's public 
health infrastructure over the last decade, especially since 
the anthrax attacks that we had and even faced here in 
Washington, DC. Most importantly, however, our State and local 
health departments, who serve as the backbone of our 
distribution and dispensing efforts, have made great progress 
in planning and navigating through complex logistical 
challenges.
    However, we must ensure that the Federal efforts support 
State and local health departments, who, under law, have the 
primary responsibility for the health of our citizens. 
Therefore, when we consider the Federal efforts that should be 
taken, unfortunately a decade of gains to our State and local 
public health departments are endangered based upon the budget 
cuts, or the proposed budget cuts.
    According to a December 2010 study by the Trust for 
America's Health, entitled, ``Ready or Not? Protecting the 
Public's Health from Diseases, Disasters, and Bioterrorism,'' 
33 States and Washington, DC, have cut funding for public 
health since 2008. Also, since fiscal year 2005, Federal 
support for public health preparedness has also been cut by 27 
percent. Funds for public health allocated during the 2009 
pandemic flu response and through the Recovery Act helped to 
provide some support but did not address the need to build a 
sustainable capacity for a large-scale response.
    The erosion of the State and local public health 
infrastructure and workforce leaves us at risk of not being 
adequately prepared to have the basic capabilities to meet 
time-sensitive goals of dispensing medical countermeasures.
    I look forward to hearing specific effects that you might 
feel would be impacting your area based upon the cuts that have 
been proposed. We, in Congress, must assure you and provide the 
support you deserve to address these health challenges. 
Inadequate emergency health preparedness puts our Nation at 
risk, and we must be resolved now, prior to being tested by 
another large-scale emergency.
    In addition to funding issues, I would like to hear about 
the lessons learned from the 2009 H1N1 response and what is 
being done to protect our at-most-risk populations, especially 
children in schools and daycare centers.
    Again, I thank you for being here today, and I look forward 
to your testimony.
    Mr. Bilirakis. Thank you very much.
    Others Members of the subcommittee are reminded that 
opening statements may be submitted for the record.
    Before I introduce our first panel, I ask unanimous consent 
to insert in the record a statement from the National 
Association of Chain Drug Stores.
    Without objection, so ordered.
    [The information follows:]
       Statement of The National Association of Chain Drug Stores
                              May 12, 2011
    NACDS thanks the committee for the opportunity to submit a 
statement for the hearing on ``Taking Measure of Countermeasures: A 
Review of Efforts to Protect the Homeland Through Distribution and 
Dispensing of CBRN Medical Countermeasures.'' Rapid access to medical 
countermeasures is critical for preventing and treating illness caused 
by public health emergencies. As the Institute of Medicine reported, 
public health cannot do this job alone--collaboration from the private 
sector will be necessary to reach large numbers of people in the 
community. NACDS, its member companies, and the 120,000 dedicated 
pharmacists who work in community pharmacies are uniquely equipped and 
stand ready to assist policymakers and public health officials at all 
levels of government in ensuring convenient access to countermeasures 
in a medically-relevant time frame following an emergency.
    The National Association of Chain Drug Stores (NACDS) represents 
traditional drug stores, supermarkets, and mass merchants with 
pharmacies--from regional chains with four stores to National 
companies. Chains operate 39,000 pharmacies, and employ more than 2.7 
million employees, including 118,000 full-time pharmacists. They fill 
nearly 2.6 billion prescriptions annually, which is more than 72 
percent of annual prescriptions in the United States. The total 
economic impact of all retail stores with pharmacies transcends their 
$830 billion in annual sales. Every $1 spent in these stores creates a 
ripple effect of $1.96 in other industries, for a total economic impact 
of $1.57 trillion, equal to 11 percent of GDP. NACDS represents 137 
chains that operate these pharmacies in neighborhoods across America, 
and NACDS members also include more than 900 pharmacy and consumer 
packaged goods suppliers and service providers, and over 60 
international members from 23 countries. For more information about 
NACDS, visit www.NACDS.org.
         engage the private sector in countermeasure dispensing
    Experts in emergency preparedness have reported that most 
communities lack adequate mechanisms and capacity in public health to 
expeditiously dispense countermeasures to all of the target populations 
following a public health emergency. Various dispensing modalities have 
been discussed, including home delivery by the U.S. Postal Service, the 
development of Points of Dispensing (PODs) and pre-positioning of 
medications in households, among others.
    Policymakers should be encouraged to engage the Nation's community 
pharmacies as primary PODs to help extend the reach of public health. 
Put simply, dispensing is a normal pharmacy function; nearly 2.6 
billion prescriptions are filled in community pharmacies annually. 
Pharmacists are among the most accessible health providers, and most 
Americans live within 5 miles of a community pharmacy. In a July 2009 
PriceWaterhouseCoopers survey, respondents reported the least amount of 
difficulty in accessing care from pharmacists. In addition, pharmacists 
are highly trusted health care professionals, and have rated in the top 
three in each of the past 8 years in Gallup's survey of integrity 
across professions. Pharmacists also have the advantage of being able 
to administer vaccinations in all 50 States. More than 100,000 
pharmacists Nation-wide are qualified to administer vaccinations.
            pharmacies: extending the reach of public health
    The value of community pharmacies in extending the reach of public 
health has clearly been recognized by Federal officials and State 
public health officials following their active participation in the 
response following Hurricane Katrina and during the 2009 H1N1 influenza 
pandemic. Pharmacists have performed a range of services to targeted 
patient populations following emergencies, including dispensing 
countermeasures, administering vaccines, patient screening and triage, 
education of the public, and monitoring for adverse events. Pharmacies 
have existing technological infrastructures that can be leveraged to 
triage patients, have lot space to accommodate surges in patient 
demand, and sell personal protective equipment and medical supplies 
that may also be important in preventing or treating CBRN threats. An 
increasing percentage of pharmacies have drive-through windows that can 
augment patient throughput and assist with social distancing to prevent 
infectious exposure.
Pharmacy Engagement During H1N1 Influenza Pandemic
    The 2009 H1N1 vaccination campaign was the largest such undertaking 
in history, requiring broad coordination across the entire health care 
continuum to increase the number of vaccine providers. NACDS and its 
members were actively engaged in the planning and execution of public 
health H1N1 influenza response. NACDS convened a stakeholder workgroup 
meeting that produced the Operational Framework for Partnering with 
Pharmacies for the Administration of 2009 H1N1 Vaccine, published by 
the Association of State and Territorial Health Officials, which served 
as guidance for the relationship between community pharmacies and State 
public health planners. The Framework included a template ``provider 
agreement'' between public health and community pharmacies, and a 
template ``executive order'' proposing emergency amendments to expand 
State-level use of community pharmacies in H1N1 vaccination programs. 
As a result of the framework, community pharmacies enrolled broadly in 
State vaccine provider networks. Several States also issued emergency 
orders to expand the ability of pharmacists to administer H1N1 vaccine, 
by lowering age limits and streamlining vaccination protocols. While 
the vaccine was first available in October 2009, many pharmacies did 
not start receiving them from State and local health departments until 
November or December.
    In December 2009, the Centers for Disease Control and Prevention 
(CDC) launched the H1N1 Vaccine Retail Initiative to supplement State 
and local public health vaccination efforts. Through this program, CDC 
partnered with retail pharmacies and retail clinics to directly provide 
H1N1 vaccine. Ten retail pharmacy chains participated, totaling 10,700 
retail locations served. These pharmacies received over 5.4 million 
doses of 2009 H1N1 vaccine directly from CDC. All told, 10% of 2009 
H1N1 influenza vaccinations were provided in a community pharmacy 
location.
    Pharmacies were also the primary provider of countermeasures to 
H1N1 influenza, including Tamiflu and Relenza. The shortage of 
commercially manufactured Tamiflu oral suspension--an important 
treatment for high-priority pediatric patients--necessitated that 
trained pharmacy personnel compound the product with guidance from the 
Food and Drug Administration (FDA) and CDC. The unique skill set of 
pharmacists make them well-prepared to compound countermeasures into a 
formulation that can be used by the most vulnerable populations.
Preserving Adherence to Chronic Medications
    In addition to rapid access of countermeasures, it is critical that 
patients continue to access life-sustaining medicines for chronic 
conditions such as diabetes, high blood pressure, or respiratory 
disorders during public health emergencies. This problem, known as poor 
``medication adherence'' is a well-documented, enduring challenge to 
achieving positive outcomes in patients with chronic disease. The New 
England Healthcare Institute (NEHI) estimated that poor medication 
adherence in all its manifestations costs the Nation $290 billion 
annually--13% of total health care expenditures--resulting from a 
worsening of disease, avoidable hospitalizations, and emergency room 
visits. Preserving patient medication adherence can mitigate patient 
surges at hospitals and emergency rooms, which may free up these venues 
to focus on the most at-risk patients. Utilizing pharmacies as PODs may 
reinforce the message that patients must continue the safe and 
appropriate use of their chronic medications during public health 
emergencies.
       maximizing pharmacy participation in public health efforts
    Community pharmacy support of public health programs has led to 
partnerships that have significantly improved patient care, but also 
has involved on-going challenges. During the H1N1 influenza pandemic, 
the wide variety of State and local processes and restrictions added 
complexity to community pharmacy support and we would recommend a more 
uniform process in the future. Aligning processes in and across States 
for ordering products, claims process, reimbursement, inventory 
monitoring, vaccine regulations, and reverse distribution would serve 
to enhance the ability of pharmacies to participate in public health 
campaigns. Policymakers must also address liability issues related to 
employing rapid countermeasure dispensing models. To enhance 
preparedness and response to any CBRN attack, it is critical that any 
National medical countermeasure dispensing strategy actively engage 
private sector partners--including community pharmacies--to address 
these issues prior to an attack.
                               conclusion
    NACDS thanks the committee for consideration of our comments on 
efforts to engage pharmacies in countermeasure dispensing. As the face 
of neighborhood health care, community pharmacies remain committed to 
assist public health efforts to protect our citizens through convenient 
access to countermeasures. We look forward to working with Congress and 
the public health community to ensure the Nation's community pharmacies 
are used to the greatest extent possible.

    Mr. Bilirakis. I am pleased to welcome our witnesses.
    Our first witness is Dr. Alexander Garza. Dr. Garza is the 
Assistant Secretary for Health Affairs and Chief Medical 
Officer of the Department of Homeland Security. He manages the 
Department's medical and health security matters, oversees the 
health aspects of contingency planning for all chemical, 
biological, radiological, and nuclear hazards, and leads a 
coordinated effort to ensure that the Department is prepared to 
respond to biological and chemical weapons of mass destruction.
    Prior to joining the Department in August 2009, Dr. Garza 
spent 13 years as a practicing physician and medical educator. 
He most recently served as the Director of Military Programs at 
the ER One Institute at the Washington Hospital Center and has 
served as the Associate Medical Director of Emergency Medical 
Services for the State of New Mexico and Director of EMS for 
the Kansas City, Missouri, Health Department.
    Dr. Garza holds a medical degree from the University of 
Missouri Columbia School of Medicine, a master's of public 
health from the St. Louis University School of Public Health, 
and a bachelor's degree of science and biology from the 
University of Missouri-Kansas City.
    Prior to earning his medical degree, he served as a 
paramedic and an emergency medical technician. He is a fellow 
of the American College of Emergency Physicians and a member of 
the American Public Health Association.
    Welcome, Dr. Garza.
    Our next witness is Rear Admiral Ali Khan. Dr. Khan is the 
Assistant Surgeon General and Director of the Centers for 
Disease Control and Prevention's Office of Public Health 
Preparedness and Response, a position he assumed in August 
2010. In his capacity, Dr. Khan leads the CDC's efforts to 
prepare for and respond to public health threats and manages 
the Strategic National Stockpile.
    Dr. Khan joined CDC and the U.S. Public Health Service 
Commission Corps in 1991. Over the course of his career, Dr. 
Khan has focused on bioterrorism, global health, and emerging 
infectious diseases and serves as one of the main architects of 
the CDC's Public Health Bioterrorism Preparedness Program.
    Dr. Khan received his medical degree from Downstate Medical 
Center in Brooklyn, New York, and completed a joint residency 
in internal medicine and pediatrics at the University of 
Michigan--Ann Arbor. He has a master's of public health from 
Emory University, where he also serves as an adjunct professor.
    Welcome.
    Your entire written statements will appear in the record. I 
ask that you each summarize your testimony for 5 minutes.
    We will start with Dr. Garza. Thank you.

STATEMENTS OF ALEXANDER G. GARZA, MD, MPH, ASSISTANT SECRETARY 
   FOR HEALTH AFFAIRS, CHIEF MEDICAL OFFICER, DEPARTMENT OF 
                       HOMELAND SECURITY

    Dr. Garza. Thank you, sir.
    Good afternoon, Chairman Bilirakis, Ranking Member 
Richardson, and distinguished Members of the subcommittee. 
Thank you for inviting me to testify before you today. It is an 
honor to be here to discuss the Office of Health Affairs 
programs that support the Department of Homeland Security's 
efforts in medical countermeasures.
    Today I will discuss a number of OHA initiatives that help 
to mitigate biological threats and help prepare the Nation to 
detect and respond to a biological incident. I will also speak 
about how DHS coordinates with State and local governments, how 
our activities were related to the Executive Order No. 13527, 
and how we worked to ensure to a resilient DHS workforce.
    OHA supports and coordinates with our Federal partners, 
especially the Centers for Disease Control and Prevention and 
the Food and Drug Administration, on medical countermeasure 
issues. OHA works closely with the DHS Science and Technology 
Directorate to assess current and emerging chemical, 
biological, radiological, and nuclear risks to the United 
States population.
    The threat of an attack using a biological agent is real 
and requires vigilance. A wide-area attack using Bacillus 
anthracis is one of the most serious biological threats facing 
the United States. However, even a small, well-coordinated 
biological attack will have significant consequences.
    The Federal Government has recognized that, in order to 
minimize the effects of such an attack, two critical 
capabilities must be in place: First, the Nation must be able 
to rapidly determine that an attack has occurred before people 
become ill. Second, we must have the capability to rapidly 
distribute medical countermeasures to the affected population.
    Through early detection via our BioWatch system, OHA works 
to mitigate the consequences of a biological incident. BioWatch 
is a Nation-wide environmental surveillance system that detects 
the release of selected aerosolized biological agents of 
concern. Early detection give decision-makers the capability to 
act to protect their communities by providing medical 
countermeasures in a timely fashion, with the goal of saving 
lives.
    Through the BioWatch program, we have essentially built 
local biodefense capability by expanding public health 
participation in, and coordination with, the National network 
of BioWatch jurisdictional advisory committees as well as local 
fusion centers.
    In addition, OHA provides health and medical expertise in 
planning and exercise efforts that advance National 
preparedness and response capabilities. In 2009, Secretary 
Napolitano directed OHA to develop the Anthrax Response 
Exercise Series. These were comprehensive anthrax response 
exercises that have been conducted in each of the 10 FEMA 
regions in coordination with State and local governments. OHA 
has also led efforts to provide our State and local partners 
with guidance for the protection of personnel responding to a 
wide-area anthrax attack.
    On December 30, 2009, President Obama signed Executive 
Order 13527 establishing Federal capability for the timely 
provision of medical countermeasures following a biological 
attack. OHA participated in all aspects of the response for DHS 
to this Executive Order and is the lead office for the 
Department's efforts on section 4, which directs Federal 
agencies to establish mechanisms for the provision of medical 
countermeasures to personnel to ensure the continuity of 
mission-essential functions.
    In addition, the Department and HHS have the responsibility 
to develop a plan to provide medical countermeasures to 
mission-essential personnel to ensure the continuity of 
operations. We lead this efforts for DHS, and we set the stage 
for the Federal interagency.
    The Department builds National resilience by ensuring the 
protection of our workforce. Due to the nature of our 
workforce's security mission, DHS personnel could be exposed 
during response activities or in their interactions with the 
millions of people they meet every day at airports, ports of 
entry, to name a few.
    As previously discussed, individuals exposed to anthrax 
spores must be protected in a timely manner. Added to this is 
the understanding that a biological attack is an act of 
terrorism. These issues underlie the importance of the 
Department's plans to preposition medical countermeasures in 
caches across the country for our workforce.
    We have spearheaded the MCM strategy and oversee the 
purchase and storage of our countermeasures for our workforce. 
This strategy includes all of our employees and personnel, as 
well as those in care and custody of DHS. We collaborate with 
offices across the Department to assure the Department-wide 
strategy is met.
    We are following the Secretary's directive to lead by 
example and continue to work on developing strategies to make 
sure countermeasures are available to support our mission-
critical functions.
    I thank you again for the opportunity to testify today, and 
I look forward to any questions that you may have. Thank you.
    [The statement of Dr. Garza follows:]
                Prepared Statement of Alexander G. Garza
                              May 12, 2011
    Good afternoon, Chairman Bilirakis, Ranking Member Richardson, and 
distinguished Members of the subcommittee. Thank you for inviting me to 
testify before you today. It is an honor to be here to discuss the 
Office of Health Affairs' (OHA) programs that support the Department of 
Homeland Security's efforts in medical countermeasures (MCM) 
distribution and dispensing.
    Today I will discuss a number of OHA initiatives that help to 
mitigate biological threats and help prepare the Nation to quickly 
detect and respond to a biological attack. I will also speak about how 
DHS assists and coordinates with State and local governments, our 
activities relating to Executive Order (E.O.) 13527, and how we work 
every day to ensure a resilient Nation and DHS workforce.
OHA Initiatives That Help Mitigate Biological Threats and Help Prepare 
        the Nation to Quickly Detect and Respond to Biological Events
    OHA supports and coordinates routinely with our Federal partners, 
especially the Department of Health and Human Services (HHS), including 
the Assistant Secretary for Preparedness and Response (ASPR), the 
Centers for Disease Control and Prevention (CDC), and the Food and Drug 
Administration (FDA), on medical countermeasures issues. OHA and the 
DHS Science and Technology Directorate (S&T) represent DHS as ex 
officio members of the HHS-led interagency Public Health Emergency 
Medical Countermeasures Enterprise Senior Council, which is the primary 
conduit for communication among entities involved in the MCM mission.
    OHA also works closely with S&T, which has the DHS lead to assess 
current and emerging threats that occur naturally or are chemical, 
biological, radiological, or nuclear agents, and to determine which 
agents present a significant threat to the U.S. population. S&T 
produces the Bioterrorism Risk Assessment (BTRA), a strategic 
assessment of bioterrorism risk, updated biennially, that integrates 
the findings of the intelligence and law enforcement communities with 
input from the scientific, medical, and public health communities. OHA 
provides subject matter expertise to S&T in developing the BTRA, and 
has worked closely with the BTRA program managers to develop tailored 
assessments designed to address specific knowledge gaps or areas of 
uncertainty identified within OHA programs. OHA applies these 
assessments when operating, managing, and supporting the Department's 
biodefense programs.
    The threat of an attack using a biological agent is real and 
requires that we remain vigilant. A wide-area attack using aerosolized 
Bacillus anthracis, the bacteria that causes anthrax, is one of the 
most serious mass casualty biological threats facing the United States. 
An anthrax attack could potentially encompass hundreds of square miles, 
expose hundreds of thousands of people, and cause illness, death, fear, 
societal disruption, and economic damage. If untreated, the disease is 
nearly 100 percent fatal, which means that those exposed must receive 
life-saving MCM as soon as possible.
    The Federal Government recognizes two critical capabilities must be 
in place in order to minimize the effects of a biological attack. 
First, the Nation must be able to rapidly determine that an attack has 
occurred. Second, we must have the capability to quickly distribute MCM 
to the entire affected population before clinical symptoms appear.
    Through early detection, OHA works to mitigate the consequences of 
a biological incident. OHA's Biowatch program is a Federally managed, 
locally operated, Nation-wide environmental surveillance system that 
detects the release of certain aerosolized biological agents before 
exposed individuals develop symptoms of illness. This ``detect to 
treat'' approach provides the public health community with an 
opportunity to respond to a release of a biological agent as quickly as 
possible in order to mitigate the potentially catastrophic impact on 
the population. Early detection allows communities to provide medical 
countermeasures to affected persons in a timely manner in order to save 
more lives.
    For this reason, OHA is investing in the development of advanced 
detection technology that aims to significantly reduce the time between 
a release of a biothreat agent and confirmation of the release by 
Biowatch technology. The transition to an automated detection system, 
called ``Generation 3'', is intended to confirm a release within 4 to 6 
hours in the locations that Biowatch covers. Reducing the time it takes 
to properly detect and confirm a release is critical because earlier 
detection allows for earlier distribution of lifesaving MCM to 
effectively protect the exposed population.
DHS Assists and Coordinates with State and Local Governments
    OHA works directly with State and local leaders to develop 
capabilities to respond to health threats. We have done this by 
expanding local public health participation in, and coordination with, 
the National network of BioWatch jurisdictional advisory committees as 
well as State and urban area fusion centers.
    Furthermore, OHA provides health and medical expertise to planning 
and exercise efforts that advance National preparedness and response 
capabilities. To increase preparedness for and resilience to biological 
threats, Secretary Napolitano initiated the Anthrax Response Exercise 
Series (ARES) exercises, which are comprehensive anthrax response 
exercises conducted in each of the 10 Federal Emergency Management 
Agency (FEMA) regions in coordination with State and local governments. 
Completed in fall 2010, the ARES series was valuable to State, local, 
and regional stakeholders for a number of reasons. It increased 
awareness in the areas of biodetection, notification, and early 
response protocols. It also provided the opportunity to combine 
exercise program requirements (biodetection strategies, including 
BioWatch and State exercise plans) while engaging both large and small 
metropolitan areas throughout the United States.
    ARES successfully provided an opportunity for Federal, State, 
local, and regional partners to come together and better understand 
their roles and responsibilities supporting biodetection, notification, 
and response. ARES created an opportunity for all levels of government 
to define and refine their MCM programs and plans. We plan to continue 
to build on the success of ARES by conducting workshops in additional 
cities for 2011 and 2012.
    In addition to ARES and other exercise activities that allow State 
and local governments to strengthen their National response 
capabilities, OHA also provides our State and local partners with 
guidance for protection of personnel responding to a wide-area anthrax 
attack. Through the Federal interagency process, OHA led the effort to 
develop consensus guidance regarding appropriate protective measures 
for responders in the immediate post-attack environment of an 
aerosolized anthrax attack. The guidance reflects the most current 
understanding of the unique environment that would exist after a wide-
area anthrax release. The guidance is a prudent step to provide to 
first responders the best information on protective measures currently 
available. The responder community had requested guidance in this area, 
and DHS and Federal partners are committed to continually updating the 
guidance to ensure that it reflects the best science.
Executive Order 13527: Establishing Federal Capability for the Timely 
        Provision of Medical Countermeasures Following a Biological 
        Attack
    In addition to assisting and coordinating with State and local 
governments, OHA also actively engages in Federal interagency efforts 
to strengthen the Nation's ability to prepare for, respond to, and 
recover from natural disasters and terrorist attacks. On December 30, 
2009, President Obama signed Executive Order (E.O.) 13527, 
``Establishing Federal Capability for the Timely Provision of Medical 
Countermeasures Following a Biological Attack.'' The E.O. seeks to 
mitigate illness and prevent death, sustain critical infrastructure, 
and complement State, local, territorial, and Tribal government MCM 
distribution capacity.
    Section 2 of the E.O. directs the development of a National United 
States Postal Service (USPS) MCM dispensing model for U.S. cities to 
respond to a large-scale biological attack. This model has the capacity 
for rapid residential delivery of MCM for self administration across 
all U.S. communities. In collaboration with the Departments of Justice, 
Defense, HHS, and USPS, DHS supported the development of the USPS 
model. Upon request, DHS will assist State and local governments 
through Emergency Support Function (ESF)-13 to provide required law 
enforcement support for the U.S. Postal model in those jurisdictions 
considering this modality of distributing MCM.
    Section 3 of the E.O. directs the development of a Federal rapid 
response capacity to supplement State and local governments and the 
private sector's capabilities to deploy MCM. This effort is being co-
led by FEMA and ASPR, and OHA has provided subject matter expertise.
    Section 4 of the E.O. directs Federal agencies to establish 
mechanisms for the provision of MCM to personnel to ensure that the 
mission essential functions of the Executive branch departments and 
agencies continue to be performed following a biological attack. In 
addition, the Department and HHS have the responsibility to develop a 
plan to provide MCM directly to mission-essential personnel to ensure 
continuity of operations. OHA leads this effort for DHS. We are pleased 
to say that DHS is among the first Federal agencies to have met this 
requirement of the E.O.
    In April 2010, DHS established the Anthrax Preparedness and 
Response Steering Committee to develop specific products to improve 
preparedness and response efforts that include the activities mandated 
in the E.O. The Steering Committee leads the Department's efforts in 
enhancing readiness and immediate response in the event of wide-area 
aerosolized anthrax attack and includes senior leaders from across the 
Department.
    DHS Workforce and Health Protection OHA works each day to build 
resilience across the country and within the Department. We do so by 
leading and strengthening our Nation's collective efforts to secure our 
country from the threats we face. We also build resilience by ensuring 
the protection of our workforce, as mandated in Section 4 of the E.O.
    In Section 4, the President ordered the Federal Government to 
establish mechanisms for the provision of MCM to personnel performing 
mission-essential functions. Secretary Napolitano further directed the 
Department to develop a plan and seek funding for a capacity to provide 
emergency antibiotics to all DHS employees in an attacked area, not 
just those who are mission-essential.
    The DHS workforce includes a wide variety of mission-essential 
personnel who work in varying geographical locations throughout the 
United States and internationally. Due to the nature of DHS workforce's 
security mission, some DHS personnel could be exposed during response 
activities or in their interactions with millions of people each day at 
airports and ports of entry.
    As previously discussed, individuals exposed to anthrax spores can 
survive if they take antibiotics quickly, underlining the importance of 
the Department's plans to pre-position MCM in caches across the country 
for employees. In the event of an anthrax attack, all affected DHS 
personnel and their families will also have access to MCM through 
existing community MCM dispensing plans.
    OHA spearheaded an MCM strategy for DHS employees and oversees the 
purchase and storage of MCM for the DHS workforce. This includes all 
employees and personnel and individuals in the custody and care of DHS. 
The MCM strategy and implementation plan is a multi-year, multi-layered 
approach which consists of four phases, each building upon the previous 
and is subjected to the availability of funding to achieve its goal of 
covering the entire DHS workforce. This scalable approach will ensure 
the sustainability of the program.
    The goal of the first phase is to protect and mitigate the effect 
of an anthrax exposure by delivering MCMs post-event to employees. This 
phase is currently underway. We purchased courses of MCM that are 
stored at a central location and at regional locations to cover Federal 
employees and those in DHS's care and custody. OHA, in coordination 
with DHS components, identified accessible and secure facilities for 
storage of MCM. Additional cache locations will be identified over time 
to improve coverage and proximity to employees. OHA also builds points 
of dispensing capability to dispense MCM as needed by providing 
training to appropriate personnel.
    Leading by example and pushing forward the Federal interagency 
effort for MCM dispensing and distribution, OHA collaborates routinely 
with various offices within DHS to ensure synergistic efforts in 
implementing this Department-wide strategy. OHA provided guidance and 
comprehensive planning information to DHS components through the 
Anthrax Operations Plans Department Guidance Statement (DGS). We also 
provide medical guidance and logistical and operational support to DHS 
component offices as they finalize their MCM plans. To supplement the 
DGS, OHA has also provided medical guidance in the form of Standard 
Operating Procedures, including for storage of MCM, administration of 
MCM for anthrax spore exposure, non-medical points of dispensing for 
MCM, and working and service animal anthrax spore exposure. OHA is now 
in the process of credentialing DHS personnel who will provide the 
medical oversight of MCM storage and dispensing.
    Among the first departments to fulfill the mandates required by the 
E.O., OHA is also sharing lessons learned and coordinating with the 
interagency process to ensure the consistency of plans across the 
Federal Government, including our partners at HHS, CDC, and FDA. Along 
with ASPR, we co-chair a working group to protect mission-essential 
employees of Executive branch departments and agencies in the event of 
a wide-area aerosol anthrax attack.
Conclusion
    OHA manages and oversees the DHS MCM program and works to mitigate 
biological threats by preparing the Nation to quickly detect and 
respond to a biological attack through early detection and rapid 
distribution of MCM. DHS leads and strengthens our Nation's collective 
efforts to secure our country from threats, assisting and coordinating 
with State and local governments, and helping to ensure a resilient DHS 
workforce. Thank you again for the opportunity to testify today. I look 
forward to any questions that you may have.

    Mr. Bilirakis. Thank you.
    Dr. Khan, welcome, sir.

   STATEMENT OF REAR ADMIRAL ALI S. KHAN, MD, MPH, DIRECTOR, 
OFFICER OF PUBLIC HEALTH PREPAREDNESS AND RESPONSE, CENTERS FOR 
                 DISEASE CONTROL AND PREVENTION

    Dr. Khan. Good afternoon. Thank you for the invitation to 
address the subcommittee today. My remarks will focus on the 
role of the medical countermeasures, including the CDC's 
Strategic National Stockpile, to protect the public's health 
and, ultimately, our Nation's security.
    I would like you all to imagine a 5-pound bag of sugar. 
Instead of sugar, let's imagine that it is full of anthrax 
spores. Now, while the anthrax bacterium is a naturally 
occurring organism, there is nothing natural about well-
produced anthrax spores. In 2001, these anthrax spores were 
mailed to news reporters and U.S. Senators, and you know better 
than most of the world about anthrax and the risk of anthrax 
and how real it is. I had the opportunity and privilege to 
serve here for 3 months during those attacks in Washington, DC.
    Now, these attacks involved letters which held just one 
gram of powdered spores, about the amount in a sugar packet. 
Yet, 22 people were infected and 5 died. In comparison, an 
equivalent of this 5-pound bag that I mentioned earlier could 
infect 100,000 people or more.
    If that were to occur, every hour of delay in pretreating 
these people with antibiotics will lead to not just increased 
illness and death but also social, political, and economic 
disruption, as we saw with the limited attack in 2001. Given 
this, it is quite clear that this is a National health security 
issue.
    That is why the Strategic National Stockpile is such a 
vital resource for us here in the United States for the 
American people. Fortunately for us, CDC, DHS, and Federal, 
State, and local partners are working diligently to make sure 
that, if such an attack would ever occur, our Nation would be 
ready to minimize disease and loss of life--ready to rapidly 
detect and identify disease in our communities, ready to 
quickly deploy these lifesaving countermeasures from CDC's 
Strategic National Stockpile, ready to mitigate the attack, and 
ready to assess the effectiveness and safety of our public 
health interventions.
    Now, to be ready, we require an entire public health system 
to use these medical countermeasures for the people who need 
them most. This public health system includes public health 
nurses, disease detectives, lab workers, who are essentially 
helping protect health every day from threats.
    During an emergency, CDC also must be able to provide 
clinical guidance, track these medical countermeasures and how 
they are used, and monitor adverse events. Thus, to protect our 
National health security, CDC goes beyond stockpiling and 
delivering medical countermeasures. We support our State and 
local partners to help them build their capabilities and 
abilities to distribute, dispense, and utilize those assets, 
recognizing that all response is essentially local. We provide 
approximately $600 million in funding and technical assistance 
to our State and local partners to help them develop tests to 
improve their public health preparedness capability, including 
this distribution and dispensing of medical countermeasures.
    In my visit to States, including the States represented by 
the two of you, I have seen really visible, measurable 
improvements in preparedness in multiple areas, specifically 
incident management, laboratory capabilities, and risk 
communications. Throughout the Nation, we have seen the value 
of this investment in public health in how much better we were 
able to respond to H1N1 than if we had not made that 
investment.
    Now, public health preparedness is a dynamic process, and 
we must remain responsive to both the changing threats out 
there and the environment. To do this, we work very closely 
with our Federal partners. DHS is one of our strongest 
partners. We work together on deciding the best medical 
countermeasures to have ready, developing new lab tests, 
including for BioWatch that you just heard, and improving our 
ability to utilize medical countermeasures better than we 
currently do.
    Now, it is important for us to be very innovative in this 
time, to make sure that we have rapid, efficient, and cost-
effective ways to protect our National health security. Since--
you referenced--the meeting in January 2010, we are 
reconsidering the number of SNS storage sites to have drugs 
more available to people rapidly; we are phasing out legacy 
perhaps for more efficient programs; we are continuing to 
examine the formulary of the SNS, specifically for drug-
resistant anthrax; and we are thinking about stretching the 
amount of countermeasures we have by using various studies to 
look at using different amounts of those existing 
countermeasures.
    So, in the end, let me say, we cannot control when or where 
an outbreak pandemic or natural disaster, terrorist attack may 
occur to threaten the public's health, but we can control how 
we respond to it. This is an issue of National health security 
for us.
    I thank you again for the invitation to testify before you 
today, and I will be happy to answer any questions you may 
have.
    [The statement of Dr. Khan follows:]
                   Prepared Statement of Ali S. Khan
                              May 12, 2011
                              introduction
    Good afternoon, Chairman Bilirakis, Ranking Member Richardson, and 
Members of the subcommittee. I am Dr. Ali Khan, an Assistant Surgeon 
General and Director of the Office of Public Health Preparedness and 
Response, at the Centers for Disease Control and Prevention (CDC). 
Thank you for the invitation to address the subcommittee today. My 
remarks will discuss the role of medical countermeasures (MCM), 
including the CDC Strategic National Stockpile (SNS), in strengthening 
our Nation's public health preparedness and response, and ultimately 
our Nation's health security.
                               background
    Threats to the public's health are always present. These threats 
can range from a local food-borne disease outbreak to the tornadoes 
that devastated the southeastern United States 2 weeks ago to the 
anthrax attacks in the fall of 2001. We cannot control when or where an 
outbreak, pandemic, natural disaster, nuclear incident, or terrorist 
attack may occur and threaten the public's health, but we can control 
how we respond to it. Threats to public health are threats to the 
Nation's health security.
    Because of its unique abilities to respond to infectious, 
occupational, or environmental incidents, CDC plays a pivotal role in 
ensuring that State and local public health systems are prepared for 
public health emergencies. CDC provides funding and technical 
assistance for State, local, Tribal, and territorial public health 
departments through the Public Health Emergency Preparedness (PHEP) 
cooperative agreement. PHEP cooperative agreement funding provides 
approximately $700 million annually to 50 States, four localities, and 
eight U.S. territories and freely associated States for building and 
strengthening their abilities to respond to public health threats.
    The same systems that we use to meet everyday public health needs 
are at the core of public health preparedness and response for 
unforeseen and unpredictable public health threats. State and local 
surveillance and epidemiologic investigations allow us to detect an 
emerging health threat and assess its scope, and laboratories identify 
and characterize the biological, chemical, or radiological agent 
causing it. The public health workforce at the State, local, and 
Federal levels uses information from these resources to make decisions 
about how to respond to a public health emergency. In some cases, 
responding involves the use of MCM to protect or treat people who have 
been exposed, infected, or injured, or to protect the health care 
workers and others responding to the incident such as first responders 
and critical infrastructure personnel.
    The SNS is a National repository of MCM. It contains antibiotics, 
antiviral drugs, chemical antidotes, antitoxins, vaccines, life-
supporting medications, and medical supplies that are available to 
State and local health departments during a public health emergency and 
when local supplies are depleted or unavailable. The specific MCM in 
the SNS formulary for response to CBRN events are based largely on 
assessments by HHS of the need for MCM to address material threats to 
National security identified by Department of Homeland Security (DHS).
    The SNS is a vital and valuable resource for protecting the 
American people. Many threats against the public health component of 
National security are from chemical, biological, radiological, or 
nuclear (CBRN) agents for which there are few, if any, commercially 
available life-saving MCM. The SNS is, in many cases, the only viable 
purchaser and holder of necessary quantities of these scarce materials 
which are vital for a successful response to many incidents.
    As important as the National capability to obtain and hold these 
MCM is, the success of health security interventions of the SNS depends 
on several factors. These include the detection and characterization of 
an event to the timely delivery of these assets to the site of an 
incident to the local plans for receiving, distributing, and dispensing 
them in the communities. The SNS has developed, tested, and used 
pathways to accomplish these goals. CDC's job is not finished, and the 
SNS continues to work towards more rapid, efficient, and cost-effective 
ways to accomplish this mission.
               importance of state and local partnerships
    CDC is working to continually improve our capability to deliver SNS 
assets to affected areas during a public health emergency. This work 
has led to the recent reformulation of the 12-hour push packages--
assets designed to provide a broad spectrum of potentially beneficial 
interventions in the early hours of an emergency when we do not have 
complete information--that expanded the capability of each 12-hour push 
package for use in response to a biological incident, such as an 
anthrax release. CDC has also increased the number of storage locations 
to allow for better and faster distribution across the country. The 
result is that the SNS can deliver large amounts of MCM anywhere in the 
United States and the U.S. territories in a very short window of time, 
and CDC continues to work to decrease that time window even further.
    Getting these products to the people who need them during an 
emergency depends on sufficient infrastructure and planning at the 
State and local levels. CDC goes beyond stockpiling and delivering SNS 
MCM assets to supporting our partners at the State and local levels to 
develop and refine their abilities to effectively receive and utilize 
MCM delivered from the SNS. CDC is also exploring innovative ways to 
dispense them to communities by cultivating strong collaborative 
partnerships among planners, emergency responders, and businesses at 
the State and local levels. CDC supports these partners by providing 
funding through the PHEP cooperative agreement, technical assistance, 
distribution plans, and performance measurement consultation.
    CDC provides technical assistance to State and local health 
departments on receiving and dispensing SNS and other medical assets. 
This assistance includes written guidance, on-site and video 
teleconference consultations, training and exercise support (e.g., 
workshops, National training summit, tools to design and test response 
plans), and direct assistance of CDC personnel at State health 
departments. Just as the nature and contents of the SNS have evolved 
over time, the guidance, assistance, and support CDC offers to States 
have also adapted to changing needs. SNS Program Services Consultants 
(Consultants) are CDC employees available to support States and 
localities that receive PHEP cooperative agreement funding to engage 
the SNS. SNS Consultants regularly provide direct, on-site technical 
assistance to State and local personnel on interpreting guidance, 
developing and refining plans, conducting training and exercises, and 
evaluating capabilities and performance. SNS Consultants are backed up 
by dedicated training, exercise, and response teams from CDC that 
conduct regular training in Atlanta and provide on-site training and 
exercise support to States.
    State and local public health responders depend on the 
implementation of emergency contracts and, in some cases, mobilization 
of volunteer workforces to distribute MCM during an event. CDC 
recognizes that volunteers are critical to the final dispensing of MCM 
and sponsors grant-funded pilot studies of innovative means to recruit 
volunteers. All of these functions feed into the on-going development 
of the capabilities critical to the effective dispensing of MCM to the 
communities of each State.
    Every State maintains plans to receive, distribute, and dispense 
MCM received from the SNS. These plans are all unique and account for 
the local infrastructure and supporting Government and commercial 
partnerships at the State and local levels. These plans are evaluated 
and exercised by the SNS coordinators at the State and local levels and 
reviewed by the SNS Consultants as part of annual reviews. To 
facilitate the improvement of plans and aid in the development of new 
capabilities, CDC maintains several forums to actively share promising 
practices and innovative concepts and foster discussions among SNS 
Consultants and State and local staff. CDC has also developed several 
modeling tools that facilitate planning at the Federal, State, and 
local levels, providing officials with ways to evaluate plans without 
resource-intensive drills or exercises.
    To evaluate the effectiveness of each State's plans to use MCM, SNS 
Consultants conduct regular Technical Assistance Reviews (TARs) at 
least annually to ensure continued readiness. These reviews use an 
objective, quantitative scoring framework to assess plans for 
receiving, distributing, and dispensing SNS assets. CDC conducts these 
reviews at the State, local, and territorial levels and provides each 
level with a tool to help them identify gaps in their plans.
    The purpose of this technical assistance and performance 
measurement consultation is to ensure that each State and local health 
department has the ability to utilize SNS MCM assets during the window 
where it would make a difference from a public health standpoint. 
Because different incidents require different modes of dispensing and 
different timelines for effective treatment, CDC has established a 
flexible framework for the delivery of MCM from the SNS, through 
partnerships with air and ground transportation providers, from a 
network of storage locations. Within this framework, CDC staff can 
ensure the best combination of location and method of transportation to 
support the delivery of MCM within the required time frame.
    During the 2009 H1N1 influenza pandemic response (April 2009 to 
spring 2010), there was a clear need to provide antiviral drugs and 
personal protective equipment to minimize illness and death. The SNS 
distribution planning and MCM holdings helped CDC to rapidly deploy 
large quantities of key medical assets, including 11 million regimens 
of antiviral drugs as part of the deployment of 25% of pro rata 
allocations of pandemic influenza MCM, including personal protective 
equipment to all U.S. States and territories. CDC also released 300,000 
bottles of Tamiflu oral suspension for pediatric use to fill 
production gaps and meet increasing demand. Later, SNS distributed 
234,000 additional bottles of the suspension to all U.S. States and 
territories. HHS also authorized the release of 59.5 million N95 
respirators from the SNS to all U.S. States and territories that 
requested them. The SNS achieved all planned timelines for this 
distribution.
    Lessons learned from real-world events such as the 2009 H1N1 
influenza pandemic response and on-going work with the SNS have been 
applied to a broad range of public health problems. For example, 
California relied on its extensive public health preparedness, 
planning, and training to distribute and dispense MCM to respond to an 
outbreak of pertussis, or whooping cough, in 2010.\1\ Surveillance 
systems first brought the increase in the number of cases among 
pediatric hospital patients to the attention of the California 
Department of Public Health (CDPH) in early 2010. To prevent 
transmission of pertussis to vulnerable infants, CDPH offered free 
vaccine and encouraged hospitals and local health departments to 
support vaccination of new mothers and newborn caregivers. County 
public health departments across California applied elements of SNS 
planning and public health preparedness to develop and disseminate 
educational materials and clinical guidance, raise community awareness, 
and set up accessible and innovative vaccine dispensing points, from 
mobile clinics to grocery stores, to reach their communities. The 
success of this response can be attributed to not only prior SNS 
planning among CDC, State, local, and private partners, but also the 
capability of the public health workforce in counties across California 
to receive and administer the vaccine in a timely manner.
---------------------------------------------------------------------------
    \1\ CDC. Notes from the Field: Pertussis--California, January--June 
2010. MMWR June 9, 2010; 59(26):817.
---------------------------------------------------------------------------
                     federal partner collaboration
    CDC collaborates with Federal partners on several MCM efforts. The 
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is 
a coordinated interagency effort to define and prioritize public health 
emergency MCM requirements, focus research, development, and 
procurement activities for identified requirements, and establish 
deployment and use strategies for MCM in the SNS. PHEMCE is led by the 
HHS Office of the Assistant Secretary for Preparedness and Response 
(ASPR) and includes key Federal interagency partners, including DHS. 
Together, the PHEMCE partners work to optimize our preparedness for 
public health emergencies with respect to the creation, stockpiling, 
and use of MCM.
    CDC also collaborates with ASPR and other Federal partners on the 
interagency implementation of Executive Order 13527, ``Establishing 
Federal Capability for the Timely Provision of Medical Countermeasures 
Following a Biological Attack.'' CDC is currently looking at ways to 
further reduce the time required to deploy assets at the Federal level 
and to better understand the costs associated with these changes, 
particularly at the State and local levels, where resources are 
limited. CDC subject matter experts have participated in DHS- and ASPR-
led interagency working groups to generate the planning documents 
required by the Executive Order. Through these working group 
interactions, CDC is addressing the public health issues associated 
with the implementation of the Executive Order. These collaborative 
efforts with DHS have resulted in plans to respond that will better 
protect the public's health.
    CDC is also working with Federal partners to optimize the use of 
MCM. For example, CDC is collaborating with DHS and the Food and Drug 
Administration (FDA) to establish a process to validate laboratory 
methods that will enable the public health community to respond 
effectively and appropriately. This process will be used in the 
Laboratory Response Network, which is managed by CDC. CDC is also 
working with the Biomedical Advanced Research and Development Authority 
(BARDA) to enhance our abilities to rapidly test clinical specimens and 
determine who has been exposed to a biological agent in order to 
provide effective post-exposure prophylaxis. DHS and CDC are also 
working to develop rapid antimicrobial resistance testing to quickly 
identify agents that may be resistant to first-line MCM in the SNS, 
conduct anthrax-related exercises, and develop risk assessments for 
CBRN threats.
             phemce recommendations guide sns procurements
    The contents of the SNS are determined by the PHEMCE, which 
assesses the SNS' formulary and makes recommendations based on current 
scientific evidence about future procurements. PHEMCE provides 
priorities to guide the allocation of funds to the most critical MCM 
requirements and the recommended MCM are added to the SNS as resources 
allow.
    The current PHEMCE process for identifying MCM requirements 
includes activities to identify and assess CBRN threats through DHS 
threat prioritization; assess medical and public health consequences 
for a given threat scenario and use of MCM for each threat agent 
through HHS public health modeling; and consult with subject matter 
experts. ASPR then assesses MCM requirements by incorporating the DHS 
threat prioritization and medical and public health consequence 
assessments with evaluations of current levels of preparedness, 
concepts of utilization, and product specifications.
    Maintaining the inventory of the SNS poses a significant challenge. 
All MCM stockpiled in the SNS are subject to FDA regulations. These 
regulations include a requirement to label products with expiration 
dates that are intended to protect the public from ineffective 
products. While some of these FDA-approved MCM are included in the FDA 
Shelf Life Extension Program, extension is not an option for the 
majority of MCM, and so all of the MCM will eventually expire. SNS 
appropriations must be used not only to procure new MCM, but also to 
replace items that have expired. Therefore, there are many resource 
demands for expanding capabilities to meet PHEMCE requirements.
    Innovation is critical to ensuring that public health preparedness 
remains dynamic and responsive to changing needs. For example, we 
continue to examine the formulary to address new threats like multi-
drug resistant anthrax. CDC is also seeking innovative ways to use the 
existing, limited supply of MCM in the SNS. For example, CDC is 
providing technical support to the National Institutes of Health (NIH) 
and BARDA to conduct anthrax vaccine dose sparing studies to explore 
the effectiveness of using smaller doses of anthrax vaccine for each 
person to potentially use the current product in the SNS to treat more 
individuals.
                  optimizing the use of mcm in the sns
    In addition to the previously mentioned Federal partnership 
activities to optimize the use of MCM, CDC's ability to use the MCM 
provided by SNS during an event depends on the necessary regulatory 
mechanisms that allow for deployment, dispensing, and utilization of 
SNS MCM assets. In order to treat individuals at the State and local 
level with MCM that have not been approved, licensed, or cleared by FDA 
for their intended uses, Emergency Use Authorization (EUA) or 
Investigational New Drug protocols must be in place for each product 
for the intended purpose. CDC also continues to prepare for potential 
deployment and use of MCM by preparing pre-EUA documents and working 
with FDA to streamline the process for obtaining an EUA at the time of 
an incident. For example, at the request of DHS and with FDA, CDC is 
assisting in the development of an EUA for certain MCM that could be 
pre-authorized, rather than waiting until an emergency occurs. This 
supports continuity of operations planning through implementation of 
Executive Order 13527 and would allow Federal agencies to store and 
forward place caches of MCM to treat mission-essential personnel, 
thereby shortening the time frame in which MCM would be made available 
for use and ensuring continuity of operations.
    In addition, during an emergency, CDC must be able to provide 
clinical guidance for public health and medical professionals. 
Difficult allocation decisions should also be made in advance of an 
emergency to the extent possible. For example, prioritization policies 
are needed to identify populations at highest risk of exposure 
following an incident because the need for certain limited MCM would 
likely exceed supply. CDC is currently beginning the process of 
developing an anthrax vaccine policy that would provide guidance on 
priority populations for vaccination as well as those who should not be 
vaccinated, much like we do annually for influenza.
    CDC is also working with State and local partners to identify ways 
and develop systems to better track MCM supply during a public health 
emergency response. During the 2009 H1N1 influenza pandemic, the 
Federal Government was able to distribute antiviral drugs and other MCM 
to the States, in accordance with pandemic influenza response plans. 
This activity ensured the availability of MCM at the State level. 
However, there was no standard mechanism to track distribution at the 
local level. While State and local partners cooperated in CDC's efforts 
to establish this level of visibility as the response progressed, the 
lack of detailed, accurate inventory tracking information was 
challenging for the decision-making process for further SNS 
deployments. CDC is applying lessons learned from the response to 
understand the most effective and efficient means to distribute and 
track antiviral drugs during a pandemic.
    The optimal use of MCM also requires rapid feedback on how well 
drugs and other interventions are working and how effectively 
individuals are able to use public health information to protect 
themselves and their families. As with other drugs, monitoring for 
adverse events related to the use of MCM is important to guide future 
recommendations. Providing decisionmakers and public health authorities 
with adverse event data is useful not only for identifying new 
concerns, but also for demonstrating that safety monitoring is a vital 
part of any emergency response.
          challenges to maintaining a strong, flexible system
    We have been successful in expanding CDC and public health 
resources for preparedness through Federal interagency support and 
strong State and local collaboration, but there is still much work to 
do.
    CDC staff and the interagency participants in PHEMCE diligently 
evaluate the SNS to ensure that the public receives the best value for 
the funding invested, and that the holdings of the SNS are 
scientifically reviewed and prioritized.
    The result of this decoupled system for determining requirements 
and budgets is that CDC prioritizes the use of funds to meet the 
requirements.
    Other challenges include professional shortages in State and local 
workforce and limited subject matter expert capacity for MCM data 
review. In addition, limited safety and efficacy data is available for 
many MCM for special populations such as children and pregnant women. 
CDC is working with HHS, FDA, and NIH to seek innovative ways to obtain 
critical data to improve the evidence base for use in these 
populations.
                              conclusions
    The SNS is a unique Federal asset. Effectively using the SNS 
requires a collaborative effort by State, local, Tribal, territorial, 
and Federal partners on everything from MCM development to development 
of diagnostics to detection of an event to distribution and dispensing 
of MCM. CDC is seeking ways to ensure appropriate use of resources in 
the current fiscal environment. We see examples every day across the 
Nation of how public health preparedness and planning to use MCM from 
the SNS are being incorporated into everyday public health systems.
    CDC continues to work with Federal partners, including DHS, to 
integrate Federal capabilities in the overall effort to identify, 
develop, acquire, distribute, and dispense MCM--with the ultimate goal 
of getting MCM to the people who need them. Being prepared to protect 
the public's health is ultimately an issue of health security.
    I thank you again for the invitation to testify before you today. I 
will be happy to answer any questions you may have.

    Mr. Bilirakis. Thank you. Thank you, Dr. Khan. I appreciate 
it.
    Thank you, Dr. Garza.
    We are in the middle of votes now, and we expect it to be a 
pretty long series of votes. So we are going to submit our 
questions for the record, if that is okay.
    I appreciate that. We will reconvene with the second panel 
following the last vote, as soon as we get a quorum.
    So thank you very much. We should be back in roughly 1 
hour, but we want to dismiss the first panel. Thank you.
    Ms. Richardson. Thank you very much. I will not return. We 
are meeting with the President this afternoon. Thank you very 
much.
    Dr. Khan. Thank you very much.
    [Recess.]
    Mr. Bilirakis. I want to welcome our second panel. Thanks 
for being so patient with us.
    I have Mr. McHargue--I believe that is how you pronounce 
it--and he is the Director of Emergency Operations for the 
Florida Department of Health.
    Welcome, sir.
    Next we have Mr. David Starr, and he is the Director of the 
Countermeasures Response Unit within the Office of Emergency 
Preparedness and Response at the New York City Department of 
Health and Mental Hygiene.
    Then we have Chief Lawrence Tan. If you could tell where 
you are from, as well.
    I believe we have one more witness. I believe there is one 
more. Dr. Levi--excuse me--and he is the Executive Director of 
the Trust for America's Health.
    So why don't we go ahead and start, begin testimony with 
Mr. McHargue.
    I have a markup. I know that the Member over here, Mr. 
Marino, also has, I think, an intelligence classified briefing. 
But let's get in as much as we possibly can. We look forward to 
asking you questions and your responses. Thank you.
    We will go ahead and start with Mr. McHargue. Thank you.

STATEMENT OF MIKE MC HARGUE, DIRECTOR OF EMERGENCY OPERATIONS, 
DIVISION OF EMERGENCY MEDICAL OPERATIONS, FLORIDA DEPARTMENT OF 
                             HEALTH

    Mr. McHargue. Thank you, Chairman Bilirakis and 
distinguished Members of the committee. On behalf of Dr. Frank 
Farmer, State surgeon general, we thank you for allowing us to 
be here today to speak on this most important matter.
    Consistent with the National Response Framework, we plan 
under the assumption that CBRN incidents will produce 
catastrophic impact and will overwhelm local resources, 
requiring immediate and sustained State and Federal support. 
The ability to quickly assess and meet local needs for medical 
supplies and search capability, including pharmaceuticals, is 
vital to stabilize the impacted community. This simply cannot 
be accomplished in a vacuum and without effective partnerships, 
defined through plans and honed by training and exercises.
    At the State level, we rely heavily on partnerships with 
the Federal agencies charged with developing strategies, plans, 
and stockpiles through the Public Health Emergency Medical 
Countermeasures Enterprise and the array of programs and 
initiatives it sponsors. It is through these efforts that 
States have mechanisms to rapidly surge medical countermeasures 
in the face of CBRN threats.
    The contribution by our Federal partners through the 
regional medical coordinators and other medical countermeasure 
program staff are invaluable. To be effective, we must work 
together at all levels to be prepared to address the 
potentially devastating consequences of such incidents. The 
stakes are high, the challenges are real, and our commitment to 
meet them, like yours, is unwavering.
    In Florida, preparedness is operationalized in three 
overlapping structures: Public health, emergency management, 
and domestic security. Our preparedness and response strategy 
is built upon the 37 National target capabilities. The 
Department of Health coordinates an integrated public health 
system with a network of county health departments. The 
structure enhances the integration and coordination between 
other local and State entities, such as emergency management 
and domestic security.
    Chapter 252, Florida statute, establishes the comprehensive 
emergency management plan and provides the framework for 
responses to all hazards. Also, as a member State with FEMA 
Region 4, our partnerships fully engage Federal agencies and 
assets.
    Florida's domestic security structure is an 
interdisciplinary one that is implemented through a framework 
of seven regional domestic security task forces involving 
disciplines at all levels. Florida's strategy is dependent upon 
first-responder input to recommend what needs to be done, how 
do we do it, and what resources are required.
    Through a variety of Federally-sponsored or -recognized 
programs, Florida has an on-going and robust capability to 
identify the characteristics of a variety of chemical, 
biological, and radiological agents and their effects on 
populations. These programs integrate with Federal partners at 
every touchpoint.
    We also learn from every incident. In the 2010 H1N1 
pandemic, a series of advisory groups was used to provide 
clinical guidance on our State strategies and response. This 
has developed into the establishment of a standing medical 
advisory group to assist the department and the State emergency 
response team with several things, such as: Recommendations on 
protective actions for the public; providing protection for 
first responders; evaluation of contraindications in a mass 
prophylaxis incident; and, of course, with SNS or managed 
inventory, the allocation and apportionment to impacted 
populations.
    Further, the State has broadened that capability through 
demonstrated partnership with the Poison Control System to 
rapidly identify both the conditions within the State as well 
as serve as the key contact point for adverse reactions 
reported by citizens.
    As we talk about points of dispensing and their 
effectiveness, the Florida strategy provides that points of 
dispensing would be utilized for countermeasure dispensing in 
every county of our State. These PODs can be used to dispense 
medications into the community for virtually any disease 
outbreak or CBRN threat. This includes dispensing material from 
the Strategic National Stockpile or its managed inventory.
    The State has deployed medical countermeasures during real-
world events, things like antivirals and antibiotics; the 
anthrax event in Palm Beach in 2001; vaccines for H1N1; and 
PPE, personal protective equipment, to hospitals, county school 
systems, and other partners.
    Florida caches pharmaceuticals locally to be dispensed to 
the responders at the onset of an incident, with the Strategic 
National Stockpile and managed inventory stockpiles then being 
apportioned to meet the civilian need. We are pleased to say 
that just today, sir, our plan just received a score of 100 
percent from the CDC technical assistance review that was 
conducted in January of this year. We believe our plan is 
effective.
    Since the development of the first three Federal programs--
SNS, CHEMPACK, and the Cities Readiness Initiative--Florida has 
continued to develop its program to best manage the logistics 
efforts to maximize the time windows to move this important 
product. The SNS capability provided, we feel, is the most 
significant partner asset we have utilized to date to meet the 
needs of citizens impacted by CBRN incidents.
    The State uses an on-line training program that has trained 
over 3,000 Florida Department of Health staff, volunteers, and 
partner agencies on the operations and management of the SNS 
program. This is available on-line and should be of interest to 
the committee and partners.
    In closing, the determination of the scope of the 
distribution of medical countermeasures is one best determined 
by the collective guidance of State and Federal subject-matter 
experts, our partners. Once we receive the guidance, it is our 
mission to provide the appropriate countermeasure to the 
affected population and to do so quickly and effectively. Given 
the recent events that affect the Nation, with influenza to the 
broad range of services required for Nationally-occurring 
events, I feel that we have developed an appropriate structure 
to meet the demand.
    I thank you for your time, and I am open to your questions.
    [The statement of Mr. McHargue follows:]
                  Prepared Statement of Mike McHargue
                              May 12, 2011
    Good afternoon, Chairman Bilirakis, and distinguished Members of 
the subcommittee. On behalf of Dr. Frank Farmer, State Surgeon General, 
I want to thank you for allowing me to represent the Florida Department 
of Health on this most important matter here today. My name is Michael 
McHargue, Director of Public Health and Medical Planning and Response 
for the Bureau of Preparedness and Response of the Florida Department 
of Health. My role is the Emergency Coordinating Officer and lead for 
Emergency Support Function 8, Public Health and Medical, of the State 
of Florida. I work in concert with the State Emergency Response Team 
(SERT), which functions at the behest of Governor Rick Scott. As the 
lead for ESF8, I coordinate Health and Medical resources and 
capabilities as one of 18 Emergency Support Functions of the Florida 
State Emergency Response Team. Integrated planning and response is 
critical to achieving successful outcomes. Though important, the health 
and medical countermeasures that are of interest to this committee are 
but one part of the total response required to address a threat of this 
type. The medical logistics structure, partnership, and process are the 
lifeblood of public protection.
    Over the next few minutes, I hope to provide you with an overview 
of Florida's on-going efforts in meeting the broad array of challenges 
that either impact the State on a regular basis, or that we sincerely 
hope to not have to confront.
                          state level overview
    Preparedness is founded on the principle of incremental, integrated 
and, simultaneous planning across all disciplines and layers of 
government--local, State, and Federal--for all types of hazards, and is 
accomplished in a continuous cycle of planning, equipping, training, 
and exercising, underpinned by evaluation at each phase. In Florida, 
preparedness is operationalized in three overlapping structures: Public 
health, emergency management, and domestic security. As stated above, 
our preparedness is heavily reliant on the local, State, and Federal 
partnerships necessary to span jurisdictions and to provide resources 
for incidents that might be deemed as catastrophic. Public health and 
medical preparedness is essential to ensuring that the Florida 
Department of Health's mission of protecting the health and safety of 
all residents and visitors to our State is achieved. Facilitating 
collaboration among the State's health care partners, including pre-
hospital, hospital, and medical practitioners, is critical in order to 
respond as a system of care. Florida's Public Health and Health Care 
Preparedness Strategic Plan 2011-2013 goals, objectives, and strategies 
unifies the principles of the three structures and provides the 
direction for preparing the State's public health and medical system. 
This strategy is built upon the 37 National Target Capabilities.
                          public health system
    Public Health Preparedness is essential to achieving the Florida 
Department of Health's mission of protecting the health and safety of 
all residents and visitors to our State. Facilitating collaboration 
among the State's health care partners, including pre-hospital, 
hospital, and medical practitioners, is critical to responding as a 
health care system. The Department of Health is structured as an 
integrated public health system with the county health departments 
being statutory entities under the direction of the State Department of 
Health. This structure enhances the integration and coordination 
between other local and State entities such as emergency management and 
domestic security. Emergency Management Structure Chapter 252, Florida 
Statutes, establishes the Comprehensive Emergency Management Plan, and 
provides the framework through which the State of Florida prepares for, 
responds to, recovers from, and mitigates the impact of a wide variety 
of disasters that could adversely affect the health, safety, and/or 
general welfare of residents and visitors to the State. It also 
provides guidance to State and local officials on procedures, 
organizational structure and responsibilities, and serves as a 
blueprint for an integrated and coordinated local, State, and Federal 
response. As a member State within FEMA Region IV, our plans and 
partnerships fully engage Federal partners and assets. Domestic 
Security Structure Florida has a dynamic interdisciplinary domestic 
security strategy which is founded on five goals:
    1. Prepare for all hazards, natural or man-made, to include 
        terrorism.
    2. Prevent, preempt, and deter acts of terrorism.
    3. Protect Florida's citizens, visitors, and critical 
        infrastructure.
    4. Respond in an immediate, effective, and coordinated manner, 
        focused on the victims of the attack.
    5. Recover quickly and restore our way of life following a 
        terrorist act.
    The framework for Florida's strategy is seven Regional Domestic 
Security Task Forces. From its inception, Florida's strategy has 
depended on the first responders to recommend what is needed and to 
prioritize implementation of planning, training, and equipment projects 
through the domestic security structure.
                 monitoring and detection of the threat
    The State has an on-going and robust capability to identify the 
characteristics of a variety of chemical, biological, and radiological 
agents and their effects on the population. The ESSENCE syndromic 
surveillance system is operational in three-fourths of all hospitals 
throughout the State, covering approximately 85% of all emergency 
department visits. This system is coupled real-time with regional 
epidemiologists working in disease control, as well as food and 
waterborne investigations.
    Constant updating of the health care system occurs through the use 
of the Florida Department of Health Emergency Notification System 
(FDENS), as well as the EpiCom system, a State reporting and messaging 
board built along the structure of Epi-X, the CDC notification and 
update system for a variety of threats to our subject matter experts. 
This system, coupled with local surveillance within the county health 
department structure, provides an on-going framework for the response. 
To aid in the rapid identification of the threat agent, the State 
Laboratory Response Network (LRN) laboratory capability is available, 
coupled with a laboratory surge structure that utilizes both hospital 
and academic laboratory capability.
                          populations affected
    Due to the on-going activities the State faces with natural 
disasters, the on-going analysis of all populations, including 
vulnerable populations, has been a yearly activity since the storms of 
2004. Every county has a profile developed that analyzes the age, race, 
indigence, medical status, and birth rates for the community. These 
data are coupled with environmental factors that may impact the 
community in any event. Florida possesses the capability to rapidly 
access, compile, and depict these data using sophisticated GIS mapping, 
and can share the results of same using web-based communication, as 
well as, redundant mobile communications systems.
          evaluations and recommendations for countermeasures
    In the 2010 H1N1 pandemic, a series of advisory groups was used to 
provide clinical guidance on various aspects our State strategies and 
response. This has developed into the establishment of a Medical 
Advisory Group to assist both the Department and the SERT in:
   Evaluating CDC guidance for appropriateness to the State 
        situation.
   Evaluation of contraindications in a mass prophylaxis event.
   Other issues as needed. In an event such as BioWatch, for 
        example, the group would be evaluating the allocation and 
        apportionment strategy.
   Provide both protective actions and the medical protocols.
   Make recommendations to protect first responders.
    The State has broadened that capability by developing a key rapport 
with the Poison Control system to rapidly identify both the conditions 
within the State, as well as, serve as the key contact point for 
adverse reactions reported by the citizens.
                     information management branch
    During the response deployments for H1N1, Haiti, then Deepwater 
Horizon, there was an increasing and diverse need for information. The 
proliferation of rumors and the expanding role of social media 
necessitated the development of this Branch in the Operations section 
of the Incident Management Structure. The Branch is assigned all of the 
messaging for the Department of Health and functions within the Joint 
Information Center (JIC) established by the State Emergency Response 
Team (SERT). As stated previously, the SERT is the vehicle that ensures 
the coordinated input and output of public information for Florida's 
citizens.
                  points of dispensing (pod) strategy
    The Florida strategy provides that Points of Dispensing (POD) would 
be utilized for countermeasure dispensing in every county in the State. 
Local PODs have been established in both open and closed environments. 
Adaptation of the POD for issues related to radiation, for example, are 
incorporated into the current planning for the incident. Most recently, 
the H1N1 pandemic provided an opportunity to demonstrate Florida's POD 
Strategy State-wide.
    The H1N1 campaign highlighted two successes for the Florida plan. 
Forty-three of the 67 counties provided school-based immunization 
clinics for students (an example of a closed POD). One of Florida's 
counties received a National award for the vaccine strategy within its 
school system. The second success was incorporating major 
pharmaceutical chains to dispense antiviral medication during the early 
days of the pandemic. This partnership, combined with distribution 
within the county health department system, led to increased access and 
availability.
                            logistics annex
    The Florida Department of Health's Emergency Operations Plan 
Logistics Support Annex integrates with the State Unified Logistics 
Plan to ensure that the flow of medical supplies, equipment, 
pharmaceuticals, and auxiliary personnel is performed in a unified 
manner in cooperation with other State of Florida emergency response 
elements. Effective public health and medical logistics management 
ensures that all functions are executed in a unified manner in order to 
reduce costs and ensure the appropriate support actions are 
accomplished in a timely manner.
    The scope of the Logistics Support Annex is to develop and 
coordinate a FDOH State-wide strategy including operational objectives 
and tactical standard operating procedures for the procurement, 
receipt, storage, distribution, dispensing, and recovery of 
pharmaceuticals, medical supplies, and equipment in support of State-
wide response activities.
    Florida strategy for delivery systems incorporates a hub and spoke 
concept for delivery. The Department uses two main warehousing 
facilities, coupled with Receive, Stage, and Store (RSS) sites 
strategically located throughout the State. The present format is being 
developed to establish a single drop point within the county and then 
redistribution to the POD sites. Given the unique nature of Florida's 
structure and communities, the apportionment of countermeasures will be 
a highly dynamic event.
    Florida has provided personal protective equipment (PPE) to 
Advanced Life Support Pre-Hospital Emergency Medical Services (EMS) 
providers and acute care hospitals. A pre-defined standard PPE package 
was allocated based on the number of licensed vehicles for EMS 
providers and number of licensed beds for hospitals. Allocation to the 
agency level was determined through an assessment of current capacity 
and prioritized by the Regional Domestic Security Task Force, Health 
and Medical Committees. A minimum standard level of PPE has been 
established by the State Working Group for Preparedness, Health, 
Medical, Hospital, EMS Committee's Hospital Equipment Task Team. The 
current focus of PPE provision is on the sustainment and maintenance of 
PPE and the training required for using the PPE.
    The State has deployed medical countermeasures during events such 
as antivirals, antibiotics (anthrax event in Palm Beach), vaccines, and 
PPE to the hospital and county school systems. Caches of ventilators 
and a concurrent strategy for them is part of the overall response 
continuum. Other key items presently part of the core distribution 
strategy include PPE and other protective measures from responders.
    In terms of the pharmaceutical strategy, the caches held by the 
State are designed to be dispensed to the responders at the outset of 
the event, with the Strategic National Stockpile and Managed Inventory 
stockpiles then being apportioned to meet the civilian need.
                   strategic national stockpile (sns)
    CDC's Strategic National Stockpile (SNS) is a National repository 
of antibiotics, chemical antidotes, antitoxins, vaccines, and other 
life-saving medications. During a public health emergency, State and 
local public health systems may be overwhelmed. SNS is designed to 
supplement and re-supply State and local public health agencies in the 
event of such an emergency.
    Florida has a robust State-wide SNS program with an emphasis on 
maintaining a ready Receipt, Staging & Storage (RSS) infrastructure 
which includes enhancement of current State plans and supporting 
documentation for receipt of SNS assets, development and conduct of 
training and exercise activities for State and Federal partners.
    The State has an on-line training program which allows Florida 
Department of Health staff, volunteers, and partner agencies an 
opportunity to learn the operations and management of the SNS program. 
The program, Florida's Introduction to Strategic National Stockpile and 
Mass Dispensing, http://www.doh.state.fl.us/demo/php/
FL_Mass_Dispensing.html has trained over 3,000 people. The objectives 
of this course are: The scope and purpose of Florida's Strategic 
National Stockpile Program, the community's mass dispensing roles and 
responsibilities, the two primary methods of distributing and 
dispensing supplies, and how mass dispensing incidents are managed.
                   cities readiness initiative (cri)
    The Cities Readiness Initiative is a Federal funding mechanism 
targeted at major U.S. cities to assist with preparedness activities 
related to the achievement of State and county SNS program goals.
   Florida's CRI program includes providing consistent 
        guidance, feedback, and evaluation to 14 CRI counties and 53 
        non-CRI counties via multiple venues.
   Provide technical assistance to 67 counties for planning 
        development/refinement, training, and exercise related to the 
        SNS/CRI programs.
   Perform program monitoring, tracking, and presenting project 
        funding, program deliverables, and performance measures.
                                chempack
    CHEMPACK is a joint Federal-State program designed to implement the 
forward placement of chemical nerve agent antidotes to State/local 
areas in order to reduce treatment response times. Placement of 108 
CHEMPACK containers in the State of Florida was completed in November, 
2007. The program is currently in sustainment phase.
    In closing, the determination of the scope of the distribution of 
medical countermeasures is one best determined by the collective 
guidance of State and Federal subject matter experts. Once we receive 
this guidance, it is our mission to frame the structure to provide the 
appropriate countermeasure to the affected population. Given the recent 
events that affected the Nation with influenza, to the broad range of 
services required for naturally occurring events, I feel that we have 
developed an appropriate structure to meet the demand. I thank you for 
your time and will now hopefully be able to answer any questions you 
might have.

    Mr. Bilirakis. Thank you very much.
    Mr. Starr, you are recognized.
    I failed to say, the entire statement will be entered into 
the record.
    You are recognized for 5 minutes, sir.

 STATEMENT OF DAVID STARR, DIRECTOR, COUNTERMEASURES RESPONSE 
   UNIT, EMERGENCY PREPAREDNESS AND RESPONSE, NEW YORK CITY 
            DEPARTMENT OF HEALTH AND MENTAL HYGIENE

    Mr. Starr. Good afternoon, Chairman Bilirakis and Members--
Member--of the committee. Thank you for inviting me here today 
to testify on New York City's efforts to prepare for the rapid 
distribution of dispensing of medical countermeasures in the 
event of a public health emergency. My name is David Starr, and 
I am the director of countermeasures response at the New York 
City Department of Health and Mental Hygiene.
    In New York City, our goals are simple: To maximize the 
speed and efficacy of distribution operations and to increase 
access to countermeasures by the general public. New York City 
has worked hard to develop robust plans for the receipt of the 
Strategic National Stockpile assets and their distribution 
dispensing to the public. Currently, two warehouses stand ready 
to receive and distribute SNS assets, and we have identified 
close to 200 facilities city-wide that could be used as points 
of dispensing, or PODs.
    PODs, of course, are temporary dispensing sites set up at 
the time of an emergency, and each is designed to dispense oral 
medications to approximately 40,000 people in less than 48 
hours. We have trained more than 1,500 city employees as POD 
managers.
    We have developed our capacity to provide critical supplies 
and medication to hospitals and primary-care centers after the 
initial 72 hours and have reviewed plans for these facilities 
to dispense medication to their staff and patients. We maintain 
a local cache of medications for our first responders.
    In response to the emergence of H1N1 influenza in 2009, we 
had an opportunity to implement existing emergency plans. Our 
ability to mobilize quickly was proven when the SNS notified us 
of inbound assets at approximately 1:00 a.m. on Monday, April 
27, and our receiving warehouse was ready as the first trucks 
arrived around 5:00 a.m.
    That fall, New York City implemented an ambitious school-
based vaccination program and the largest POD operation in 
recent history. We directed the receipt, repackaging, and 
delivery of more than 1,800 orders of vaccine and supplies to 
schools, providing more than 200,000 flu vaccinations to 
children across the city.
    We mobilized several thousand city employees and volunteers 
for POD operations in 29 sites over 5 weekends, vaccinating 
close to 50,000 more New Yorkers. At one site, almost 6,000 
people were vaccinated over 2 days. The response from the 
public at this site, even from those who waited an hour in a 
cold rain, was overwhelmingly positive.
    Even these experiences did not reach the threshold we set 
for ourselves for a city-wide dispensing effort. Though we are 
pleased with our accomplishments, complacency is the greatest 
enemy to progress. Preparedness is a continuum that must be 
nurtured with constant attention, creativity, and predictable 
financial support.
    When terrorism or a potentially deadly influenza outbreak 
is in the news, Federal resources increase. However, once the 
threat dims, interest and resources dwindle.
    In 2004, Cities Readiness Initiative funding was provided 
to prepare 21 high-risk U.S. cities and metropolitan areas to 
effectively respond to a large-scale bioterrorist attack. In 
the following years, the number of CRI cities increased to 72, 
but, without additional resources, many of the highest-risk 
cities experienced a decrease in support. In 2008, New York 
City's CRI grant was cut by 25 percent and has remained at that 
level since.
    Since 2002, New York City has also experienced a decrease 
of about 26 percent in overall public health emergency 
preparedness, or PHEP, P-H-E-P, financial support. The 
administration's fiscal year 2012 budget request includes 
another cut to this funding. On a per capita basis, New York 
City, despite its obvious high risk, ranks 13 out of the 18 
jurisdictions awarded a new risk-based funding allocation in 
this year's proposed CDC grant. Even that is partially offset 
by a cut in our basic program grant.
    Stable Federal funding is absolutely necessary for State 
and local responders to increase and maintain current levels of 
preparedness. If preparedness funds continue to decline, New 
York City's ability to sustain its preparedness infrastructure, 
so carefully constructed over the last decade, will be in 
jeopardy.
    There are also operational issues that need attention. We 
continue to work for the prepositioning of countermeasures in 
local warehouses and the relaxation of the terms of the FDA's 
emergency use authorization for the legal dispensing of 
countermeasures in the first hours of an emergency.
    There is also a need to better align the requirements, 
timelines, and deliverables of the different funding streams. 
The PHEP grant from the CDC, the Hospital Preparedness Grant 
from the Office of the Assistant Secretary for Preparedness and 
Response, and the Urban Areas Security Initiative Grant from 
the Department of Homeland Security all have unique reporting 
and administrative requirements. Any effort to align these 
requirements would reduce administrative costs and improve 
efficiency. Fortunately, our Federal partners are willing to 
listen, and we are making progress on these and other issues.
    We very much appreciate the work of Chairman King, Chairman 
Bilirakis, and the other Members of this committee. Thank you 
for your support of our efforts to protect our citizens and for 
the opportunity to speak to you today.
    [The statement of Mr. Starr follows:]
                   Prepared Statement of David Starr
                              May 12, 2011
    Good afternoon Chairman Bilirakis, Ranking Member Richardson, and 
Members of the subcommittee. Thank you for inviting me here today to 
testify on New York City's efforts to prepare for the rapid 
distribution and dispensing of medical countermeasures in the event of 
a public health emergency. My name is David Starr and I serve as the 
Director of Countermeasures Response in the Office of Emergency 
Preparedness and Response at the NYC Department of Health and Mental 
Hygiene. I have been privileged to be involved in NYC's emergency 
medical countermeasure planning for more than 5 years. I currently 
supervise operational planning for the receipt and distribution of 
Strategic National Stockpile (SNS) assets and the opening of emergency 
dispensing sites city-wide, development of emergency staffing plans to 
support such an operation--including the expansion of New York City's 
Medical Reserve Corps (MRC)--and special projects to supplement current 
dispensing plans. Our goals remain consistent: To maximize the speed 
and efficacy of distribution and dispensing operations and to increase 
access to countermeasures by the general public.
    Over the last decade, New York City has worked hard to develop 
robust plans for the receipt of SNS assets and their further 
distribution and dispensing to the public. Currently, two receiving 
warehouses stand ready to receive and distribute SNS assets within 
hours of notification. We are linked to the two sites with a state-of-
the-art warehouse management system, enabling us to both monitor and 
direct warehouse operations remotely. We have identified close to 200 
facilities city-wide that could be used as ``Points of Dispensing'' or 
PODs--temporary dispensing sites set up at the time of an emergency. 
Each POD is designed to dispense oral medications to approximately 
40,000 people in less than 48 hours. Setting up and running these PODs 
would present enormous logistical challenges.
    We are working hard to overcome the challenges. In New York City, 
each POD is operated with pre-trained leadership teams of 6 and about 
90 additional staff who receive ``Just-in-Time'' training. If NYC were 
to open all PODs for a city-wide emergency dispensing operation, we 
would need approximately 1,200 leadership staff and 20,000 general 
staff for the first shift. To support the leadership staffing needs of 
such an operation, we have trained over 1,500 city employees as 
potential POD leadership team members. We continue to build that number 
by identifying and training additional staff. For general staff, NYC 
plans include accessing the city's substantial workforce of nearly 
300,000 individuals, and engaging volunteers from various organizations 
to respond. The New York City Medical Reserve Corps is another source 
of staff for PODs, and consists of more than 9,000 pre-credentialed and 
pre-registered health care professionals who have volunteered their 
services during emergencies.
    We have also developed our capacity to provide critical supplies 
and medication to hospitals and primary care centers after the initial 
72 hours, and we have reviewed plans for these health care facilities 
to dispense medication to their staff and patients. We maintain a local 
cache of medications for our first responders, whose agencies maintain 
internal plans for dispensing these medications to their own employees.
    Admittedly, these plans and protocols are merely words and ideas 
until implemented in exercises and real-life responses. The response to 
the H1N1 influenza outbreak in 2009 allowed us to put into practice 
many of our plans and protocols. Within days of its emergence in a 
Queens high school, New York City received antiviral medications and 
respirators from the SNS. Our ability to mobilize quickly was proven 
when the SNS notified our staff of inbound assets at approximately 1:00 
a.m. on Monday, April 27 and our receiving warehouse was ready as the 
first trucks arrived around 5:00 a.m. As the response in the fall 
unfolded, our operational capacity was further tested. New York City 
planned an ambitious school-based vaccination program, as well as the 
largest POD operation in recent history. Our warehouse quickly set up a 
parallel vaccine distribution operation, expanding their refrigerated 
vaccine processing area, purchasing additional vaccine supplies and 
training select staff on vaccine handling. New York City then directed 
the receipt, repackaging, and delivery of more than 1,800 orders of 
vaccine and supplies to schools--at the peak, making 90 deliveries per 
day, including 15 priority deliveries before 9:00 a.m. Through this 
emergency school-based vaccination program, we provided an estimated 
202,000 flu vaccinations to children across the city.
    In addition, New York City mobilized several thousand city 
employees and Medical Reserve Core volunteers for POD operations in 29 
sites over five weekends. The vast majority of these employees were 
trained ``Just in Time'' per our current protocols. We vaccinated close 
to 50,000 New Yorkers in these PODs, and in one site on the Upper East 
Side, almost 6,000 people were vaccinated within 2 days. The response 
from the public at this site--even from those who waited an hour in a 
cold rain--was overwhelmingly positive. However, even the valuable H1N1 
experience did not reach the threshold we set for ourselves for a city-
wide dispensing effort.
    These operations allowed us to test our distribution and dispensing 
site selection, staffing, command and control, and training protocols 
and a substantial number of changes to existing plans resulted from 
this experience. We have altered our process for selecting POD sites to 
assure selected sites are most suitable to support the operation and we 
made selection criteria more stringent. In addition, we have conducted 
population-density analysis to achieve optimal coverage among our 
selected sites. We have revamped our training program and are 
conducting drills to test these new protocols. We know that we must not 
stop with these accomplishments. Opening 200 temporary sites across an 
urban area the size, density, and diversity of New York City is fraught 
with obstacles, and while we attempt to identify and mitigate these 
obstacles, we are constantly seeking innovative solutions to maximize 
dispensing speed and increase access to needed countermeasures.
    The greatest danger to our efforts is complacency; the hard work 
doesn't end. The Federal Government has worked to define target 
capabilities and benchmarks relative to countermeasure distribution and 
dispensing, and we meet and exceed those that have been defined. 
However, in the absence of a real-life catastrophic incident, the 
operational success of our plans is extremely difficult to predict. We 
don't have a textbook we can open, or a workbook or checklist to 
complete that tells us if we are truly prepared or not. Preparedness is 
not a binary concept, you are not either prepared or not prepared, it's 
a continuum that must be nurtured with constant attention, creativity, 
and predictable financial support. However, I can say with assuredness 
that in the arena of countermeasure distribution and dispensing, we are 
far more prepared than we were a decade ago, or even 3 years ago. 
Maintaining these achievements and continuing our progress requires 
constant vigilance.
    When terrorism, or H5N1, or H1N1 is in the news, Federal resources 
increase. However, once the threat dims, interest and resources dwindle 
as well. After 9/11, everyone was a New Yorker, and there was no debate 
about the increased threat faced by New Yorkers and other urban areas. 
In 2004, Cities Readiness Initiative (CRI) funding in the Public Health 
Emergency Preparedness grant was provided to prepare major U.S. cities 
and metropolitan areas to effectively respond to a large-scale 
bioterrorist event by building capacity to dispense antibiotics to 
their entire identified population within 48 hours.
    New York City initially received $5.1 million in 2004 as one of 21 
cities in the country considered at highest risk. In the following 
years, the number of CRI cities increased to 72. The Cities Readiness 
Initiative became everybody's readiness initiative, but without 
additional resources, many of the highest-risk cities saw a decrease in 
support. In 2008, New York City's CRI grant was cut by 25%, and has 
remained at that level since.
    New York City has also experienced decreases in overall Public 
Health Emergency Preparedness (PHEP) grant funding as well--
approximately 26% since 2002; the administration's budget for fiscal 
year 2012 proposes another cut in funding for PHEP State and Local 
Capacity. While the Center for Disease Control has developed a pilot 
risk-based funding pool for fiscal year 2011, this additional funding 
for New York City is--in current proposals--partly offset by a 4% cut 
in our basic grant. Furthermore, we have been informed that current 
proposals are not final, and levels are expected to decrease even more. 
In regard to the new risk-based funding, on a per capita basis, New 
York City, despite its obvious high risk, ranks 13th out the 18 
jurisdictions to be awarded risk funding. Although we have long 
supported risk-based funding, we are also concerned that the 
uncertainty of continuation of this funding stream and the large cut in 
program funding would leave us with a much larger overall funding gap 
in fiscal year 2012 and beyond.
    Stable Federal funding is absolutely necessary for State and local 
responders to increase and maintain levels of preparedness. As we 
undertake new initiatives and maintain our state of readiness, there is 
a cost. We pay contingency fees to various private partners to build 
operational capacity and integrate response planning. We pay to 
identify, survey, and map POD sites. We pay for modeling and other 
scientific analyses to improve our plan elements. We pay for 
transportation redundancy to deliver countermeasures to our citizens. 
We pay to maintain a robust warehouse management system, and for 
climate monitoring systems that operate in all sites where we store 
pharmaceuticals. We pay for the annual training of POD leadership 
staff. We continually strive to identify gaps, holes, and weaknesses in 
our plans and often pay to fill, patch, and reinforce them. Most of 
all, we pay for essential staff, including the highly dedicated 
individuals in public health that help to build and maintain our 
preparedness. Simply put, if preparedness funds continue to decline, 
our city's ability to sustain its preparedness infrastructure will be 
jeopardized.
    There are also many operational issues that need additional 
attention--as we have communicated to the various Federal agencies we 
depend on for guidance and support. We continue to push for the pre-
positioning of a limited quantity of Federal countermeasures in local 
warehouses to speed the opening of the first PODs to the public. We 
have advocated for the relaxation of the terms of the Emergency Use 
Authorization that the FDA will require for the legal dispensing of 
countermeasures in an emergency. And while our plans center primarily 
on the rapid dispensing of oral medications, we are moving forward with 
planning for the dispensing of the additional days of antibiotics 
needed by an exposed population following a widespread anthrax attack, 
as well as the administration of the three-dose course of anthrax 
vaccine as recommended by the CDC. There is great need for more 
guidance in regard to these matters, and we continue to push for 
clarity.
    The structure of our funding is also confusing and sometimes 
encourages duplication of effort. We continue to use, to the best of 
our ability, funds from many different sources including the PHEP grant 
from CDC, the hospital preparedness grant from the office of Assistant 
Secretary for Preparedness and Response/HHS and the UASI grant from 
Department of Homeland Security. However, each of these funding streams 
has unique characteristics and requirements. We understand that a 
perfect synergy may not be possible, but some effort to align 
requirements, timelines, and deliverables could significantly reduce 
the administrative burden that draws resources from efforts to improve 
public health preparedness.
    Fortunately, we benefit from having Federal partners that are 
willing to listen, and there has been marked improvement over the 
years. We've seen our Federal partners consider options to speed the 
initial delivery of countermeasures to our warehouses, and a 
willingness to entertain different models of Emergency Use 
Authorizations that would help States and local jurisdictions dispense 
countermeasures legally in the first hours of an emergency.
    We are also grateful for the continued interest of Congress and the 
work of Chairman King and this committee. Thank you for your support of 
our efforts to protect our citizens, and for the opportunity to comment 
today.

    Mr. Bilirakis. Thank you very much.
    Now, Mr. Lawrence Tan, Chief Tan, you are recognized for 5 
minutes.

   STATEMENT OF LAWRENCE E. TAN, EMERGENCY MEDICAL SERVICES 
   DIVISION, DEPARTMENT OF PUBLIC SAFETY, NEW CASTLE COUNTY, 
                            DELAWARE

    Mr. Tan. Thank you, Chairman Bilirakis and Members of the 
subcommittee. Thank you for giving me this opportunity to 
discuss the issue of medical countermeasures' development and 
distribution from the perspective of the emergency services 
sector.
    I am Lawrence Tan, Chief of Emergency Medical Services for 
New Castle County, Delaware, and here representing the 
Emergency Services Sector Coalition on Medical Countermeasures. 
I am also the current president of the International 
Association of Emergency Medical Service Chiefs, a professional 
organization that represents the leadership of EMS agencies 
that performed over 3.3 million emergency responses and 
transported over 2.78 million patients in America.
    Recent events underscore the importance of these hearings 
and the responsibilities of subcommittee in developing policies 
that prepare the Nation and ensure our resilience. Given the 
recent events and the impending anniversary of September 11, it 
is clear that we may yet face another terrorist attack in the 
coming months.
    The events of 9/11 demonstrated the potential for long-term 
health effects and unforeseen costs resulting from terrorism on 
unprotected populations. The anthrax attacks of 2001 
demonstrated the vulnerability of the United States to 
intentional threats from chemical, biological, radiological, 
and nuclear incidents. More recently, the earthquake and 
resulting tsunami in Japan and implosion of the Fukushima 
nuclear plant have dramatically heightened awareness about the 
fragility of response capability and capacity and have focused 
international awareness on the potential impact of 
unintentional radiological exposure.
    A biological attack on an unprepared nation has significant 
potential to disrupt our Nation's security, hospitals, public 
health services, and critical infrastructure, to include the 
emergency services sector.
    As the Chair cited in his opening statement, the Graham-
Talent Commission has stated, ``It is more likely than not that 
a weapon of mass destruction, and most likely a biological 
weapon, will be used in a terrorist attack sometime in the 
world by the end of 2013.''
    The issue the terrorism aside, our society operates with 
the potential for a hazardous-material disaster each day. 
Accidental chemical and biological incidents can occur anytime 
and could have significant detrimental effect on our local 
communities.
    The current methods of distributing medical countermeasures 
have not proven capable of meeting our National goals--in 
particular, the protection of the emergency services sector. 
New approaches are needed to ensure that those on the front 
lines of the response community and their families are 
protected.
    Several exercises and reports have described that the 
stockpiling and distribution practices are currently inadequate 
in many parts of the Nation to protect the population against 
an intentional anthrax attack. The prospect of critical 
infrastructure failure is real and will be compounded by lack 
of a National strategy to protect first responders. Ensuring 
our first responders' capability and capacity must be a 
priority in any National medical countermeasure strategy.
    We have examples of when the Nation has shown it is not 
prepared to protect emergency services personnel, such as 
during the H1N1 pandemic, when determinations about the 
protective value of masks were inconsistent with the 
operational needs. Additionally, changes in prioritization of 
vaccine distribution were made without consulting local 
incident commanders.
    The emergency services sector is, by definition, the tip of 
the spear during a domestic response within the United States 
and its territories. Emergency services personnel are likely to 
be among the first exposed in an event and need the earliest 
possible access to medical countermeasures.
    History has demonstrated there is no front line in the 
global war on terrorism and that all parts of the world, 
including our local communities, are potential targets. 
Protecting those who we depend on to respond during these 
crises is essential for our community response, resilience, and 
recovery and, thus, our Nation's security. This includes 
planning with, by, and for the emergency services sector a 
medical countermeasure program that protects these personnel 
and their families.
    As an emergency medical services chief, I have a 
responsibility not only for the community for which I am 
charged to provide critical lifesaving services but for the 
safety and welfare of the personnel that deliver that care each 
and every day. We ask these personnel to rise to the needs of 
the community during a chemical, biological, radiological, or 
nuclear incident. Imagine the potential stressors on that 
individual responder being asked to handle the community's 
needs during a catastrophic event, all the while wondering if 
the needs of their own family members are being fulfilled.
    It is imperative that we include the families of the 
emergency services sector personnel in the planning for any 
medical countermeasures. The effective continuity of operations 
of the emergency services sector as a fundamental component of 
the Nation's critical infrastructure may well depend on these 
personnel having timely access to medical countermeasures both 
for themselves and their families.
    The time is right to provide emergency service sector 
personnel with emergency caches of prepositioned, personal, and 
institutional medical countermeasures.
    A more fundamental review of the medical countermeasure 
enterprise is warranted if we, as a Nation, want a medical 
countermeasure system that will protect us through the threats 
of the 21st Century. The alphabet soup of programs--the Cities 
Readiness Initiative, the Metropolitan Medical Response System, 
the Biological Advance Research Development Authority--were 
conceived separately and remained uncoordinated.
    The Medical Countermeasure Enterprise Review provides the 
emergency services sector and the Federal agencies an 
opportunity to improve our Nation's protective posture. But the 
medical countermeasure enterprise must maintain a larger 
perspective than just the Federal Government and must evolve to 
include an end-user's point of view.
    Many of the emergency services sector professional 
associations have joined together to form a new coalition on 
medical countermeasures to assist with this effort and provide 
a single voice in these important issues for the Nation and 
ensure that the evolving National policy protects our response 
personnel and their families. We offer the following 
recommendations for your consideration:
    First, develop an advisory board comprising emergency 
services representative to engage in defining end-user 
requirements, similar to battlefield medicine practices, and to 
advise on the effective distribution practices.
    Second, develop a medical countermeasures strategy that 
enhances National resilience by protecting the protectors of 
our Nation's critical infrastructure.
    Third, develop pilot projects to position medical 
countermeasures for emergency services personnel and their 
families.
    Fourth, ensure the continuity of the CHEMPACK program, 
including pilot programs to expand the formulary and examine 
local pharmaceutical control.
    We thank you for your time and attention. We realize that 
you certainly have my complete remarks already entered in the 
record. I sincerely appreciate the opportunity to come before 
you this afternoon to present a perspective from the emergency 
response community on this vital subject.
    I would certainly welcome any feedback or questions from 
the Chairman.
    [The statement of Mr. Tan follows:]
                 Prepared Statement of Lawrence E. Tan
                              May 12, 2011
                              introduction
    Chairman Bilirakis, Ranking Member Richardson, and Members of the 
subcommittee, thank you for giving me this opportunity to discuss the 
issue of medical countermeasures development and distribution from the 
perspective of the emergency services sector. I am Lawrence E. Tan, 
Chief of Emergency Medical Services for New Castle County, Delaware, 
and here representing the Emergency Services Sector Coalition on 
Medical Countermeasures. I am also the current President of the 
International Association of Emergency Medical Service Chiefs, a 
professional organization that represents the leadership of emergency 
medical services agencies that performed over 3.3 million emergency 
responses and transported over 2.78 million patients in America.
    Recent events underscore the importance of these hearings and the 
responsibilities of the subcommittee in developing policies that 
prepare the Nation and ensure our resilience. Given the recent events 
and the impending anniversary of September 11 it is clear that we may 
yet face another terrorist attack in the coming months.
    The events of 9/11 demonstrated the potential for long-term health 
effects and unforeseen costs resulting from terrorism on unprotected 
populations. The anthrax attacks of 2001 demonstrated the vulnerability 
of the United States to intentional threats from chemical, biological, 
radiological, and nuclear incidents. More recently, the earthquake and 
resulting tsunami in Japan and implosion of the Fukushima nuclear plant 
have dramatically heightened awareness about the fragility of response 
capability and capacity, and have focused international awareness on 
the potential impact of unintentional radiation exposure.
    A biological attack on an unprepared nation has significant 
potential to disrupt our Nation's security, hospitals, public health 
services, critical infrastructure to include the emergency services 
sector (ESS). The Graham-Talent Commission on the Prevention of Weapons 
of Mass Destruction Proliferation and Terrorism stated ``it is more 
likely than not that a weapon of mass destruction [most likely a 
biological weapon] will be used in a terrorist attack somewhere in the 
world by the end of 2013.'' The issue of terrorism aside, our society 
operates with the potential for a hazardous materials disaster each 
day. Accidental chemical and biological incidents can occur anytime and 
could have significant detrimental effect on our local communities.
    The current methods of distributing medical countermeasures have 
not proven capable of meeting our National goals, in particular the 
protection of the emergency services sector. New approaches are needed 
to ensure that those on the front lines of the response community and 
their families are protected. Several exercises and reports have 
described that the stockpiling and distribution practices are currently 
inadequate in many parts of the Nation to protect the population 
against an intentional anthrax attack.
    The prospect of critical infrastructure failure is real, and would 
be compounded by a lack of a National strategy to protect first 
responders. Ensuring first responder's capability and capacity must be 
a priority in any National medical countermeasure strategy. There are 
examples when the Nation has shown it is not prepared to protect 
emergency services personnel: During the H1N1 pandemic, determinations 
about the protective value of masks were inconsistent with operational 
needs. Additionally, changes in prioritization of vaccine distribution 
were made without consulting local incident commanders.
    The emergency services sector is, by definition the tip of the 
spear during a domestic response within the United States and its 
territories. Emergency services personnel are likely to be among the 
first exposed in an event, and need the earliest possible access to 
medical countermeasures. History has demonstrated there is no ``front 
line'' in the Global War on Terrorism, and that all parts of the world, 
including our local communities, are potential targets. Protecting 
those who we depend on to respond during these crises, is essential for 
our community response, resilience, and recovery, and thus our Nation's 
security. This includes planning with, by and for the emergency 
services sector a medical countermeasure program that protects these 
personnel and their families. As an emergency medical services chief, I 
have a responsibility not only for the community for which I am charged 
to provide critical lifesaving services, but for the safety and welfare 
of the personnel that deliver that care each and every day. We ask 
these personnel to rise to the needs of their communities during a 
chemical, biological, radiological, or nuclear incident. Imagine the 
potential stressors on an individual responder being asked to handle 
the community's needs during a catastrophic event, while wondering if 
the needs of their own family members are being fulfilled. It is 
imperative that we include the families of the emergency services 
sector personnel in the planning for any medical countermeasures. The 
effective continuity of operations of the emergency services sector as 
a fundamental component of the Nation's critical infrastructure, may 
well depend on these very personnel having timely access to medical 
countermeasures for both themselves and their families.
    The time is right to provide emergency service sector personnel 
with emergency caches of pre-positioned personal and institutional 
medical countermeasures. The existing processes developed since 2004 to 
distribute ``medkits'' to postal workers could be extended to include 
the protection of our fire service, law enforcement, emergency medical 
services, public works, emergency health care, public health providers, 
and other components of our critical infrastructure or in short--the 
Emergency Services Sector.
    In an age of asymmetrical threats, where the ``battlefield'' 
extends far from foreign fields into our local communities, we must 
take advantage of our strengths, in this case our innovations in 
medical protection and stockpiling. The Graham-Talent commission 
clearly identified our lack of preparedness to ensure the continuity of 
government and civil society in the event of a biological attack. Given 
the already identified gaps in preparedness; innovation and new methods 
will be needed to address these shortfalls.
    The recent Public Health Emergency Medical Counter-measure 
Enterprise (PHEMCE) review, which was reported to this subcommittee 
last month, took important steps towards improving the process of 
developing medical countermeasures in our private and military labs. 
The recommendations from the review, as were previously reported are:
   the establishment of a Concept Acceleration Program at the 
        National Institutes of Health to identify promising scientific 
        discoveries;
   the establishment of a strategic investment corporation to 
        spur innovation;
   the establishment of a Center for Innovation in Advanced 
        Development and Manufacturing; and
   a major investment in regulatory sciences and review 
        capabilities at the Food & Drug Administration.
    Each recommendation is important; however the review did not 
address the crucial issues of distribution and dissemination of 
currently stockpiled countermeasures. The review also failed to 
substantially engage the emergency services sector either as end-users 
of the countermeasures or in their role within the incident command 
component of a response. The medical countermeasure enterprise is not 
exclusively a public health mission separate and singular from the 
response to a large-scale incident. Medical counter-measure dispensing 
is one part of an overall response that includes resource allocation, 
security, and public information. It is important to note that even 
with the existing Federally stockpiled assets, the overall response 
will likely be coordinated through local emergency management 
resources.
    A more fundamental review of the medical countermeasure enterprise 
is warranted if we as a Nation want a medical counter-measure system 
that will protect us through the potential threats of the 21st Century. 
The alphabet soup of programs (Citizen Ready Initiative, Metropolitan 
Medical Response System, Biological Advance Research Development 
Authority) were conceived separately and remain uncoordinated. The 
PHEMCE review provides the emergency services sector and the Federal 
agencies an opportunity to improve our Nation's protective posture. But 
the PHEMCE must maintain a perspective larger than the Federal 
Government and must evolve to include an end user's point-of-view.
    Many of the emergency services sector professional associations 
have joined together to form a new Coalition on Medical Countermeasures 
to assist with this effort and provide a single voice on these 
important issues for the Nation, and to insure that the evolving 
National policy protects both our response personnel and their 
families.
    We offer the following recommendations for your consideration:
   develop an advisory board comprising emergency services 
        representatives to engage in defining end-user requirements 
        similar to battlefield medicine practices, and to advise on 
        effective distribution practices;
   develop a medical countermeasure strategy that enhances 
        National resilience by protecting the protectors of our 
        Nation's critical infrastructure;
   develop pilot projects (in at least the Tier 1 Urban Area 
        Security Initiative ``UASI'' cities) to position medical 
        countermeasures for emergency services personnel and their 
        families;
   ensure the continuity of the Chempack program, including 
        pilot programs to expand the formulary and examine local 
        pharmaceutical control.
    The Strategic National Stockpile, the Biological Advanced 
Development and Research Authority, and the Metropolitan Medical 
Response System are all mature systems which in cooperation with each 
other, are capable of devising a new level of protection for the 
Nation, and ensuring the protection of the emergency services sector.
    A medical countermeasure program that does not effectively protect 
the emergency services sector as the first group likely to be exposed 
during the performance of their duties, is insufficient. It would seem 
logical to include those we depend on to respond to the needs of our 
communities during these catastrophic incidents, and have the most to 
lose during a chemical, biological, radiological, or nuclear event, in 
the development of an effective medical countermeasure program. 
Protecting America's emergency responders will not only contribute to 
our National resilience, but it's the right thing to do. The axiom of 
``form follows function'' leads us to urge the policymakers to verify 
the inclusion of the first response community at the beginning, and 
throughout the development of any medical countermeasure system.
    Thank you for your time and attention. I sincerely appreciate the 
opportunity to come before you this afternoon to present a perspective 
from the emergency response community on this vital subject. I would 
welcome any feedback or questions.

    Mr. Bilirakis. Thank you, sir.
    Dr. Levi, you are recognized for 5 minutes.

STATEMENT OF JEFFREY LEVI, PH.D., EXECUTIVE DIRECTOR, TRUST FOR 
                        AMERICA'S HEALTH

    Mr. Levi. Thank you, Mr. Chairman. Thank you, Mr. Marino. I 
am delighted to be testifying here on behalf of Trust for 
America's Health, a non-profit, non-partisan organization 
dedicated to saving lives by protecting the health of every 
community and working to make disease prevention a National 
priority.
    I have two major points to make in my testimony today. 
First, our Nation faces continuing natural and manmade threats 
that require an on-going commitment to public health 
preparedness. This is a National security threat as direct as 
any we face abroad. Second, if we are to achieve the goal of 
rapid distribution and dispensing of CBRN medical 
countermeasures, we must fund public health preparedness with 
the same level of commitment as we have made to other National 
security priorities.
    As you know, research and development of medical 
countermeasures are only half of the battle in our capacity to 
quickly respond to a public health disaster. These medicines, 
diagnostics, vaccines, and devices must also reach the 
potential victims. That is why we need a well-staffed, well-
trained, and well-funded public health system to ensure these 
drugs reach the mouths or arms of every impacted individual.
    This means we must assure reliable, predictable funding for 
public health preparedness, in contrast to the 27 percent 
decline faced over the last several years. We must also 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. We 
must fully embrace the spirit of all-hazards in the Pandemic 
and All-Hazards Preparedness Act by recognizing that almost 
every public health program contributes to preparedness.
    Since 2003, Trust for America's Health has been tracking 
our Nation's progress and improving our preparedness through 
our annual report, entitled, ``Ready or Not? Protecting the 
Public's Health from Diseases, Disasters, and Bioterrorism.''
    In our 2010 report, 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 and hospital preparedness programs, Federal, 
State, and local attention to the role of public health in 
emergency preparedness, 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 gain 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 laid out several remaining public health gaps 
that need to be addressed, each of which affects our ability to 
distribute and dispense medical countermeasures. We have a 
workforce and infrastructure gap, a surge capacity gap, a 
surveillance gap, and also a gap in community resiliency 
support, and, finally, gaps in medical countermeasure 
development.
    My written testimony details these issues, but let me focus 
on just a few key points now.
    The economy recession has led to cuts in public health 
staffing and eroded the basic capabilities of State and local 
health departments. Our report found that 33 States and the 
District of Columbia cut public health funding between fiscal 
years 2009 and 2010, with 18 of these States cutting funding 
for the second year in a row. If we took another snapshot 
today, I fear to say that almost every State would have cut 
public health funding.
    In addition, Federal support for public health preparedness 
has dropped by 27 percent between fiscal 2005 and 2010, when 
you adjust for inflation. We are fully expecting further cuts 
to the public health preparedness programs in fiscal 2011 and 
2012.
    The National Association of County and City Health 
Officials reports that we have lost 19 percent of the local 
health department workforce since 2008. This poses a growing 
threat to our response capacity.
    Surge capacity--the ability of the medical system to care 
for a massive influx of patients--requires on-going planning, 
funding, and coordination across health care, public health, 
first responders, and the private sector. The medical system 
will be an integral partner in distributing countermeasures, as 
we saw during H1N1, so we must prepare them to triage and 
identify targeted recipients. We believe efforts currently 
under way to build regional collaboration into the Hospital 
Preparedness Program are essential to leveraging the capacity 
of the inpatient and ambulatory care health-care systems for 
medical asset dispensing.
    Finally, the Nation still lacks an integrated National 
approach to biosurveillance, the gathering and analysis of data 
related to threats to human health, to achieve early-warning 
detection and situational awareness. An interoperable, 
coordinated National biosurveillance system would significantly 
improve the country's capability to quickly detect an outbreak 
or attack and, thus, target our medical countermeasures 
appropriately.
    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. We urge HHS to lead the development of a 
National strategy, which should examine means to achieve 
interoperability and transparency among the various 
surveillance systems.
    Thank you for this opportunity to weigh in with this 
subcommittee as you consider the end-to-end realities of a 
medical response to a disaster. I look forward to your 
questions.
    [The statement of Mr. Levi follows:]
                   Prepared Statement of Jeffrey Levi
    Chairman Bilirakis, Ranking Member Richardson, and Members of the 
subcommittee: My name is Jeffrey Levi, and I am Executive Director 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 testify before the 
subcommittee today on the distribution and dispensing of medical 
countermeasures (MCM) for chemical, biological, radiological, and 
nuclear (CBRN) threats.
    I have two major points to make in my testimony today:
    First, our Nation faces continuing natural and man-made threats 
that require an on-going 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 the Pandemic and All-Hazards Preparedness Act (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.
    As you know, research and development of medical countermeasures 
are only half of the battle in our capacity to quickly respond to a 
public health disaster. These medicines, diagnostics, vaccines, and 
devices must also reach the potential victims. That is why we need a 
well-staffed, well-trained, and well-funded public health system to 
ensure these drugs reach the mouths or arms of every impacted 
individual.
    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, on-going communication updates, 
carrying out vaccination campaigns and the coordination of response 
efforts with partners.\1\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    Since 2003 TFAH has been tracking our Nation's progress in 
improving our preparedness through our annual report entitled Ready or 
Not: Protecting the Public's Health from Diseases, Disasters, and 
Bioterrorism. In our 2010 report, 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 and 
Hospital Preparedness Programs, 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 laid out several remaining public health gaps that need 
to be addressed, each of which impacts our ability to distribute and 
dispense medical countermeasures: A workforce and infrastructure gap, a 
surge capacity gap, a surveillance gap, a gap in community resiliency 
support, and gaps in medical countermeasure development. I'll address 
these in turn.
    Workforce and Infrastructure Gap.--The economic recession has led 
to cuts in public health staffing and eroded the basic capabilities of 
State and local health departments. Our report found that 33 States and 
the District of Columbia cut public health funding from fiscal years 
2008-09 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 also expect to see major cuts to 
Federal public health preparedness programs in both fiscal year 2011 
and 2012. 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. Strengthening the public health 
preparedness infrastructure is critical to ensuring the health 
protection of our Nation through distribution and dispensing of medical 
material. It also requires adequate funding and human resources to 
recruit and train personnel, stockpile life-saving countermeasures, 
develop and exercise plans to distribute assets, 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.
    During the 2009-2010 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 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.''
    The Department of Health and Human Services (HHS) and Department of 
Homeland Security (DHS) have been working to align grant programs that 
aim to build our Nation's emergency preparedness capacity, including 
the Public Health Emergency Preparedness (PHEP) grants, Hospital 
Preparedness Program (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. We hope this 
committee works with your counterparts in Energy & Commerce to ensure 
the alignment process continues.
    Surge Capacity Gap.--Surge capacity, the ability of the medical 
system to care for a massive influx of patients, requires on-going 
planning, funding, and coordination across health care, public health, 
first responder, and private sectors. The medical system will be an 
integral partner in distributing medical countermeasures, as we saw 
during H1N1, so we must prepare them to triage and identify targeted 
recipients. We believe efforts currently underway to build regional 
collaboration into the Hospital Preparedness Program are essential to 
leverage the capacity of the inpatient and ambulatory health care 
system for medical asset dispensing.
    Surge planning must also take into account the important role of 
volunteers in mass dispensing. The Medical Reserve Corps (MRC) is a 
National network of community-based groups which include volunteers 
from public health, medicine, nursing, and non-medical support fields. 
During the H1N1 outbreak, MRC units across the country participated in 
2,500 response activities, including vaccination clinics, significantly 
augmenting the capacity of local public health to implement the 
immunization strategy.\2\ However, in a survey conducted during the 
outbreak, MRC units reported that fear of liability was a significant 
barrier to full participation.\3\ HHS has also acknowledged that a 
patchwork of Federal liability laws is confusing and frustrating to 
other health care providers.\4\ HHS should clarify 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. There should 
also be Federal Tort Claims Act protection for MRC volunteers year-
round, as these personnel participate in public health drills and 
training during times of non-disaster.
---------------------------------------------------------------------------
    \2\ Office of the Civilian Medical Reserve Corps, ``Report on the 
Medical Reserve Corps Response to the H1N1 Influenza Pandemic April--
December 2009.'' http://www.medicalreservecorps.gov/file/PandemicFlu/
MRC-H1N1-2009-final.pdf.
    \3\ Office of the Civilian Medical Reserve Corps, ``Medical Reserve 
Corps Units and H1N1 Influenza Related Activities: September 2009.'' 
http://www.medicalreservecorps.gov/file/SwineFlu/
MRC_Units_H1N1_Flu_Activities.pdf.
    \4\ 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.
---------------------------------------------------------------------------
    Surveillance Gap.--The Nation still lacks an integrated, National 
approach to biosurveillance, the gathering and analysis of data related 
to threats to human health to achieve early warning, detection, and 
situational awareness.\5\ An interoperable, coordinated National 
biosurveillance system would significantly improve the country's 
capability to quickly detect an outbreak or attack and thus target our 
medical countermeasures appropriately. 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.\6\, \7\ We urge HHS to lead the 
development of a National strategy, which should examine means to 
achieve interoperability and transparency among various surveillance 
systems.\8\
---------------------------------------------------------------------------
    \5\ Centers for Disease Control and Prevention, ``Biosurveillance: 
A Definition, Scope, and Description of Current Capability for a 
National Strategy,'' Presentation before International Society for 
Disease Surveillance, 2008. http://www.syndromic.org/conference/2008/
presentations/Track%203/
ISDS%20Presentation_Fleischauer_Biosurveillance_2008.ppt.
    \6\ 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_biosurveillance.html.
    \7\ 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.
    \8\ Nuzzo, 2009.
---------------------------------------------------------------------------
    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 (ONC). 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.
    Community Resiliency Support Gap.--We continue to face challenges 
in preparing communities to recover from a disaster, especially at-risk 
people. Without an ability to reach these populations, such as home-
bound individuals or those with limited-English proficiency, we face 
significant barriers in distributing medical countermeasures to them. 
Public health must work with the private sector, community-based and 
faith-based organizations, health care organizations, and community 
leaders to develop trust and communication with at-risk communities 
before a disaster occurs. We also must address on-going vaccine access 
issues during times of non-disaster, especially in high-risk 
communities. For example, according to 2008 data, 70 percent of older 
non-Hispanic whites received the seasonal influenza vaccination, 
compared to only 51 percent and 56 percent of older African-Americans 
and Hispanics, respectively.\9\ This indicates a systemic problem with 
access, acceptance, and education that must be addressed before the 
next mass-dispensing campaign occurs.
---------------------------------------------------------------------------
    \9\ HHS Office of Minority Health, Immunizations Data/Statistics, 
April 20, 2010. http://minorityhealth.hhs.gov/templates/
browse.aspx?lvl=3&lvlid=60.
---------------------------------------------------------------------------
    Gaps in Medical Countermeasure Enterprise.--As you explored in your 
April hearing, although we are miles ahead of where we were during the 
2001 anthrax outbreak, our ability to spur innovation in limited-use 
technologies has been hampered by a lack of stable funding and some 
breakdowns in program administration. 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.
    We believe a Federal MCM strategy should lead to: (1) Increased 
coordination between all of the involved agencies within HHS, DHS, and 
State and local public health, from initial investment through 
dispensing; (2) improved transparency of the development and 
distribution process; and (3) an end-to-end approach--not just focused 
on initial investments, but on advance development, procurement, 
distribution, and surveillance.
    There should also be a plan for stocking the Strategic National 
Stockpile (SNS) and for on-going replacement of expiring product, 
especially vaccines,\10\ 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.
---------------------------------------------------------------------------
    \10\ 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.
---------------------------------------------------------------------------
    Success at Risk: The Urban-Rural Experience.--Urban and rural areas 
face very different challenges in capacity to distribute and dispense 
medical countermeasures. For all jurisdictions, adequate workforce and 
resources are a continuing obstacle to effective dispensing.
    The Cities Readiness Initiative (CRI) is a Federal program that 
directly funds the largest metropolitan statistical areas (MSA) and 
provides technical assistance to develop capacity to receive and 
distribute medical countermeasures. Fifty percent of the U.S. 
population is covered by the 72 jurisdictions in the CRI program.\11\ 
The program requires each area to demonstrate plans to be able to 
distribute antibiotics to the entire population within 48 hours. An 
analysis by RAND in 2009 found that CRI had helped cities develop the 
workforce, partnerships, planning, and purchasing capacity to dispense 
medical assets, but evaluation of the real capacity of cities to carry 
out these plans was limited due to the nature of the data 
collected.\12\ We hope CDC continues to refine these measures to enable 
evaluation of the actual capacity and capabilities of each 
jurisdiction, rather than just the adequacy of plans, and we urge CDC 
to release this data at the local level.
---------------------------------------------------------------------------
    \11\ Centers for Disease Control and Prevention, ``Cities Readiness 
Initiative,'' May 20, 2010. http://www.bt.cdc.gov/cri/.
    \12\ Willis, H.H., et al. RAND Corp, Initial Evaluation of the 
Cities Readiness Initiative, 2009. http://www.rand.org/content/dam/
rand/pubs/technical_reports/2009/RAND_TR640.pdf.
---------------------------------------------------------------------------
    The impact of CRI in urban areas was demonstrated during the H1N1 
outbreak. In Los Angeles County, for example, 200,000 people received 
free H1N1 vaccines at 109 points-of-dispensing (PODs) in a 6-week 
period.\13\ And the county has in place plans to distribute medical 
assets to 10 million people within 48 hours, as required by CRI. Los 
Angeles is also in the process of developing partnerships with schools 
and child care facilities to serve as alternative dispensing sites. 
These kinds of partnerships are key to achieving coverage of an at-risk 
population (during H1N1, children), and ensuring that income, language, 
and transportation are not barriers to receipt of the product.
---------------------------------------------------------------------------
    \13\ Plough, A. et al, ``Pandemics and Health Equity: Lessons 
Learned From the H1N1 Response in Los Angeles County,'' Journal of 
Public Health Management & Practice: January/February 2011--Volume 17--
Issue 1--p. 20-27.
---------------------------------------------------------------------------
    The rural perspective varies based on whether the area is part of a 
CRI. Those rural areas within a CRI's MSA have the benefit of 
additional resources and technical assistance from the Federal program, 
with fewer people to serve. However, in truly rural areas, additional 
creativity is required. For example, one rural Virginia health 
department pursued agreements with fast-food establishments and banks 
to serve as drive-thru PODs.\14\ Rural areas also face different 
challenges due to the limitations of communications. In many areas, 
land-lines are the only consistent form of telecommunication, while 
cities can depend more reliably on internet and cell phone use.\15\
---------------------------------------------------------------------------
    \14\ McMorrow, Julie, National Association of County and City 
Health Officials, personal communication, May 10, 2011.
    \15\ Ibid.
---------------------------------------------------------------------------
    In both rural and urban areas, local health departments have had to 
rely on public-private partnerships to achieve maximum coverage of 
dispensing planning. During H1N1, health departments depended on big 
box stores, retail pharmacies, schools, and private physician offices 
to serve as distribution points. These partnerships are an 
acknowledgement that public health does not have the personnel to reach 
everyone in a community, but also demonstrates that the private sector 
and other community-level organizations often have better access to the 
population. Federal assistance, both before and during an emergency, 
should embrace and grow these partnerships. This is one of the reasons 
we support expansion of the mission of the Hospital Preparedness 
Program to include the entire medical system of a region.
    Thank you for this opportunity to weigh in as the subcommittee 
considers the end-to-end realities of a medical response to a disaster. 
I look forward to your questions.

    Mr. Bilirakis. Thank you, Dr. Levi.
    I want to thank all of you for being so flexible with the 
schedule today. You know, initially, the meeting was scheduled 
in the morning, but to accommodate the minority party, we--in 
the afternoon, we did not anticipate votes. So I apologize for 
that.
    I would like to recognize Mr. Marino, because I know he has 
an important meeting to go to, for 5 minutes or so.
    Sir, you are recognized.
    Mr. Marino. Thank you, Mr. Chairman.
    This meeting here is just as important to me; it is just 
that we have to be in three different places at one time 
anymore.
    Gentlemen, I was a district attorney for 12 years and very 
active in my community and in my region with emergency 
services. I am going to pose a scenario to you and ask you to 
respond to it. I may interrupt politely to expand on it, 
bearing in mind that we only have about 5 minutes.
    We will start with the doctor, if you don't mind, sir.
    Let's assume that the money that you have been budgeted 
last year will be cut by 50 percent. What do we do 
collectively--and I know people come in and say, money is the 
issue, money is the issue. But let's just assume the bottom 
line is cut 50 percent. What do we do, and how do we use it 
most efficiently?
    I know that is a tough one, so you have a moment to think 
about it, but not too much. And I say ``we'' collectively.
    Mr. Levi. Right, right. So, you know, that is obviously a 
very difficult question. I mean, I think the first thing is 
that one would have to be honest with the American people and 
say, if we make cuts of this magnitude, you cannot expect the 
level of protection that you have assumed exists for you today.
    Mr. Marino. Okay, then where would you start? What are the 
priorities with that 50 percent cut?
    Mr. Levi. I think my priorities probably would be, to a 
large degree, the focus of this panel, making sure that State 
and local health departments had a true emergency response 
capacity. What I would be looking at are some of the things you 
heard from some of the other witnesses as well: Making sure we 
are eliminating duplication, making sure that the existing 
programs are as efficiently managed as possible.
    I will be honest with you, I don't think that we can 
sustain a 50 percent cut. So it is very hard for me to even 
imagine what we would focus on. I think we would have to make--
and I wouldn't feel comfortable doing this on the spot--would 
have to make some decisions. There are some threats that we 
just couldn't prepare for.
    Mr. Marino. Okay.
    Mr. Levi. You know, I don't think that is an acceptable 
approach to, you know, the most vital Government function, 
which is protecting us from threats over which we have no 
control.
    Mr. Marino. Okay.
    Chief, do you want to add something to that?
    Mr. Tan. I think one of the first things you would have to 
look at is, do we have sufficient information to determine what 
our greatest threats are?
    From an EMS standpoint, one of the biggest gaps that we 
find is there is no lead Federal agency with responsibility for 
EMS to help coordinate what is the emerging threat for the 
emergency services sector so that we can focus what remaining 
funding we have left, in your scenario, on what is the greatest 
threat that is going to do the greatest amount of good for the 
greatest number of people.
    The other is early detection and preparedness, that if we 
can take the intelligence and the information that is available 
on where our greatest gaps and threats are, push that 
information out to the response community so that there is 
preparedness activities rather than consequence management, 
that may leverage some greater savings, from the perspective of 
minimizing potential exposure rather than having to deal with 
the aftereffect.
    Mr. Marino. Mr. Starr, do you want to add anything 
different to that?
    Mr. Starr. Not really. I would just like to concur with Dr. 
Levi. I think that you would--we couldn't fathom that kind of 
cut to our programs. I think that it would be a tangible and 
real decrease in the ability for us to function and for us to 
protect our population.
    I don't think--our ability to cooperate with the Federal 
Government, to fulfill the mandates that we receive from the 
Federal Government under our current grant programs would be 
severely impacted. I mean, I doubt we could fulfill the 
mandates that we are getting from our Federal partners.
    Mr. Marino. Okay.
    Mr. McHargue, I am going to change the question a little 
bit. How much of a stockpile do we need and how much notice 
would the pharmaceutical industry need if we avoided 
inventories for great periods of time for medications that you 
would have to dispense? Do you understand my question? You look 
a little perplexed.
    Mr. McHargue. I am. Are you speaking, sir, about the 
National stockpile in concert with local?
    Mr. Marino. Yes.
    Mr. McHargue. Well, those numbers are a moving target, I 
will admit that. I don't know how much testimony you want in 
terms of actual figures, because the strategic placement of a 
lot of those materials and the ability for them to be exploited 
or used against us, or eliminated in the case of a threat, 
but----
    Mr. Marino. Let me rephrase that a little bit. Say you 
need--I am just going to take penicillin just as an example. 
How long would it take, in your opinion, for you to have enough 
to start distribution if--how much time if you need to contact 
the pharmaceutical that, ``Hey, we need this, and we need it 
now. How much can you give us?''
    Mr. McHargue. Well, according to the Strategic National 
Stockpile Plan, those assets would be rolled immediately and on 
the ground within 12 hours. Then it becomes our responsibility 
to receive, break those packages down, and distribute them into 
the community.
    Mr. Marino. Now, you are saying they are already produced, 
though, correct?
    Mr. McHargue. Well, that assumes availability, yes, sir.
    Mr. Levi. Right. The whole assumption of the Strategic 
National Stockpile is that these are things that we would need 
so quickly that you couldn't go to a manufacturer and say, you 
know, ``Start producing a large quantity now.'' The whole 
principle of the Strategic National Stockpile is that we have 
to be able to respond immediately.
    Mr. Marino. Thank you.
    Mr. Tan. Mr.----
    Mr. Marino. I have gone over my time. Please, Chief--is 
that all right, Chairman?
    Chief, do you want to respond?
    Mr. Tan. Just, I mean, in looking at medical 
countermeasures, one of the things that I would just offer is 
the fact that sometimes the cost of these medical 
countermeasures is prohibitive of local government being able 
to sufficiently have supplies that would protect the 
population.
    A good example is the Cyanokits that are used as a medical 
countermeasure against cyanide. It is $700 a kit. When you 
start looking at trying to protect the local population, local 
government, local emergency response agencies would have a 
tremendously difficult time, in your scenario, trying to 
adequately prepare not only their own personnel but respond to 
the population, as well.
    Mr. Marino. Gentlemen, thank you very much. Thank you for 
waiting. I apologize for that.
    Mr. Bilirakis. Thank you, Mr. Marino. Appreciate it. That 
first question was hypothetical, correct?
    Mr. Marino. Yes.
    Mr. Bilirakis. Yes, I figured that. Just getting that on 
the record.
    All right. My first question is to Mr. McHargue.
    The Council on State and Territorial Epidemiologists 
conducted a survey last year to assess State-level preparedness 
for a radiological or nuclear event, exclusive of a nuclear 
plant emergency.
    Can you please describe Florida's planning efforts with 
regard to stockpiling, distribution, and dispensing of medical 
countermeasures that can be used to respond to a radiological 
dirty bomb or nuclear attack?
    Mr. McHargue. Okay, I can to a limited degree, sir.
    We have three nuclear power facilities in Florida that you 
are very familiar with, being from that State. We work very 
closely with the National Regulatory Commission, the State 
Emergency Response Team, through regular drills and exercises 
to test the safety of the response plans.
    The caching of pharmaceuticals are limited, at best, 
locally. We are aware--I don't know the numbers, but in the 
communities surrounding the nuclear power plants, it is our 
understanding that there are limited quantities of KI, for 
example, or like drugs. I cannot, at this moment, tell you the 
quantities, but I will be glad to report off-line following the 
hearing.
    Mr. Bilirakis. Yeah, we would appreciate that very much.
    Mr. McHargue. I would be glad to do it.
    Mr. Bilirakis. Thank you.
    Mr. Starr, I am concerned about your comments regarding the 
considerable need for more Federal guidance and more action on 
matters such as prepositioning of Federal emergency medical 
countermeasures and some relaxation of the emergency use 
authorizations. I know that some locales would also like to see 
local implementation of the Federal Shelf-Life Extension 
Program for expiring countermeasures.
    Two questions: Who in the Federal Government have you 
worked with to address these issues? Is it FDA or DHS?
    Mr. Starr. It is actually, particularly in the first case, 
it is the CDC we have been working with about the 
prepositioning of medical countermeasures and the relaxation of 
the FDA's emergency use authorization. It is not really our 
place, being a recipient of CDC funds, to go past the CDC to 
contact the FDA.
    If you remember some of Dr. Khan's comments from the first 
panel, they have made--and this is one of the things that is 
very heartening to us--they have made advances on that. I don't 
have details on how far they have gotten. I think that is a 
question for them.
    The guidance, really, that we were looking for is in regard 
to the follow-on 50 days of antibiotics needed for anthrax 
exposure after the 10 days of initial distribution, as well as 
the three-dose regimen of vaccine that is necessary to an 
exposed population. Again, they have convened work groups to 
identify some of the issues surrounding these and provide 
further guidance.
    So, again, we push for this type of guidance, and we are 
lucky enough to have partners, I think, at the Federal level 
that are responding as best they can.
    Mr. Bilirakis. Thank you.
    This is for Chief Tan. Anyone else who wants to chime in, 
you are perfectly welcome.
    Your coalition was established to provide a forum for the 
first responder medical countermeasures policy issues. Why do 
you think the emergency services sector, which is one of the 18 
critical infrastructure sectors, has been left out of important 
policy discussions surrounding review of our MCM enterprise and 
promulgation of guidance for response to WMDs?
    Mr. Tan. I think part of the dilemma is that there is a 
disconnect between the public health portion and the actual 
response community. It is likely that when the public health 
community was looking at the medical countermeasures, they 
weren't necessarily looking at it from an emergency response 
perspective. They were probably looking at it more from a 
global population perspective.
    As you prioritize these types of responses, one of the 
things that the coalition is looking at is, who are the people 
on the front lines that are going to be potentially the first 
to be exposed in these types of events? As I indicated during 
my remarks, the emergency services personnel, the emergency 
services sector, which is, as you indicated, part of the 
critical infrastructure, is going to be at the front lines and 
potentially exposed to any one of these CBRNE types of events 
and also is most likely living within the impact area of these 
types of events, so their families are going to be involved, as 
well.
    What we are hoping to do through the coalition is to raise 
awareness regarding the needs of the emergency services sector 
to have, as a part of the planning for medical countermeasures, 
prepositioned caches for those personnel.
    Mr. Bilirakis. Thank you.
    Anyone else want to add anything on that? Okay.
    Mr. McHargue, in your testimony, you spoke of your 
successes in dispensing the flu vaccine during the H1N1 
pandemic in 2009. In particular, you mentioned that Florida's 
planning incorporated major pharmaceutical chains to dispense 
antivirals in the early days of the pandemic.
    To what extent do your State plans leverage the capacity of 
the private sector to dispense the CBRN medical 
countermeasures?
    Mr. McHargue. We learned through that experience with H1N1, 
and with the encouragement of our Governor, Rick Scott, that 
private enterprise is an expansion of local or public 
capability. Through contracts with some nationally-known 
pharmacies, we were able to secure and administer a lot of the 
H1N1 vaccines through pharmacy locations in neighborhoods where 
people typically go to buy their other medications, their 
trusted deliverers of that service.
    We have not fully exploited other partnerships for the 
provision of the wider range of CBRN medications, but we are in 
the process of continuing those expanded partnerships, sir.
    Mr. Bilirakis. Thank you.
    Anyone else want to add to that?
    Mr. Levi. I guess what I would add is that, particularly in 
rural communities, having those public-private partnerships is 
going to be incredibly important. You know, in large cities, 
you have a relatively large infrastructure of the public health 
system that is able to respond. In rural communities, your 
health department may be one or two people serving a very large 
geographic community. Without those public-private 
partnerships, we just will not reach lots and lots of people.
    Mr. Bilirakis. Okay, Mr. Levi, certain Federally-funded 
initiatives, such as the Cities Readiness Initiative, the 
Metropolitan Medical Response System program, and other grant 
programs, have a key impact at the local level with regard to 
preparedness and response.
    In your experience examining State readiness, have you 
found that the States are taking full advantage of these 
programs? Do you think that these separate but related efforts 
are well-coordinated?
    Mr. Levi. Coordination could always be better, but I think 
we found over time that the partnerships have improved and that 
State preparedness programs and their counterparts in the 
Cities Readiness Initiative have been working more closely 
together. I think that is--you know, certainly, making sure 
that those are well-coordinated is a responsibility for the 
CDC.
    I think the larger coordination issue is less a State-local 
issue and more of what Mr. Starr was referring to, which is 
these multiple grant mechanisms from multiple Federal agencies 
coming into either a State or into a city with different 
requirements, different timelines, multiple application 
processes, all ultimately serving the same goal. If those could 
be rationalized, coordinated, integrated in a more effective 
way, I think we would find people spending less time on 
administration and applying for grants and more time on 
actually doing the preparedness work.
    Mr. Bilirakis. How many States would you say take advantage 
of these programs?
    Mr. Levi. Well, every State is a recipient of the Public 
Health Emergency Preparedness Program, as well as the Hospital 
Preparedness Program, which are sort of the core programs.
    Mr. Bilirakis. Anyone else?
    Okay. Well, thank you.
    I have a little time. We don't have Members on the panel. 
Does anybody else want to maybe expand on their testimony on 
any particular issues since you are here?
    Mr. Starr. I just wanted to say----
    Mr. Bilirakis. Sure, please. You are recognized. Please.
    Mr. Starr. Thank you.
    I just wanted to add one point about Mr. Marino's earlier 
comment about the use of the private sector. New York City, and 
particularly the pharmaceutical supply chain, if the stockpile 
was eliminated--if I am not mistaken, his question was, if the 
stockpile was eliminated, how fast could the private 
pharmaceutical supply chain swing into action to supply the 
needed countermeasures in a public health emergency, and 
specific to anthrax and other extremely short-timelined 
incidents. It is too long. It would be far too long, and there 
is absolutely no way.
    I have some experience with the pharmaceutical supply 
chain, at least around my region. Without any kind of Federal 
intervention or any kind of interaction with us, it would be 
too long for the private supply chain to swing into action at 
the level that we would need to in the timeline that we would 
need. I think I speak for the rest of the panel on that.
    Mr. Bilirakis. Anyone else want to add to that?
    Okay, well, thank you. I do have a markup, but I want to 
thank the witnesses for their valuable testimony and the 
Members for their questions.
    The Members of the subcommittee may have some additional 
questions--I am sure they will, because, as I said, the 
Minority party is at the White House at this particular time--
but we ask you to respond in writing, please. The hearing 
record will be open for 10 days.
    Without objection, the subcommittee stands adjourned.
    Thank you, folks. Appreciate it very much.
    [Whereupon, at 3:35 p.m., the subcommittee was adjourned.]


                            A P P E N D I X

                              ----------                              

    Questions From Chairman Gus M. Bilirakis for Alexander G. Garza
    Question 1. What is the Department of Homeland Security's strategy 
for relaying imminent threat information to the public? I am not just 
speaking of the new National Terrorism Advisory System, but also about 
the need for detailed information for the public on whether to shelter 
in place or evacuate, and on health information like what 
countermeasures are appropriate and where to get them.
    How will DHS get this information out in real time to local 
authorities and/or the public?
    Answer. Thank you for the opportunity to provide information 
pertaining to how we disseminate information to the public and the 
coordination that is required with State and local governments, and 
with the Department of Health and Human Services (HHS), which has the 
Federal lead on public health communications.
    The public information response to a wide-area aerosolized anthrax 
attack would require significant participation of many Government 
agencies, non-profit organizations, and the private sector. The 
information provided to the public about the nature of the threat, the 
attack, and the response would require parallel communication efforts 
through various channels. Different audiences will need difference 
pieces of the overall flow of information. It is first important to 
recognize that the responsibility and authority to provide detailed 
information to the public on immediate public health and safety matters 
such as shelter-in-place, evacuation, or appropriate medical 
countermeasures is held at the local level under a State's police 
powers. DHS will work with local authorities to ensure they have the 
most up-to-date and comprehensive information available.
    The audience of those not immediately affected by the attack will 
require different information, particularly since identification of an 
anthrax attack will likely occur well after thousands have traveled 
across a State, the Nation, and even other parts of the world. As 
characterization of the event becomes better understood, DHS will be 
coordinating with these communities and States affected but not 
necessarily targeted in the attack itself; therefore, the information 
and strategy to provide information to those audiences will involve 
less details about immediate response efforts and more information 
about what we know about the nature of the threat (i.e. potential for 
multiple attacks) and the need to work closely with HHS's CDC on 
education (i.e. why the SNS isn't being deployed to other cities, 
personal protective measures to take and not to take, etc.). 
Communication and coordination with this group will be essential to a 
National response and recovery in the early stages so that limited 
resources are not misallocated and local officials and their 
constituents are educated about the decisions that are being made and 
why.
                                strategy
    White House Communications will provide strategic communications 
direction following a terrorist attack. In addition, the U.S. Domestic 
Communications Strategy (DCS), developed by the DHS Office of Public 
Affairs and Federal interagency, was designed to counter the intended 
consequences of terrorism against the United States. The DCS details a 
comprehensive set of pre-identified counterterrorism communications 
options that each agency could and likely would take following a 
terrorist attack.
    Because the DCS is a broad-based strategy to meet counterterrorism 
objectives for all terrorist attacks, the DHS Office of Public Affairs 
has also developed an anthrax specific communications coordination 
plan. HHS and CDC will retain the Federal lead on public health 
communications, including providing technical assistance to State and 
local governments to improve their planning for emergency public 
information and warning. DHS's responsibilities in both operations and 
public communications under Homeland Security Presidential Directive--5 
are to coordinate those response efforts. For this reason, DHS has 
developed a draft communications coordination plan that lays out roles 
and responsibilities within the Federal Government and the mechanism 
the Department will use to coordinate public communications activities 
across State, local, Federal, international, and private sector 
partners following an anthrax attack. The mechanisms include the 
National Incident Communications Conference Line (NICCL) and the State 
Incident Communications Coordination Line (SICCL). The NICCL and SICCL 
are managed once DHS stands up the National Joint Information Center 
(NJIC) and are used to coordinate Federal and State communications, 
respectively. A similar private sector coordination capability also 
exists through the NJIC. Coordination is essential to a successful 
response to an incident of the magnitude of a wide-area aerosolized 
anthrax attack, and DHS will use all of the communications channels 
(print and broadcast media, internet, social media, etc.) and its 
proven ability to coordinate large-scale incidents to provide 
information the public will seek during such a high-profile National 
incident. These communication channels include new media, such as 
blogs, Twitter, and other on-line publications, as well as traditional 
media sources.
    Finally, under the National Response Framework, DHS Public Affairs 
is responsible for Emergency Support Function (ESF) 15--External 
Affairs. ESF-15 is the standard operating procedure for how the U.S. 
Government will conduct the external affairs response to a National-
level incident requiring a large coordinated Federal response. There is 
intentional overlap between the anthrax planning process and the ESF-15 
standard operating procedure. ESF-15 largely addresses the efforts for 
a large on-scene Federal communications presence.
    Question 2a. OHA released draft guidance in 2009 for protecting 
first responders immediately after an anthrax attack.
    Can you please provide a status update on when that guidance will 
be finalized for use by first responders? The guidance has been with 
OMB for sign-off for a long time.
    Answer. OMB and NSS staff has been working with DHS/OHA to ensure 
the document is responsive to the concerns raised by Federal 
departments and agencies that will be our partners in implementing this 
guidance. OHA is now finalizing the guidance for approval and 
publication. It is important to note that in the interim, the draft 
guidance that was initially published for public comment in 2009 should 
guide first responders; no major changes to that guidance are being 
contemplated.
    Question 2b. Can you please address whether the final guidance will 
recommend pre-event vaccination for first responders, and how would OHA 
help to implement such a program?
    Answer. The draft guidance provides information for consideration 
by the responder community. It provides specific planning and program 
considerations if such a pre-event vaccination program is desired. In 
that regard, OHA and others are evaluating strategies for making some 
portion of the vaccine in the Strategic National Stockpile (SNS) that 
would otherwise go unused available to this community.
    Question 3. We've heard from different avenues that it can be 
confusing to State and local governments to work with so many different 
grant programs, many of which have related guidance, and that this can 
encourage duplication of efforts. I know that some work has been 
undertaken to address this problem.
    Can you please provide a description and update of DHS' work with 
HHS to align related grants?
    Answer. The Department of Health and Human Services (HHS), Office 
of the Assistant Secretary for Preparedness and Response (ASPR) is 
leading an interagency effort to align public health and medical 
preparedness grants having separate authorizations, appropriations, 
applications, reporting, and measurement requirements. One of the main 
goals is to standardize the grant process--a large portion of that 
process includes streamlining the application submission process for 
the States as they respond to multiple Federal Government funding 
opportunities. The core interagency partners critical to the success of 
this endeavor are HHS/ASPR; HHS/Centers for Disease Control and 
Prevention (CDC); HHS/Health Resources and Services Administration; 
Department of Homeland Security (DHS), Federal Emergency Management 
Agency (FEMA); and Department of Transportation (DoT), National Highway 
Traffic Safety Agency (NHTSA).
    The Department of Homeland Security's Office of Health Affairs has 
been actively engaged in the DHS/HHS Coordinating Committee. In this 
role, DHS along with our partners are working to align emergency 
preparedness grant programs throughout the Federal Government to 
support National preparedness strategies for end users at the State, 
local, Tribal, and territorial level. These funding opportunities, and 
related alignment activities, need to be coordinated in the most cost-
effective manner possible, consistent with the applicable laws and 
missions of the respective agencies. This collaboration and integration 
is essential for establishing an effective and coordinated response 
between all levels of government during a public health emergency.
    Question 4. In response to President Obama's Executive Order on 
countermeasure distribution, I understand that your office has taken 
the lead for DHS on the conops plan for mission-essential personnel of 
the Executive branch. OHA has also spearheaded an MCM strategy for DHS 
employees, and oversees the purchase and storage of MCMs for the DHS 
workforce.
    Can you please provide us with an update on the status of the 
conops plan?
    What is your approach to stockpiling, distributing, and dispensing 
countermeasures within DHS?
    Answer. Per Section 4 of President Obama's Executive Order 13527, 
the Department of Homeland Security (DHS) Office of Health Affairs 
(OHA) and the Department of Health and Human Services (HHS) have formed 
a joint task force in order to plan a common path forward for 
continuity of operations among Federal agency mission-essential 
functions (MEF), inclusive of Executive branch departments and 
agencies.
    OHA and DHS Operations Coordination and Planning (OPS) have 
coordinated in ensuring that plans are in place across all of the DHS 
Components. Per the Department Guidance Statement (DGS) developed by 
OPS and approved by the Secretary of DHS, each of the DHS Components 
has developed its own Anthrax Operation Plan, which is a requirement of 
each Component outlined as part of this DGS. These plans identify how 
each Component will protect its personnel by ensuring each DHS employee 
will be able to receive medical countermeasures (MCM). OHA is engaged 
in meetings with Federal partners outside of DHS to discuss planning 
and coordination to improve our MCM capabilities, and is able to offer 
assistance, make recommendations, and share existing training and 
educational resources and reference materials.
    Focusing specifically on stockpiling, distributing, and dispensing 
MCM within DHS, OHA has developed a DHS MCM Program at the direction of 
Secretary Napolitano to provide MCM to DHS employees in an attacked 
area. Currently, OHA has over 6 million tablets of antibiotic and 
antiviral MCM purchased and stored in a pharmaceutical logistics center 
ready for rapid deployment, to protect DHS employees and individuals 
under DHS care and custody. OHA has identified two dozen medical 
storage locations for local MCM stockpiles, or ``caches,'' and has pre-
positioned MCM in these storage caches around the Nation. OHA has 
entered into an inter-agency agreement partnership with the HHS Supply 
Service Center (SSC) to provide MCM supply chain management support, 
including sourcing, bottling/repackaging, labeling, storage, and 
distribution services.
    In preparation for activation of Points of Dispensing (POD) for DHS 
employees utilizing these stockpiled MCM, OHA has established POD 
training material to assist all DHS Components in selecting their 
appropriate POD locations and POD staff members. POD training includes 
the roles and responsibilities for DHS POD staff members to 
successfully stand-up, implement, and close-down a POD for DHS 
employees and those under DHS care and custody. OHA has worked with 
each of the DHS Components to exercise their POD implementation and OHA 
created POD demonstration videos to assist Components in educating 
their personnel. OHA is also working with the DHS Office of the Chief 
Learning Officer to develop and disseminate training on-line for the 
DHS workforce with regards to Anthrax and MCM POD education.
       Question From Chairman Gus M. Bilirakis for Mike McHargue
    Question. The Council on State and Territorial Epidemiologists 
conducted a survey last year to assess State-level preparedness for a 
radiological or nuclear exclusive of a nuclear power plant emergency.
    Can you please describe Florida's planning efforts with regard to 
stockpiling, distribution, and dispensing of medical countermeasures 
that can be used to respond to a radiological dirty bomb or nuclear 
attack?
    Answer. The Florida Department of Health maintains primary caches 
of Potassium Iodide (KI) at three County Health Departments in the 
State. The Health Departments have primary response capability for the 
nuclear reactors located in their jurisdictions. To meet this need, 
there are 1.615 million total doses of KI at these sites. An additional 
300,000 doses are maintained in Tallahassee by the bureau of Pharmacy 
for a cache of approximately 2 million doses.
    In addition, the State has four radiological countermeasure kits 
that are controlled by the State pharmacy. These kits total 2,000 doses 
and are designed for treat emergency responders and victims in an 
emergency. Each kit contains KI, Prussian blue, Zn-DTPA and Ca-DTPA. 
The kit also contains the appropriate medical supplies for 
administration. The distribution capability of this product is covered 
under the Logistics Support Annex and utilizes the response deadlines 
established for SNS level events.
    In an event, the State has developed a Medical Advisory Group to 
evaluate an allocation and apportionment methodology of both these 
caches as well as the use of the SNS or Vendor Inventory. Once the 
apportionment is made, the Health Departments, using their all-hazards 
approach, activate their Points of Dispensing protocols that are 
developed to utilize a 48-hour window to a longer more extensive 
delivery needs.
        Questions From Chairman Gus M. Bilirakis for Ali S. Khan
    Question 1a. The Nuclear Regulatory Commission is responsible for 
stockpiling and distributing potassium iodide in the 10-mile zone 
around nuclear reactors. But I am concerned about our preparedness for 
a radiation/nuclear terrorist event.
    Can you please describe the role of your office and of the SNS in 
the event of a radiological or nuclear attack?
    Answer. I share your concern about the Nation's preparedness for a 
radiation event, whether it is an accidental release or a radiological 
or nuclear attack. During such an event, the Centers for Disease 
Control and Prevention (CDC) and the Agency for Toxic Substances and 
Disease Registry (ATSDR), stand ready to assist State, local, and 
territorial authorities in protecting people's health by providing 
technical assistance and science-based advice on steps people can take 
to reduce their exposure to radiation. During a radiation incident, 
CDC/ATSDR focuses on its public health strengths, which include:
   Laboratory and epidemiological detection and 
        characterization of event;
   Technical assistance to States upon request;
   Clinical and self-help guidance;
   Medical countermeasures (where appropriate) to mitigate 
        morbidity and mortality;
   Risk communication with stakeholders and the public;
   Linkage across the health system from local to State, 
        National, and even international levels to ensure an integrated 
        health system response; and
   Participation in interagency radiation response systems 
        including the Federal Radiological Monitoring and Assessment 
        Center and the Advisory Team for Environment, Food, and Health.
    Many systems that we use to meet everyday public health needs are 
at the core of public health preparedness and response for unforeseen 
and unpredictable public health threats.
    Within CDC, the Office of Public Health Preparedness and Response 
(PHPR) leads CDC's preparedness and response activities by providing 
strategic direction, support, and coordination for activities across 
CDC as well as with public health emergency response partners. When a 
disaster occurs, CDC must respond effectively and support 
international, National, State, local, Tribal, territorial, and private 
sector public health emergency response partners. A critical component 
of CDC's work during an incident is to coordinate public health 
response activities and provide resources to State and local public 
health departments. PHPR manages CDC's Emergency Operations Center 
(EOC), which serves as the command center for monitoring and 
coordinating CDC's emergency response to public health threats in the 
United States and abroad. Staffed around the clock, the EOC serves as 
CDC's central point of contact for reporting public health threats and 
supports the Department of Health and Human Services (HHS) Secretary's 
Operations Center. The EOC organizes CDC scientific experts in one 
location during an emergency response to analyze, validate, and 
efficiently exchange information as well as connect with public health 
emergency response partners.
    PHPR also manages the Strategic National Stockpile (SNS), a 
National repository of large quantities of medicine, vaccines, and 
other medical supplies stored in strategic locations around the Nation. 
SNS assets, when combined with Federal, State, and local technical 
expertise to manage and distribute them efficiently, help ensure that 
key medical supplies are available during emergencies.
    Question 1b. Are we stockpiling radiation/nuclear countermeasures, 
and if so, which countermeasures, and do we have a workable plan to 
distribute them?
    Answer. The SNS includes radiation countermeasures which may be 
used to mitigate health effects from radiation exposure. In addition, 
the SNS maintains inventories of medical supplies that can be used for 
burn and blast injuries and other trauma such as those resulting from 
large-scale events such as an improvised nuclear detonation. Complete 
listings of the contents and quantities of materials held in the SNS 
are considered sensitive but unclassified information, and distribution 
of this information is limited to guard against exploitation of gaps 
that could be identified through a review of SNS holdings. We will 
happily provide an opportunity for you to review additional information 
in hard copy at your convenience.
    The SNS has proven plans for distribution of these products to the 
States. State and local authorities are then responsible for 
distribution to local areas and dispensing to the affected population.
    CDC guidance and technical assistance have assisted the States and 
major cities in developing their plans to receive, distribute, and 
dispense SNS assets. These plans have been exercised and were used to 
guide implementation of their core capabilities for providing SNS 
assets to their populations during the 2009 H1N1 influenza pandemic.
    Question 1c. What countermeasures (including preventives, 
treatments, and diagnostics) are missing from our arsenal?
    Answer. Requirements for medical countermeasures against chemical, 
biological, radiological, and nuclear threats are established by the 
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). In 
July 2006, HHS established the PHEMCE, creating a coordinated framework 
as we advanced an ``end-to-end'' approach in the development, 
procurement, and use of medical countermeasures. The HHS Office of the 
Assistant Secretary for Preparedness and Response (ASPR) leads the 
PHEMCE, which includes principal representatives from CDC, the U.S. 
Food and Drug Administration (FDA), and the National Institutes of 
Health (NIH) as well as key interagency partners from the Department of 
Defense (DoD), the Department of Homeland Security (DHS), the 
Department of Veterans Affairs (VA), and the Department of Agriculture. 
The overarching mission of the 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 
SNS. The PHEMCE also conducts an annual review of the SNS, which allows 
for a thorough accounting of the SNS contents each year, and an 
evaluation of those contents against the current medical 
countermeasures requirements.
    As the statutorily designated entity for this activity, DHS has 
identified 13 specific material threats to prepare and respond to 
biological, radiological, and nuclear hazards. In response, HHS has 
taken the lead through a coordinated strategic approach--led by the 
PHEMCE--to maximize our preparedness to the range of threats we face 
while also ensuring the most efficient use of limited taxpayer dollars. 
Under the leadership of the ASPR, we have improved the Nation's 
preparedness through the development of new medical countermeasure 
products and procurements.
    The available, existing countermeasures to hasten the body's 
excretion of radionuclides (chelation) cover only a limited number of 
radioactive isotopes, but the SNS continues to work towards stockpiling 
the existing radiation countermeasures to meet the current PHEMCE-
established goals.
    There currently are very few licensed pharmaceuticals that reduce 
the risk of radiation-related illness following severe radiation 
exposure. The PHEMCE has established goals for the development of such 
medical countermeasures, and BARDA and NIH, in collaboration with 
partners at the DoD, are supporting research towards those goals.
    To date there have been no PHEMCE requirements or resources 
available for procurement of diagnostics for the SNS. However, 
radionuclide diagnostics are essential for diagnosing which 
radionuclides people have been exposed to, and at what levels, as well 
as the overall level of radiation exposure. Results of these 
diagnostics indicate which medical countermeasures should be delivered 
and for how long based on the exposure dose. Current U.S. radionuclide 
exposure diagnostic capability is provided by CDC's National Center for 
Environmental Health, in the Environmental Health Laboratory. At this 
time, CDC's Environmental Health Laboratory can test for only half of 
the priority threat radionuclides for a large-scale emergency incident, 
a gap that can only be filled by additional research and development. 
In addition, this laboratory is the only U.S. facility that can rapidly 
diagnose radionuclide internal contamination in people. This limits 
National surge capacity.
    Finally, the Nation does not have the capability to rapidly conduct 
external monitoring of people who may have been contaminated by fallout 
or other sources of airborne release of radionuclides. CDC has 
developed guidance for State and local health departments on how to 
conduct a population monitoring program, but most health departments 
lack equipment and trained human resources to implement such a program
    Question 2a. I understand that funding for the Cities Readiness 
Initiative comes out of HHS' Public Health Emergency Preparedness fund. 
The budget for that program has been steadily decreasing.
    In a time of continued risk, can you please explain your rationale 
for that decrease?
    Answer. CDC is continually evaluating what we do and constantly 
looking at ways to efficiently utilize existing resources to maximize 
health impact. Without the dedicated Cities Readiness Initiative (CRI) 
funding, awardees are still able to use PHEP funding for CRI-related 
activities within their jurisdictions. The PHEP program is structured 
so that awardees assess their current capabilities against the targeted 
public health preparedness capabilities and plan their activities to 
meet those targeted capabilities. Awardees that prioritize medical 
countermeasure dispensing may apply their PHEP funding to improving 
those related capabilities within their jurisdictions.
    Funds for the CRI are provided through a carve-out from the total 
dollars appropriated annually for the Public Health Emergency 
Preparedness (PHEP) cooperative agreement. The distribution of PHEP 
funds is calculated using a formula established by statute that 
includes a base amount for each awardee, as determined by the 
Secretary, plus population-based funding. Funding also is awarded for 
specific preparedness activities, including CRI. Fiscal year 2011 funds 
for the CRI ($54 million), Chemical Laboratories ($10 million), and 
Risk-Based Projects ($10 million) are provided through a carve-out from 
the total dollars appropriated for the PHEP cooperative agreement.
    Dedicated funding for CRI has decreased as overall PHEP funding has 
declined. The fiscal year 2011 PHEP funding level is $613,610,342, 
which represents a 12% ($84.6 million) reduction from fiscal year 2010 
when about $698 million was awarded. CRI funding for fiscal year 2011 
accounts for 8.85% of the total PHEP funding and is consistent with CRI 
funding levels in prior years. For instance, CRI funding was 8.87% of 
the total PHEP funding in fiscal year 2010, 8.50% in fiscal year 2009, 
and 9.1% in fiscal year 2008.
    The fiscal year 2011 PHEP reductions were proportionally allocated 
in an effort to preserve core PHEP funding used in support of other 
critical preparedness activities and systems which ultimately also 
impact response capability for medical countermeasure use. The base 
portion of the PHEP funding is used by States for activities that 
support both CRI and non-CRI jurisdictions.
    Question 2b. Can you also please explain how that drop in funding 
will impact the Cities Readiness Initiative? I understand you are 
considering a risk-based funding scheme for this program, and I would 
appreciate further clarity in what that means for funding distribution.
    Answer. At this point, it is too early to have a full appreciation 
of the impact of the fiscal year 2011 reductions in PHEP funding on CRI 
as the funding will not be awarded until August 2011. However, 
anecdotal evidence received by our staff as the States prepare their 
cooperative agreement applications and budgets suggests that both State 
and local jobs may be in jeopardy of being lost. Furthermore, our State 
and local partners have identified their inability to sustain minimal 
program requirements, including the maintenance of plans, the need to 
preserve critical response resources, and their ability to recruit, 
train, and drill/exercise staff and volunteers. The success of CRI is 
largely contingent on plans and people. With a fiscal impact to both, 
the ability to sustain an effective medical countermeasure distribution 
and dispensing infrastructure is diminished and may result in fewer 
individuals adequately protected from disease and death following a 
public health threat.
    In addition to CRI, CDC intends to direct a portion of the fiscal 
year 2011 PHEP funds to 10 major urban areas (including 14 States and 
the four directly-funded localities) for an all-hazards public health 
risk reduction funding initiative. This risk-based funding scheme is a 
pilot intended to promote and accelerate the development of strategies 
that mitigate the public health risks associated with higher population 
areas.
    The jurisdictions selected for this initiative include the 10 Tier 
1 urban areas in the U.S. Department of Homeland Security's Urban Area 
Security Initiative (UASI) grant program for fiscal year 2010. However, 
the purpose of the CDC funding is for all-hazards public health risk 
reduction and is not restricted to terrorism preparedness.
    A total of $10 million will be awarded for this project, with 
funding to be directed to the following 10 urban areas: Boston; 
Chicago; Dallas/Fort Worth/Arlington; Houston; Jersey City/Newark; Los 
Angeles/Long Beach; New York City; Philadelphia; San Francisco; and the 
National Capitol Region (Washington DC).
    CDC may elect to extend and/or expand the project in future years 
based on available funding and a review of how well initial strategies 
developed during the pilot may demonstrate evidence of mitigating 
public health, medical, and mental/behavioral health system risks 
associated with hazards that may be more likely to affect higher 
population areas.
    Question 3a. HHS' budget request for the Strategic National 
Stockpile is $655 million, a $59 million increase over fiscal year 2010 
levels. These funds will be used to replace expiring countermeasures in 
high-priority categories.
    Can you discuss what these high-priority categories are, or at 
least explain how you prioritize funds for replacement countermeasures?
    Answer. Requirements for medical countermeasures are set by the 
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). 
The PHEMCE establishes goals based on analyses of scenarios that lead 
to the numbers of persons likely to require medical countermeasures. 
Priorities for purchase of replacement and new medical countermeasures 
are established by this group through a documented, robust governance 
process. The current high priorities include medical countermeasures 
for anthrax, smallpox, and other bacterial threats, as well as 
maintaining current levels of inventory.
    To inform this decision process, CDC has built a capacity for on-
going life-cycle analysis, which it uses to make recommendations on 
replacement and shelf-life extension decisions, as well as to 
accurately cost long-range projections of the fiscal needs relating to 
various products in the SNS inventory.
    CDC has used these more accurate and robust cost figures in its 
annual budget requests to give decisionmakers at the agency, 
Departmental, and Congressional levels the most convincing possible 
notion of the true financial requirement for maintaining this National 
security asset.
    Question 3b. Will your requirements for replacement funding 
increase as the Biomedical Advance Research and Development Authority 
(BARDA) add new countermeasures to the stockpile?
    Answer. BARDA-purchased medical countermeasures are funded from the 
Project BioShield Special Reserve Fund for which there is no authority 
to provide funding for storage, management, or replacement of the 
medical countermeasures by the SNS. As a result, any replacement of 
BARDA-procured countermeasures would likely be funded by the SNS.
    Question 4a. In its fiscal year 2012 budget request, HHS stated 
that the SNS will continue to explore non-traditional methods of 
distribution and dispensing of countermeasures within 48 hours, 
including public-private collaborations and the implementation of the 
closed point of dispensing (POD) concept.
    Can you please describe the ``closed POD'' concept in greater 
detail?
    Answer. Closed points of dispensing (PODs) will be important during 
a large-scale public health emergency that requires the provision of 
medical countermeasures, as health care providers and open or public 
PODs will likely be overwhelmed. A closed or private POD refers to an 
organization-specific POD operated by a large employer, university, or 
other organization with a significant employee/student/resident 
population that, in collaboration with its local health department, 
develops plans to provide medical countermeasures to its employees, 
contractors, students, residents, and their families. The goal of a 
closed POD is to use the resources of the partnering organization to 
take care of itself by rapidly dispensing medical countermeasures. 
Doing so protects its constituency and associated families and reduces 
the number of people that would need to go to the open PODs. Benefits 
of closed PODs include ease of access to life-saving medications; quick 
dispensing to employees and their families; enhanced business 
continuity plans; and the potential for increased numbers of volunteers 
to support open PODs, since in some cases, organizations participating 
as closed PODs have agreed to provide their staff as volunteers. In all 
cases, operation of closed PODs by other than State and local public 
health organizations has the effect of increasing the numbers of people 
who could rapidly receive medical countermeasures. Some examples 
include, but are not limited to employer-specific closed PODs, 
homeowners-association closed PODs, community-organization closed PODs, 
and hotel-based closed PODS.
    Question 4b. Operationally, how does a closed POD like a school 
differ from an open POD?
    Answer. Open and closed PODs differ in the size and scope of their 
dispensing operation because they serve different populations. Open, or 
public, PODs are available to the general public and are the 
cornerstone of all jurisdictional plans. Open PODs are often located in 
large community facilities known to the population, accessible by 
common modes of transportation, and capable of accommodating many 
persons at one time. They also allow for efficient dispensing to the 
public. Open PODs are generally staffed by State and local public 
health personnel, other State and local personnel, or volunteers.
    Closed PODs are characterized by their focus on dispensing to a 
pre-defined population rather than the general public, e.g., the 
employees of a private company. Closed PODs are generally staffed by 
qualified personnel who are members of the organization operating the 
closed POD rather than by those persons who operate open PODs. This 
arrangement effectively increases available resources to dispense 
medical countermeasures without adversely impacting staff at open PODS.
    Question 4c. Which POD modalities have you found to be the most 
successful?
    Answer. The experience of developing and testing these varying POD 
modalities in public health communities allows for the selection and 
implementation of the most complementary array of planned modalities to 
reach a given population.
    Ultimately, the most successful dispensing modalities employed 
depend on the community. Each community is unique and has its own 
challenges, resources, and capabilities. No one modality or prescribed 
combination will work for all communities. A large-scale public health 
event in any community will require a layered system of dispensing 
using modalities that match and maximize the available resources and 
infrastructure.
    However, if success is measured in terms of the percentage of 
population covered, then the most successful modality is the 
traditional large-scale public health-run open POD, which is typically 
situated at a school, auditorium, or sports arena. This modality is the 
cornerstone for mass dispensing for most jurisdictions. An open POD is 
scalable and can easily be expanded or retracted to meet the complexity 
of an event. Open POD operations have also been modified to include 
drive-through PODs, mobile PODs (using trailers to take PODs to remote 
locations), and household delivery of medical countermeasures by home 
health care nurses, Meals on Wheels, or other community-based 
organizations. Targeted home delivery strategies, complemented by 
additional strategies such as closed PODs, combine to help reduce the 
volume pressure on traditional open PODs.
    Question 5a. What other dispensing models is CDC considering, and 
are guidance and funding provided to State and local governments so 
they can establish the modality that best fits the needs of their 
jurisdiction? Some of modalities would need to be Federally-driven, 
such as pre-deployment of medkits to peoples' homes. I am also 
wondering to what extent your dispensing activities are driven by a 
formal National dispensing strategy.
    Answer. CDC has worked with State and local jurisdictions since 
2002 to help them develop their plans to receive, store, distribute, 
and dispense medical countermeasures. CDC has provided numerous 
guidance documents, tools, and technical assistance opportunities to 
assist and assess State and local medical countermeasure distribution 
and dispensing plans. As noted previously, the ultimate decision of 
what works best is up to the individual States and localities. Listed 
below are some examples of dispensing modalities developed by State and 
local health departments.
    General examples of innovative dispensing:
   Closed PODs (such as private business, faith-based 
        organizations, military installations, homeowners 
        associations),
   Drive-through PODs (see variations listed below),
   Mega PODs to facilitate mass dispensing in highly congested 
        areas that are conducive to traffic gridlock,
   Mobile POD trailers,
   Tiered POD system (where the most-needed and highest 
        population PODs open first),
   Civic groups for delivery of medication during an event,
   Community Emergency Response Team (CERT) for door-to-door 
        delivery,
   Unusual dispensing locations such as grocery stores, long-
        term care facility pharmacies, mass transit stations, private 
        physicians' offices, retail pharmacies,
   School bus delivery,
   Tele-pharmacy dispensing operations,
   U.S. Postal Service (USPS) dispensing.
    Examples of variations of drive-through countermeasure dispensing:
   Omaha, Nebraska (in conjunction with the Nebraska Department 
        of Roads and the Nebraska State Patrol): A highway closed to 
        through traffic and with ``pit stops'' spaced along the 
        highway. The car pulls into the ``pit stop'' and dispensing 
        staff come to the car to conduct full-service prophylaxis 
        dispensing. The car re-enters the highway upon completion.
   Seattle, Washington: Trailers cached throughout the county 
        to allow almost immediate setup of multiple countermeasure 
        dispensing locations with the ability to be mobile as needed.
   Cabell-Wayne Counties, West Virginia: Mobile countermeasure 
        dispensing units reach rural populations. This is achieved with 
        a 9-County ``bundle team'' to form a Threat Preparedness 
        Planning Region along with the Homeland Security Committee and 
        the local emergency planning committee.
    The USPS mode of delivery is currently operational in only one 
city, Minneapolis, Minnesota. Other communities have shown an interest, 
but are unable to rally the necessary numbers of law enforcement 
personnel to support the 1:1 escort of volunteer postal carriers as 
required by the USPS unions.
    The MedKit at this point is a concept product only. It is not a 
licensed or commercially available product. The feasibility and 
commercial interest in developing the product is under further 
investigation by the PHEMCE.
    Question 5b. BARDA published a requirement for smallpox that 
includes sufficient second generation smallpox vaccine to treat the 66 
million people for whom the traditional smallpox vaccine is 
contraindicated. Enough vaccine for dispensing to 10 million people (20 
million doses) is due to be delivered to the Strategic National 
Stockpile in 2013.
    Will BioShield exercise its contract option to purchase an 
additional 60 million doses?
    Answer. HHS is committed to ensuring that the Nation is able to 
respond to known threats, such as that posed by smallpox. A decision on 
whether to exercise the option will be made upon completion of product 
delivery in the base contract and after appropriate consultation with 
the Public Health Emergency Medical Countermeasures Enterprise 
(PHEMCE).
    Question 5c. Why does the pre-Emergency Use Authorization (EUA) for 
this pharmaceutical apply only to individuals with HIV? This population 
is much smaller than the 66 million stated in the BARDA requirement. 
Will CDC work with FDA to expand the EUA, therefore aligning it with 
the BARDA requirement? Does CDC have a response plan for how it would 
actually use this drug?
    Answer. The determination of product use under an EUA is made by 
the FDA based on the totality of available scientific information. 
Based on the FDA's review of IMVAMUNE (or MVA, a third-generation 
investigational smallpox vaccine) data from clinical studies conducted 
by Bavarian Nordic (BN), FDA has communicated to CDC that the only 
eligible individuals for MVA vaccination under a potential EUA during a 
smallpox post-event emergency are HIV-positive individuals (18 years of 
age or older) with CD4 counts greater than 200 cells/ul who have not 
received a diagnosis that their condition has progressed to AIDS. FDA 
has stated that the eligible population for MVA under an EUA must 
correspond to those in which the vaccine has been studied. Therefore, 
at this time, only HIV-positive individuals could be vaccinated with 
IMVAMUNE (MVA) if an EUA were issued at this time.). Any updates to 
proposed product use, including additional eligible populations, will 
be made to the pre-EUA in accordance with FDA review determination as 
additional scientific information becomes available.
    The PHEMCE has estimated that approximately 66.5 million 
individuals have relative contraindications to receiving a live-virus 
vaccine. This population includes those with a variety of conditions 
that impair the immune system such as cancer, HIV, and transplant 
patients. As described previously, the determination of eligible 
populations for IMVAMUNE (MVA) will be made by the FDA based on its 
review determination of the available data in the target populations 
and/or extrapolated from existing data. CDC is aware of BN's submission 
of clinical data from its study of MVA in adult subjects (18-40 years) 
with diagnosed atopic dermatitis to FDA. Currently, the FDA's review 
determination is pending; however, CDC will include any expanded use(s) 
of MVA under pre-EUA in accordance with FDA's review determination and 
in concert with the overarching post-event smallpox vaccine utilization 
policy/strategy.
    ASPR is currently forming an interagency Smallpox Vaccine Strategy 
Working Group to begin initial discussion in July 2011 to determine a 
National smallpox vaccine strategy that considers all stockpiled 
smallpox vaccines, including MVA.
    Question 5d. Can you please explain what an ``Integrated Project 
Team'' is, who sits on it, and to whom they report?
    Answer. The PHEMCE is an interagency effort coordinated by the HHS 
Office of the Assistant Secretary for Preparedness and Response (ASPR). 
The PHEMCE includes three HHS internal agencies: CDC, FDA, and NIH. 
DHS, DoD, USDA, and VA have been supporting members of the PHEMCE. An 
Integrated Program Team (IPT) is formed for a specific threat. IPT 
memberships represent different Federal agencies, and composition may 
vary. At a minimum, membership includes CDC, FDA, NIH, BARDA, and DoD. 
IPTs are chaired by personnel from the ASPR. IPT chairs report to the 
Enterprise Executive Committee of the PHEMCE.

                                 
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