[Senate Hearing 109-702]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-702

                   BIODEFENSE AND PANDEMIC INFLUENZA

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                            SPECIAL HEARING

                      MAY 23, 2006--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


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                      COMMITTEE ON APPROPRIATIONS

                  THAD COCHRAN, Mississippi, Chairman
TED STEVENS, Alaska                  ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         PATRICK J. LEAHY, Vermont
CHRISTOPHER S. BOND, Missouri        TOM HARKIN, Iowa
MITCH McCONNELL, Kentucky            BARBARA A. MIKULSKI, Maryland
CONRAD BURNS, Montana                HARRY REID, Nevada
RICHARD C. SHELBY, Alabama           HERB KOHL, Wisconsin
JUDD GREGG, New Hampshire            PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah              BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas                MARY L. LANDRIEU, Louisiana
WAYNE ALLARD, Colorado
                    J. Keith Kennedy, Staff Director
              Terrence E. Sauvain, Minority Staff Director
                                 ------                                

                   Subcommittee on Homeland Security

                  JUDD GREGG, New Hampshire, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
TED STEVENS, Alaska                  DANIEL K. INOUYE, Hawaii
ARLEN SPECTER, Pennsylvania          PATRICK J. LEAHY, Vermont
PETE V. DOMENICI, New Mexico         BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HERB KOHL, Wisconsin
LARRY CRAIG, Idaho                   PATTY MURRAY, Washington
ROBERT F. BENNETT, Utah              HARRY REID, Nevada
WAYNE ALLARD, Colorado               DIANNE FEINSTEIN, California

                           Professional Staff
                             Rebecca Davies
                              Carol Cribbs
                            Shannon O'Keefe
                             Nancy Perkins
                           Mark Van de Water
                       Charles Kieffer (Minority)
                        Chip Walgren (Minority)
                         Scott Nance (Minority)
                      Drenan E. Dudley (Minority)

                         Administrative Support

                            Christa Crawford

























                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening Statement of Senator Judd Gregg..........................     1
Prepared Statement of Senator Larry Craig........................     3
Prepared Statement of Senator Robert C. Byrd.....................     4
Statement of Paul A. Offit, M.D., Chief of Infectious Diseases, 
  Children's Hospital of Philadelphia............................     4
    Prepared Statement of........................................     6
Statement of John M. Clerici, J.D., Mckenna Long & Aldridge, LLP.     8
    Prepared Statement of........................................    10
Statement of Scott R. Lillibridge, M.D., Director, Center for 
  Biodiversity and Public Health Preparedness, University of 
  Texas Health Science Center, Houston School of Public Health...    13
    Prepared Statement of........................................    15
Challenges to National Preparedness..............................    16
Road Map Forward.................................................    17
Statement of Frank J. Cilluffo, Associate Vice President for 
  Homeland Security, and Director, Homeland Security Policy 
  Institute, George Washington University........................    19
    Prepared Statement of........................................    22
Prepared Statement of Steven D. Rice, Senior Manager, Battelle's 
  Health and Life Sciences Division..............................    44






















 
                   BIODEFENSE AND PANDEMIC INFLUENZA

                              ----------                              


                         TUESDAY, MAY 23, 2006

                               U.S. Senate,
                 Subcommittee on Homeland Security,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:28 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Judd Gregg (chairman) presiding.
    Present: Senators Gregg, Allard, and Kohl.
    Also present: Senator Burr.


                opening statement of senator judd gregg


    Senator Gregg. We will begin this hearing, which is an 
important hearing on bioterrorism and pandemic influenza and 
our preparation, our status of the government's preparation for 
either of these events, which we obviously hope will never 
occur. As a society, I think we recognize and as a culture I 
think we recognize that there are certain elements of threat 
which the government has a responsibility to prepare for even 
though we hope that they will never impact us.
    Number one on that list, of course, is the use of a 
biological or nuclear or weapon of mass destruction used by an 
enemy of America, terrorists specifically, against us, and our 
preparation for that has been a major focus of this committee, 
myself and Senator Byrd. We have reoriented funds to address 
that.
    Number two--not in that sense; they are equal in status--is 
the potential of a major outbreak of influenza along the lines 
of what happened in the early part of the last century, which 
would potentially harm and kill millions, potentially hundreds 
of thousands, of citizens across the world and in the United 
States and would obviously disrupt the entire world and the 
economy of the world, especially America, if it were not 
prepared for adequately. There has been a lot of talk about 
that because of the issues of bird flu and the possible 
mutation of that virus into a form that can be conveyed to 
humans and human-to-human conveyance from there.
    So these are big issues that need to be constantly focused 
on and that we as a government need to be constantly addressing 
and talking about and making sure that the agencies in our 
government which are responsible are on top of these issues.
    So what we have done today is convene a panel of experts 
from outside the government who have looked at the government 
response and will tell us, hopefully, where the weak points 
are, where the good points are, what we should be doing, what 
we should be strengthening, and what we are not doing that we 
should be doing. That is the purpose of this hearing, to get 
critical assessment, constructive critical assessment of where 
the Federal Government is on the issue of preparing for these 
potentially horrific events, but events which, even though we 
do not want them to occur, we know we must be ready for.
    We are joined today by Senator Burr. Senator Burr is the 
chairman of the subcommittee on the HELP Committee which has 
jurisdiction over bioterrorism. I have asked him to participate 
in this hearing. This was originally going to be structured as 
a joint hearing, but for logistical reasons we were not able to 
get that going. So I appreciate Senator Burr participating in 
this hearing. He is a leading expert on this.
    Senator Byrd, who is equally an expert on this issue, 
unfortunately has other commitments today, so he is not going 
to be able to make this hearing. He has shown immense 
leadership and commitment to making sure that these areas of 
biological terrorism potential threat are prepared for, and I 
have greatly appreciated his help and support and leadership. 
More than help and support, he has shown the way in many 
instances in how we try to tool up for these issues.
    So with that, we are going to go right to the panel. I have 
advised the panel that we have a vote at 11 o'clock and I 
unfortunately am going to have to stay after the vote in order 
to do a confirmation of Ambassador Portman to become OMB 
Director, as chairman of the Budget Committee. So I may not be 
able to make it back until about 11:20, 11:25. But we will 
continue the hearing. If I am not here somebody else will take 
the chair.
    So why do we not begin going left to right and start with 
our witnesses. Let me begin with Dr. Offit. Why do I not 
introduce all the witnesses first and then we will begin. Dr. 
Offit is the Chief of Infectious Diseases at the Children's 
Hospital of Philadelphia and is a professor of pediatrics at 
the University of Pennsylvania School of Medicine. He is an 
internationally recognized expert in immunology. Dr. Offit has 
published over 130 scientific medical journal articles. He has 
also co-authored several books, including The Cutter Incident, 
which chronicles how the first polio vaccine led to the current 
vaccine crisis.
    We have John Clerici, who is a partner with McKenna Long 
and Aldridge and specializes in homeland security and 
procurement of anti-terrorism technology. Mr. Clerici is a 
recognized expert on liability reform policies.
    We have Dr. Lillibridge, who is professor of epidemiology 
and Director of the Center of Biosecurity and Public Health 
Preparedness at the University of Texas Health Science Center 
at Houston. Dr. Lillibridge recently served as Special 
Assistant for National Security and Emergency Management at 
HHS, where he oversaw the development of the National 
Bioterrorism Preparedness Program. He also established and 
directed the bioterrorist preparedness and response programs at 
CDC and was the lead physician during the Oklahoma City bombing 
and the 1995 sarin terrorist attack in Tokyo.
    We have as our final witness Frank Cilluffo.
    He is the Associate President of Homeland Security at 
George Washington University and the Director of the Homeland 
Security Policy Institute. Prior to joining the faculty at GW 
he served as the Special Assistant to the President for 
Homeland Security at the White House. He also served in a 
senior policy position with the Center for Strategic and 
International Studies, with a focus on homeland security and 
counterterrorism.
    Obviously an extraordinarily qualified panel and we look 
forward to their critique of where we are and where we are 
going.
    We have written statements from Senator Craig and Byrd that 
will be entered into the hearing.

               Prepared Statement of Senator Larry Craig

    Thank you Mr. Chairman. I appreciate your holding this hearing 
today to focus our Subcommittee on the important topic of bioterrorism 
and pandemic flu preparedness.
    Mr. Chairman, there has been no shortage of reviews of the Federal 
Government's capability to respond to another serious emergency across 
this country. Countless assessments have been done by non-governmental 
entities, such as the ones represented by our panel this morning. There 
have been dozens of hearings by multiple Committees in the House and 
Senate. And certainly the media has highlighted several areas that must 
be addressed.
    I do not want to take a lot of the Subcommittee's time this morning 
outlining my thoughts on all of those assessments and where I think we 
need to move this government to respond to a bioterrorism attack or a 
pandemic flu. But, what I will say is that Congress must make some 
decisions about which agency of this government will be in charge 
during an emergency and who in that agency should direct all of our 
efforts. I know that Senator Burr and the HELP Committee have been 
working on a bill to answer some of these questions. Once we answer the 
questions though, I think this subcommittee must ensure that all of the 
Federal financing efforts necessary to carry out the Federal 
responsibilities will be available to the right agency for their part 
of the mission.
    That may sound obvious to some. But, I say that Mr. Chairman 
because, as you know, I Chair the Veterans Affairs Committee. And many 
people in and out of government believe that VA's performance in 
response to the terrible storms that ravaged the Gulf Coast was so 
impressive that they should be given a larger role in the overall 
Federal response plan. Frankly, I think I agree with those who want to 
assign a larger role for VA. The agency has the medical infrastructure, 
the dedicated Federal employees, the purchasing power, and the 
logistics management system to do the job. But, I don't really want to 
argue the merits of the agency's role right now.
    What I am concerned about is that VA, or other agencies like it, 
will be given an expanded role and then expected to find the financing 
within their current budget to carry out their new mission. I don't 
know if that is even possible in the case of VA, let alone how that 
would impact its other missions. But, what I do know is that such an 
approach--if applied government-wide--would have us relying on each 
subcommittee of the Appropriations Committee to separately fund the 
needs of each agency under its jurisdiction for a nationwide response 
plan. Then, we would be relying on appointed officials and bureaucrats 
to dedicate the proper amount of money to the preparedness and response 
missions of their agency. I sincerely hope we do not go down that road 
Mr. Chairman.
    So, as we work through these issues and consider the HELP 
Committee's legislation on the floor later this year, I want to make 
certain that we identify what needs to be funded and for what efforts 
in each Federal agency for preparedness and responsiveness. We then 
have to weigh all of those needs in this subcommittee and provide 
preparedness and response funding from this subcommittee for that 
specific purpose.
    There are many Federal agencies, like VA, that are well-suited to 
assist in the Federal response to a national emergency or a pandemic 
flu. But, the old adage is that we are only as strong as our weakest 
link. And it is incumbent on this subcommittee to make sure we are 
coordinating the funding for our response efforts in one bill so that 
we do not discover a weak link that cripples our response efforts right 
in the middle of the next emergency.
    Mr. Chairman, again I want to thank you for holding this hearing. I 
look forward to the testimony and asking some questions of our 
witnesses.
                                 ______
                                 

              Prepared Statement of Senator Robert C. Byrd

    A flu pandemic or bioterror event is a real threat to the United 
States. Medical experts warn that a global, cataclysmic pandemic is not 
a question of ``if,'' but ``when.'' Like any natural disaster, it could 
hit at anytime. And when it does, it could take the lives of millions 
of people.
    Our current public health infrastructure and emergency management 
system are not equipped today to cope with a major flu pandemic or 
biological event. A coordinated, comprehensive, and aggressive national 
plan must be implemented for combating biological weapons or infectious 
diseases. This plan must serve to detect, identify, contain, and 
respond to threats abroad and to bolster domestic preparedness and 
response.
    The September 11, 2001, terrorist attacks cost America many 
precious human lives. Hurricane Katrina's impact was devastating in its 
harsh impact over 93,000 square miles. A pandemic or biological attack 
will combine human toll and geographic dispersion with an added element 
of long duration that previous disasters have not yet demonstrated.
    A pandemic or biological terrorist attack would likely overwhelm 
our medical capabilities. In the Twentieth Century, there were three 
influenza pandemics, killing over 600,000 people in the United States, 
including my beloved mother. The anthrax attacks of 2001 fell short of 
mass causalities, but five lives were lost, and the attack serves to 
illustrate the viability of a biological attack. We should be prepared, 
not scared.
    Congress has appropriated over $4.1 billion for pandemic influenza 
prevention and preparedness and the Senate has approved another $2.3 
billion on the supplemental. Since 9/11, Congress has appropriated over 
$10 billion for State and local government efforts to prepare for and 
respond to a bioterrorist attack, or other public health emergency. In 
addition, Congress has advance-appropriated $5.6 billion for Project 
BioShield to procure countermeasures for biological threats.
    Our job here in the Congress is to write the law, appropriate 
funding, and provide oversight. I continue to be frustrated with this 
Administration's pace in getting the job done, and I have told the 
Administration as much. I am concerned that we have appropriated 
billions of dollars and, yet, we do not seem to be prepared for the 
wide range of threats facing us. I am particularly concerned that our 
public health system lacks the surge capacity to deal with mass 
casualties.
    I thank our witnesses for being here today to discuss how we--as a 
nation--are doing in preparing for pandemic and biological threats. I 
look forward to hearing their frank comments and insights so that the 
Congress can continue to provide the leadership that the nation needs 
on this important topic.
    I commend Chairman Gregg for his leadership on this important 
issue.

    Senator Gregg. Dr. Offit.
STATEMENT OF PAUL A. OFFIT, M.D., CHIEF OF INFECTIOUS 
            DISEASES, CHILDREN'S HOSPITAL OF 
            PHILADELPHIA
    Dr. Offit. Good morning, Senator. My name is Paul Offit. I 
am Chief of Infectious Diseases at Children's Hospital in 
Philadelphia and a former member of the Advisory Committee on 
Immunization Practices to the CDC.
    I would like to talk briefly today about an event that 
occurred 50 years ago in 1957, the only time in our history 
that we have made influenza vaccine in advance of a pandemic, 
because I think there are several lessons that can be learned 
from that event. On April 17, 1957, Maurice Hilleman, a 
scientist working at the Walter Reed Army Medical Research 
Institute, read an article in the New York Times titled ``Hong 
Kong Battling Influenza Epidemic.'' The article stated that 
250,000 people, 10 percent of the entire population of Hong 
Kong, had suddenly come down with the flu.
    Hilleman found that this outbreak signaled--feared that 
this outbreak signaled the start of the next pandemic. So the 
next day he sent a telex to the Army's 406th Medical General 
Laboratory in Zama, Japan, asking them to send him specimens 
from people infected with the virus. The first specimens 
arrived 1 month later on May 17, 1957.
    For 5 days and nights, Hilleman worked to determine whether 
the influenza virus circulating in Hong Kong could be a 
pandemic strain. He tested sera from members of the American 
military and adults in the general population, but could not 
find anyone whose immune systems had seen this virus before. 
Hilleman then sent the virus for testing to the United States 
Public Health Service, the Commission on Influenza of the Armed 
Forces Epidemiological Board, and the World Health 
Organization. They found that only a handful of people in the 
United States and the Netherlands had antibodies to the virus. 
Because few people in the world had antibodies to stop it, the 
influenza virus circulating in Hong Kong in 1957 could spread 
from one country to the next unchecked.
    Hilleman then sent the virus, now called Asian flu, to six 
American-based companies. He figured that if he were to have 
any chance of saving lives companies would have to make and 
distribute tens of millions of doses in only 4 months. Hilleman 
sped up the process by ignoring the Division of Biologic 
Standards, the Federal agency responsible for regulating 
vaccines.
    He also asked vaccine makers to advise chicken producers 
not to kill their roosters, even though it was late in the 
hatching season. He knew that production of tens of millions of 
doses of vaccine would require at least 200,000 eggs a day.
    As predicted, in September 1957 Asian flu entered the 
United States from both coasts. The first laboratory-proven 
cases occurred aboard naval vessels in Newport, Rhode Island, 
and San Diego, California. The first outbreak was triggered by 
a San Diego girl who carried the virus to an international 
church conference in Grinnell, Iowa. The second occurred in 
Valley Forge, Pennsylvania.
    Companies made the first lots of Asian influenza vaccine in 
June 1957 and vaccination began in July. By late fall, 40 
million doses were distributed in the United States. Within a 
few months, influenza infected 20 million Americans. 70,000 
died from the disease. Worldwide, the pandemic killed at least 
4 million people.
    The Surgeon General of the United States, Leonard Burney, 
later said, quote: ``Many millions of persons we can be certain 
did not contact Asian flu because of the protection of the 
vaccine.'' For his efforts, Maurice Hilleman won the 
Distinguished Service Medal from the American military.
    Several features of this outbreak and our response to it 
are instructive. First, Hilleman had to rely on reading an 
article in a newspaper to know what was happening in Southeast 
Asia and he had to wait 1 month before he received samples of 
the virus. Today the international community of scientists, 
clinicians, and public health officials, armed with 
sophisticated virological techniques, are much better at 
surveillance of outbreaks and characterization of possible 
pandemic strains.
    Second, Hilleman called on six U.S.-based influenza vaccine 
makers. Today no U.S.-based companies make the inactivated 
vaccine. Sanofi Pasteur has a manufacturing facility in 
Swiftwater, Pennsylvania, but is not a U.S.-based company.
    Third, Hilleman had to rely on eggs to produce vaccines. 
Recognizing that egg production is unreliable, the President's 
pandemic flu plan has effectively encouraged vaccine makers to 
gear up facilities to grow influenza virus in mammalian rather 
than avian cells. For example, GlaxoSmithKline recently 
purchased a manufacturing facility in Marietta, Pennsylvania, 
and MedImmune, the makers of a live attenuated influenza 
vaccine, will manufacture vaccine in mammalian cells in 
Maryland. Given that the influenza vaccine is generic and 
inexpensive, it is unlikely that vaccine makers would have done 
this without financial encouragement.
    Fourth, Hilleman completely ignored the Division of 
Biologic Standards, the Federal agency responsible for 
regulating vaccines. At the time vaccine regulation was in its 
infancy, regulated by a small division within the National 
Institutes of Health. Today vaccines are regulated by the Food 
and Drug Administration and they do an excellent job. Vaccine 
regulation I think has helped to make vaccines arguably the 
safest and best-tested products that we put into our bodies. 
But the process is slow and if we are to make vaccine quickly 
the regulatory process would have to be streamlined 
significantly.
    Fifth, Hilleman was a committee of one. He took 
responsibility for shepherding each step of the process. It 
would be impossible for him to do that today, but it would 
certainly be of value for one central agency to be held 
accountable for making sure that vaccine was made, tested, and 
distributed quickly and efficiently.
    Sixth, Hilleman never considered liability protection for 
vaccine makers. In 1957 pharmaceutical companies were not held 
liable if they were not negligent in the production or design 
of their product. Ironically, the birth of liability without 
negligence for pharmaceutical companies began with a jury 
verdict against a vaccine maker, Cutter Laboratories, only a 
few months later. However, it is clear that vaccine makers 
would not make a pandemic flu vaccine today without substantial 
protection from frivolous litigation.
    Thanks for giving me an opportunity to speak before this 
committee.
    [The statement follows:]

                  Prepared Statement of Paul A. Offit

    My name is Paul Offit. I'm the Chief of Infectious Diseases at The 
Children's Hospital of Philadelphia, Professor of Pediatrics at the 
University of Pennsylvania School of Medicine, and a former member of 
the Advisory Committee on Immunization Practices to the CDC.
    I'd like to talk briefly today about an event that occurred 50 
years ago, in 1957: the only time in our history that we have made 
influenza vaccine in advance of a pandemic. Several lessons can be 
learned from that event.
     On April 17, 1957, Maurice Hilleman, a scientist working at the 
Walter Reed Army Medical Research Institute, read an article in the New 
York Times titled Hong Kong Battling Influenza Epidemic. The article 
stated that 250,000 people--ten percent of the entire population of 
Hong Kong--had suddenly come down with the flu. Hilleman feared that 
this outbreak signaled the start of the next pandemic. So the next day 
he sent a Telex to the Army's 406th Medical Laboratory in Zama, Japan 
asking them to send him specimens from people infected with the virus. 
The first specimens arrived 1 month later, on May 17, 1957.
    For 5 days and nights Hilleman worked to determine whether the 
influenza virus circulating in Hong Kong could be a pandemic strain. He 
tested sera from members of the military and adults in the general 
population, but couldn't find anyone whose immune systems had seen this 
virus before. Hilleman then sent the virus for testing to the United 
States Public Health Service, the Commission on Influenza of the Armed 
Forces Epidemiological Board, and the World Health Organization; they 
found that only a handful of people--in the United States and the 
Netherlands--had antibodies to the virus. Because few people in the 
world had antibodies to stop it, the influenza virus circulating in 
Hong Kong could spread from one country to the next, unchecked.
    Hilleman then sent this virus--now called Asian flu--to six 
American-based companies. He figured that if he were to have any chance 
of saving lives, companies would have to make and distribute tens of 
millions of doses in about 4 months.
    Hilleman sped up the process by ignoring the Division of Biologics 
Standards, the Federal agency responsible for regulating vaccines. He 
also asked vaccine makers to advise chicken producers not to kill their 
roosters, even though it was late in the hatching season. He knew that 
production of tens of millions of doses of vaccine would require at 
least 200,000 eggs a day.
    As predicted, in September 1957, Asian flu entered the United 
States from both coasts. The first laboratory-proven cases occurred 
aboard naval vessels in Newport, Rhode Island and San Diego, 
California. The first outbreak was triggered by a San Diego girl who 
carried the virus to an International Church Conference in Grinnell, 
Iowa. The second occurred in Valley Forge, Pennsylvania.
    Companies made the first lots of Asian influenza vaccine in June 
1957 and vaccinations began in July. By late fall, 40 million doses 
were distributed in the United States. Within a few months influenza 
infected 20 million Americans; 70,000 died from the disease. Worldwide, 
the pandemic killed at least 4 million people.
    The Surgeon General of the United States, Leonard Burney, later 
said ``many millions of persons, we can be certain, did not contract 
Asian flu because of the protection of the vaccine.'' For his efforts, 
Maurice Hilleman won the Distinguished Service Medal from the American 
military.
    Several features of this outbreak, and our response to it, are 
instructive.
    First, Hilleman had to rely on reading an article in a newspaper to 
know what was happening in Southeast Asia and he had to wait 1 month 
before he received samples of the virus. Today, the international 
community of scientists, clinicians, and public-health officials, armed 
with sophisticated virological techniques, are much better at 
surveillance of outbreaks and characterization of possible pandemic 
strains.
    Second, Hilleman called on six US-based influenza vaccine makers. 
Today, no US-based companies make the inactivated influenza vaccine. 
Sanofi pasteur has a manufacturing facility in Swiftwater, 
Pennsylvania, but is not a US-based company.
    Third, Hilleman had to rely on eggs to produce vaccine. Recognizing 
that egg production is unreliable, the President's pandemic flu plan 
has effectively encouraged vaccine makers to gear up facilities to grow 
influenza vaccine virus in mammalian rather than avian cells. For 
example, GlaxoSmithKline recently purchased a manufacturing facility in 
Marietta, Pennsylvania. And MedImmune, the makers of a live, attenuated 
influenza vaccine, will manufacture vaccine in mammalian cells in 
Maryland. Given that the influenza vaccine is generic and inexpensive, 
it is unlikely that vaccine makers would have done this without 
financial encouragement.
    Fourth, Hilleman completely ignored the Division of Biologics 
Standards, the Federal agency responsible for regulating vaccines. At 
the time, vaccine regulation was in its infancy, regulated by a small 
division within the National Institutes of Health. Today vaccines are 
regulated by the Food and Drug Administration and they do an excellent 
job. Vaccine regulation has helped to make vaccines arguably the safest 
and best tested products that we put into our bodies. But the process 
is slow. And if we were to make vaccine quickly, the regulatory process 
would have to be streamlined signficantly.
    Fifth, Hilleman was a committee of one. He took responsibility for 
shepherding each step of the process. It would be impossible for him to 
do that today. But it would certainly be of value for one central 
agency to be held accountable for making sure that vaccine was made, 
tested and distributed quickly and efficiently.
    Sixth, Hilleman never considered liability protection for vaccine 
makers. In 1957, pharmaceutical companies were not held liable if they 
weren't negligent in the production or design of their product. 
Ironically, the birth of liability without negligence for 
pharmaceutical companies began with a jury verdict against a vaccine 
maker--Cutter Laboratories--only a few months later. However, it is 
clear that vaccine makers would not make a pandemic flu vaccine today 
without substantial protection from frivolous litigation.
    Thank you for giving me the opportunity to speak before this 
committee.

    Senator Gregg. Thank you, Dr. Offit.
    Mr. Clerici.
STATEMENT OF JOHN M. CLERICI, J.D., McKENNA LONG & 
            ALDRIDGE, LLP
    Mr. Clerici. Chairman Gregg, Senator Burr, members of the 
committee: It is an honor for me to testify before you today 
regarding my views on the state of biodefense and pandemic 
planning in the United States. Just over a year ago I had the 
opportunity to testify before this same committee on these 
subjects and particularly the need for liability protection to 
promote participation in these markets. I am happy to report 
since that time significant progress has been made.
    In the area of biodefense, the Department of Health and 
Human Services has recently acquired 10 million doses of a 
safe, effective, FDA-licensed anthrax vaccine. From a policy 
standpoint, Deputy Secretary Azar has recently announced that 
he and Secretary Leavitt have completed a revised 
implementation strategy for BioShield and intend to implement 
that policy. Of course, reintroduction of legislation by 
Senator Burr with the chairman's co-sponsorship creating the 
Biomedical Advanced Research Development Agency and the 
commitment of the President to fund advance development to 
almost $200 million in his budget is a very, very critical 
development and deserves strong industry support.
    In the area of research and development of pandemic 
vaccines, recent events have also been very positive. On May 3 
Secretary Leavitt announced the award of almost $1 billion in 
advanced development contracts for cell culture influenza 
vaccines. The committee should take heart in both the size and 
the diversity of the companies awarded these contracts. From 
the very large companies like GlaxoSmithKline to emerging 
innovative biotechs like MedImmune, which developed the first 
licensed innovation in flu vaccine in almost 50 years in its 
FluMist vaccine, it is clear that HHS has made substantial 
progress in attracting the best and brightest of industry over 
the last year.
    But perhaps most importantly, under your leadership, Mr. 
Chairman, as well as the leadership of Majority Leader Frist 
and Senator Burr in the Senate and Speaker Hastert, Congressman 
Lewis, Congressman Issa in the House, the President has signed 
into law the Public Readiness and Emergency Preparedness Act of 
2005. Through this legislation, the PREP Act, the Congress has 
provided a key tool to protect the Nation from infectious 
disease and other threats that could cripple the United States 
in a global economy.
    As a result of the PREP Act, vaccine and countermeasure 
developers are now better protected from the massive lawsuits 
that could have eviscerated and have eviscerated the vaccine 
and countermeasure manufacturing base in the United States. 
With the implementation of these strategic and valuable 
protections, the United States is now in a far better position 
to revitalize the domestic capabilities and to produce the 
tools needed to secure the health and wellbeing of its 
citizens.
    However, with all the outstanding progress we have made 
over the last year, both in the area of biodefense and 
pandemic, much more can and should be done. First, I would urge 
Congress to consider providing incentives to private entities 
to better prepare for a pandemic. A recent study by Mercer 
Human Resources Consulting has estimated that only 7 percent of 
U.S. companies have established budgets for pandemic 
preparedness, with 12 percent of European companies and over 25 
percent of Asian companies having such budgets. The private 
sector must take the lead in preparing for a pandemic, not only 
for their own businesses but also for the communities in which 
they operate. They cannot rely on the government to prepare the 
Nation on its own.
    To that end, Congress should now consider changes in policy 
similar to those asked to prepare the Nation for the Y2K 
threat. This includes providing additional incentives such as 
expanded liability protection to those entities that have 
reasonable and prudent efforts to prepare for a pandemic. 
Congress should provide at a minimum the same level of 
protections provided by Congress on a bipartisan basis in the 
Y2K Act of 1998, signed by President Clinton.
    Like Y2K, if a pandemic worst case scenario never happens, 
providing the legal certainty for businesses to upgrade their 
infrastructure and adequately prepare the Nation's fragile 
health care system, leading to better patient care, lower 
costs, fewer medical mistakes, and better patient privacy, is a 
win-win scenario.
    Second, we must examine the supply chain delivery of 
clinical countermeasures that would be deployed in a pandemic. 
Congress should deal now with the policies to ensure 
protections from both counterfeiting of these critical 
countermeasures as well as theft. Congress should encourage 
private sector solutions to these problems. In fact, given the 
timing, the Federal Government should rely on the expertise and 
experience of the private sector in developing and executing 
supply chain management inventory controls.
    Finally, Congress should act now to implement policies that 
will bolster our fragile public health infrastructure, 
especially the hospital systems. Should a pandemic strike the 
Nation, the surge in the hospitals nationwide from patients who 
are actually sick with influenza or other illnesses as well as 
the worried well could cripple our American health care system 
for years to come. Painfully hard triage decisions on who will 
receive care and when they will receive it are certain to lead 
to baseless lawsuits unless some protections from liability are 
provided to these health care providers. The trial lawyers are 
already lying in wait, planning their litigation strategies 
around the occurrence of these events. The last thing the 
Nation needs during a flood of illness is a flood of lawsuits, 
and Congress should act now to stem the tide of these events.
    Turning briefly to implementation of BioShield, there were 
many challenges that we made to the Department last year when I 
had the opportunity to testify to you. Unfortunately, progress 
has not been made in certain areas. In particular, the 
regulations implementing Project BioShield required by the 
statute have yet to be promulgated. The material threat 
assessment process, which has come under criticism as slowing 
BioShield, still has not provided the clarity to industry that 
it needs.
    I close by noting that none of the proposals I have 
suggested, Mr. Chairman, call for a single appropriation 
outside of what has been appropriated or within the chairman's 
budget--within the President's budget. I know that will appeal 
to your senses as chairman of the Budget Committee. There are 
real things that we can do here today without taxing the 
American taxpayers any more than they are to prepare the 
country for a pandemic.
    I welcome your questions and thank you for your support and 
the support of the President in this effort.
    [The statement follows:]

                 Prepared Statement of John M. Clerici

    Chairman Gregg, Senator Byrd, and Members of the Committee, it is 
an honor for me to testify before you today regarding my views on the 
state of biodefense and pandemic planning in the United States.
    Just over 1 year ago, I had the honor to testify before you and 
this Committee on the state of implementation of the Project BioShield 
Act of 2004 and the need for liability protections to promote 
participation in the biodefense market, but also to stimulate 
development of influenza pandemic countermeasures. Since that time, 
significant progress has been made.
    In the area of biodefense, the Department of Health and Human 
Services (HHS) has acquired 10 million doses of a safe and effective 
FDA licensed anthrax vaccine from BioPort Corporation to better prepare 
the Nation against another anthrax attack like the one suffered by this 
body in October 2001. In addition, HHS has announced that the long-
awaited purchase of anthrax therapeutics for postexposure treatment of 
anthrax victims will be completed very shortly.
    From a policy standpoint, Deputy Secretary Alex Azar recently 
announced that he and Secretary Leavitt are about to complete a revised 
implementation strategy for Project BioShield to eliminate many of the 
delays that have been observed in the BioShield program. Given the 
substantial talents of Deputy Secretary Azar, his personal involvement 
in this effort is welcome and encouraging.
    Of course, reintroduction of legislation by Senator Burr, with the 
Chairman's co-sponsorship, creating the Biomedical Advanced Research 
and Development Agency (BARDA), and the commitment by the President in 
his fiscal year 2007 budget to fund such an effort with nearly $200 
million, is a very positive development. Creation of BARDA will go a 
long way to address the ``valley of death'' in biodefense 
countermeasure development and merits the strong support of industry 
for passage this year.
    In the area of research and development for pandemic vaccines, 
recent events have also been very positive. On May 3, 2006, Secretary 
Leavitt announced the award of almost $1 billion in advance development 
contracts for cell-culture influenza vaccines. These contracts are 
milestone driven, and support multiple companies pursuing diverse 
technologies. Given the recent challenges HHS has faced with its 
contractor, VaxGen, for an experimental anthrax vaccine being developed 
under BioShield, it is clear that HHS understands the need not put its 
eggs in one basket with influenza countermeasures.
    We should also take heart in the size and diversity of the 
companies awarded the cell-culture contracts. From successfully 
engaging a large company like GlaxoSmithKline, to making awards to 
innovative biotechnology companies like MedImmune--which has developed 
the first licensed innovation in flu vaccine technology in over 50 
years with its FluMist vaccine--it is clear that HHS has made 
substantial progress over the last year. HHS is now moving forward with 
development of adjuvant technology to improve the disappointing 
effectiveness of the H5N1 vaccine purchased last year, as well as to 
continue development of exciting new vaccine technologies such as DNA-
based vaccines and novel antivirals. At the same time, HHS has 
recognized the need to accelerate the development of critical rapid 
diagnostics, and has announced plans to move forward with an advance 
development program for such technology in the coming weeks.
    But perhaps most importantly, under your leadership, Mr. Chairman, 
as well as the leadership of Majority Leader Frist and Senator Burr in 
the Senate, and Speaker Hastert, Congressman Lewis, and Congressman 
Issa in the House, on December 30, 2005, President George W. Bush 
signed into law the ``Public Readiness and Emergency Preparedness Act'' 
(PREP Act).
    Through this legislation, the United States Congress has provided a 
key tool to protect the nation from infectious disease and other 
threats that could potentially cripple the United States and the global 
economy. As a result of the PREP Act, vaccine and countermeasure 
developers are now better protected from the mass of lawsuits that have 
basically eviscerated the U.S. vaccine and countermeasure manufacturing 
base, leaving it ill prepared for threats such as avian influenza. With 
the implementation of these strategic and valuable protections, the 
United States is now in a far better position to revitalize its 
domestic capability to produce the tools needed to secure the health 
and well-being of its citizens.
    In short, the PREP Act offers targeted liability protections to 
those involved in the development, manufacturing and deployment of 
pandemic and epidemic products and security countermeasures. The Act 
creates a shield of immunity for claims arising out of, related to, or 
resulting from the administration or the use of a covered 
countermeasure (i.e., vaccines, countermeasures, devices and certain 
other products). This immunity covers a wide range of uses, including 
design, development, testing, manufacturing, distribution, 
administration, use and other activities so that the protections can be 
applied as broadly as possible.
    This law dramatically improves the ability of the United States to 
develop the tools it needs to be prepared for a naturally occurring or 
terrorist-related public health emergency. However, it is absolutely 
critical for HHS take the necessary steps now to implement fully the 
PREP Act, as intended by Congress and the President, to prepare the 
Nation for a influenza pandemic. To that end, industry eagerly awaits 
the Secretary's declaration of a potential public health emergency for 
an influenza pandemic, thereby triggering the protections of the PREP 
Act for covered countermeasures. In addition, industry looks forward to 
the release of the 4 regulations required by the Act to provide further 
clarity on the scope of the Act and its protections.
    However, will all the outstanding progress the United States has 
made over the last year, both in the area of biodefense and pandemic 
planning, more can, and must, be done.
    First, I would urge Congress to consider providing incentives to 
private entities to better prepare for a pandemic. A recent study by 
Mercer Human Resource Consulting has estimated that only 7 percent of 
U.S. companies have established budgets for pandemic preparedness, 
compared with 12 percent for European companies and 25 percent for 
Asian businesses. The private sector must take the lead in properly 
preparing for a pandemic threat, not only for their own businesses, but 
also, for the communities where they operate, and not rely upon 
government to prepare the Nation on its own.
    Pandemic preparedness is first and foremost an issue of public 
health. But it is also an issue of ensuring American competitiveness in 
the global markets. If we are less prepared than the rest of the World, 
not only will our Nation's health suffer more, but so will our economy 
and our path to recovery from such an event. Companies must plan now 
for the possibility that 40 percent or more of their work force may not 
be able to show up to work during a pandemic, including, according to a 
recent study by the Johns Hopkins Bloomberg School of Public Health, up 
to 67 percent of back office health care workers providing technical 
support, payroll and payment processing, and other administrative 
functions. Public companies, of course, have an even greater obligation 
to implement internal controls to address such an event to assure that 
shareholder assets are protected and their business recovers as quickly 
as possible.
    To that end, Congress should act now to consider changes in policy 
similar to those passed to prepare the Nation for the Y2K threat. This 
includes providing additional incentives, such as expanded liability 
protections, to those entities that make reasonable and prudent efforts 
to prepare for a pandemic. Congress should provide, at a minimum, the 
same level of protections provided by Congress on a bipartisan basis in 
the Y2K Act of 1998, signed by President Clinton.
    Policy changes to improve telework and increase high-speed internet 
access should also be part of this effort. The Administration's 
pandemic plan recommends that employers keep employees three feet apart 
in a pandemic event. Given that more and more companies are enabling 
employees to work remotely, perhaps Congress should provide incentives 
now to ensure that telework options are widely available. With 
sufficient bandwidth and data security to operate with large numbers at 
the same time, workers could work safely from home, thereby stemming 
spread of the pandemic while reducing the economic impact.
    To the greatest degree possible, we must also ensure that certain 
critical functions for maintaining the operations of our health care 
infrastructure can be automated or operated remotely in those 
circumstances. Thus, Congress should expedite passage of legislation 
promoting electronic medical records as soon as possible.
    The Y2K legislation served as a national wake up call to Americas 
businesses and gave them the comfort of liability protection to 
identify and correct the problems with their IT infrastructure. Many 
businesses then (like many hospitals, health insurers, and other 
businesses critical to our nation's health care infrastructure today), 
were afraid to even explore their vulnerabilities for fear of creating 
a paper trail for eager trial lawyers to launch baseless lawsuits in 
the future. U.S. businesses, particularly those critical to our health 
care infrastructure, need a similar wakeup call--and equal liability 
protection--to upgrade, test, and retest our public health 
infrastructure to ensure pandemic readiness. Like with Y2K, even if a 
pandemic worst case scenario never happens, providing the legal 
certainty for businesses to upgrade their infrastructure and adequately 
prepare will improve our Nation's fragile health care system--leading 
to better patient care, lower costs, fewer medical mistakes, and better 
patient privacy. It is truly a winwin scenario.
    Second, we must examine the supply chain for delivery of critical 
countermeasures that must be deployed during a pandemic, as well as the 
supply chain for delivery of good and services, as a whole, during a 
state of emergency caused by a pandemic. Most certainly, some--if not 
all borders--will close during a pandemic, thereby crippling food 
distribution and delivery of critical goods and component parts made 
outside of the United States. For critical countermeasures, Congress 
should deal now with policies to ensure protection from counterfeiting 
and theft of public health supplies. Congress should encourage the 
private sector to pursue implementation of workable, non-burdensome 
tracking mechanisms, while ensuring the protection of data and other 
information needed to allow the supply chain to function.
    Because timing is essential, the Federal Government should rely on 
the expertise and experience of the private sector in developing and 
executing missioncritical functions like supply chain management and 
inventory control. We should ensure that policies encourage 
implementation of commercially tested systems--preferably those already 
in place in key parts of the health care infrastructure, that can be 
quickly and easily implemented. Effective supply chain management 
solutions for the strategic stockpiles must be proven and reliable, and 
be able to link thousands of stakeholders including pharmaceutical and 
medical supply companies, health care providers, distributors, 
shippers, security and customs organizations, and private and public 
local, State, Federal and international health care agencies.
    Effective supply chain management may also require considerable 
automation, since significant numbers of personnel throughout the 
supply chain may be sick or fail to show up for work. Information must 
also, to the greatest degree possible, be readily accessible, but yet 
secure, among multiple jurisdictions. In addition, the communication 
channels must be easily interoperable with multiple existing systems 
using different levels of technical standards and training of operating 
personnel.
    Finally, Congress must act now to implement policies that will 
bolster our fragile public health infrastructure, and especially, our 
hospital system. Should a pandemic strike the Nation, the surge on the 
hospitals, nationwide, both from patients who are actually sick with 
influenza or another illness, as well as the ``worried well,'' will 
cripple our Nation's healthcare system unless we are fully prepared. 
Addressing a U.S. News & World Report meeting on health and 
preparedness, Secretary of Homeland Security Michael Chertoff noted 
that hospitals, nursing homes, and other health facilities ``have a 
legal and moral obligation to develop evacuation plans and other 
emergency plans to ensure that people with special needs whose care has 
been entrusted to these caregivers will, in fact, be taken care of and 
will get the appropriate care in an emergency.'' We must give these 
entities the tools they need to meet this legal and moral obligation.
    Under the best of circumstances, emergency response workers may 
receive a vaccine that provides some level of immunity prior to a 
pandemic, and thus, will have some small degree of protection. However, 
the hospital administrators, claims processors, and support personnel 
are unlikely to receive any vaccine in time. With hospital support 
staff either at home to avoid illness, or already sick, while the 
hospitals are being pummeled by acute care patients, no claims will be 
processed to insurers. Thus, hospitals will be under significant 
financial strain, potentially unable to recover, and likely will be 
taken over by the Federal Government, as has already occurred in some 
of the areas impacted by Katrina.
    In addition, painfully hard triage decisions on who will receive 
care, and when they receive it, are certain to lead to baseless 
lawsuits unless some protections from liability are provided to health 
care providers. Trial lawyers are already lying in wait, planning their 
litigation strategies around the occurrence of such an event. The last 
thing the Nation will need during a flood of illness is a flood of 
lawsuits--Congress should act now to stem the tide of such an event.
    In terms of other policy changes that would benefit overall 
preparedness for a pandemic, the United States has the opportunity to 
build the infrastructure today to support improved access to influenza 
vaccine and better immunization for annual influenza--which kills over 
30,000 American each year. Expanded immunization recommendations for 
influenza vaccine, particularly among the young who drive disease 
transmission, should be strongly considered. Congress should also 
challenge healthcare providers and the public health system to not 
squander the opportunity to begin building and testing the influenza 
vaccine infrastructure within the framework of current immunization 
recommendations. Policymakers should act quickly to accelerate those 
recommendations, including universal pediatric vaccination up to 18 
years of age, in order to build as much vaccine infrastructure capacity 
as possible to better prepare the Nation for a pandemic without the 
expenditure of any additional Federal dollars. The bottom line is that 
we should build out the vaccine infrastructure with a seasonal flu 
approach, which will, in turn, not only protect the population today 
for the annual flu strain, but also allow us to look for any leaks that 
might sink the ship under the wave of a pandemic flu crisis.
    Turning briefly to the implementation of Project BioShield, while 
implementation has been improved, and according to HHS, additional 
improvements are under way, more can be done. When I last testified 
before you in April 2005, I noted that the regulations mandated under 
Project BioShield had yet to be promulgated. Unfortunately, that is 
still the case today. I also noted that the material threat assessment 
(MTA) process conducted by the Department of Homeland Security under 
BioShield provided neither the speed nor the clarity necessary to allow 
the full promise of BioShield to ``build a market'' to materialize. 
While some improvements have been announced in the MTA process, 
industry has seen little evidence that this problem has been adequately 
addressed. For example, when I testified last year, I noted that the 
market for badly needed countermeasures for cyanide--a well known and 
clearly established threat--was uncertain due to implementation issues 
with BioShield. Again, unfortunately, that remains the case today.
    Finally, HHS must learn from the set back in the VaxGen anthrax 
contract and not allow itself, or industry, to be deterred from this 
apparent failure by a single contractor. It is clear from the recent 
statements by Secretary Leavitt that HHS appears to be doing just that, 
and that is very encouraging. However, additional clarity and greater 
speed in implementing BioShield, along with the fast passage and 
implementation of BARDA, will provide industry with greater confidence 
in the long-term viability of the overall effort.
    I close by noting that the proposals I have suggested have one 
thing in common--they do not require the appropriation of any 
additional dollars other than those that have already been passed or 
are proposed in the President's budget. While that may not appeal to 
you, Mr. Chairman, in your role as an Appropriations Cardinal, I 
suspect it may appeal to your views as Chairman of the Budget 
Committee. Thus, through changes in policy alone, we can make 
substantial progress in improving the Nation's preparedness for a 
pandemic or bioterrorist attack, as well as enhancing and protecting 
public health as a whole.
    I very much appreciate the opportunity to offer testimony on this 
very important public health and anti-terrorism issue. Again, I applaud 
your efforts, and the efforts of President Bush and his Administration, 
and look forward to continuing our work with Congress and the 
Administration in this critical area.
    I am happy to respond to any questions you may have.

    Senator Gregg. Thank you, Mr. Clerici. I would note that 
the supplemental there is an additional $2.3 billion for this 
effort relative to pandemic flu. So the commitment remains 
fairly strong from the administration.
    Dr. Lillibridge.
STATEMENT OF SCOTT R. LILLIBRIDGE, M.D., DIRECTOR, 
            CENTER FOR BIODIVERSITY AND PUBLIC HEALTH 
            PREPAREDNESS, UNIVERSITY OF TEXAS HEALTH 
            SCIENCE CENTER, HOUSTON SCHOOL OF PUBLIC 
            HEALTH
    Dr. Lillibridge. Thank you, sir. Good morning, Chairman 
Gregg, Senator Burr, other guests. I am Scott Lillibridge. I am 
a professor at the University of Texas School of Public Health. 
I am honored to be here today to talk about the important issue 
of bioterrorism preparedness and pandemic influenza 
preparedness.
    Let me step back a little bit from when I used to be in my 
Federal role as CDC Director of Bioterrorism Preparedness and 
Response. As I survey the landscape over the past 5 years, I 
think we have had great strides in the area of stockpiling. I 
think we have a national laboratory response network in place 
and we have bioterrorism coordinators at work in almost every 
State and major county in the United States. That is progress.
    However, as we look forward there are things that need to 
happen to move to the next level of preparedness to face the 
new threats that we have, ranging from influenza to SARS to 
NEPA virus to any other emerging disease that we have around 
the corner, and we still have the specter of bioterrorism 
dogging us.
    My comments really fall into six major areas: leadership, 
organization, accountability, surge capacity, stockpile, and 
training. Let me just from the grassroots level as an ex-
administrator, a person who has been both in the private and 
public sector, kind of give you my overview of these things.
    First of all, under the issue of leadership, I look at this 
as a complex of biomedical, clinical, hospital, health system 
endeavor preparedness activity. The feeling at the State and 
local level where I work is that this has not been under clear 
medical control associated with a clear agency responsible for 
this endeavor.
    I will give you a case in point. If you look at the issue 
of the National Disaster Medical System, which was crafted to 
take care of mass care contingencies for civilian populations, 
we find that that resides in one Department, yet the lifesaving 
disease detection, epidemic control measures reside in another 
Department. Now, as a former administrator I will tell you that 
you can coordinate across and integrate, but you cannot develop 
in the Federal context a budget, personnel issues, when the 
responsibility for one program resides in one Department and 
the program resides in another Department. It just does not 
happen. I think that that is a setup for failure.
    The issue of accountability has been on our desk for some 
time now. I think after $28 billion, nearly 7 years, as we look 
back some things are still on the to-do list. We looked at in 
2003, when the GAO looked at DHS, HHS, and began to look at 
what the training doctrine was and how to coincide those things 
and bring those into harmony. That is still on the to-do list. 
I think that is an important accountability issue.
    The second, on Trust for America. A number of things in 
2005 really were left undone. Those were issues of having a 
common surveillance strategy, our surge capacity issues were 
not intact, and about half the States really did not have 
hospital preparedness fully in order. Those are still out there 
and I think we need to look at some solutions for those things.
    Might I propose the following. We have been through 
benchmarks in 1999, performance capacities. We have been 
through capabilities and now we are looking at target 
capabilities, and we are on to the next measure of 
accountability, somehow to make sure this Federal money ends up 
in the right place, doing the right sorts of things. I think 
until we get the leadership and until we get the organizational 
framework, until we get a regional plan that is understandable 
to the States, I think getting more compliance and 
accountability at the State and local level simply will not 
happen.
    Let me move to surge capacity, as I want to highlight that 
as probably the most undone part of emergency preparedness in 
the Nation. I think we have achieved a place where we can 
detect and warn people better than ever about bioterrorism and 
flu. We are less able to take care of patients in surge and 
large meaningful capacity, to mobilize hospital level services 
or regional medical activities, than ever before. I think 
fixing and resourcing and getting the NDMS properly situated 
will go a long ways to addressing those issues.
    The second thing is I think the medical services that we 
need and the health services really reside in private and 
public sector at the State and local level and HMO's, 
hospitals, academic health centers. Those things need to get 
mobilized to do the job at hand to a greater extent.
    Let me talk briefly about stockpile and vaccine. I am 
really for a stockpile that is strategic, less things in the 
stockpile that can actually be moved into areas and implemented 
in harm's way.
    The other thing that I think we have been dancing around 
with for a lot of years is the issue of whether we need 
Government capacity in vaccine production, and I say yes, we 
do. The Government will need all the tricks in its toolbox to 
respond to an epidemic. It needs both private and public 
capacity. The first thing that we did when we set about to 
develop the smallpox vaccine after the 2001 threats of anthrax 
was we had to contract with the private sector and build 
capacity internally.
    Last, let me close with a few statements on training and 
exercise. I want to tell you that, after 7 years, I think this 
is an area that we really need to emphasize because it brings 
the issues of stockpile, vaccine implementation, surveillance, 
and leadership together. That is the training and education. 
Unfortunately, those who have most to offer, the academic 
health centers, academic sectors, our schools of medicine, 
nursing, and public health, so forth, have been the least 
involved in that effort when you look at the total amount of 
money spent and the amount of money that went into satisfying a 
national strategy.
    I think getting those groups involved and those 
powerhouses, academic powerhouses, are going to do a great 
chore for us in getting our national strategy implemented and 
our health providers trained.
    Let me close by saying just simply thank you for this 
opportunity to testify. We have made great progress, but I 
think those issues still require leadership, accountability, 
organizational changes, strategic orientation of our stockpile, 
and we have got to emphasize our training if we are going to be 
prepared.
    Thank you very much.
    [The statement follows:]

               Prepared Statement of Scott R. Lillibridge

                              introduction
    Good morning, Chairman Gregg, Senator Byrd and distinguished 
members of the Subcommittee. I am Dr. Scott Lillibridge of the 
University of Texas Health Science Center at Houston, where I serve as 
Director of the Center for Biosecurity and Public Health Preparedness, 
and am Professor of Epidemiology at the School of Public Health. It is 
an honor to appear before you today to discuss our Nation's 
preparedness for bioterrorism and pandemic influenza.
    As a Nation, we have made steady improvements in medical and public 
health preparedness since the founding of the CDC Bioterrorism 
Preparedness and Response Program in fiscal year 1999. At that time, as 
the former Director of that program, I surveyed a landscape where CDC 
had no bioterrorism preparedness laboratory; few early detection 
disease surveillance programs were in place in our urban areas; and no 
health department within the United States had a bioterrorism 
coordinator to foster preparedness or planning. Today, we have a 
National Laboratory Response Network and expanded biological detection 
systems in urban areas throughout the United States. Drills and 
exercises involving influenza and bioterrorism are common place in 
almost all municipal jurisdictions throughout the United States. 
However, there are several important issues to be addressed if we are 
to move forward with National preparedness for epidemics, pandemic 
influenza or other emerging infectious diseases.
                  challenges to national preparedness
    I believe the most important challenges related to National 
preparedness for bioterrorism and pandemic influenza fall into six 
major categories.
  --Leadership
  --Organization
  --Accountability
  --Medical and Public Health Surge Capacity
  --Stockpiling
  --Training and Education
Leadership
    Bioterrorism and pandemic influenza preparedness are areas of great 
concern to the public because of their potential for catastrophic 
effects on our population's health. The policies that guide these 
programs are based on complex biomedical and life science decisions 
that must be crafted with the expertise of health professionals, 
hospital workers and public health guilds whose constituents provide 
the life-saving, ``hands on'' measures that these programs seek to 
provide. However, most health care providers and public health workers 
feel these programs reside outside clear medical control by health 
professional's, and that there is no clear Federal lead health agency 
(research or operational) guiding this endeavor.
 Organization
    Nearly 5 years after the anthrax attacks of 2001 and after spending 
$28 billion Federal, there is still confusion as to which organization 
within the Federal Government is directly responsible to address the 
medical and public health needs of citizens from these types of 
disasters. The most glaring example of this inconsistency relates to 
the National Disaster Medical System (NDMS), which was originally 
founded as a loose federation of DHHS, DOD, VA and FEMA. NDMS was 
designed to provide catastrophic health services to our populations 
following a disaster.
    Currently, the responsibility for NDMS resides within DHS while the 
essential disease surveillance, control, medical personnel, and health 
authorities reside in an agency of another department (most notably 
DHHS). In the Federal Government this is a problem because proper 
budget and staffing decisions cannot be made for activities that reside 
outside of one's Agency or Department's authority. I believe the 
current organizational framework is a setup for failure and leaves our 
population's health at risk. Ironically, we are spending more money on 
public health preparedness than the rest of the world combined, and in 
my opinion we are getting less than we deserve, largely because the 
leadership and the organizational framework have yet to be connected 
effectively.
Accountability
    After 7 years of funding for biodefense and recently pandemic 
influenza, there are still no common measures available to evaluate 
medical and public health readiness for States, hospitals, or health 
departments. The General Accounting Office recommended in a 2003 report 
that DHHS and DHS collaborate to develop specific benchmarks that 
define adequate preparedness for a bioterrorist attack that can be used 
by jurisdictions to guide their preparedness efforts. To date, DHHS and 
DHS have not finalized performance measures to guide these preparedness 
efforts. A recent report by Trust for America's Health published in 
2005 revealed the following problems:
  --The CDC recognized only 7 States as adequately prepared to 
        administer and distribute vaccines and antidotes in the event 
        of an emergency.
  --Over one quarter of States do not have sufficient bioterrorism 
        laboratory response capabilities.
  --Almost half of the States do not use national standards to track 
        disease outbreak information.
  --Hospital Preparedness--Nearly one-third of States are not 
        sufficiently prepared, through planning or coordination with 
        local health agencies, to care for a surge of extra patients.
Medical and Public Health Surge Capacity
    Much of the U.S. healthcare system operates at or near capacity on 
a daily basis. We have witnessed over the past several years an 
attrition of available hospital beds due to the downsizing of 
facilities and the rising costs of health care. In the United States, 
in every major city, on any day, is not uncommon for one of their 
medical centers to be in a position where the beds needed to receive 
emergency patients are full. Lack of health care access due to lack of 
health insurance adds to this strain. Consequently, I am worried that 
we have developed a system where we are better able to alert the health 
community to bioterrorism and pandemic influenza but less able to 
actually care for victims.
    In developing our Nation's clinical and public health surge 
capacity strategy, we have not gone far enough to invest the private 
and non-Federal public sector into regional mass care strategies. In 
addition, we still continue to funnel preparedness dollars into mass 
care strategies on a ``per capita'' or formula basis. This results in a 
cycle of planning and ``replanning'' and adds little or no additional 
emergency bed capacity to deal with victims from such catastrophes.
Stockpiling
    The strategic national stockpile has grown based on requests, 
passing threats, and amid confusion as to whether it is to supply all 
matters of medical equipment to victims or whether it is to be 
strategic in design, and focus on critical vaccines and medications 
that will be needed for victims affected by bioterrorism or other 
epidemic.
    Currently, the stockpile resides within DHHS but has been moved 
twice in the past 3 years. The main problem with the growth of the 
stockpile has been disagreement on what its contents should be and how 
distribution should be implemented. In addition, States are being asked 
to determine their own risks and are in the process of making their own 
stockpile decisions and supplemental stockpiles. This has led to the 
development of a cumbersome collection of drugs for ailments, ranging 
from exotic radiation exposures to equipment caches for ventilators for 
patients suffering from respiratory distress. These activities may be 
undermining the strategic focus of stockpiling, drive up the costs and 
ultimately hurt the cause of preparedness.
Training, Education, and Exercises
    The backbone of public health preparedness is not merely the 
purchase and storage of expensive equipment, but rather a continual 
cycle of education, training, exercises, and evaluation. Hospitals and 
healthcare delivery organizations, particularly those in the private 
sector have not been fully included in such a training cycle; 
therefore, they lag behind in the needed training to address community 
or regional planning goals. It is also important to mention the fact 
that there is also no consensus as to the needed core-level of training 
and education to achieve our Nation's public health and medical 
planning goals. Today, the menu of educational offerings is disparate 
and non-uniform. Specifically, there is no national training curricula 
to support NDMS capacities or our regional preparedness efforts. This 
deficiency is compounded by the fact that those who have the most to 
offer in terms of health training and education (our Nation's academic 
health centers) have been the least incorporated into our preparedness 
strategies.
                            road map forward
    In summary, from a public health and medical standpoint there is no 
significant difference between epidemic preparedness for SARS, Pandemic 
Influenza, bioterrorism, or any other emerging infectious disease at 
the National level. The differences are only in the nuances of 
prevention, treatment, and public health disease control measures. The 
key to saving lives in epidemics resulting from new and unexpected 
threats is early detection and timely epidemic control. The areas which 
I would emphasize are as follows:
Leadership
    Our National bioterrorism and influenza preparedness programs 
should move forward under clear medical and public health leadership by 
professionals experienced in emergency clinical and public health 
services. While the lessons of military medicine are extremely 
important, this preparedness task primarily involves the mobilization 
of the civilian public and private health care sectors.
Organization
    Strengthening the public health infrastructure remains important. 
However, the ability to alert populations to danger via early disease 
detection or surveillance will be meaningless if we are not able to 
ultimately address the medical and public health needs of victims in 
harms way. Consider the resulting anger and frustration citizens and 
victims will feel when health interventions do not occur on a timely 
basis, as in the recent case following Hurricane Katrina. I believe the 
most important priority for Federal preparedness at this time is to 
refine our notions for mass patient care involving the National 
Disaster Medical System (NDMS) and define how these capacities will 
support regional preparedness efforts. NDMS needs a clear 
organizational ownership and a better definition of its roles and 
responsibilities. It also must be resourced properly.
Accountability
    The implementation of these programs will need more accountability 
if we are to achieve the bioterrorism and pandemic influenza 
preparedness goals of the Administration. First, I would start with 
better clarity concerning the leadership and organizational framework 
of these programs. Second, the Federal authorities in charge of these 
programs have already issued a series of benchmarks, performance 
measures and target capabilities, and are moving to the next oversight 
measure that attempts to ensure that grant money is spent appropriately 
at the State and local level. However, I seriously doubt that another 
accountability gimmick under a new label will stop the supplanting of 
funds, the presence of large carry-over monies, and the fragmentation 
of this National effort.
    I believe the emphasis on accountability should start with a focus 
on the development of National capacities that result in the 
development of regional (multi-state) capabilities that are supported 
by strong central government reference laboratory and clinical 
capacities. In my opinion it will be easier for the State and local 
health preparedness programs to achieve measurable outcomes if they 
know how to link to the larger emergency response system.
Medical and Public Health Surge Capacity
    We have made great strides in public health preparedness, but our 
clinical surge capacities have not been as well developed. These 
capacities cannot be developed without a fundamental shift in the 
emphasis of our clinical preparedness programs. First, the clinical 
capacities in the United States reside largely within the private 
sector and public sector at the State and local level. The Federal 
Government should look towards developing a collaborative preparedness 
program that allows Academic Health Centers, Large HMOs, and major 
hospital organizations to play key regional roles in addressing the 
medical needs of victims during disasters. In addition, given the 
limited clinical resources available in the Federal system when 
compared to what is available in the State private and public sector, a 
strategy that fully utilizes State-to-State mutual aid should be 
emphasized and supported.
Stockpiling
    Stockpiling of medical equipment, vaccines or therapeutics should 
be strategic and based on medical and public health priorities linked 
to what we know about the risks confronting our population. The 
Strategic National Stockpile cannot be all things to all people without 
consideration for economic trade-offs. From a preparedness standpoint, 
I recommend developing the stockpile with fewer items, which have a 
greater likelihood of actually being used effectively at the time of 
crisis rather than expanding the program until it becomes a static 
warehouse enterprise.
    Vaccines deserve special mention in the context of National 
preparedness for bioterrorism and pandemic influenza. The most pressing 
need at this time is to commit to the development of a Government 
Owned--Contract Operated (GOCO) vaccine production capacity. The 
Federal Government must use all the tools in the biotechnology tool box 
in both the private and the public sector to address biological threats 
to human health. Our government needs to have standby vaccine 
development capacity so it can quickly begin the production of life 
saving vaccines at the time of crisis. In addition, it must be able to 
produce vaccines that will never have a viable commercial market. Such 
a facility should meet FDA requirements for production and quality 
control. My preference would be to have such a facility tied closely to 
the academic research community and private sector expertise.
Training and Education
    The cycle of preparedness is straightforward and involves the 
assessment of capacity, which is then followed by training to develop 
the desired proficiency. Subsequently, we exercise and evaluate the 
performance of those who were trained to ascertain a state of 
readiness. To the extent that our program fits into this model, it will 
be easier for DHHS to connect with the other partners in the Federal, 
State and local response.
    One of the first priorities is to finally establish training 
standards that support field deployments and other emergency planning 
notions. The academic health community is well suited to this 
challenge. Once such a doctrine is clearly enunciated, educators in 
schools of medicine, public health, nursing, and allied health fields 
can then concentrate their training efforts to prepare our health care 
providers for the task at hand. I do not believe this training capacity 
currently resides (or will ever reside) within the Federal Government. 
DHHS should be required to immediately establish the core training and 
educational requirements for our health care providers and public 
health workers that address these important preparedness efforts. We 
need the powerhouses of health education in America squarely behind 
this training effort. To accomplish this task we need to finalize our 
Nation's training doctrine so we can better target of our vital 
training resources.
    In conclusion, the threats of bioterrorism and pandemic influenza 
will always present challenges to our health and medical community, but 
we are making steady progress in preparing our Nation. It is time to 
refine and redirect this National effort if we are to advance the cause 
of preparedness.
    Thank you for the opportunity to be here today. I would be happy to 
address any questions that you may have.

    Senator Gregg. Thank you, Dr. Lillibridge.
    Mr. Cilluffo.
STATEMENT OF FRANK J. CILLUFFO, ASSOCIATE VICE 
            PRESIDENT FOR HOMELAND SECURITY, AND 
            DIRECTOR, HOMELAND SECURITY POLICY 
            INSTITUTE, GEORGE WASHINGTON UNIVERSITY
    Mr. Cilluffo. Chairman Gregg, Senator Burr. It is a 
privilege to join you today for this important dialogue. I will 
try to be brief, not my strong suit as I have rarely had an 
unspoken thought, but a lot of territory to cover. Five years 
ago, in testimony before the Senate Foreign Relations Committee 
on the threat of bioterrorism and infectious diseases I 
suggested that the country was at a crossroads and that the 
time had come for a cold-eyed assessment and evaluation. While 
much has been accomplished in the intervening period, our level 
of preparedness remains very much a work in progress and it is 
not yet where it needs to be.
    Bioterrorism and infectious disease preparedness marks the 
convergence of public health and national security. The 
intersection gives rise to the pressing need for careful 
coordination on a range of matters, including budgets and 
resources, policies and programs, and organizations and 
structures. The cultural differences between these areas are 
significant. Not to be tongue in cheek, but historically the 
law enforcement community focused on stringing people up, the 
intelligence community on stringing people along, whereas the 
health community focused on treating the strung out.
    Bioterrorism and pandemic influenza preparedness represents 
a challenge for the full spectrum of traditional and in this 
instance nontraditional first responders. Federal leadership 
requires that clear guidance be provided for those at the tip 
of the spear--State and local governments, hospitals and health 
care workers, businesses, families, and communities. It is at 
the State and local levels where the rubber truly meets the 
road, and it would be folly to try to micromanage from 
Washington. Expectations of all involved must be framed in 
realistic terms before something happens.
    The good news--and I agree with Scott--is that important 
strides have been made. The United States is a global leader in 
terms of pandemic preparedness, leveraging international 
partnerships, and Secretary Leavitt's outreach and engagement 
of the States to foster jurisdiction-specific response efforts 
is laudable. At the end of the day it all comes down to 
implementation and execution. To this end, several pieces of 
Federal legislation already exist on the biodefense side, and 
with respect to pandemic flu the President issued his national 
strategy last November, followed up by an implementation plan 
earlier this month.
    Collectively, these initiatives helped move the ball 
forward by defining parameters for action and serving as a 
catalyst. The danger is if we allow these measures to instill a 
false sense of security when we should be conducting an honest 
and rigorous assessment of whether we are truly prepared. On 
this front, I am sorry to say that we are currently 
experiencing a pandemic, a proliferation of plans. What we need 
now are the operating tenets that will marry up national and 
State strategies with implementation. Unless and until the 
focus shifts to competent execution, the Nation's preparedness 
posture will not be solidly grounded.
    Despite this need, the various moving parts of the 
preparedness and response enterprise are not yet fully 
synchronized and harmonized. As Scott mentioned, the ongoing 
debate as to where we should situate NDMS suggests that we are 
still stuck to some extent in neutral and are not using our 
time and mind share to best advantage. What we should really be 
focusing on are the back end capacities and capabilities, 
irrespective of where NDMS is situated.
    From plans to planning, and I believe we need to leverage 
an all-hazards approach. Where do we go from here? To shrink 
the delta to get to where we need to be, the most critical 
first step is to shift our focus from plans to planning and 
execution. To do so will require the development and 
elaboration of doctrine. Without significant doctrine, our best 
laid plans will never be translated into action. Being prepared 
means standing ready to exercise command and control through a 
fully integrated incident command system. Therefore it is 
crucial to align the National Response Plan, with the national 
pandemic influenza strategy and implementation plan. Unless the 
two fully mesh up operationally, we will have nothing more than 
a series of plans to plan.
    The difficulty of this task should not be underestimated, 
as the NRP's focus tends to be on events that are 
geographically and temporally concentrated, not characteristics 
shared by pandemics. Underlying the NRP is an all-hazards 
approach which has consistently guided our preparedness 
efforts. Too often, to our detriment, we have allowed ourselves 
to be focused on the crisis de jure. Yes, there are important 
differences when it comes to preparedness for bad weather, bad 
people, and bad bugs. But we need to leverage the fact that 
many similarities exist.
    Measures undertaken to prepare for a pandemic should not 
and will not constitute wholly sunken costs even if a pandemic 
does not materialize. Many of these steps have broader 
applicability and enable us to maximize secondary and tertiary 
returns on our investment beyond simply guards, guns, gates. 
This is an important concept since we simply cannot afford to 
protect everything, everywhere, all the time, from every 
perpetrator and every modality of attack. With finite 
resources, near infinite vulnerability, and a morphing threat, 
we simply must prioritize our actions based on solid risk 
management principles.
    Public health capacity. This is clearly the touchstone and 
the foundation upon which everything else rests, and we need to 
have nationwide public health infrastructures that make sure we 
can maintain and enhance the capacities across the board. 
Bioterrorism in particular merits greater attention, I think, 
in two areas. First, the strategic national stockpile. There 
must be a robust capacity not only to deliver needed items to 
affected communities, but also to rapidly distribute 
prophylaxis on site. Depending on the situation, I think we can 
also look to some unique ways to do that by leveraging UPS, the 
U.S. Postal Service, FedEx, DHL, WalMart and others, all of 
whom ran circles around the feds after the Katrina response, 
and I believe there is no shortage of ingenuity and creativity 
in our communities, but the time to do so is now, not after the 
balloon goes up.
    Second, although our epidemiological investigation 
capabilities and supporting lab capacity are in much better 
shape than they were 5 years ago, our biosurveillance 
capacities still need work. An effective national bioterrorism 
surveillance system should allow public health and emergency 
managers to monitor the condition of human, livestock, and crop 
populations simultaneously, track outbreaks, and act as an 
alert in the event of an attack.
    Nontraditional first responders such as agricultural 
services inspectors, entomologists, veterinarians, they need to 
be lashed up into this effort fully. A holistic approach also 
requires consideration of the pre-hospital piece of the puzzle, 
and that is EMS. Here again, surge capacity is an issue. The 
vast majority of EMS systems in this country operate at close 
too max capacity daily. A large-scale event, particularly a 
sustained one like pandemic flu, would tax most of our EMS 
systems beyond their ability to respond unless we are able to 
ramp up from the ordinary to the extraordinary. We should not 
be creating little black boxes that say ``break glass when 
something bad happens.'' The trick should be to make sure we 
can ramp up from ordinary events to extraordinary events.
    Clearly, when we're looking at these issues, vaccination 
policies and priorities, who gets vaccinated first, is a big 
issue. If people are afraid that their families are not 
protected, obviously they will have hesitancy going into harm's 
way.
    I also believe, and in the interest of time, that we need 
to look at a Goldwater-Nichols Act, not only in the traditional 
sense, in the military sense, as it aligned budgets, 
priorities, and plans, but specifically with respect to 
homeland security and specifically with respect to the health 
and medical community. That will go a long way in driving unity 
and unifying plans, programs, policies, procedures, and 
exercises, where we should make the big mistakes on the 
practice field, not Main Street, USA.
    Let me just touch really quickly performance metrics. What 
gets measured gets done, but we need to constantly ask 
ourselves if we are measuring what really matters. I think 
there is an awful lot more that can go on in terms of 
performance measures to make sure that there is an alignment 
between all the funds coming out from DHS and HHS and to make 
sure that the HRSA grants, the CDC grants, and the DHS grants 
are based on outcome, performance-driven objectives.
    I think that the national planning guidance, the national 
planning goal, HSPD-8, will do a good job in the 15 scenarios 
to be able to look to how we can do that most effectively.
    Regions. We have got to regionalize our approach, and I can 
get into that in much greater depth during question and answer. 
But I think, Senator Burr, North Carolina is the model we 
should be looking to, not only in terms of mobile hospitals, 
but also in terms of how they have aligned some of their grants 
to be able to get an outcome-driven perspective.
    I also think there is an area that most people have not 
touched on and that is community shielding. This is a concept 
where it is shelter in place. Think of it as shelter in place 
on steroids, where most people will not shelter themselves even 
if they are being told to do so, but if they have the right 
vehicles and mechanisms to distribute food, prophylaxis, and 
the like, they will be much more likely to do so in the event 
of a crisis.
    Let me just close with a couple of thoughts here. The 
subcommittee should clearly be commended for its determination 
to address the difficult issues before us today. Nothing short 
of a highly sophisticated, multifaceted, and integrated 
response will suffice. But I am confident that the creativity 
and the resolve demonstrated by the American people as they 
have done so often in our history will once again meet the bar, 
which has been set so high.
    I thank you, Mr. Chairman, for the opportunity to share my 
thoughts.
    [The statement follows:]

                Prepared Statement of Frank J. Cilluffo

    Chairman Gregg, Senator Byrd, and distinguished members of the 
Homeland Security Subcommittee of the Senate Committee on 
Appropriations, it is a privilege to appear before you today to testify 
on this subject of national importance. Your leadership on preparedness 
issues related to bioterrorism and pandemic influenza in particular is 
both crucial and commendable. While our Federal, State and local 
governments as well as the private sector and healthcare community, 
have taken steps in the right direction, our level of preparedness 
remains a work in progress and it is not yet where it needs to be. Five 
years ago, the Senate Committee on Foreign Relations invited me to 
testify on the threat of bioterrorism and how we, as a Nation, might 
best organize and marshal our resources so as to meet that threat and 
combat the spread of infectious diseases. At the time, I suggested that 
the country was ``at a crossroads'' and that, ``[w]hile credit must be 
given where it is due, the time has come for cold-eyed assessment and 
evaluation . . . .\1\ These words are equally apt today.
---------------------------------------------------------------------------
    \1\ Testimony of Frank J. Cilluffo, ``The Threat of Bioterrorism 
and the Spread of Infectious Diseases,'' Before the U.S. Senate 
Committee on Foreign Relations, September 5, 2001.
---------------------------------------------------------------------------
    Neither bioterrorism nor pandemic influenza is a challenge for the 
Federal Government alone. It is at the State and local level that the 
rubber will truly meet the road, and it would be folly to try to 
micromanage these matters from Washington. What Federal leaders can and 
should offer, however, is clear guidance to their partners at the tip 
of the spear, including hospitals and healthcare providers, so that 
expectations are framed in realistic terms in advance of an event and 
preparedness plans are implemented effectively. To this end, several 
pieces of Federal legislation already exist on the bio-defense side, 
and with respect to pandemic flu, the President issued a National 
Strategy in November 2005, followed by an Implementation Plan earlier 
this month. Collectively, these initiatives and many others undertaken 
help move the ball forward by defining parameters for action and 
serving as a spur to it. The danger is if we allow these measures to 
instill a false sense of security, when we should be asking ourselves 
honestly whether we are truly prepared.
    The good news is that important strides have been made. For 
instance, it is no exaggeration to say that we are a global leader in 
terms of pandemic preparedness (while recognizing that this is not an 
area where we can go it alone; to the contrary, international 
partnerships are, and will remain, crucial). Certainly Secretary 
Leavitt's national tour, reaching out to all U.S. States to foster 
tailored, jurisdiction-specific response efforts, is laudable. At the 
end of the day, though, it all comes down to implementation and 
execution. Yet currently we are experiencing a ``plandemic''--a 
proliferation of plans. Unless and until the focus shifts to competent 
execution, the nation's preparedness posture will not be solidly 
grounded.
    Similarly, extant legislation concerning bio-defense is in 
principle an important piece of the puzzle but, in practice, there have 
been difficulties with applying the law. While challenges including the 
financing of vaccines and countermeasures have been partly addressed by 
legislation such as the Project BioShield Act of 2004, delays have 
plagued the process and framework established by that law. By way of 
illustration, only a handful of the roughly sixty ``material threat'' 
assessments envisioned by BioShield have actually been completed. 
Further, while BioShield addressed the need for a guaranteed market for 
countermeasures, the so-called ``valley of death'' problem relating to 
investment in advanced development remains, and there is still a lack 
of clarity regarding who is in charge of the overall effort. This sends 
the wrong signal to industry and the manufacturing community, which are 
crucial components of the solution, and is at odds with the public 
interest.
    These areas which could stand improvement highlight a broader 
issue, namely the convergence of public health and national security. 
This intersection gives rise to a pressing need for careful 
coordination of a range of matters including budgets and resources, 
policies and programs, and organizations and structures. Despite this 
need, the various moving parts of the preparedness and response 
enterprise are not yet as synchronized and harmonized as they ought to 
be. Indeed, ongoing debates such as that over where to situate the 
National Disaster Medical System (NDMS) suggest that we are still stuck 
in neutral, and not using our time and mindshare to best advantage. 
Focusing on where to place the NDMS is a distraction from the real 
issues, which are function and capacity--where NDMS sits is at best a 
subsidiary matter, so long as it gets the job done. To do so, the NDMS 
must be empowered with the authorities and resources required to 
effectively execute the mission, whether within the Department of 
Health and Human Services (HHS) or the Department of Homeland Security 
(DHS).
From Plans to Planning
    To shrink the delta and get to where we need to be in terms of 
preparedness, the most critical first step is to shift our locus from 
plans to planning and execution. Doing so will require the development 
and elaboration of doctrine--something that has never been done in a 
meaningful way for bio-defense. Without significant doctrine, however, 
all of our best-laid plans will remain paper tigers, never translated 
into action or operationalized. As we transition squarely into the 
realm of implementation, moreover, it will be crucial to thoroughly 
align the National Response Plan (NRP) with, among other things, the 
National Pandemic Influenza Strategy and Implementation Plan. The 
potential for conflict clearly exists given the NRP's focus on events 
that are both geographically and temporally concentrated--
characteristics not shared by the pandemic phenomenon. Being prepared 
means standing ready to exercise command and control through a fully 
integrated incident command system. Unless the NRP and the President's 
Implementation Plan fully mesh with each other in actual operational 
terms, we will have nothing more than a series of plans to plan.
Leveraging an All-Hazards Approach
    Underlying the NRP is an all-hazards approach, which should 
consistently guide our planning and preparedness efforts. Too often, 
and to our detriment, we have allowed ourselves to become focused on 
the ``crisis du jour.'' While recognizing that there are important 
differences when it comes to preparedness for bad weather, ``bad 
guys,'' and ``bad bugs,'' we should aim to leverage the fact that many 
similarities exist. Measures undertaken to prepare for a pandemic, for 
instance, will not constitute wholly sunk costs even if a pandemic does 
not materialize. Many of these steps will have broader applicability 
and we should bear that in mind while also seeking to maximize 
secondary and tertiary returns on our investments, beyond simply guns, 
guards, and gates.
Public Health Capacity--The Touchstone
    Our medical and public health response structures are the 
foundation upon which all else rests. To meet the challenges posed by 
bioterrorism and pandemic influenza, these structures must be shored up 
and bolstered. A uniform system, whose hallmark is enhanced public 
health capacity, must be built nationwide. Every community must have 
surge capacity. Admittedly, this is an ambitious goal, especially when 
market forces press in the opposite direction, against the creation or 
maintenance of any excess capacity. It is also important to consider 
that the safety net that is the NDMS may be of limited value if there 
is a need to maintain those healthcare practitioners in their local 
communities. The challenge is not insurmountable though, and Homeland 
Security Presidential Directive 8, which establishes the National 
Preparedness Goal (NPG) and accompanying scenarios, demands nothing 
less. Expanding the medical reserve corps would certainly be one step 
in the right direction.
    Concerning bioterrorism in particular, two areas merit heightened 
attention and focus. First, with respect to the Strategic National 
Stockpile (SNS), it is crucial that there be a robust capability not 
only to deliver needed items to affected communities, but also to 
rapidly distribute prophylaxes once they have arrived on-site. 
Depending on the situation, it may be possible to convey the relevant 
items directly to affected residents. When a healthcare provider is not 
required in order to administer the treatment, it may be possible to 
draw on existing distribution and delivery systems, such as that of the 
U.S. Postal Service or other private sector entities like FedEx, DHL, 
UPS, and Wal-Mart. There is no shortage of ingenuity and creativity in 
communities across the country, but the generation of ideas should take 
place now, in advance of an event, and feed into planning efforts that 
should also be ongoing currently, at the local level.
    Second, although our epidemiological investigation capabilities 
(and supporting laboratory capacity) are in better shape than they were 
5 years ago, our bio-surveillance capabilities still need work. An 
effective national bioterrorism surveillance system would: allow public 
health and emergency managers to monitor the condition of human, 
livestock, and crop populations; track outbreaks; and act as an alert 
in the event of an attack. (This list is merely illustrative, not 
exhaustive). Non-traditional first responders, such as agricultural 
services inspectors, entomologists, and veterinarians, must have a seat 
at the national security table, and their expertise must be lashed up 
and fed into the broader surveillance effort. Moreover, since ``bugs'' 
know no borders, partnerships at the international level are important, 
and the United States should continue to work with the World Health 
Organization (WHO) to monitor infectious disease trends and outbreaks. 
Similarly, with U.S. military services deployed around the globe, our 
military medical organizations may provide us with a sentinel system to 
monitor a multitude of health environments and serve as an early 
warning system.
    A holistic perspective on preparedness for bio-terrorism and 
pandemic flu also requires consideration of the pre-hospital piece of 
the puzzle, that is, emergency medical services (EMS).\2\ Here again, 
surge capacity is an issue. More often than not, EMS systems in this 
country operate at close to capacity on a day-to-day basis. A large-
scale event, particularly a sustained one, would tax the majority of 
our EMS systems beyond their ability to respond unless we commit now to 
focusing, with unprecedented determination, on the ramp-up from the 
ordinary to the extraordinary. In connection with such efforts, perhaps 
we should examine the merits of creating an equivalent to the Emergency 
Management Assistance Compact (EMAC), not only for EMS but also for the 
public health system more generally. In any case, expansion of 
operational capabilities should not take place in a vacuum--supporting 
policy and doctrine must be developed concurrently. Continuity of EMS 
operations may not be assured if EMS providers fear that their own 
families may not be taken care of during extraordinary times. This 
issue resonates across the board with all first responders, and 
highlights the need to think through carefully the implications of 
allocating and prioritizing the distribution of finite amounts of 
vaccines, antidotes, and the like.
---------------------------------------------------------------------------
    \2\ For a more detailed examination of EMS issues, see: Homeland 
Security Policy Institute (HSPI) Issue Brief, Back to the Future: An 
Agenda for Federal Leadership of Emergency Medical Services, May 2, 
2005.
---------------------------------------------------------------------------
A Goldwater-Nichols Equivalent for Public Health
    Honing our technical capacities alone will not be enough. 
Intangibles are an equally important element of the equation. 
Specifically, a culture of preparedness that is common to the health 
sector and the national security sector alike, as well as beyond, is 
the glue that will hold together the sprawling enterprise that is our 
national preparedness and response system. Cultural change is 
notoriously difficult to bring about, but it is absolutely essential 
that we cultivate the mindset that will support the convergence that 
has taken place on the ground, between public health and national 
security. The two are now inextricably and indisputably intertwined, 
and only if a genuine culture of ``jointness'' prevails will we be able 
to achieve in practice the requisite reforms to our system, be they 
structural, procedural, budgetary, programmatic, or policy-related. 
Notably, this is a two-way street: the national security community 
needs to be well versed in public health matters where the two domains 
intersect, just as healthcare providers and medical experts need to be 
fluent in the language and practice of national security.
    Put another way, perhaps a Goldwater-Nichols equivalent is needed 
for the homeland context and for the public health and medical arena in 
particular. In recent testimony before the Senate Homeland Security and 
Government Affairs Committee, during their after-action hearings on 
Hurricane Katrina, I emphasized that the challenge of successfully 
executing interagency coordination is age-old and that, although we 
probably should never transpose wholesale a military model into the 
civilian context, there is substantial merit in looking to the military 
context given its success in institutionalizing the concept of 
jointness.\3\ As you know, the 1986 Goldwater-Nichols Act unified and 
streamlined the defense structure, and realigned budgets accordingly. 
Over time, greater cohesion has resulted in heightened effectiveness. A 
Goldwater-Nichols equivalent for the homeland should not be limited to 
the Federal level, but should apply also between and among the States 
themselves.
---------------------------------------------------------------------------
    \3\ Testimony of Frank J. Cilluffo, ``Hurricane Katrina: 
Recommendations for Reform,'' Before the Senate Homeland Security and 
Government Affairs Committee, March 8, 2006.
---------------------------------------------------------------------------
Performance Metrics, End-States, and Budget Realignment
    As a starting point, better and sustained coordination (at all 
levels) between the Departments of Health and Human Services, and 
Homeland Security, is sorely needed. By way of illustration, both HHS 
(the Centers for Disease Control and Prevention, the Health Resources 
and Services Administration, and the National Institutes of Health) and 
DHS are directing substantial funds towards bio-terror and pandemic 
preparedness and response initiatives. Yet, these monies are not being 
distributed or allocated according to a streamlined and well-
coordinated process. Instead, there is a multiplicity of funding 
sources and the left hand does not always know what the right hand is 
doing at least in so far as grants are concerned. An outcomes-based 
system, with built-in performance measures and metrics, would go a long 
way towards remedying the present situation. By focusing on end-States 
and capabilities, just as the outcome-oriented NPG scenarios guide us 
to do, and by giving life to the adage ``what gets measured gets 
done,'' both our goals and the paths to achieving them would be 
clarified. Realignment of budgets, and coordination of the various 
departmental and agency funding streams would follow, as a logical 
corollary. This level of organizational rigor would promote an 
efficient and effective use of our limited resources. It would, after 
all, break the bank if we were to try to fight each ``bug of the day'' 
with vaccines, antidotes, and prophylactics.
    A more harmonized approach at the Federal level would also serve 
the nation well. As things now stand, no common threat assessment 
exists in the form that is truly needed. This is a disservice to us 
all. At the very least, the various departments concerned should be 
looking to one another to remain informed, and relevant information 
should be disseminated to the frontlines, where it may be acted upon.
A Regional Approach
    It is on the frontlines that the bulk of decisions during an event 
will, and should be, made. For this reason, we need to build capacity 
in the field, and regionalizing our national preparedness system--the 
linchpin that connects all of the elements of our preparedness and 
response--is, to my mind, perhaps the best way to build the robust 
capabilities that we seek to achieve on the ground. Co-locating 
Regional Health Administrators with regional components of DHS and 
field components of DOD as well as other stakeholders, including 
representation from the private sector, would foster synergies and 
forge strong partnerships before disease or disaster strikes. In turn, 
these bonds would (among other things) facilitate the management and 
deployment of the SNS and the NDMS. Encouragingly, it appears that DHS 
is, in fact, expecting to establish a planning mechanism through joint 
field offices that would serve as a framework for coordinating response 
for all levels of government (including any military joint task forces 
that may be established), non-governmental organizations, and the 
private sector.
    A muscular regionalized system serves the best interests of the 
States and their governors by providing the latter with an all-purpose 
Federal point of contact that is well-versed in the particularities of 
a relevant area. Conversely, from a national perspective, 
regionalization offers a means of unifying planning, training, and 
exercising efforts--a prerequisite for identifying and developing 
needed Federal, State, and local capabilities and capacities. Looking 
forward, HHS and its regional coordinators should be consistently 
plugged into DHS' exercise schedule, and future exercises should 
specifically focus on bioterrorism and pandemic influenza scenarios. At 
a time when the convergence of public health and national security is 
plain, it is at our peril that we allow any disconnect to persist. It 
should also go without saying that after-action ``hotwashes'' should be 
conducted to identify lessons learned during exercises, and that such 
lessons should then be fed back into the system in order to prevent the 
same mistakes from being made once again as well as to benefit those 
who were not party to the actual exercise.
    Taking a regional approach to hospital preparedness would also be 
valuable, though most hospitals are not now regionally oriented in 
their planning, activities, and outlook. Exceptions to the rule include 
the National Capital Region (NCR) and North Carolina, where real 
regional medical capabilities exist in the form of mobile hospital 
capacity. The lessons learned from these experiences should serve as a 
model for the country as a whole, demonstrating the benefits of joint 
planning and exercising between and among hospitals at the regional 
level.
    Although limited regional surge capacity remains a significant 
problem, it is undeniably mitigated by surge protection--a strategic 
solution known as ``community shielding.'' A recent study of the NCR 
revealed that many area residents would abandon their protected home 
and work environments during a contagious epidemic, despite government 
instructions to shelter-in-place. However, if there is an effective 
mechanism for community shielding through distribution of food, water, 
medication, and information to those who need it, those potential 
evacuees would in fact follow instructions, thereby enhancing community 
resilience by remaining safely in their homes and localities until the 
regional threat has abated.\4\
---------------------------------------------------------------------------
    \4\ M.T. Williams, G.B. Saathoff, T.M. Guterbock, A. MacIntosh, and 
R. Bebel, Community Shielding in the National Capital Region: A Survey 
of Citizen Response to Potential Critical Incidents (Final Report, 
Volume 16), September 2005, http://cipp.gmu.edu/archive/Vol-16-
%20Community%20Shielding%20in%20the%20NCR.pdf.
---------------------------------------------------------------------------
Key Partners
    In our zeal to ``get it right'' when it comes to preparedness for 
bioterrorism and pandemic influenza, we should take care not to stretch 
too thin those assets that have proven their worth time and again in 
many and varied contexts. Our military forces proved to be able and 
responsive in the aftermath of Katrina and, as the saying goes, ``no 
good deed goes unpunished.'' This month alone, the National Guard has 
been assigned a significant role in furthering border security as well 
as implementation of the National Strategy for Pandemic Influenza. 
While the National Guard brings valuable skill sets to domestic needs, 
the Guard has a dual character and mission, and its war-fighting aspect 
should be respected and retained. Moving forward, it will be important 
to bear this bigger picture in mind, and exercise caution and balance 
accordingly, when drawing and planning to draw on such treasured and 
proven national resources.
    The nature of the challenges before us dictate that everyone be 
involved in preparing for them. It is no exaggeration to suggest that 
this is not only a community-wide responsibility, but also an 
individual one. Families, schools, places of worship, and business--all 
have an important role to play in containment of infectious disease, 
and all must be well integrated into the operationalization of relevant 
strategies and plans. Personal preparedness will take on a much greater 
importance in pandemic influenza than even natural disaster. 
Ultimately, it will be up to individuals to take personal 
responsibility for their own support, namely enough food and water 
should they be required to stay at home. Framing expectations in 
advance will be necessary to avoid hysteria. Just last week, Buncombe 
County, North Carolina, provided an excellent example of a local 
physician and the local media partnering to manage expectations and to 
let people know that they will not be able to rely on State and local 
governments, in particular health departments. There, a small newspaper 
in Asheville published an editorial piece written by the doctor in 
question, stating that the Federal and State governments have outlined 
what they will need to do to respond to pandemic flu, but in the final 
analysis, ``[o]ur job as citizens is to be informed and prepared.'' \5\
---------------------------------------------------------------------------
    \5\ Marilyn A. Roderick, ``As threat of the avian flu looms, one 
question remains: Will we be ready?'' Asheville Citizen-Times (May 16, 
2006). See also David Heyman, Model Operational Guidelines for Disease 
Exposure Control (Center for Strategic & International Studies, 2005), 
at http://www.csis.org/media/csis/pubs/051102_dec_guidelines.pdf 
[offering detailed guidance on non-pharmacological measures that public 
officials and individuals could take for protective purposes].
---------------------------------------------------------------------------
    Preparing for bioterrorism and pandemic influenza also requires 
robust partnerships between the private and public sectors. At the same 
time, each sector must do its utmost to put its own house in order. 
While a majority of U.S. businesses have expressed their concern about 
pandemic flu, only a much smaller fraction have actually done robust 
continuity of operations planning, which is crucial to maintaining 
critical infrastructure operations and services in a crisis.\6\ During 
and after Hurricane Katrina, however, the private sector was a 
tremendous source of both materiel and expertise, including logistical 
support. Industry, and particularly ``Big Pharma,'' offers a wealth of 
knowledge that must be thoroughly tapped for present purposes. With 
proper incentives, the private sector's research and development 
capacity, and production capability, could be fully marshaled and 
harnessed for national ends, with striking results. Incentives offered 
by Project BioShield have been insufficient to garner the full support 
of investors, whose support of the fledgling countermeasure industry is 
critical. To the extent that prevailing legislation and frameworks come 
up short in their incentive structure, it is crucial to complement 
those measures with needed new ones, and to re-structure and redesign 
existing mechanisms in a more rational, market-oriented manner that 
effectively addresses potential deterrents such as liability issues, 
and profit and cost factors. The ``DARPA-like'' proposed Biomedical 
Advanced Research and Development Authority, contained in bill S. 2564, 
could serve to assist companies in crossing crucial thresholds and 
allow relatively advanced products to actually reach the marketplace. 
In order to make progress on this front, it is imperative that industry 
perceive the Federal Government to be a reliable partner in this 
endeavor.
---------------------------------------------------------------------------
    \6\ David Brown, ``Business Plan for a Pandemic? Most Firms Haven't 
Prepared for Possibility of a Global Outbreak,'' Washington Post (May 
2, 2006), p. D1.
---------------------------------------------------------------------------
Conclusion
    As we strive to create a performance-based, outcomes-driven 
preparedness system that is responsive to all hazards but also to the 
unique needs under study at this hearing, it must be remembered that 
policy without resources is rhetoric. Though redressing a number of the 
gaps and shortfalls in our preparedness posture identified herein will 
turn less on matters of financing than on other issues, in some cases 
funding will be essential to realizing requisite unique capabilities. 
The SNS is but one area which would benefit strongly from an injection 
of new monies, specifically to ``plus up'' its contents. Not only are 
the caches for that ``very bad day'' insufficiently supplied, but our 
current stock of basic but fundamental items such as facemasks and 
ventilators is simply not adequate, and the same is true of certain 
drugs and countermeasures. Dual-use elements that are also instrumental 
to the provision of ``ordinary'' or day-to-day medical care should be 
viewed as sound investments that will yield significant rates of 
return--an important fact and a feature that is consistent with a 
system founded on accountability and on end-State capabilities and 
capacities. Throughout, it bears remembering that what gets measured 
gets done, though we need to make sure that we are always measuring 
what matters.
    The Subcommittee should be commended for its determination to study 
the difficult issues before us today. Tempting as it might be to alter 
focus, and direct time, money, and energy exclusively to other less 
complex challenges that might be easier to master, it would be a 
mistake to do so. The scale of the challenges under examination today 
is undoubtedly large, and even an entity the size of the Federal 
Government cannot tackle these issues alone. Northing short of a highly 
sophisticated, multifaceted, and integrated response will suffice--but 
I am confident that the creativity and resolve demonstrated by the 
American people so often in our history will once again serve as a 
solid foundation upon which to build as we endeavor to meet that bar 
which has been set so high. Thank you and I would be pleased to try to 
answer any questions you may have.
    The George Washington University Homeland Security Policy Institute 
(HSPI) is a unique, nonpartisan ``think and do tank'' that builds 
bridges between theory and practice to advance homeland security, 
through a multi and interdisciplinary approach. By convening 
policymakers and practitioners at all levels of government and the 
private sector, HSPI creates innovative strategies and solutions to 
current and future threats to the Nation.

    Senator Gregg. Thank you very much.
    Those were excellent presentations and I appreciate that 
you were under time restraints.
    What I am going to do now I think is recess this, and then 
Senator Burr is going to come back and chair as soon as he 
votes. I will have to do this and then I want to come back. I 
have got a whole series of thoughts and questions I want to 
engage with you on.
    So this is a typical Senate situation. They always call 
votes in the middle of hearings that are interesting and 
important and we have to rush off and vote and then come back. 
So if you do have the time, we hope you will be able to stay 
and indulge us for this vote, and then I suspect Senator Burr 
will be back about quarter after, and I will try to get back 
here by 11:30. Thank you.
    We will recess until Senator Burr returns.
    Senator Burr [presiding]: I call the hearing back to order. 
I will take whatever time that we need to until Senator Gregg 
comes back. Let me thank all of you again for your willingness 
to be here.
    I asked the question last week of my committee staff, 
should we take the fact that we have not heard anything 
publicly about pandemic flu as publicly as we did for literally 
the entire first part of this year as a sign that the concern 
is over with. I was very quickly pointed to an article of May 
18, with an additional seven cases of human infections in 
Indonesia, six members of an extended family all dead, at this 
point no sign of human to human transmission. This is the 
largest cluster of cases closely related in time and place 
reported to date in any country and is being carefully 
investigated.
    I put that into the record for the purposes of suggesting 
to other Members of the United States Senate that might not 
have seen it prominently placed on the evening news or the 
front page of the morning paper that pandemic threats are not 
something that are here today and gone tomorrow. Until the 
scientific community and health community looks at it and says, 
this particular strain is no longer a threat, there has to be a 
very concerted effort on the part of the United States, on the 
part of the world, to prepare for.
    I draw that distinction because I think somebody's 
testimony talked about plans and preparation and we are at the 
point that we need to be in the preparation stage.
    Mr. Offit, let me turn to you for just a second. Are 
children more susceptible to becoming ill from pandemic flu? 
And do you know of any special considerations that would impact 
our planning as it relates specifically to treating children 
for pandemic?
    Dr. Offit. It depends on the virus that is causing the 
pandemic. So for example, the 1918 pandemic, which has 
certainly gotten a lot of play following John Barry's book, 
that virus caused a very interesting problem, which is that 
when it infected people it actually turned their immune systems 
against them. So it would infect these specific kind of cells 
that actually present foreign proteins, including viruses, to 
the immune system and it would cause those cells to make large 
quantities of a protein, proteins called cytokines. It would 
induce this phenomenon of cytokine storm. So just paradoxically 
what happened in 1918 is it was the healthiest people among us, 
the sort of 20 to 40 year olds, who died disproportionately of 
that disease because they had the healthiest immune systems, 
therefore they made the largest quantities of this protein.
    So I think, so there is an example where children were 
especially at risk for death. Now, traditionally children are 
actually the reservoir of flu. So if you look at the way flu 
spreads across our country or other countries, it usually goes 
from children, and that is why the 1957 pandemic that I talked 
about started in schools. It started in church congresses and 
schools. It started in September because that is when schools 
got, all those kids got together.
    So they are often the reservoir of infection, and so that 
is why I think they are a perfect group to target because you 
target the reservoir.
    I think in terms of treatment, if you are talking about 
agents like Tamiflu, ossiltamavir, it again depends on the 
virus. I think, for example, if you took Tamiflu back to 1918 I 
honestly do not think it would have made much difference, the 
reason being that what Tamiflu does is it prevents the virus 
from reproducing itself, from replicating. I am not sure it 
would have done anything for a cytokine storm.
    Senator Burr. If in fact we were exposed to a strain like 
1919, that healthy community that you talked about that was 
most susceptible died how quickly?
    Dr. Offit. Very quickly, within 36, 48 hours. I will say 
this. Children still die of that kind of phenomenon. I tell 
you, we had a child last year in our hospital who came in, a 
healthy 11-year-old, no risk factors, boy, who within 36 hours 
died of flu, and came into our hospital laughing and making 
jokes. So it can be overwhelming. That child was treated with 
ossiltamavir very early in its course; it made no difference.
    I got the feeling from watching this child go from face 
mask oxygen to a ventilator to an oscillator to a heart-lung 
machine to his death that if we had taken our entire intensive 
care unit and transported it back in time to 1918 we would have 
had the same effect, which is no effect.
    One thing I just wanted to pick up on, the business about 
whether our interest in pandemic flu is maybe fading a little 
bit, is that I think the one, it is not a mistake necessarily, 
but I personally, as do many scientists, do not believe that 
this particular bird flu, this H5N1 strain, is going to be the 
next pandemic strain. It just, it is not transmitted easily 
from person to person, and H5 viruses never have been and they 
have been around for 100 years. This virus has been around for 
about 9 years.
    So I do not think this is going to be the pandemic strain. 
But the good of all this preparedness is that there will be a 
pandemic. There are three pandemics a century. There is no 
reason to believe this century is spared, will be spared. So I 
think getting things in place to get ready for that is all a 
good thing.
    Senator Burr. Well, we all hope that in fact you are right 
and those that have suggested that this strain may not be the 
one--and I think that supports the reason that anything that we 
do and everything that we do should be an all-hazards approach, 
that we should use this opportunity to make sure, not knowing 
what that threat is or what that strain is, but knowing that it 
is down the road, or that new biologic threat or chemical 
threat, or in fact something else that Mother Nature throws at 
us, that we have got an infrastructure that is able to adapt to 
whatever in fact we throw at it.
    Let me just ask you one more question about children, 
because I think you reference to the fact that historically 
they are the source of spreading this infection. Who decides 
when to close the schools? If H5N1 becomes the pandemic or if 
next year there is a pandemic with a different strain, is it 
the local community, is it the State, or is it the Federal 
Government that triggers that?
    Dr. Offit. I am not sure I am the one to answer that 
question. But I will say just this one thing. There was a study 
done in Japan a number of years ago, just to sort of amplify 
your point, where they immunized all children below 5 years of 
age. What they found was that not only did they decrease 
hospitalizations and the less common deaths in that group, they 
decreased hospitalizations and deaths in the elderly.
    So when you attack the reservoir, in this case children, 
you really have an impact on all people who come in contact 
with children. When the elderly die of this disease, they die 
often because they are coming in contact with children. But in 
terms of the logistics of who closes schools, I am not the one 
to answer that question.
    Senator Burr. So if the health professionals that are 
tasked with the job of determining who is vaccinated first, 
given that you have a delay in full production--where would you 
tell them children fit?
    Dr. Offit. You are asking a pediatrician, but I would 
obviously put children first on the list.
    Senator Burr. Yes, but I truly believe that you look at it 
from an overall perspective.
    Dr. Offit. That is true. I think that is true. I think if 
you are trying to--the disease invariably starts in children. 
They are commonly hospitalized. They do not die as commonly, 
obviously, as the elderly, but they are typically the source. 
That is true of many viral infections. This is sort of the 
opposite of whooping cough, where adults and adolescents give 
the disease to children. This is the opposite of that.
    Senator Burr. Dr. Lillibridge, you talked about an all-
hazards approach, but you also mentioned something really 
important that I would like you to expand on. Clearly, your 
prior life gives you some degree of expertise on this. How 
important is the structure of our logistics plan, from a 
standpoint of how we respond to this or any threat?
    Dr. Lillibridge. Senator, I think our logistics plan in 
support of regional planning or our preparedness strategy is 
extremely important. Let me emphasize that health care 
organizations are typically weak or absent in their capacity to 
have logistics mobilization, staff, support, field units, or 
even expanded units in warehouses, hotels, and so forth, if you 
need supernumerary beds in a major epidemic.
    We have looked at that. We think that there are probably 
two ways to begin to look at that. One is partner with the 
private sector; second, deal with larger organizations that 
have internal logistics. For example, when expanding health and 
medical services during Hurricane Katrina, Houston had 
somewhere between 100,000 to 200,000 people come into our town. 
We put them in the Dome, in the Coliseum activity, and we 
supported them with two field hospitals.
    Now, that worked because each of those field hospitals were 
supported in turn by health care organizations that had 
multiple hospitals and logistics capacities in place to nurse, 
resource, and to service those things. I think it is those 
kinds of arrangements as you begin looking through HMOs, 
academic health centers, large hospital organizations, that are 
going to be extremely important.
    The second part is that there may be a security element 
with the logistics support or a rugged field element of 
airplane transportation, security, and so forth. We have always 
thought and made a decision to do this in the private sector, 
but always thought at CDC early in the inception of this 
program that maybe the Department of Defense or an organization 
like that needed to be intimately involved when you needed to 
have a no-fail transport in a security context, as in a 
bioterrorism attack or an event like Katrina, where law and 
order were clearly at a premium.
    Senator Burr. Let me ask the same question in a slightly 
different way. Does the Federal Government understand the 
importance logistics will play in our ability to meet the 
threat?
    Dr. Lillibridge. Sir, I think they understand the issue of 
logistics when it comes to standard emergency management. I 
think we have yet to learn the lessons of resourcing and 
providing logistics support to health and medical operations in 
the field.
    Senator Burr. I look at the national stockpile and question 
whether today we could move the stockpile to the place that we 
need it in a timely fashion to meet the current threat. It is a 
concern that many on the Hill have engaged, not just this 
administration but past administrations, and will future 
administrations, the importance to plan and to prepare.
    I know that we have looked at all sorts of options on 
logistics. But I am not sure in the Federal plan that a 
determination has been made on this piece and whether we are 
going to hand it over to DOD, or use UPS, or use the Postal 
Service. To me, that seems like one of the most important 
things for us to get an answer to, because if it were to happen 
tomorrow we would not be prepared to execute that piece. I see 
that as a vital piece and a necessary component.
    Agree, disagree?
    Dr. Lillibridge. Senator, I agree. Let me frame it how I 
see this. One is we cannot get to those kinds of decisions and 
cooperative engagement unless we can fix the sort of medical 
high ground and make the decision what really needs to be in 
the stockpile and then organizationally frame it in an 
organization to make those decisions.
    Senator Burr. I agree totally.
    Mr. Cilluffo. Senator Burr, if I could just expand on that, 
because I think you are hitting the crux of much of the 
operational side of the issues here. There is an old Marine 
adage: Amateurs talk strategy, professionals talk logistics. 
Quite honestly, it does come down to logistics, logistics, 
logistics, supply chain, and to make sure that you have a 
requirements-driven process put in place.
    One of the take-aways after Katrina was you do not 
necessarily want to say, we need 5,000 MREs. What you 
ultimately want to have is a system or a requirements system in 
place that says, we need to be able to feed 5,000 people for 3 
days, and then you find the best way to be able to meet those 
needs. The military has done that well and they have got the 
scar tissue and learned the lessons the hard way to be able to 
do that most appropriately.
    I do not think that that has been translated as robustly as 
we need it in the domestic context. So I do think you are 
hitting a key issue.
    Mr. Clerici. Senator, if I may just add one comment. There 
is a commonality between your question to Dr. Offit and your 
question to Dr. Lillibridge. At least in the area of influenza 
and the area of influenza vaccines, we run a war game every 
year. We vaccinate people every year for annual influenza, and 
we need to do that in order to keep public health.
    That is a good thing because at least there is a system in 
place to get, depending on what kind of year it is, 70 million 
doses of vaccine out to the American people. With respect to 
pediatrics, if we can increase that penetration up to 18 years 
old, then that war game, if you will, is going to be run in the 
event of a pandemic, all the better. And when you are dealing 
about annual vaccine, if we look at the supply chain 
distribution, there is only a handful of providers of licensed 
vaccine right now. We can look at the way that they are doing 
things and try to emulate that, and also drive that demand up 
because there is no down side to vaccinating more people 
annually. That is only a good thing. If we get that demand up 
to where the market can sustain it, the manufacturing base 
could sustain it, the logistic transport can sustain it, and we 
have enough vaccine for kids all the way up to the elderly, 
then when the pandemic hits all we just do is turn the system 
around, secure it, make sure that there is security surrounding 
it, make sure that there is authenticity measures surrounding 
it, and we are off and running. That is a great opportunity 
that we have with the annual flu vaccine program, to build from 
that and learn from it.
    Senator Burr. Let me throw one last question out to anybody 
that would like to address it. Can we address a pandemic threat 
or any other potential threat that we will face in the future 
without redefining the face of public health in America?
    Be brave, Dr. Lillibridge.
    Dr. Lillibridge. Okay, Senator, I will take that one. One 
of the things I think is refining and developing the public 
health infrastructure is extremely important. We have put an 
effort that largely concentrated on that with our first $28 
billion that we put in the last 6 or 7 years. I think there are 
some things we need to redirect, to think about how we get more 
value out of that money in the future in terms of building 
preparedness, that looks the same or has an all-hazards 
approach, whether you are dealing with radiation exposure or a 
pandemic influenza.
    The kinds of things that we talked about with leadership 
organization are important. The surge capacity, building the 
clinical element, needs to get under the tent this time, and we 
need to galvanize our academic health centers. I think we need 
a better training doctrine, and get those solidified.
    But I think you are going to have to make a shift from 
infrastructure and public health building into national 
preparedness around health and security if you are going to get 
more value out of these dollars in the future.
    Senator Burr. Can you have a Federal response plan or a 
State response plan without public health having a uniform 
consistancy of services that are provided everywhere in the 
country?
    Mr. Clerici. I think you are absolutely right. I think you 
need the bedrock of surveillance, laboratory detection, and a 
basic public health infrastructure. But you also must have an 
honest purchase on the preparedness measures that you need in 
place to build those capacities. I honestly believe North 
Carolina is the model. I have worked there extensively lately 
and they have what I think is a good tradeoff between 
infrastructure, training, capacity-building from the public 
health base out there to the critical capacities they need to 
respond regionally. And they have built a system that can 
respond nationally.
    The North Carolina system responded admirably to bring 
hospitals into Mississippi and provide health care on a State 
emergency management compact. That is a real model.
    Senator Burr. Dr. Offit.
    Dr. Offit. Just to extend what Dr. Lillibridge said, it has 
started to happen. It is interesting, the CDC has started to 
sing a different tune regarding influenza, epidemic influenza 
preparedness. So a couple of years ago they increased their 
recommended group to include the healthy 6 to 23 month old, and 
in the last year the healthy 6 month to 5 year old. That has 
really for the most part exceeded the capacity of physicians' 
offices to give vaccine. You are talking about giving a yearly 
seasonal vaccine to basically your entire group, meaning less 
than 5 year olds.
    My wife is in private practice pediatrics and so what they 
have done, what she has started doing, I think what many people 
are starting to do, is they are trying to sort of expand out so 
that, for example, you have school-based programs. So that has 
changed things a little bit. So now, because we are expanding 
the vaccine recommendation in children with hopefully a goal 
toward a universal recommendation, I think you have to get it 
at some level out of the physician's office into the community, 
and that all works toward pandemic preparedness.
    Mr. Cilluffo. Senator Burr, could you briefly expand on 
that? I do think that it is the cultural things as well. I 
think Scott touched it at the end. It is the health and 
security. Right now the two are treated to some extent as if 
they are mutually exclusive, short some of the implementation 
plans and the national strategy that came out recently. These 
take time, though. This is not something that instantaneously 
can merge and converge.
    But I do think that unless you look at it through the full, 
not a particular lens, but a prism that reflects both those 
perspectives, it will not occur. You cannot expect the public 
health infrastructure to suddenly have all the transportation 
assets that perhaps Department of Transportation or DOD or some 
of the other entities do. They are going to have to leverage 
and ramp up from the extraordinary to the extraordinary, to 
certain capacities and capabilities that reside through the 
country.
    The way I look at it, it is Federal, Federal-State-local, 
Federal-State-local-community, Federal-State-local-community 
down to the individual. In this case, unlike most natural 
disasters, the role of the individual is very significant in 
terms of what they can do to better protect themselves, their 
families, and their communities from the spread of infectious 
disease.
    Senator Burr. Once again, I thank the witnesses. I thank 
the chairman for allowing me to participate in this hearing, 
and I turn everything back over to the chairman.
    Senator Gregg [presiding]. Well, it is great to have you 
here. You are leading the efforts here in the Senate and we 
very much appreciate your leadership on this, Senator.
    Senator Kohl.
    Senator Kohl. Thank you very much, Senator Gregg.
    As ranking member on the Aging Committee, I chaired a 
hearing last week on emergency preparedness for seniors. As you 
know, seniors are particularly vulnerable during emergencies, a 
point made clear during Hurricane Katrina, where 71 percent of 
the people killed were older than 60, and our hearing witnesses 
told us that seniors need more information to prepare for 
emergencies, first responders need better training to help 
seniors, and communities need better plans to locate seniors 
who live alone during and after an emergency like the pandemic 
flu.
    Do programs exist to train first responders and medical 
professionals to meet seniors' needs in the event of a pandemic 
flu outbreak? Should the Federal Government provide funding for 
programs such as these at the State and at the local level? Do 
we have programs that particularly focus on seniors? Should the 
Federal Government take an active role in developing these 
programs? Do first responders have the resources to do this?
    What is the role of the Federal Government in this whole 
area as it relates particularly to seniors?
    Dr. Lillibridge. Sir, I will take a stab at that, Senator 
Kohl. There are two things. One is that there are programs in 
HRSA, the Health Resources and Services Administration, to deal 
with preparedness for seniors and for that segment of the 
population. It is not one of our biggest programs and certainly 
could be expanded. One of the two things that I think would be 
a good direction to go was educating the health providers that 
interface with seniors. That was a powerful way to provide 
training. The second was community outreach to assist them at 
the time of crisis with the things they needed to do to help 
make themselves safe. Those have been the thrust of these 
programs in the past.
    My impression is they could certainly be expanded and 
better integrated if we had a larger and more robust 
educational program targeting our health providers.
    Mr. Clerici. Senator, I am aware that at least HHS has 
categorized and looked at special populations, and I would 
imagine that both seniors living alone as well as seniors 
living in retirement homes or collective areas are a targeted 
population, much like students living in a dorm room. Any time 
you have a collective living situation, the planning needs to 
go into that.
    So I would hope that HHS has taken into account the types 
of resources as well as the type of surge capacity that might 
be required or taps on other resources that seniors might be 
living with that might get redirected in the event of a 
pandemic perhaps to other areas. So I believe that is part of 
their plan, but I do not have any great clarity into how much 
that has risen through the ranks.
    Mr. Cilluffo. Senator Kohl, just to expand on that and to 
lead back to a previous point. I do think there are special 
needs populations in general, not just seniors but many others, 
that we need to be able to target, different languages, 
different cultures, different perspectives, so we can actually 
induce changes of behavior or initiate action; that we have got 
to continually improve our capacities.
    But I do not think that we should look at it in isolation 
of our other plans, programs, and procedures. Quite honestly, 
it is going to be the EMS, it is going to be those that deal 
with these sorts of situations every day, that need to build in 
and build the capacity to surge, not to create a separate 
program per se targeted, obviously, to meet the special needs, 
but ultimately it is going to be the people who act and 
respond. You need to make sure that they are up to date.
    There are some programs within EMS, the EMS community, to 
deal specifically with seniors and geriatric programs that I 
think could potentially deserve a boost. I do not know what the 
budget numbers are here and I know policy without resources is 
rhetoric, so I am coming out of this a little blind.
    But I just want to underscore that it needs to be part of a 
holistic approach. I do not think we should bifurcate some of 
those responses, but rather enhance capacities of those who 
respond to crises on a daily basis.
    Senator Kohl. Well, generally speaking I would not disagree 
with you, but we need to, I think, learn from Katrina, where 
again 71 percent of the people who were killed were over 60. So 
it does, I think, dramatically illustrate that the seniors 
population is not like all the other segments of our 
population, for all the reasons we can understand.
    Mr. Cilluffo. You are right, Senator.
    Senator Kohl. Another question. Many seniors live alone and 
rely on others for transportation, supplies, and information. 
One Florida county that we heard from last week set up a 
voluntary registry so that first responders will know where to 
find seniors who need help during or after an emergency. Do you 
think that the Federal Government should participate in helping 
to set up such registries as part of national preparation for 
an outbreak of pandemic flu?
    Dr. Offit.
    Dr. Offit. I do not think I am the one who is best to 
answer that question. I would turn it over to Dr. Lillibridge.
    Dr. Lillibridge. Senator, I will tell you that at the State 
and local level we are increasingly in the planning of 
preparedness activities related to flu and so forth, beginning 
to look at which community outreach things can we do to better 
identify and get services to the elderly population at the time 
of crisis. So whether it is a registry or a better planning 
function or a block captain, how that unfolds at the State and 
local level is unclear to me which is best. But I know that 
greater emphasis in that area is needed.
    We had the tremendous evacuation activity post-Katrina, 
just before Hurricane Rita, when we thought when a level 5 
hurricane was going to hit Houston. It veered to the east and 
missed us. But we lost a lot of people on freeways, on 
transportation, and we learned that our vulnerable population 
is going to have a lot of trouble mobilizing, getting cared 
for, without preplanning.
    So those are now part of our routine planning elements in 
Texas as well as in other States.
    Mr. Clerici. Senator, without commenting on whether it is a 
State, local, Federal, or family responsibility, I do think 
that, as Mr. Cilluffo said, we need to kind of think one step 
deeper. It is not just EMS care if we are in a pandemic. It is 
whether they can get food, whether they have the ability to 
transport, to get to a grocery store, and whether the shelves 
of the grocery store are full when they get there.
    So the whole supply chain issue as it impacts not only the 
distribution of critical countermeasures, not only vaccines and 
therapeutics and respirators, but also food, water, clothing, 
medicine, typical medicine, not just the medicine to treat a 
flu. What happens when 40 percent of the workforce is sitting 
home in the event of a pandemic and how those populations are 
impacted?
    So those are the issues, I think, that are probably the 
next level of penetration in the Nation's thinking and 
preparedness. To Frank's point, those do not only necessarily 
hit just pandemic. That is any natural disaster.
    Dr. Offit. One point just regarding vaccines. As compared 
to say 50 years ago, the demographics of our population as the 
baby boomers get older has gotten older. Traditionally, what 
the CDC has done, and I think in retrospect maybe not best, is 
to target the greater than 65 year olds: Here is a person who 
is most likely to die; let us make sure this person gets the 
vaccine.
    But the fact of the matter is that people at greater than 
65 years old do not make a great immune response to the 
vaccine, they do not. Their immune response in general is not 
what it was when they were 18 or up to 30. So therefore it 
becomes all the more important, I think, to try and immunize 
those people to whom they are most likely to be exposed. In 
this case, young children, that is certainly true.
    I think the Japanese experience, where they immunized 
children less than 5 and had a dramatic decrease in the number 
of deaths in the elderly, I think was instructive. Just a 
point. The greater than 65 year old is not great at responding 
to flue vaccines.
    Similarly, the other difference between 1957 and now is 
that we have a lot more people who are immune compromised. We 
use steroids a lot more than we did, we do solid organ 
transplants and bone marrow transplants. So we have a much 
greater population that are immune compromised. Now, that came 
up I think with the smallpox vaccine, fears associated with 
contact spread of smallpox.
    Mr. Cilluffo. Senator Kohl, and this may suggest asking a 
little more from some of the NGOs as well as the Medical 
Reserve Corps and some of these other entities that can perhaps 
plan a more active role in that special needs community, 
because, unlike in the Katrina event, in most cases we are 
going to want to shelter in place. The last thing you want to 
do is evacuate and put everyone in a common place where it 
could spread that much more quickly.
    So I think that perhaps this could be a mission area for 
the Medical Reserve Corps to play a more active role, not to 
mention many seniors are very active in the Medical Reserve 
Corps, playing an active role in protecting one another, and 
that should not be lost in this, is that there is so much 
talent that we want to be able to tap into that may not be in 
the traditional way tapped into, and to be able to do that.
    Senator Kohl. I thank you for your comments, gentlemen. It 
has been very helpful.
    Thank you, Senator Gregg.
    Senator Gregg. Thank you. Thank you, Senator.
    Senator Allard.
    Senator Allard. Thank you, Mr. Chairman.
    My question I guess I would direct to Dr. Lillibridge or 
Dr. Offit. How do you assess risk with a disease that, 
according to the last time I looked at the CDC web page, we 
have only had one documented case of human to human 
transmission? We have lost thousands of birds, but just a few 
people have actually contracted influenza relatively speaking 
to the bird population, and it does not occur yet in this 
country.
    So how do we assess risk to the population in America?
    Dr. Lillibridge. Do you want to go first?
    Dr. Offit. I think that traditionally with typical epidemic 
influenza those most likely to die are those greater than 65, 
those who have chronic medical conditions such as problems, 
chronic conditions of the lung, heart, kidneys, etcetera. That 
has traditionally always been true.
    Senator Allard. Based on an individual basis. That is an 
individual basis, is it not? I am looking at a public health 
assessment for the total population.
    Dr. Offit. Sir, I think it depends on what the nature of 
the strain is. For example, you knew in 1957--you were not here 
to hear my initial comments, but in 1957 you knew it was going 
to be a pandemic because very quickly one-tenth of Hong Kong's 
entire population was infected. Tens of thousands of people 
were in line trying to get medical care. Then you know, so now 
it has started. It is clearly spreading easily from person to 
person. That has to happen in order for a pandemic to exist. 
And not only do you know that it is now a likely pandemic 
because it is easily spread and it is a novel virus, but you 
know who it is infecting and who is getting hospitalized and 
who is dying, which is to say what kind of strain it is.
    I think the 1918 experience was an unusual experience. That 
particular virus, the surface protein of that virus, which is 
called the hemagglutinin, which is where the ``H'' comes from, 
was a very unusual hemagglutinin. It had the unique capacity, 
frankly, to stimulate the body's immune system to react against 
itself, which put that 20 to 40 year old or even younger person 
at great risk.
    But you would know that early on, I think, in a pandemic.
    Senator Allard. But early on in those outbreaks that you 
described, we recognized early on that there was a pandemic 
there because, like you said, the cases showed up and all of a 
sudden you noticed. But even though we have had people get ill 
now, we have no indication of a pandemic other than the fact 
that we know that influenza virus has a tendency to mutate.
    Dr. Offit. No, I think personally we have every indication 
that the H5 virus is not going to be a pandemic strain. But 
that does not mean there will not be a pandemic. There will be 
a pandemic.
    Senator Allard. Okay, so what is all the excitement about?
    Dr. Offit. Well, the excitement is about the fact that 
there are three pandemics every century, that this century will 
not be spared, that you have what has clearly been a crumbling 
in the infrastructure to make and produce vaccines.
    Senator Allard. But should not our efforts be, instead of 
thinking so much about this influenza attack and getting 
everybody all hyped and everything, should we not be looking 
generally at our public health procedures, on how we handle 
public health infectious diseases generally, and whether--maybe 
it is influenza this time, but it could be some other virus or 
bacterial infection in some other aspect.
    Would we not be better off to look at just the total public 
health approach and how you handle infectious disease with a 
very virulent organism, no matter what that is?
    Dr. Offit. Well, keep in mind--good point. I think one has 
to keep in mind that if you take the inter-pandemic periods and 
just add up the number of deaths from epidemics, they dwarf the 
amount of deaths that come during a pandemic. So I think we are 
not very good, frankly, at taking care of the infectious 
disease influenza, which kills 35,000 to 40,000 people in the 
United States every year. Can we avoid a lot of that death by 
expanding influenza immunization programs? Absolutely. But 
somehow we seem to grandfather in that 35,000 to 40,000 deaths, 
that is okay, because it is the pandemic that we focus on.
    But as I said earlier, I think that the degree to which we 
take the epidemic threat seriously, that we make vaccine and 
educate the public that they need to get this vaccine, is the 
degree to which we will have an infrastructure in place for 
when the pandemic does come, and it will come. There will be a 
pandemic. When the pandemic comes, it may be a pandemic like 
1957 or 1968, when maybe 100,000 people in the United States 
die or 150,000 die. But remember, 35,000 to 40,000 die every 
year.
    Senator Allard. My time is expiring, Mr. Chairman.
    Senator Gregg. Do you have other questions?
    Senator Allard. Yes, I could follow more.
    Yes, go ahead.
    Dr. Lillibridge. Senator, I think we are singing from the 
same page. I agree with you that I think the issue at hand on 
pandemic flue preparedness is that epidemic preparedness as a 
Nation is an important issue. I do not see any difference from 
bioterrorism preparedness, pandemic flu preparedness, SARS 
pandemic, or preparedness for other emerging diseases.
    I think we are right to focus on the detection and the 
disease control measures of the system and the leadership, 
organization, and methods by which we control disease, is much 
more important to me than each individual widget or new vaccine 
or new lab test.
    Mr. Clerici. Senator.
    Senator Allard. Yes?
    Mr. Clerici. Senator, if I could follow up on that point. I 
think your message is exactly correct. It is not just pandemic 
or Avian flu or whatever it might be. It is the global 
preparedness of public health. But if you look at what we have 
done with Avian influenza in preparing, we passed liability 
protection not just for Avian flu, for any pandemic, epidemic 
or bioterrorist event. There are currently eight licensed 
vaccine makers of any type of vaccine in the United States 
versus the 30, 20 to 30, there were several years ago. That 
problem hopefully is along the way to being fixed.
    We make our annual flu vaccine, as Dr. Offit pointed out, 
which kills 30,000 people every year, from chicken eggs. Last 
month we ordered a contract for a billion dollars to multiple 
companies, some very large companies, to go to cell-based 
manufacturing.
    So all of that progress--and the bird flu has been 
analogized already by the New York Times to Y2K, as all about 
nothing. I actually take a good heart in that because if Y2K 
caused us to upgrade our IT infrastructure from 1980 to 2000, 
led to a lot of increase in American efficiency, and nothing 
happened, we are all the better. If we spend $7 billion here, 
raise the awareness of public health preparedness, and a 
pandemic does not happen to the degree that we think it will, 
but yet we are better prepared as a society and our public 
health infrastructure are upgraded, I think that is a win.
    Senator Allard. But I think risk assessment is really 
critical, because the treatment, there is a risk assessment, 
too. So you need to know what are the risks. If you do not have 
any risk on treatment, then that is mute. But I have yet to see 
treatment that does not have at least a little bit of risk in 
it, I think. Then you have got the other risk of the disease or 
the virus, in this case the Avian influenza variety H5N2, and 
that virus shows from what I can tell very little tendency 
right now to spread from human to human.
    But if you are going to go on to a vaccination program and 
you have two people die out of every 100 vaccines you give, 
that is not a very good--see, this is where risk assessment is 
so very important, and I do not see many people talking about 
how we get about doing risk. They are talking about, well, what 
if. But we need to look at the degree of risk that we have 
there, and that is what I am trying to get at.
    Mr. Cilluffo, you had something.
    Mr. Cilluffo. Senator Allard, not to speak lightly about a 
very serious matter, but I think it is fair to say since the 
end of the cold war to some extent threat forecasting has made 
astrology look respectable. So I do not know what the future 
will bring.
    I do think that there are some back end capacities and 
capabilities that will maximize and we need to be very diligent 
to make sure our finite resources, our infinite vulnerability, 
is based on a risk management, solid risk management 
principles, where you can maximize those secondary and tertiary 
returns on investment that will be beneficial, not only for the 
bad bug, but also for the bad weather and also for bad people, 
because the other component that I think is not being discussed 
here is bioterrorism.
    With respect to bioterrorism, that can be a transforming 
sort of an event to the United States. Unfortunately, our 
adversaries have made clear that if they could build the 
capacity and disseminate and deliver the capacity to do so they 
would. So I think that we want to look to what are the 
resources that could be spread across the board that will get 
that return on investment and maximize our efficiency.
    I do think you are underscoring another important point. I 
am not sure we have really built the business case yet for 
homeland security, not just pandemic influenza, not just--
because I agree with you, if we were to chase every bad bug we 
will break not only our bank but every bank. But we need to be 
able to look to what is that business case across the board, 
and I think it is incumbent upon us to look at it from an all-
hazards perspective, where we will yield return irrespective of 
whether or not we see H5N1 or it morphs into H5N7 or whatever 
it may be.
    So I think you raise some very good points, but I do not 
think the panel here--at least agrees with your points, but 
recognize that, as President--or as Benjamin Franklin, not 
President--they did not promote him yet--once said, failing to 
prepare is preparing to fail. So I think we need to be able to 
act.
    Senator Allard. Thank you, Mr. Chairman.
    Senator Gregg. Thank you. You have covered a lot of really 
important topics and given us some interesting ideas.
    Let me ask, to try to filter this off a little bit, if you 
can each give a grade to where we are as a government in our 
preparations for an all-hazards event and our preparations 
specifically for influenza? Do you have a grade you would give 
the Government at this point?
    Dr. Offit. I think I can best answer the question, the 
grade I would give the Government for influenza preparedness is 
a B-plus, because I think the two things that have happened 
that have been really important is a recognition that the 
vaccine manufacturing infrastructure has crumpled and that it 
needs to be bolstered; two, that we need to get away from what 
is a fairly archaic, egg-based technology to mammalian cell 
technologies. I think that is really important. So a solid B-
plus.
    Senator Gregg. That is good news. I presume you think we 
have got the vaccine issue moving in the right direction, in 
part because we have addressed the liability issue?
    Dr. Offit. So you want to talk about liability. I think 
that liability--I guess I do not completely agree with the way 
that we have done liability. Do you want me to talk about that?
    Senator Gregg. Absolutely. That is why we are here. We want 
to know your thoughts.
    Dr. Offit. I guess the program that I think works is the 
vaccine injury compensation program, because at the heart of 
that program is essentially a Federal excise tax on every dose 
of vaccine, that then creates a poll of money and then if there 
is a problem following a vaccine, as occasionally happens, as 
Senator Allard said, then the way that works in the vaccine 
injury compensation program is essentially a group of 
epidemiologists and clinicians and people who understand the 
data look at the data and say, okay, this is a problem. 
Rotashield, the rotavirus vaccine that was on the market for a 
year, caused intestinal blockage. Influenza vaccine can--was, 
at least for the swine flu, it was a rare cause of Guyon-Baret 
syndrome. And influenza vaccine currently has egg proteins, so 
it can be a rare cause of severe and occasionally allergic 
responses.
    Those things are real. What you worry about is--and this is 
why it should never go to a jury, frankly--is the fact of all 
these unreal things that vaccines are blamed for. That was what 
was great about vaccine court. Essentially, the vaccine injury 
compensation program is vaccine court.
    So I think when you ask a populace, for example, to get a 
vaccine en masse, if it does cause unanticipated side effects, 
I think that it is fair to compensate those people who were 
hurt by that, I do. I think my concern about the current plan 
is that I think it sets too high of a bar for that. In other 
words, it does not--other than, I think my understanding is it 
is--I am not a lawyer, but I will pretend I am because they 
pretend that they are doctors, so why not.
    The notion of the bad actor provision, the knowingly 
negligent provision, I think is a bit much. Believe me, I am a 
big fan of tort reform. I just think it is not fair, if it 
really was found to cause harm, harm that was not due to 
negligence, harm that had nothing to do with design or 
production, but was found to cause a negative effect--I think 
it would be fair to compensate those who are being asked to get 
that vaccine, but not like the $253 million you get if you have 
an arrhythmia with Vioxx in east Texas, but something like what 
the vaccine injury compensation program does, which is in the 
sort of $250,000.
    So I think that is fair.
    Senator Gregg. I will move on in a second. I just want to 
respond with the public policy reasons why we went the way we 
did, which was because I presume and I think most of the people 
who worked on the decision presume that if we had a national 
epidemic and we had the vaccine, we had a huge national vaccine 
program that was brought on line very quickly, that any sort of 
personal harm that was caused by that vaccine would 
inevitably--the responsibility would inevitably be picked up by 
the Government for compensation. But to try to guess where that 
was going with a pre-vaccine program, like we did with polio 
where we had a predictable number or with smallpox where you 
have a predictable number, was probably counterproductive to 
bringing vaccines on line.
    Everybody is presuming that there is going to be a 
compensation event if, or at least I am, if there is a national 
vaccination event which involves a vaccine that is rushed to 
market or rushed to the population, simply because we had the 
event and we had to respond and this was the only thing we had 
available in our toolbox.
    So I think it is almost a moot point. It is going to be 
done. It is just to do it on an estimate that has no relevance 
at all because nobody knows what the harm is going to be, as 
compared with smallpox where we know the harm because you know 
the percentage. That was why that decision was made on purpose, 
to get the vaccine industry functioning.
    I think the fact that you think we may have accomplished 
that, that is good news. That is very good news if it is true.
    Mr. Clerici, what would be your rating of where we are in 
this exercise? A grade, you have got to start with a grade 
here. We have got to keep this simple. We are simple people.
    Mr. Clerici. In terms of flu preparedness, I would 
definitely put it at a B. The good news is a year ago when I 
sat at this table I would have put it at a D-minus to an F. So 
I think the last year, both with liability protections as well 
as the resources and focus that the Federal Government has put 
into pandemic planning, has been very positive.
    I would say, with respect to annual flu vaccine, we are 
probably back at a C and, ironically, if we can get that annual 
flu program up to an A, then that is going to make the stronger 
grade for pandemics. So there is more that can be done in 
messaging in terms of----
    Senator Gregg. Well, what is it that gives us a B? Give me 
a thumbnail. What are we doing right right now and what do we 
still need to do, in a thumbnail?
    Mr. Clerici. I think with respect to vaccination we are 
well along our way there. I think the fact that the liability 
leash has been removed from the neck of the industry to 
actually participate, and that is all they want to do is 
participate, has proven out with the billion dollars in 
contracts that were given to big companies that were never in 
the United States market before, which is very, very positive.
    With respect to other countermeasures, including 
antivirals, more needs to be done there, which is probably why 
the grade is lower than even Dr. Offit gives, in terms of 
finding next generation antivirals and promoting those 
resources. As I understand it, stockpiling--I am a lawyer, not 
a doctor, to take Dr. Offit's point. Tamiflu may not be the 
solution, so perhaps we need to be putting that same type of 
focus in finding those next areas.
    Areas such as rapid diagnostics have not gotten the 
attention they deserve. We need to know what we are dealing 
with when these people show up at a hospital so we can treat 
them appropriately and also triage the very few resources that 
we have. As I understand it, HHS is moving toward that. They 
have not yet. There is a lot of dysfunction between the CDC and 
HHS in what sort of processes are in place for rapid 
diagnostics.
    Then with respect to annual vaccination, which is also 
dragging down the grade with pandemic, until we get our 
messaging right on who should take the vaccine--unfortunately, 
things were moving along very nicely towards a very strong 
message from the CDC up until October 2004, when we had to take 
back that message and say: Okay, no one get a flu vaccine, 
because one of the suppliers collapsed.
    That set us back in terms of messaging. For the good of the 
Nation, it was a very mild flu season that winter, which means 
that people did not take a vaccine and did not get sick to the 
extent that they had in the past, which was good for the 
country. It was bad for the message to get people back on track 
saying you really do need to take a vaccine, and to make sure 
that we have the capacity to get that universal recommendation 
where it needs to be as very, very important.
    With respect to bioterrorism, I think we are still in the C 
range. BioShield is still moving too slow in order to generate 
the type of market interest that we need it to. As I said in my 
testimony, Secretary Leavitt and Deputy Secretary Azar have 
committed to fixing that, and they are both incredibly able and 
capable of doing that.
    We had a setback in the last few weeks, with the first 
BioShield contract well on its way to failure. I think that we 
cannot take that as a bad message. We need to learn from it, 
build from it, as they have with flu, quite frankly, in 
implementing the flu program, and not take the failure of 
VaxGen to drag down all of BioShield.
    There are good signs: the fact that they purchased another 
vaccine, the fact that the anthrax therapeutic awards should be 
made relatively shortly, according to HHS, and that new RFPs 
are going to be hitting the streets for things we have not 
dealt with--plague, botulism, antitoxin. But until that 
happens, I think we need to keep the grade probably at a C to 
encourage them to do better.
    Senator Gregg. Dr. Lillibridge.
    Dr. Lillibridge. Senator Gregg, I think I would give us a 
respectable C. I think preparedness in my book is an ongoing 
process. You do not just achieve an end result and then rest on 
your laurels. The things that I think need to happen to move 
that up over the next year or two--and I am pleased with the 
progress of Julie Gerberding at CDC and Secretary Leavitt at 
HHS and the other partners, DHS. But here is what I think I 
would like to see happen or what I would like to focus on.
    First of all, disease detection and epidemic control are 
not an all-hazards enterprise. Those are complex biomedic 
disease control activities. They require an infrastructure, a 
leadership, and an organization that is a little different. I 
believe they can work in an all-hazards framework, but I think 
they are different than all-hazards preparedness because of the 
science, the laboratory, the medical components, the health, 
and so forth that have to be tickled, nurtured, and developed. 
That is one.
    The second thing, as I alluded to earlier in testimony, is 
the issue of leadership and agency organization. I would fix, 
and I would have high on my emphasis list to fix, the National 
Disaster Medical System such that we really do have the surge 
capacity and can get our academic health centers, HMOs, and 
large hospital organizations better involved in supporting our 
national strategies.
    Senator Gregg. Thank you.
    Mr. Cilluffo. Senator Gregg, let me preface my answer with 
the fact that I believe anything short of an A-plus is 
unacceptable. So with that as sort of a backdrop, I think at 
the Federal level we are actually doing quite well in terms of 
the strategies, in terms of the policies, in terms of the 
plans, and in terms of the laws. I think we would be that much 
further if we were to actually legislate and pick up your bill 
in particular, Senator Gregg, Senate Bill 2792, which I think 
would enhance our capacities that much more, and I think 
Senator Burr's bill, S. 2564, in terms of bridging the so-
called valley of death from basic research to advanced research 
to actual, would take us to an A-plus at the plans level.
    But this really is not about what we are doing here in 
Washington. It is ultimately about execution and implementation 
at the State and local level, where the rubber hits the road. 
There I do not know what to grade because you cannot give a one 
size fits all. Some communities, some States, are much better 
prepared than others. Some are further along than others. 
Others are doing great work. So I do not know how you would 
give a fair grade because you would have to actually grade a 
whole lot of people.
    Then you have got to look at the private sector, the 
continuity of operations planning. I think there is an awful 
lot of work we need to do here, and maybe even in terms of 
prioritizing vaccines. You are going to have the owners and 
operators of our critical infrastructure who are going to be 
absolutely instrumental and critical to maintaining our 
continuity of government and our day to day issues.
    So here you have a majority of the companies recognizing it 
as a problem, yet only one-third have actually put in robust 
continuity of operations plans. So there is a delta between the 
verbiage and the action.
    I would say the same with the American public. We should 
stop asking how afraid we should be, but what is it we can 
honestly do to better protect ourselves and our families? Here 
I am not sure we have hit saturation, and that is a risk 
communication sort of issue which is a tough balance.
    So I think it is the interface between Federal, State, and 
local where there is an awful lot of work that needs to be done 
and it is ultimately operationalizing. As General Eisenhower 
said when he was then General: ``In preparation for battle I 
have often found plans to be useless, but planning to be 
indispensable.'' I am not suggesting plans are useless. They 
are very important. But we need to get the operational tenets 
that can bring the plans and the strategies together with 
operations.
    Senator Gregg. The subcommittee has received a statement 
from Steven D. Brice, Battelle's Health and Life Sciences 
Division which will be intered into the record.
    [The statement follows:]

Prepared Statement of Steven D. Rice, Senior Manager, Battelle's Health 
                       and Life Sciences Division

    Thank you, Mr. Chairman and Members of the Subcommittee on Homeland 
Security, for receiving my written testimony for the record. It is my 
privilege to provide my opinion concerning our Nation's preparedness 
and capabilities to respond to the kinds of cataclysmic events that 
could face our Nation in the near future. Both natural and 
technological disasters as well as terrorist-perpetrated incidents loom 
on the horizon, and it is vital that we honestly and forthrightly 
assess our capabilities, our strengths, and our weaknesses. Until 
January of this year, I was a Federal employee working at the Centers 
for Disease Control and Prevention (CDC). I directed the Strategic 
National Stockpile from its inception in fiscal year 1999 until January 
2006. Post-September 11, I was asked by CDC Director Dr. Julie 
Gerberding to direct emergency response at that agency, as well.
    I retired from CDC in January and joined Battelle's Health and Life 
Sciences Division where I am responsible for development of strategic 
plans for emerging infectious diseases and for overall emergency 
response. Battelle is a non-profit 501C(3) organization with a long 
history of dealing with a wide range of critical issues in the health 
and life sciences. Battelle has substantial contract research 
experience with various parts of the Department of Health and Human 
Services (DHHS), including NIH and CDC. Battelle also has a long 
history of support for bio-defense programs for a variety of Federal 
agencies. In addition, Battelle has significant long-term relationships 
with various pharmaceutical companies, primarily in clinical trial 
support and vaccine development for defense and civilian applications.
    My comments today are intended to emphasize and underscore the need 
for proper prior planning, proper resourcing, proper coordination, and 
the absolute necessity of establishing new partnerships. I will discuss 
three examples to support my observations. Specifically, I will discuss 
aspects of the Strategic National Stockpile; Federal, State, and local 
preparedness; and the urgent need to develop and exercise public-
private partnerships.
The Strategic National Stockpile
    My comments on this subject reflect only my knowledge of events 
prior to January of this year. I have not worked either at CDC or in 
the Strategic National Stockpile (SNS) since January 3, 2006. No doubt, 
many changes have since occurred at DHHS, at CDC, and within the 
Stockpile.
    I believe the SNS is overburdened by missions for which it is not 
adequately resourced and by missions that were not well thought out or 
not properly planned. These shortcomings have made it very difficult 
for CDC and its staff to operate at top effectiveness. Two examples 
will, I hope, be helpful.
    My first example comes from DHHS's implementation of project 
BioShield, a multi-billion dollar program to acquire medical 
countermeasures should our Nation be attacked by biological, chemical, 
or radiological weapons of mass destruction. As originally conceived, 
CDC's Strategic National Stockpile was not designed to handle drugs, 
vaccines, or anti-toxins in its formulary that were not licensed by the 
Food and Drug Adminstration (FDA). SNS's warehouses met the highest 
industry standards for storage of pharmaceuticals and medical equipment 
after the product had been licensed. However, the standards for 
products prior to licensure are much more costly to adhere to. The cost 
is due in good part to the labor-intensive documentation required by 
the FDA (for its licensure application package). The general purpose 
for adhering to these extra measures when handling products prior to 
licensure is to ensure that nothing in the ``handling'' of the 
unlicensed product could be responsible either for jeopardizing 
licensure or for the product's failure to be licensed by the FDA.
    Even though the SNS was not designed to handle unlicensed product, 
the fact is that it has had to handle such product. Specifically, 
licensure of a medical countermeasure may take several years and may 
not be accomplished until well after the millions of doses of the 
countermeasure are produced and stored in the SNS warehouses. It became 
necessary for the SNS to stand up (that is, plan, staff, and implement) 
a quality assurance/quality control unit similar to those of private 
pharmaceutical manufacturers. The SNS was now considered by the FDA as 
part of the manufacturing chain of events. The transport and storage 
records of the SNS would be reviewed by the FDA as it assessed whether 
or not to license a given product. The manufacturer and the SNS had to 
assure, through meticulous record keeping, that the product was 
transported and stored under good manufacturing practice (GMP) 
standards. The record keeping is much more burdensome if one is dealing 
with an unlicensed product, even though the transport and storage 
standards for cleanliness, temperature control, etc. are virtually the 
same for medical products stored at local pharmacy, hospital, or prime 
vendor warehouses. Let us use as an illustration the moving of an 
unlicensed product requiring refrigeration. A refrigerated truck that 
transports a licensed product need only ensure the product was kept at, 
let us say, 20 degrees Celsius, whereas a truck transporting an 
unlicensed product must be certified as meeting GMP standards. This 
requires many dozens of temperature probes to ensure that every place 
in the trailer's storage unit is within exact tolerances--and 
documentation of that fact becomes part of the licensure package 
submitted to FDA for review.
    This added burden was taken on willingly by CDC in order to have 
the medical countermeasure on hand (even before final licensure) should 
our Nation be attacked. Additional staff was required with expertise 
that essentially came only from the private sector. The CDC/SNS budget 
had never accounted for such hiring and program implementation. CDC was 
told to take the costs and the program burden for standing up such a 
unit out of current operating expenses. Equally debilitating, CDC was 
told to have the unit operational in 3 months' time. While this was 
indeed accomplished, it placed hardships on both CDC staff and budget 
and is one example of an inadequately resourced requirement.
    Another example occurred in 2003, when the DHHS Office of the 
Assistant Secretary for Public Health Preparedness began exploring the 
possibility of adding primary care, public health contingency beds to 
the SNS inventory. Referred to at the time as Federal Medical 
Contingency Stations (FMCS) or Federal Medical Stations, the beds, 
bedding, and limited ancillary support items were to be shipped by CDC 
to the site of an emergency and were to be used by local personnel. The 
purpose of these beds was to provide the Nation with an additional 
resource when responding both to the aftermath of natural disasters 
(hurricane-displaced persons, for example) and/or to terrorism events. 
Unfortunately, as of December 2005, the concept of operation and the 
exact use of these beds remained unclear both to CDC staff and to state 
and local emergency responders and public health personnel. Thousands 
of beds were purchased, but very few were used in the 2004 hurricane 
season in Florida and in response to hurricanes Katrina and Rita. Their 
effectiveness was blunted because state and local responders were not 
acquainted with the equipment; and further because state and local 
responders did not know they had to provide power, water, food, linen 
changes, laundry, and most importantly, health care providers to 
support the patients who might occupy those beds. Thus, instead of 
viewing the beds as an added asset, many state and local response 
coordinators considered the beds to be a burden.
    CDC was not given the human resources to train and exercise the use 
of these beds with state and local responders; CDC was not given the 
human resources to adequately store and kit the beds for use in the 
field. Yet, despite not being properly resourced to accomplish this 
mission, CDC once again did its best to purchase, kit (i.e., put 
everything together so that when the ``beds' were transported they 
arrived with as much supporting gear as CDC could afford given the 
inadequate budget), transport, and set up this medical/public health 
asset. Unfortunately, however, because the original concept of 
operation was never well articulated to either CDC or to state and 
local responders, this potential asset was rendered a liability during 
disaster response.
    Nor was the FMCS concept ever fully coordinated with the Department 
of Homeland Security's National Disaster Medical System staff or their 
primary response element, the Disaster Medical Response Teams (who 
would, it could be assumed, be called upon to staff and use these 
assets). The lack of a clear mission, the lack of a clear concept of 
operation, and the lack of coordination with Department of Homeland 
Security further reduced the potential effectiveness of these medical 
and public health assets.
    Before I leave this portion of my testimony, allow me to underscore 
that I cannot think of a better place than CDC to carry out the 
missions and assignments in the examples I provided. My point is that 
CDC must be adequately resourced when they are given future missions 
and that each assignment needs to be accompanied by a clear, well-
articulated concept of the operation that is vetted and fully 
coordinated at all appropriate levels of government, at DHHS and the 
Department of Homeland Security, down through the local level.
State and Local Preparedness
    CDC has a long and fine record working with state and local public 
health departments as the agency assists in the fight against illness 
and injury. In recent years, CDC has also taken on the fight against 
terrorism by working closely with state and local governments, not just 
public health departments, but police, fire, public safety, and 
emergency response elements as well. Within the past 2 years, CDC and 
DHHS began planning for the worst-case scenarios of a clandestine 
release of a biological agent that would require extremely close 
coordination between agencies at all levels. When I left Federal 
Service in January, I had not yet seen the kind of coordination, 
planning, and exercising required in one critical arena: namely 
coordination between the Department of Homeland Security's National 
Disaster Medical System component and the various DHHS response 
elements, including CDC's emergency responders and the SNS. The 
interface between the National Disaster Medical System units, CDC, and 
other DHHS assets such as the DHHS Secretary's Emergency Response Team 
is necessary if we as a Nation are to be able to respond to 
catastrophic natural disasters such as Katrina or to terrorists' use of 
weapons of mass destruction. My hope is that in recent months, DHHS and 
the Department of Homeland Security have undertaken such planning and 
coordination and, ultimately, have exercised together. This should 
ensure that, when they respond to the scene, they know how to 
communicate with one another; their formularies are similar, if not 
identical; their routes of supply and re-supply are well known to one 
another; and their trust in mutual capabilities is well established. 
Anything less is not good enough.
Partnerships
    In the aftermath of Katrina, much has been said about partnerships. 
I endorse and support each of the various recommendations that would 
facilitate all entities working more closely together. I would like to 
concentrate today on one aspect and in one area of partnership that I 
believe is essential to the success of a national emergency response: 
namely, partnership in the discipline of logistics, both medical 
logistics and general emergency response logistics. I define medical 
logistics' as getting medical supplies and equipment where needed, when 
needed.
    In Katrina, we failed as a Nation to move critical medical supplies 
for the chronically ill, for the aged, and for children into New 
Orleans rapidly enough. We should have known better. After every 
catastrophic natural disaster, the people who suffer most quickly in 
the hours post event are our elderly, our infants, and our chronically 
ill who have lost their medications. Diabetics, heart and hypertension 
patients, those with breathing difficulties, infants, and the elderly 
can become critically ill very quickly. In New Orleans many of these 
individuals survived the hurricane itself only to succumb to 
dehydration or to a chronic disease that went unmanaged for days.
    Keeping this example in mind, it would seem to me that the Federal 
Government must do a better job in partnering with pharmaceutical 
manufacturers, prime vendors, local suppliers, and transportation 
businesses prior to such disasters. Specifically, I believe agreements 
can be established between private corporations and public entities 
such as state and local public health agencies and DHHS and the 
Department of Homeland Security at the Federal level to ensure an 
immediate supply of medications for the chronically ill, the aged, and 
the children in an affected area.
    Yet partnerships with medical suppliers and transportation 
corporations are only one side of the partnership triangle I wish you 
to consider. Both DHHS and the Department of Homeland Security require 
help in establishing a well-functioning logistics response. There are 
many private firms (both profit and non-profit) that have discussed the 
need for a more robust logistics (and medical logistics) capability in 
our Nation. Speaking as a representative of a private non-profit 
organization, I urge Congress to call upon the private sector to create 
meaningful long-term partnerships with our Federal, State, and local 
counterparts to design, implement, and exercise a civilian logistics 
capability. This can complement Department of Defense efforts when it 
comes to responding to a natural disaster or a terrorism event, both 
within the United States and internationally when necessary.
    Thank you again for allowing me to submit my statement for the 
record for your consideration.

                         CONCLUSION OF HEARING

    Senator Gregg. Thank you.
    Well, you folks have been very generous with your time and 
this has been an excellent presentation, given us a lot to work 
with, and ideas and thoughts, which we hopefully can convert to 
action. We appreciate your courtesy in coming here to inform 
us. It is very important. As you say, Dr. Lillibridge, this is 
not a static event; it is a moving event. So as you have 
thoughts and ideas as we go forward, please do not hesitate to 
communicate them to our staffs or ourselves because we need 
that information.
    Thank you very much. I appreciate your time. The hearing is 
recessed.
    [Whereupon, at 12:10 p.m., Tuesday, May 23, the hearing was 
concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

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