[Senate Hearing 109-495]
[From the U.S. Government Printing Office]

                                                        S. Hrg. 109-495



                                 OF THE

                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION




                             MARCH 16, 2006


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                   MICHAEL B. ENZI, Wyoming, Chairman

JUDD GREGG, New Hampshire            EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee                CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
RICHARD BURR, North Carolina         BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia              JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio                    JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada                  PATTY MURRAY, Washington
ORRIN G. HATCH, Utah                 JACK REED, Rhode Island

               Katherine Brunett McGuire, Staff Director

      J. Michael Myers, Minority Staff Director and Chief Counsel


                            C O N T E N T S



                        THURSDAY, MARCH 16, 2006

Enzi, Hon. Michael B., Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Kennedy, Hon. Edward M., a U.S. Senator from the State of 
  Massachusetts, prepared statement..............................     2
Leavitt, Hon. Michael O., secretary, U.S. Department of Health 
  and Human Services.............................................     4
    Prepared statement...........................................    18
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina, opening statement....................................     5
Falkenrath, Richard A., senior fellow, The Brookings Institution; 
  Leah Devlin, D.D.S., president, Association of State and 
  Territorial Health Officials, and director, North Carolina 
  Department of Public Health; Dan Hanfling, M.D., director, 
  Emergency Management and Disaster Medicine, Inova Health 
  System; and A. Richard Melton, deputy director, Utah Department 
  of Health......................................................    24
    Prepared statements of:
        Mr. Falkenrath...........................................    27
        Dr. Devlin...............................................    38
        Dr. Hanfling.............................................    43
        Mr. Melton...............................................    49

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Questions of Senator Clinton for Secretary Leavitt...........    74





                        THURSDAY, MARCH 16, 2006

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 9:19 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Mike Enzi, 
chairman of the committee, presiding.
    Present: Senators Enzi, Burr, and Dodd.

                   Opening Statement of Senator Enzi

    The Chairman. Good morning. I will call the hearing to 
    I really appreciate the Secretary readjusting his schedule 
so that while we are debating this, the preparations can be 
made for doing some votes on it, on the floor of the Senate. We 
are really happy and honored to welcome Secretary Leavitt, and 
a distinguished panel of speakers today, as we formally begin 
the process of the reexamination of our bioterrorism and 
essential public health security. We need to get prepared for 
the bird flu, and toughen our defenses against bioterrorism. We 
do that by making sure all levels of Government are coordinated 
to face these threats.
    When we last examined these critical issues, there was a 
tremendous cooperation between Democrats and Republicans to 
address the urgent concerns raised by the events of September 
11th and the subsequent anthrax attacks. I know that we will 
work again in cooperative fashion, recognizing that as members 
of this committee, we are stewards of the public health system. 
The importance of working together cannot be overemphasized 
because the enemy we face already lies in wait on our horizon. 
Its presence cannot be ignored or denied.
    We do not know when the threat will be realized and an 
attack will begin, and we cannot identify or categorize what 
danger we will face. It could be a natural disease like the 
bird flu, or it could be an orchestrated attack by a terrorist 
group. We cannot know for certain what it will be, but we do 
know full well that we must have a public system that is 
prepared for it.
    The 9/11 attacks produced a phrase we all heard, and we 
should keep in mind during the consideration of this 
legislation. It has been said that part of the problem was a 
``failure of imagination,'' an inability to predict in detail 
the kind of threats that we face. Needless to say, we cannot 
afford to have a failure to prepare for a threat to our 
national security.
    The stewardship of the public health system is not a 
responsibility the Federal Government bears alone, but one that 
is shared with State and local health departments. The Federal 
Government cannot provide for all our public health needs. 
Rather, public health authority begins and ultimately lies with 
the States. Although we have developed and enhanced key Federal 
resources, the lion's share of public health authorities, even 
during an emergency, rests at the State level.
    When we last examined this critical infrastructure, 
Congress understood the need to invest in modernizing our State 
public health system, and to enable them to respond to newly 
emerging threats.
    As an accountant by training, I am very comfortable with 
evaluating a program by measuring the outcomes and 
effectiveness of past investments. Here, we need to do similar 
examinations. We have to determine if we are going to get 
enough bang for our buck. We have to make sure that States are 
using the Federal funds wisely, and they have the resources to 
make all Americans safe from bioterrorism or bird flu. This new 
reauthorization must provide better coordination, better 
preparation, a bigger and better supply of drugs, vaccines and 
other medical products, and better evaluations of each State's 
    I would like to take a moment to commend the Bioterrorism 
Subcommittee and its chairman, Senator Burr, and the majority 
leader, Senator Frist, and their staffs, for their persistence 
and leadership on these issues. I also want to commend Senators 
Gregg, Hatch and Hagel for their attention to these issues.
    In addition, I would like to express my deep appreciation 
to Senator Kennedy and the Democrats on this committee and 
their staffs, as well as Senators Lieberman and Obama for their 
continued hard work and leadership on these issues.
    Senator Burr and I look forward to working with the entire 
HELP Committee in developing the legislation that will lead us 
to the next level of public health preparedness.
    Again, thank you for coming here today to engage in a 
discussion of the threat that lies before us and how we can 
improve our preparedness. I look forward to working with this 
committee and our subcommittee to do what is needed to ensure a 
strong national health system, and to be sure that it is in 
place to protect and safeguard the health and well-being of all 
    When Senator Kennedy gets here, we will allow him to make 
an opening statement. He is a part of the discussion on the 
floor over there at the moment too, so his entire statement 
will be a part of the record.
    [The prepared statement of Senator Kennedy follows:]

                 Prepared Statement of Senator Kennedy

    I commend our Chairman, Senator Enzi, and our Subcommittee 
Chairman, Senator Burr, for holding today's hearing on an issue 
of extraordinary importance--preparing the Nation to meet the 
challenges of epidemics and public health disasters.
    After our disagreements of yesterday on the small business 
health plan bill, I'm glad to return to a topic on which we 
agree so well. We've worked together on BioShield, on smallpox 
compensation, on the legislation enacted in 2002--on 
bioterrorism and outbreaks of infectious disease, and on many 
other issues related to health preparedness. Our challenge now 
is to reauthorize and strengthen the legislation enacted in 
2002 and prepare for the public health threats we face.
    An indispensable partner in that effort will be our 
distinguished witness, Secretary Leavitt. All of us on the 
committee are aware of his dedication to improving our 
readiness for pandemic flu. His commitment knows no bounds--
he's even visited chicken coops across the world to see first 
hand the measures being taken in other countries to contain 
avian flu.
    As commendable as Secretary Leavitt's efforts have been, 
every expert analysis has concluded that there are dangerous 
gaps in preparedness. In December, the Trust for America's 
Health gave the Federal Government a grade of only D+ for 
public health emergency preparedness. According to a recent GAO 
report, the administration is ``still in the process of 
developing goals, requirements, and metrics'' for assessing 
national preparedness.
    The question is why--more than 4 years after the attacks of 
September 11th--we are still just in the planning stages of 
    Most Americans probably assume that major investments are 
being made in our hospitals and health departments to see that 
they have the resources, the skilled personnel, and the 
information technology needed to respond adequately to a major 
    Sadly, that assumption is mistaken. The programs to 
strengthen health agencies and to improve the readiness of 
hospitals do not receive enough funding even to keep pace with 
inflation. Other essential programs, such as anthrax research, 
pandemic planning, and emergency medical services for children, 
are being severely reduced or even eliminated.
    But even those shortfalls tell only part of the story. The 
Nation's hospitals rely on Medicare and Medicaid for much of 
their funding--yet the President's budget cuts Medicare alone 
by over $100 billion in the next 10 years. In Massachusetts, 
hospitals will have to cut their budgets by more than $400 
million. It's unrealistic to ask hospitals to invest in 
ventilators, positive pressure rooms, disaster preparedness 
exercises, and other actions to improve readiness--while 
cutting their budgets for basic services. We can't achieve 
preparedness by weakening the heart of our health care system.
    Although the budget resolution we are debating now has 
wisely rejected these drastic cuts, we have seen time and again 
that conference agreements usually reflect the President's 
proposals, not the amendments of the Senate.
    We must learn the lessons of the past and see that our 
health agencies can detect disease threats rapidly and 
accurately, that our hospitals and health professionals can 
treat the victims of disease, and that our communities have 
adequate plans to contain a disease outbreak.
    I look forward to working with the members of this 
committee, with our colleagues in the Senate and with Secretary 
Leavitt and our other distinguished witnesses today to make 
more effective progress in meeting this basic responsibility.
    The Chairman. So we will now hear from our first witness 
today. The Secretary of the Department of Health and Human 
Services joins us to discuss the Department's role in leading 
national efforts to protect the health of all Americans. 
Secretary Leavitt has a distinguished background in Government 
service, serving as the Governor of Utah, my neighboring State, 
and administrator of the Environmental Protection Agency, 
before coming to the Department of Health and Human Services in 
early 2005, and he has been really busy since then. He was even 
in Wyoming last week.
    The Secretary will discuss the current initiatives in place 
to shore up America's defenses and the ability to respond to 
public health emergencies, as well as the next steps in 
preparing more effectively and efficiently for these threats at 
all levels of Government. I think you have made trips to 22 
States already talking about this, and I appreciate that effort 
to inspire their preparedness. I look forward to your 
    Mr. Secretary.


    Secretary Leavitt. Thank you, Senator. Mr. Chairman and 
Senator Burr, I am very pleased to be here to update you on the 
steps that the Department of Health and Human Services has 
taken to prepare for the threats of bioterrorism and other 
possible public health emergencies, including pandemic 
    The events of September and October of 2001 served as a 
continuing reminder that terrorism, indeed bioterrorism, is a 
serious threat to our Nation and to the world. The 
administration and Congress responded forcefully to this threat 
on a number of fronts, including the passage and implementation 
of Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, and the Project BioShield Act of 2004.
    Together, the administration and Congress provided 
significant new funding to strengthen our medical and our 
public health capacities to protect the citizens of our Nation 
from future attacks. While public health remains chiefly at the 
local and State responsibility, HHS does play a pivotal 
leadership role, and I am very pleased to join you today to 
update the committee on our progress.
    In the summer of 2003, HHS completed its first strategic 
plan to counter bioterrorism and other public health 
emergencies. Since then, HHS has worked diligently to work 
closely with State and local departments to implement this 
strategy. These experiences, in turn, have continued to yield 
important insights regarding our strategy and our 
implementation. HHS has updated the plan during the summer of 
2005 to capture important lessons we have learned.
    The updated plan continues to focus on the same major 
    Rather than take time to go through all of those today in 
my opening statement, Mr. Chairman, I will submit it for the 
record, but I would like to comment briefly on Project 
    It is a critical part of a broader strategy to defend 
America against the threat of weapons of mass destruction. It 
provides HHS with several new authorities to speed the 
research, the development, the acquisition and the availability 
of medical countermeasures to defend against chemical, 
biological, radiological and nuclear threats.
    In exercising the procurement authorities under BioShield, 
HHS has launched an acquisition program to address each of the 
major four threats that we have deemed to be material threats 
to the United States population, that is to say, anthrax, 
smallpox, botulinum toxins and radiologic nuclear agents. HHS 
has used the special reserve fund to award two contracts for 
vaccines against anthrax, one contract for a liquid formulation 
of a drug to protect children from radiologic iodine exposure 
following a nuclear event, and one contract for agents for 
countering the effects of internal exposure to radioisotopes.
    In addition, negotiations are under way for a series of 
other purchases that we will talk about, I am sure, in more 
    Given the limits of my time, I would simply like to 
indicate to you that I am anxious to have a conversation about 
ways we can improve BioShield. I have been in this office now 
about a year. I was not here when the original act was put into 
place, but it is very clear to me we have to do some things to 
streamline this and to speed it up, and I look forward to 
working with the committee in devising those strategies. There 
are some things about the bill, the way it is written, that 
cause me pause and concern. I will be happy to talk about those 
in more detail as we get moving forward. We have suggestions, 
and I am anxious to sit down and work them out because this is 
a very important undertaking.
    Thank you, Mr. Chairman.
    The Chairman. Thank you, Mr. Secretary. We really 
appreciate you taking the time to come and visit with us today, 
and also to rearrange your schedule. Your comments on what we 
are doing are particularly critical because you are the one 
that has to put them into place.
    I also want to thank Senator Burr for his diligence on all 
of these issues. He came from the House with a vast pool of 
knowledge, and he has put that to use here, as well as getting 
some real experts on his staff, and they are definitely making 
a difference. I would defer to him for any statement that he 
would like to make, and then any questions, as I know he needs 
to get back to the floor to do some defense of some things over 

                   Opening Statement of Senator Burr

    Senator Burr. Thank you, Mr. Chairman.
    Welcome, Mr. Secretary. Since we are discussing some avian 
flu issues on the floor, I will make my time as useful over 
there as we can, because we know the urgency of that.
    Mr. Chairman, if I could, let me say that I think we are in 
one of the most crucial periods as it relates to the decisions 
we make about how well this country is prepared and our 
capabilities to respond to emergencies. We have gone through a 
lot in the last 4 years. Some has been intentional. Some has 
been natural. Some has possibly been accidental. We have seen 
the gamut of things that can be thrown at us.
    The biggest mistake we can make is not to look at those 
experiences and figure out what we learned from them that will 
enable us to be better prepared in the future. That is why I 
think there is a value in the natural disasters that struck the 
Gulf Coast, that we can look at our public health 
infrastructure, and, Mr. Chairman, we will announce a timeline 
when there will be a CODEL from this committee that goes 
specifically to the Gulf Coast to look at the public health 
infrasturcture and talk to the individuals involved in public 
health down there, and find what worked and what did not work, 
and how we might reflect those changes in conjunction with HHS 
in the reauthorization of the Public Health Security and 
Bioterrorism Preparedness and Response Act.
    Making sure that somebody is in charge, Mr. Secretary, you 
have heard me say that numerous times. I believe it is 
absolutely essential, and I think that the Katrina after-action 
report suggests, from a response standpoint, that it clearly 
needs attention. Modernizing how our public health departments 
detect, investigate and contain health threats is absolutely 
essential. Protecting the public by more quickly and 
efficiently responding to national medical emergencies, we know 
there is no substitute. America will not let us off the hook 
for not being there.
    We have a lot on our plate, and if it was not for the 
chairman's support and Senator Kennedy, the ranking member, 
quite frankly, we could not be as aggressive as we were last 
year. Mr. Secretary, I know that BARDA was a big bite. I will 
let you know today that I intend to reintroduce a bill that has 
been scrubbed, a week from Monday. I look forward to any 
further input that HHS would like to put in the bill. My hope 
is that, and my strong belief is, that we have done this in a 
way, not just with the administration, but with members of this 
committee, and more importantly, members throughout the Hill, 
where it has been, I think, one of the most transparent 
processes that we have gone through.
    To some degree further in your testimony, you do say that 
the bill, as it is currently designed, would impose an 
organizational framework on HHS that impairs your ability to 
implement a strategic approach for medical countermeasure 
development and procurement. That disturbs me. It disturbs me 
because we are a year down the road of developing a bill that 
all of a sudden there is a new issue that arises in your 
testimony that we have not heard or maybe it is on the fringe 
of something that has been brought up before. But it seems 
somewhat new to me, so my hope is that within 9 days that we 
can work this out.
    I was here when we did Project BioShield. I think it was 
communicated very clearly from the administration what their 
intent was. Like anything of this magnitude, I am not sure that 
we have necessarily structured it or implemented it in the way 
that I envisioned, and I think to some degree that is 
understandable, because I think that this is massive and it is 
a new creation, a new model, that did not exist. My hope is 
that with Senator Enzi, Senator Kennedy, Senator Dodd, you, and 
the Agency, that we can come up with legislation that 
complements what BioShield was set up to do, and I believe 
without a focused effort on advanced development of 
countermeasures, it is impossible to believe that we are going 
to speed up the timelines on development of these 
countermeasures for current and future threats.
    You have been a stalwart at carrying the message about 
avian flu. If it was not for you, America would not know about 
this. I understand next week North Carolinians are going to 
have you there, and we are delighted to hear that.
    But we have a tremendous number of decisions to make about 
all of the other threats that we know about today, but more 
importantly, the ones that we do not know about, the ones that 
we are susceptible to for the same reason that we are to avian 
flu. They might be carried by a bird, so from a migratory 
standpoint they affect us. They may be carried on an airplane, 
where 10 years ago we did not have to worry about the mobility 
of a world population. We have to have a framework that is able 
to absorb what we do not know is going to be a threat in the 
future, because, quite honestly, we are not going to have the 
luxury of coming out and saying, let's take $7 billion and 
let's put it right here and let's create an infrastructure and 
let's develop a vaccine.
    The reality is, to some degree we are a little bit behind 
the curve. This time, we have to do it this way. I think 
Congress agrees. But I am not sure it is a smart way, long-
term. Short-term we have to, but I think we need to begin to 
think about what kind of framework we should set up to be able 
to handle what we do not know in the future for vaccine 
development. I know on this committee there is not consensus on 
what we did on liability, but I better sleep every night 
knowing that I think we are going to advance faster and further 
because we made a very tough decision as it related to 
liability, and Senator Dodd was very instrumental in the 
compensation piece. It is not perfect, but we have tried to 
address it.
    It is my hope that we can go through this year with a dual-
track of one bill on advanced development for countermeasures, 
and also the reauthorization of the Public Health Security and 
Bioterrorism Preparedness and Response Act.
    I only want to ask you one question today, and it really 
does get at the heart of the pandemic flu issue. Last week it 
was carried in the news, I think, that HHS recommended--and I 
am not sure whether this is the case--that people go out and 
buy canned meat and canned milk and put it under your bed. I 
will let you address whether that was an official HHS 
    But we are at a point where we do not have a vaccine. Even 
though we are not concerned tomorrow that we are going to have 
a mass of the population affected, I think it is time for us to 
begin to think about those things that the American people can 
have at home that might protect them. One of them is a mask. I 
raise this question because I am scared that we will come up 
with a decision that says, let's go buy 300 million masks and 
let's store them. And if we get to a point when we need them, 
we will distribute them to the American people. To me, that is 
extremely flawed because we have not figured out how to 
distribute anything to the American people, and I think we 
proved that with ice after Hurricane Katrina.
    Has there been any out-of-the-box thinking at HHS relative 
to things that the American people probably should have in 
preparation for this new world of threats, and whether there is 
an ability for us to create a Federal Web site that allows us 
to negotiate a national price with manufacturers of certain 
products that meet the qualifications that we need, say, for 
protection against communicable disease, but that Americans 
could go online and purchase these products themselves and have 
them shipped directly to them, with the Government encouraging? 
I am not limiting that to masks or other products, and I am 
just curious as to your thoughts.
    Secretary Leavitt. Senator, we do feel, and have for an 
extended period of time, encouraged the American people to 
engage in activities that would amount to personal 
preparedness. We stockpile, as a Nation, certain commodities, 
not commodities, but certain medicines and medical supplies. As 
we have exercised our plans, it has become clear to me, as it 
has to you, that distribution is the challenge. It is not 
having a stockpile of medicines, it is being able to put pills 
into the palms of hands at the right moment to assure that it 
is doing what it needs to do. That is victory.
    We have been working with the States, who have the burden 
primarily of distribution, to develop their plans. We have also 
begun to look at different alternatives. One of them, for 
example, would be to have supplies in smaller caches resident 
in States, or in some cases, to put it with first responders. 
We have also looked at the development of home kits that could 
have particular pieces of medication or other purposes that 
could be procured. We are in the active process of 
experimenting with those as delivery mechanisms. We have, as 
well, encouraged people that it is a good idea, whether it is a 
blizzard on the plains of Wyoming, or a hurricane, or a 
pandemic, or a bioterrorism event, that it is a good idea to 
have food in storage in case they cannot go to the grocery 
store. It is a good idea to have a first aid kit. It is a good 
idea to have some water in storage. That is just good common 
    We are working with the Department of Homeland Security to 
provide information to people on what can be done and what 
should be done.
    Senator Burr. Mr. Chairman, if I could, one more question. 
The White House Katrina Report suggests that the National 
Disaster Medical System, NDMS, should go back under HHS. Do you 
care to comment on that?
    Secretary Leavitt. It is a very good idea. As we went 
through Katrina one of the things that was evident is we were 
responsible under ESF-8 for the medical disaster, that unless 
we were--we were not able to deploy medical resources, and we 
are not always certain where they were being deployed. We have 
had a lot of discussion about this. The recommendation, in 
fact, was made that they transfer back. We are supportive of 
it, and we will be working with the Department of Homeland 
Security to develop legislation that can be presented to 
Congress soon.
    Senator Burr. Are there other health response pieces that 
are currently housed at DHS that you feel are more appropriate 
to be at HHS?
    Secretary Leavitt. That was the primary one. There is a 
clear understanding, I believe, between the Department of 
Homeland Security and Department of Health and Human Services 
and the White House that the Department of Health and Human 
Services has primary responsibility on all medical disaster 
    Senator Burr. I do hope, Mr. Chairman, as we go through 
this, that HHS will work with us very closely if there are 
other areas, and that we might be able to handle all of them in 
this reauthorization bill and maneuver through any territorial 
battles that might or might not exist between agencies.
    If I could, Mr. Chairman, as it relates to the bill that is 
currently being discussed on the Senate floor, in that budget 
resolution it assumes that the President's budget, which 
suggests that he will ask for $2.3 billion in additional avian 
flu money at some point for the 2007 budget, this budget 
resolution assumes that that will happen. We have accounted for 
    Can members of this committee feel confident that the 
administration has asked for the number that they need, that 
any attempt to raise that would necessarily not be needed from 
a standpoint of the development, procurement, preparation, and 
response relative to the 2007 timeframe?
    Secretary Leavitt. The $7.1 billion request that the 
President made for an emergency supplemental, we believe is 
responsive to the need.
    Senator Burr. Mr. Secretary, I thank you. Again, I 
apologize for my time constraints.
    Mr. Chairman, thank you for your leniency, and I thank my 
    The Chairman. Thank you for all your effort on this.
    Mr. Secretary, your full statement will be a part of the 
record, and I appreciate the timeliness you got it to us, and 
also all the information that is contained in there.
    You did mention in your written statement, and mentioned it 
here briefly too in your oral statement, that HHS is working to 
more efficiently implement Project BioShield, and I applaud 
your efforts to work within the framework of that legislation. 
However, in your review of the bill's implementation, did you 
determine that any of the legislative authority hindered your 
    Secretary Leavitt. Are you speaking about the current 
BioShield process?
    The Chairman. Yes.
    Secretary Leavitt. Mr. Chairman, what I have found, after 
observing this for a year, is that we have just created, either 
legislatively or regulatorily--I am not sure which it is, it 
may be a combination of both--but a system that just takes too 
    I have experienced this firsthand. I mean it is basically a 
six-step process. The Department of Homeland Security 
determines what the threats are that we need to focus on. And 
then it comes to a subcommittee, the Weapons of Mass 
Destruction Medical Countermeasures Subcommittee. They 
determine what the options are. Then it goes on to HHS. As the 
Secretary, I determine whether we should do it or not. Then it 
goes from the Secretary of Health and Human Services to the 
Department of Homeland Security, and they have to make a 
decision to either endorse our recommendation or not. Then it 
goes on to the Office of Management and Budget, where it has to 
be analyzed again, and then it goes all the way back to HHS for 
us to act on it.
    At every point along that way there are delays, and it is a 
frustrating process that we just, frankly, need to improve, and 
we can. It is not something that we should not do and do 
quickly. I am looking forward to working with the committee to 
make whatever changes are necessary to accomplish that.
    The Chairman. I appreciate that. One of the things that we 
run into is there is this formality of letters, and we expect 
that the formality will still continue, but we hope that there 
will be an informal process, where, as you notice things you 
can suggest them to us, so we understand them before we, 
perhaps, get to markup, and then run into the normal 
administration letter that sometimes is a surprise to us.
    Secretary Leavitt. We will do our best to be better at 
    The Chairman. I have not had that problem with you, and I 
just wanted to make sure that we would not.
    I mentioned before your trips to the States. I really 
appreciate that. Wright, Wyoming had a tornado a couple of 
weeks before Katrina happened, and that is 38 miles south of my 
home in Wyoming, and it happened to be during a recess, and so 
I got to spend a lot of time in Wright seeing how the process 
worked, and I found out that what I thought FEMA did really was 
not what FEMA did. Consequently, I think there were some 
expectations with Katrina that really were not what FEMA does. 
The same could happen with all of HHS's efforts, and so I 
really appreciate your getting out and visiting the States. I 
think you have been to 22 now. Could you describe a little bit 
the difference in preparedness between--and you do not need to 
mention which States they are, but the difference between the 
well-prepared States and the States that need to work more on 
preparedness. What are the significant differences?
    Secretary Leavitt. Mr. Chairman, first of all, I do not 
believe anyone in the world is well prepared for a pandemic, 
and I am not sure anyone can claim to be well prepared for a 
broadly spread bioterrorism event, for example smallpox, that 
could spread across the country. We need to continue to improve 
our efforts. We are better prepared today than we were 
yesterday, and we will be better prepared tomorrow than we are 
today. It is a continuum of preparation.
    One thing that is evident is that there is a substantial 
difference between having a plan and being prepared. The 
primary difference lies in exercising the plan and what is 
being learned from it. In a large section of the States now we 
are seeing preparedness exercises, and it is evident to me, 
when I see a State that has exercised, they are far more 
advanced in their thinking than those that have not. That is 
one of the things we are emphasizing in our cooperative 
agreements. It is not just having a plan on paper, but are you 
exercising it and being accountable for those exercises.
    The Chairman. Thank you. The National Defense University 
has done some exercises for us, and involved some of the local 
groups which help them to understand what could happen under 
certain circumstances and what kind of preparations are 
necessary, and of course, I encourage all of my colleagues to 
be involved in that kind of a process. It is stark and 
enlightening. I appreciate what you are doing to help enlighten 
the States.
    Would it be helpful for the States to have more measures to 
determine if they are adequately prepared?
    Secretary Leavitt. I will make two points on this, Mr. 
Chairman. One is that every State is unique, but there are some 
overall metrics that help, should guide, and in fact, will 
inform their preparation and our knowledge that they are 
prepared. I have been, as you indicated, in 22 States. We have 
summits planned in every State.
    One of the primary messages that I want to convey when I go 
to the States is this, that when it comes to a pandemic, or 
when it comes to a bioterrorism event that could spread disease 
across the country where there is a combination of terrorism 
and disease, that any community that has failed to prepare and 
to exercise their preparation in the anticipation that somehow 
the Federal Government will come to their rescue at the last 
minute, will be sadly disappointed, not because we lack the 
will, not because we lack the wallet, but because we lack a way 
to respond to 5,000 different communities at once. When we are 
dealing with widespread disease that is, essentially, 
communicable disease, that is essentially what we are dealing 
    So it is very important that local communities are 
preparing within their community, that every community has 
surge capacity in their hospitals, and figured out a way how 
they will deal with it if their hospital is overrun with demand 
and need, how they will set up additional facilities and what 
they will do. Senator Burr mentioned masks, and the gloves, and 
the kinds of things that need to be contemplated. Those are the 
decisions that need to be made within local communities, not 
just looking to the national Government. We have a role and we 
will play it, but every community needs to be prepared.
    The Chairman. Thank you. My time has expired. I do not know 
what the American people would think of a quarantine these 
days, and how they would respond to that.
    Senator Dodd.
    Senator Dodd. Thank you, Mr. Chairman.
    Mr. Secretary, how are you?
    Secretary Leavitt. Good, Senator, thank you.
    Senator Dodd. I always tease the Secretary as the former 
Governor of Utah. My wife's family is from Utah, and I am 
considered the third Senator from Utah, and I represent those 
10 Democrats in Utah that are out there.
    Anyway, it is good to see you, Government, Secretary. Let 
me say at the outset that I have reached you in a number of 
forums, both publicly before the Congress, and I think you do a 
good job. You have your hands tied in some ways, which I am 
going to talk about here this morning, but you have a good 
demeanor. You are not an alarmist, but you are very direct and 
very honest. I listened to a number of interviews you have 
given and been asked some very tough questions, and have not 
ducked in terms of your concerns about the gaps we have to fill 
in here if we are going to be ready. That has been very 
helpful. I think it is really helpful to have people in a 
public setting, who will look in a camera and answer an 
interviewer's question in a very direct way and be very candid 
with him, so I appreciate it.
    Secretary Leavitt. Thank you, Senator.
    Senator Dodd. I want to talk about a couple of issues with 
you, and my good friend from North Carolina, Richard Burr, we 
work pretty closely. Senator Kennedy, myself, Senator Burr, 
Senator Frist, Senator Enzi, a lot of hours we have sat trying 
to work through this issue of the bioterrorism bill. I was 
disappointed in a way that we did not complete the work, and I 
want to address a couple of concerns that I have about this, 
and you commented on them as well in the past, and I agree with 
your comments. I am just worried that we are not taking the 
comments and applying them in the law here.
    It seems to me that any biodefense plan has to have two 
ingredients in terms of vaccines. One, you have to encourage 
manufacturers to produce the product, and to produce safe 
products and effective products. And to do that, it seems to 
me, while you want to get working on this stuff and you have to 
deal with some of the liability issues, I am concerned that we 
went so far over in the effort to get the products produced, 
that we got very lax on the effectiveness and safety issue, 
which relates to the second question, and that is the 
compensation issue.
    I realize there are some compensation provisions in the 
bill, but we have the experience of the smallpox issue, you 
will recall, a few years ago, where clearly we had--we thought 
we did the right thing, and then we discovered first responders 
said, forget about it. I am not going to take this stuff 
because there is no compensation. Lord forbid, I have an 
adverse reaction to all of this.
    I am trying to simplify this as tightly as I can. I am very 
worried that last December, when we sort of rushed this through 
in the Defense Appropriations Conference Report--and I realize 
there were time constraints in trying to get something done. 
But I am worried we did not seem to learn from previous 
lessons. When I look on the liability issues in terms of how we 
address them here, it was the bad actor decisions. Legal 
immunity, well, first of all, scope. the legal immunity to an 
incredibly broad range of products, which is very worrisome to 
me. All that needs to happen for the product to gain immunity 
is for the Secretary--and again, this is no indictment of you, 
Mr. Secretary--but any Secretary of HHS, to declare that it is 
necessary to respond to a pandemic or epidemic. I am just 
worried that is so loose.
    And then the bad actor provisions, the legal immunity even 
applies to drug companies and health care providers that act 
with reckless or gross negligence. The only case where immunity 
does not apply is willful misconduct. That is a very low 
standard in my view, very low, and I am worried that with that 
standard out there we end up with a product that is not as 
safe, or maybe as effective, and then we have a compensation 
program that relies on an annual appropriation, which as you 
know, around here is very hard to get, instead of having a 
reliable funding source as we have done, for instance, we 
worked up here, a lot of us--I do not know, Mike, if you were 
involved--with the childhood vaccines, the compensation fund, 
which is tremendously well funded today. They have $2 billion 
in that fund. But it provides for an ongoing source of revenues 
to make sure we have an adequate amount of compensation, to 
assure families, when we say to them, ``We hope nothing ever 
happens to your children when they get vaccinated, but if it 
does, you do not have to go through a long litigation process. 
We have a fund here to compensate you.'' Not that that is any 
great consolation if you have trouble, but nonetheless, it is 
    Here it is an annual appropriation process, and I think the 
combination of these things could pose some serious issues for 
us. You have made some wonderful statements about compensation. 
I have listened to them and heard them. I am trying to square 
your own views, I think, as I understand them, on the 
importance of a very good compensation problem so we do not 
have a smallpox problem with first responders and others.
    And second, setting such a low bar on willful misconduct, 
as opposed to gross negligence, that combined with the 
compensation, can pose some real problems. And I would like you 
to address those concerns I have. And they are not my own. 
There are others up here that share them, but it seems to me 
they pose some real problems for us.
    Secretary Leavitt. Senator, it has been my observation that 
rarely is there a piece of legislation dealing with this 
subject, or many others in Congress, that comes out with 
perfect agreement. The circumstance I found myself in was, in 
terms of pandemic preparation, for example, that we have a need 
to get vaccines made, and we do not have a capacity as a Nation 
to do it. Vaccine manufacturers were clearly seeing liability 
as an obstacle, and we needed to get it removed, and there was 
a rigorous debate, and this bill came forward. I do not have 
the illusion that it will be the last time it is discussed. 
That discussion will go on.
    What I can tell you is that the law that we have in place 
has now empowered me as Secretary of Health and Human Services 
to bring vaccine manufacturers to the table, and we are making 
very steady and important progress in being able to get 
vaccines made. I have made clear that I believe a compensation 
approach does need to be part of this, and I know that will be 
a conversation that will go forward, and we will be an active 
participant in it. We have to find the balance here, and there 
is always disagreement where the balance falls, but let me just 
say my appreciation for the fact that the Congress did act, 
because it was a clear barrier. I met with every vaccine 
manufacturer and said to them, ``I have to get a vaccine made. 
We are facing the potential of a pandemic with no capacity for 
human immunity.''
    There were three barriers. The first was liability, which 
we are talking about. The second was the need for regulatory 
streamlining, and the third was to make certain that there was 
someone there to buy the vaccine.
    We have solved the liability problem, at least for now. I 
recognize there will be ongoing conversations about it. We have 
worked with the FDA to take away those barriers. We are working 
with the FDA to assure that when we are developing new 
facilities, we are actually doing the regulation of them as we 
go, as opposed to waiting until it is finished, and that has 
helped. And then we are working with the companies on the 
    So I hear you about the debate. I think I understand the 
ramifications on both sides, but I can tell you how grateful I 
am that we are able to move, and we are moving rapidly to get 
this vaccine problem solved.
    Senator Dodd. I hear you saying that. And if we were 
sailing in uncharted waters, I might be more sympathetic to the 
answer, but we have known from previous experiences. I 
understand the manufacturers' side, they do not want to be 
sued. I do not know anybody that wants to be sued. And you want 
them to produce products. But it seems to me that we do not 
want to fall into the situation where we get vaccines produced 
that are not safe. And that is our responsibility collectively, 
both yours and ours up here, that it is not an easy path to go 
down, but it is one we have really got to try and insist upon.
    I mean, you made a very good statement, I think you were on 
Meet the Press a few months ago, and you were asked about the 
limits on liability and adequate compensation. And there, I 
thought you gave a good answer. You said: adequate compensation 
needs to be made. In fact, your colleague, Dr. Gerberding, was 
very good was well. She testified before the Foreign Relations 
Committee on the general matter, and I asked her to comment 
about the compensation issue. She said at that time, and I am 
quoting her: ``I certainly feel from the standpoint of the 
smallpox vaccination program, that an absence of a compensation 
program that was acceptable to the people we were hoping to 
vaccinate was a major barrier, and I think we've learned some 
lessons from that.''
    Are you satisfied that requiring an annual appropriation 
for the compensation fund is going to be adequate to maintain 
the strength of that compensation fund to encourage first 
responders and others to be able to take these vaccines?
    Secretary Leavitt. What is evident to me, Senator, is that 
we had to get vaccines made, and once we have them, we have 
time to deal with this issue. Once we can start putting vaccine 
into arms, that is when the compensation fund would in fact 
have to be in place. We have time to resolve that issue. We did 
not have time to do the vaccine, and I was deeply appreciative 
of the fact we were able to at least set a course for a 
compensation package, but at the same time, get the liability 
taken care of so I could start getting these companies started.
    Senator Dodd. My experience up here is we do not, once the 
doors are shut, it is awfully difficult to come back and 
relegislate again, and I realize, again, you have some power as 
Secretary here, which I appreciate, but this is law now, and 
where it succeeds you down the road, whatever, it will have the 
same authority, and whether or not they will be as judicious in 
the exercise of that authority is something we worry about. I 
just hope we are not sitting back here having a hearing and 
wondering why we did not do a better job on compensation 
requiring a consistent source of funding for this program.
    Let me raise a second issue if I can, Mr. Chairman, here, 
and this has to do with the State efforts in emergency 
preparedness, and I listened to you talk about the number of 
visits to a variety of States you have made. The Connecticut 
Center for Public Health Preparedness at Yale New Haven Health 
System is leading the State's emergency preparedness in my 
State. Interestingly, as we go through, it is the only hospital 
system in the country with a CDC and a Center for Public Health 
Preparedness designation, and the only CCHP with a primary 
focus on preparing the health care delivery workforce for 
disaster response.
    They were asked the other day to come up and to develop 
some regional partnerships. In fact, 3 weeks ago, they were 
asked by the health agency here if they would be willing to 
develop a national standardized education and training program, 
but there is no financial commitments at all going along with 
this. I am worried this is the only place in the country that 
has this designation, both designations, and yet, we are not 
adequately funding their ability, or the ability of others. I 
am hearing from other hospitals in my State, and I am a small 
State, as you know, Connecticut, but you can imagine I am 
hearing from people in Hartford or other places in the eastern 
part of the State saying, that is great you are dealing with 
that New Haven area or lower part of the State, but we are all 
sitting up here and got a separate set of issues we have to 
    Give us some indication of how this is progressing, and 
whether or not the Yale experience--by the way, are pleased to 
be designated as such, and they are a very good facility, 
obviously, and pleased to have both designations. But I was 
sort of stunned to find it was the only place in the United 
States with both designations.
    Secretary Leavitt. Senator, I must tell you that that 
designation does not come to my memory quickly. I am not sure--
    Senator Dodd. Sure. I apologize on springing it on you.
    Secretary Leavitt. I can tell you that a primary part of 
our mission at the national Government is to assure that the 
States are providing for their communities, the deep community 
sense of training. In bioterrorism alone I am aware that over 
230,000 people have been trained through those efforts. So I 
cannot respond directly. I would be happy to in writing, but I 
do not have a response for you immediately.
    Senator Dodd. Around the country, I presume other efforts 
are being made to see to it that we have facilities in these 
States that are designated by the CDC and the other centers for 
handling this kind of thing.
    Secretary Leavitt. We have a whole series, for example, of 
laboratories that--different categories of laboratories--and in 
every State now we have laboratories that have been certified 
to a certain extent and at a certain level. We have regional 
laboratories, we have national laboratories. We are working 
through a system to designate facilities in every State. One of 
the things that becomes quite evident, when you start dealing 
with bioterrorism and you deal with pandemics or any kind of an 
emergency involving disease, that will manifest itself first in 
a State. When a bird inevitably flies into the United States 
with the H5N1 virus on board, that bird will likely be 
presented at a State agricultural lab first. It will then go to 
a State agricultural commissioner. And then it will find its 
way to Washington.
    So our first line of defense is at the State level.
    Senator Dodd. Thank you.
    Mr. Chairman, going back to the first set of issues here, I 
am deeply concerned about the standards we are applying. Again, 
I have great respect. I probably represent more pharmaceutical 
companies in Connecticut than almost any other State in the 
country, and we are very proud of the work they do. They would 
be the first to tell you in some ways, because they worry. 
Their reputations suffer from time to time when competitor 
companies produce less than quality products, and they get a 
black eye. So those of us who sit on this side of the dais--and 
you have been on this side of the dais--know what that is like, 
when one or other people can do things that we all have to 
answer for to some extent. But they will tell you, Mr. 
Chairman, that this issue of making sure we have safe and 
effective products is a matter they are concerned with as well, 
and a compensation program that we do more than just the annual 
funding process for is something we have to look at, or I am 
fearful we will end up back in the smallpox situation. I raise 
those issues with you today, Mr. Chairman, and hopefully we can 
find some legislative vehicle to address those two concerns.
    I thank you, Mr. Secretary.
    Secretary Leavitt. Thank you, Senator.
    The Chairman. I thank the Senator for his questions, and 
also the intensity with which he worked with us on coming up 
with a solution, and it is my understanding that it is not the 
compensation package, it is the actual compensation that you 
are concerned about.
    Senator Dodd. More that than anything else. We just do not 
have the money there for it.
    The Chairman. We will continue to work with you on that. I 
already knew that your State had the most insurance companies. 
Now I find that it has the most pharmaceutical companies too.
    Senator Dodd. Sort of the pinata here in politics.
    The Chairman. Between Connecticut and Wyoming, we got a lot 
of stuff. Senator Dodd has one of the quickest minds that I 
have worked with, and some of the most intensity, but also some 
of the best institutional memory. So I appreciate your work on 
    I have several more questions. I will ask a couple more, 
and I will submit some in writing to you that will require a 
bit more detail, but we appreciate having all of this 
information for the record.
    In S. 1873 we included an advance development agency to 
help spur late-state commercial development of Biodefense 
projects. Similarly, the administration's budget included money 
for advanced development at the National Institutes of Health. 
You said you thought it was desirable to have a new HHS agency 
to head up the advance development of bioterrorism inventions. 
Could you discuss that a little bit further?
    Secretary Leavitt. I would like one person at HHS to report 
to me and have responsibility for this entire area, and would 
be the Assistant Secretary of Public Health Preparedness. I 
have no reluctance, in fact, I have enthusiasm for having such 
an entity within HHS, but I would like it to fall underneath 
the purview of the Assistant Secretary for Public Health 
    I have 27 direct reports at HHS. That is not an ideal 
organizational structure, and I would like not to perpetuate 
that. I think it would not be just a matter of convenience to 
me, it would be better organization and we would get better 
work across the Agency. One of the dilemmas that often occurs 
in a department the size of HHS is that you get siloed work, 
and we have a number of different operating divisions within 
HHS that are working on matters related to this, and I need a 
person who can be the point. So my only request--not only 
request--but in terms of organization, I would like very much 
to see it organized underneath that one person.
    The Chairman. I have gotten to watch you as Governor and at 
the EPA and HHS. I have always been inspired and impressed with 
your management skills and appreciate your suggestions on that.
    In January of this year you announced a new proposal to 
revitalize the Commission Corps. Specifically, your new 
proposal would increase the number of officers by 10 percent to 
6,600 members. It would improve response operations and team-
oriented deployment and it would change the recruitment process 
so it includes stronger personal incentive programs and a 
better approach for assigning officers. Now, as you mentioned, 
Commission Corps officers are key to our national response to 
emergency by providing a ready reserve of health expertise. For 
instance, the Corps officers have been deeply involved in 
responding to recent public health emergencies. More than 2,000 
Commission Corps officers were deployed to the Gulf region, 
before, during and after Katrina and Rita.
    Given that, can you give me a few more details about this 
proposal? Will you need legislative changes to implement your 
new proposal?
    Secretary Leavitt. Senator, the Commission Corps of the 
United States Public Health Service, is a public service jewel 
in America, and it needs to be enhanced, expanded, and renewed. 
We have learned over time the importance of disease in the 
safety and health of our Nation. The Commission Corps basically 
represents a deployable force, or potentially a deployable 
force in a time of need and emergency.
    So the reconfiguration basically is to expand it from 6,000 
to 6,600. You mentioned that. It is to begin to organize it 
into deployable teams, so that if we need an epidemiology team 
that can be deployed to an event in the State of Washington, I 
have people who are ready to be deployed, and we do not have to 
search around through the various departments of HHS, assemble 
them together, and then move them off in a matter of a week 
instead of hours. I need them to be deployable in an hour. We 
need the capacity for what happened in Katrina, where we had 
2,000 Commission Corps officers deployed throughout that entire 
region. It would be helpful to be able to do it more quickly 
and to have the teams designed in a way that they will not 
disrupt the operation of the places where they work.
    This is an asset that is undervalued, under-appreciated, 
and in many respects, underfunded, and I intend to give it 
substantial attention during the time that I am Secretary, and 
the Nation will be a safer and healthier place as a result.
    The Chairman. Thank you. I also want to ask you about the 
National Disaster Medical System that plays a crucial role in 
providing those emergency medical care, and ensuring patients 
are moved to the appropriate treatment setting. The National 
Disaster Medical System, which works jointly with a number of 
Federal agencies, was transferred from HHS to the Department of 
Homeland Security in 2002. Now FEMA and DHS direct its 
activation, administration and funding.
    Given that HHS has been evaluating recent response efforts 
and developing policy proposals to bolster our medical 
response, have you been working with DHS to rethink the current 
structure of NDMS?
    Secretary Leavitt. We have, and I think it is fair to 
represent an agreement that we have with DHS, that it would be 
prudent to move the DMATs back to HHS so that we have the 
entirety of the medical disaster component there. We have 
responsibility for it in its entirety, and we need to have the 
capacity to deploy and manage the assets. And we will be 
preparing legislation to suggest that the Congress deal with 
that issue.
    The Chairman. I appreciate that. We are going to have a 
vote shortly. I thank you for your testimony, and for being 
here today. We will leave the record open so that questions may 
be submitted, and as I said, I have a few more detailed ones, 
so your people can provide some numbers.
    Secretary Leavitt. Thank you. I will look forward to that.
    The Chairman. I love numbers. We will continue to work with 
you on this. I really appreciate the job you are doing. Thank 
you for being here today.
    Secretary Leavitt. Thank you, Mr. Chairman.
    [The prepared statement of Secretary Leavitt follows:]

           Prepared Statement of the Hon. Michael O. Leavitt

    Good morning, Mr. Chairman, Senator Kennedy, and members of the 
committee. I am honored to be here today to update you on the steps the 
Department of Health and Human Services (HHS) has taken to prepare for 
the threats of bioterrorism and other possible public health 
emergencies, including pandemic influenza. The events of September and 
October 2001 served as a continuing reminder that terrorism--indeed 
bioterrorism--is a serious threat to our Nation and the world. The 
administration and Congress responded forcefully to this threat on a 
number of fronts, including through the passage and implementation of 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002 and the Project BioShield Act of 2004. Together, the 
administration and Congress provided significant new funding to 
strengthen our medical and public health capacities to protect our 
citizens from future attacks.
    While public health remains chiefly a State and local 
responsibility, HHS plays a pivotal leadership role. I am pleased to 
join you today to update you on the progress we have made.

                           HHS STRATEGIC PLAN

    In the summer of 2003, HHS completed its first strategic plan to 
counter bioterrorism and other public health emergencies. Since then, 
HHS has worked diligently and in close cooperation with State and local 
public health departments, to implement the strategy. These 
experiences, in turn, continue to yield improved insights regarding the 
strategy and its implementation.
    HHS updated the strategic plan in the summer of 2005 to capture 
important lessons learned. The updated plan focuses on the following 
strategic foci, which compose the overall framework for HHS efforts:

        1. Preventing Bioterrorism
        2. Enhancing State, Local, and Tribal Preparedness for 
        Bioterrorism and Other Public Health Threats and Emergencies
        3. Enhancing HHS Preparedness for Bioterrorism and Other Public 
        Health Threats and Emergencies
        4. Acquiring New Knowledge Relevant to Bioterrorism and Other 
        Public Health Threats and Emergencies
        5. Developing, Acquiring, and Deploying Priority Medical 
        Countermeasures for Chemical, Biological, Radiological and 
        Nuclear (CBRN) Threats

    In keeping with the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, the Plan emphasizes 
bioterrorism, while recognizing that public health threats and 
emergencies can ensue from myriad other causes, both naturally 
occurring and man-made. HHS and its partners therefore must prepare for 
and respond to all manner of mass casualty incidents. As a consequence, 
bioterrorism preparedness is not an insular activity for HHS but rather 
an integral critical component within an all-hazards readiness program. 
To ensure the synchronization of HHS' efforts in this area, the Office 
of Public Health Emergency Preparedness coordinates HHS-wide emergency 
preparedness activities and serves as the principal point of contact at 
HHS for other Federal agencies and Departments.
    This year, we are proposing roughly $4.4 billion to prepare for 
possible bioterrorist and other public health emergencies. This 

     An additional $68 million in the Strategic National 
Stockpile to expand capabilities to operate, properly store, and deploy 
the rapidly increasing holdings of these critical repositories;
     Approximately $1.3 billion at CDC and HRSA to continue to 
improve State and local public health and hospital preparedness;
     $79 million to fund the Mass Casualty Initiative, which 
includes Federal Medical Stations, Medical Reserve Corps, Healthcare 
Provider Credentialing and the Commissioned Corps Transformation 
initiatives, and;
     $160 million to support advanced development of priority 
medical countermeasures.

    This $4.4 billion is complemented by an additional $2.3 billion 
allowance for an emergency appropriation and $352 million in ongoing 
efforts in the fiscal year 2007 budget for pandemic influenza 
        state and local public health and hospital preparedness
    Under the President's National Response Plan, HHS leads Federal 
public health efforts to ensure an integrated and focused national 
effort to prepare for and respond to emerging biological and other CBRN 
threats. HHS is also the principal Federal agency responsible for 
coordinating all Federal-level assets activated to support and augment 
the State and local medical and public health response to mass casualty 
    HHS' leadership strategy begins with enhancing the capabilities of 
State and local public health departments and hospitals. This approach 
is consistent with experience of emergency responders everywhere; for 
all emergency incidents--whether naturally occurring, accidental, or 
terrorist-induced--begin as local matters.
    Principally through HHS's Centers for Disease Control and 
Prevention (CDC) and Health Resources and Services Administration 
(HRSA), funds have been provided to States and localities to upgrade 
infectious disease surveillance and investigation, enhance the 
readiness of hospitals and the health care system to deal with large 
numbers of casualties, expand public health laboratory and 
communications capacities and improve connectivity between hospitals, 
and city, local and State health departments to enhance disease 
reporting. First, the Centers for Disease Control and Prevention (CDC) 
provides preparedness funding annually to public health departments of 
all the States, certain major metropolitan areas, and other eligible 
entities through cooperative agreements. Second, the Health Resources 
and Services Administration (HRSA) employs complementary cooperative 
agreements to provide preparedness funding annually within States for 
investment primarily in hospitals and other healthcare entities. HHS 
collaborates with DHS toward ensuring that the guidance associated with 
the CDC and HRSA awards is coordinated with the guidance associated 
with those DHS awards that address other aspects of State and local 
preparedness, such as emergency management and law enforcement. 
Including the funding we have requested for fiscal year 2007, CDC and 
HRSA's total investments in State and local preparedness since 2001 
will total almost $8 billion.

                          PERFORMANCE MEASURES

    HHS through the CDC and HRSA cooperative agreements has undertaken 
a conscious process to develop performance measures for public health 
and healthcare preparedness activities. HRSA conducted an expert panel 
of States and other stakeholders (to include hospitals and hospital 
associations at the local and national level) in January 2006 to 
develop a core set of healthcare preparedness measures. These measures 
are being cross-walked with the public health measures developed by CDC 
and the Target Capabilities List (TCL) developed by the Department of 
Homeland Security (DHS). The measures will be undergoing a national 
vetting and review process in the near future and progress toward 
meeting these measures will be reported during the fiscal year 2006 
funding year.


    We are also taking important steps to expand and refine our disease 
surveillance capabilities. BioSense is a national program designed to 
advance a new type of biosurveillance at the national, State, and local 
levels. Using streams of health data and advanced algorithms for 
analyzing and visualizing these data streams, the new methods supported 
by BioSense address the needs of monitoring for infectious diseases, 
for biological and chemical attacks, and for naturally occurring public 
health emergencies. BioSense supports the situational awareness 
necessary to confirm and identify possible events, to track and manage 
their size and spread, and to provide public health and government 
decisionmakers the information needed to manage preparedness and 
response. Though data have been compiled through BioSense for the last 
few years, there has been a significant time lag in the transmittal and 
analysis of data. Starting January 1, 2006, CDC has been receiving near 
``real-time'' data from over 30 hospitals in 10 cities. The goal is by 
the end of 2006 to have over 100 hospitals in all 31 BioWatch cities 
participating in BioSense.
    In responding to the threat of pandemic influenza with the support 
of additional funding in fiscal year 2006, CDC plans to further 
accelerate implementation of the BioSense program in 2006 by increasing 
the number of participating cities, the number of healthcare systems 
and real-time clinical data sources within those cites, and 
incorporating other existing health data sources of importance in 
monitoring influenza activity and the effectiveness of emergency 

                        HHS FOOD SAFETY EFFORTS

    The Bioterrorism Act provided HHS with new authorities to protect 
the Nation's food supply against the threat of intentional 
contamination and other food-related emergencies. This legislation 
represents the most fundamental enhancement to our food safety 
authorities in many years. These additional authorities improve our 
ability to act quickly in responding to a threatened or actual 
terrorist attack, as well as other food-related emergencies.
    In addition to implementation of the new authorities provided in 
the Bioterrorism Act, HHS has undertaken numerous other activities to 
ensure the safety and security of the Nation's food supply. We have 
enhanced coordination with our partners in Federal, State, and local 
governments, academia, and industry. As an example, FDA USDA, DHS, and 
the Federal Bureau of Investigation are collaborating with States and 
private industry to protect the Nation's food supply from terrorist 
threats through the Strategic Partnership Program Initiative. The 
Initiative involves using a vulnerability assessment tool to identify 
sectorwide vulnerabilities. It will also identify mitigation strategies 
and research needs.

                      TRAINING AND SURGE CAPACITY

    An integral part of emergency response is the ability to provide 
surge capacity to undergird medical and public health systems that may 
be overwhelmed by mass casualties or displaced persons. A critical new 
program is the Federal Medical Stations (FMS), which was originally 
intended to provide a deployable medical capability (equipment, 
material, pharmaceuticals) to assist hospitals in meeting needed surge 
requirements. They are designed to be staffed by Federal personnel in 
support of regional, State, or local venues. Although still in the 
proof of concept phase, FMS capability was projected into the Gulf in 
response to Hurricanes Katrina and Rita. Ten 250-bed derivatives of the 
FMS were created within days of Hurricane Katrina. These units had 
pared down pharmaceutical lists and were used to support the medical 
needs of the evacuees, rather than providing hospital surge capacity. 
While the FMS was designed to be staffed by Federal personnel, they 
were also adapted during the hurricanes to support state-run medical 
needs shelters. Current plans are to expand the program to include FMSs 
that are specifically designed to support the States in providing care 
to evacuee populations with chronic medical conditions. As we further 
develop the FMS program we are considering how it can be used to 
support multiple capabilities. For example, with the growing concerns 
regarding pandemic influenza, the FMS program is exploring the 
possibility of using these mobile medical units to support quarantine 
stations. Our fiscal year 2007 budget seeks $50 million for FMS.
    In the mass casualty setting, the ability to quickly increase the 
number of health care workers available is a critical component of 
public health emergency response capacity. HHS' Health Resources and 
Services Administration (HRSA) has supported efforts to improve 
personnel surge capacity. Funds are used to allow jurisdictions to 
develop or enhance Emergency Systems for Advance Registration of 
Volunteer Health Professionals (ESAR-VHP), authorized under the Public 
Health Security and Bioterrorism Preparedness and Response Act. ESAR-
VHP is designed to help States develop registries of volunteer health 
professionals whose credentials have been verified in advance of an 
emergency so that they can be quickly called on and utilized in an 
emergency. These systems are being developed according to national 
guidelines, standards and definitions so that States can easily 
exchange health professionals in an emergency. Once fully developed, 
these state-based volunteer registries will include up-to-date, 
verified information on health and medical volunteer identity licensure 
status, and professional credentials required for practice in hospitals 
and other facilities. These systems will include Medical Reserve Corps 
volunteers, State and local personnel, and health professionals working 
in the private sector.
    Our fiscal year 2007 budget seeks $7.6 million for development of a 
web-based portal that would create the means for integrating the State 
ESAR-VHP systems into a national system, thereby promoting a more 
coordinated national deployment of personnel. The portal is intended to 
not only integrate existing State ESAR-VHP systems, but to also provide 
a credentialing service that could assist States with the development 
of their ESAR-VHP databases.
    HRSA also continues to support the Bioterrorism Training and 
Curriculum Development Program (BTCDP). This program provides support 
to health professions schools, health care systems, and other 
educational entities to equip a workforce of health care professionals 
to address emergency preparedness and response issues. It is estimated 
that nearly 225,000 health care professionals have received training to 
enable them to recognize indications of a terrorist event, treat 
patients and communities in a safe and appropriate manner, participate 
in a coordinated multidisciplinary community response, and alert the 
public health system rapidly and effectively. HRSA is promoting 
consistency, collaboration and coordination in healthcare preparedness 
training through the alignment of curriculum with the National 
Preparedness goal, adoption and promulgation of competency-based 
training, evaluation of training and healthcare preparedness through 
exercises and drills, and establishing a system for disseminating 
tested materials.

                         PHS COMMISSIONED CORPS

    The Commissioned Corps provides a unique source of well-trained and 
highly qualified, dedicated public health professionals who are 
available to respond rapidly to urgent public health challenges and 
health care emergencies. The Corps' response to Hurricane Katrina is a 
powerful example of what the Corps can do. In response to Katrina, we 
deployed more than 2,000 Corps officers--the largest deployment in the 
history of the Corps--and we still have personnel in the field 
providing care in Louisiana today. Transformation is intended to make 
the force management improvements that are necessary for the Corps to 
function even more efficiently and effectively. We are now in the 
process of organizing our officers into teams, providing more training 
and supplying more equipment so that they can deploy more rapidly and 
with more capability than is the case presently. All of our officers 
will be required to meet readiness standards. The President's fiscal 
year 2007 budget request reflects the importance that has been given to 
the transformation of the Corps, including an additional $10 million 
for strengthening the systems that will allow us to better manage the 


    CDC also operates HHS's Strategic National Stockpile (SNS), which 
contains large quantities of medicine and medical supplies to protect 
the American public if there is a public health emergency severe enough 
to cause local supplies to run out. Once Federal and local authorities 
agree that the SNS is needed, medicines and medical supplies can be 
delivered to any State in the United States within 12 hours. 
Consequently, each State is now required to develop plans to receive 
and distribute SNS medicine and medical supplies to local communities 
as quickly as possible in the event of a deployment.
    HHS's National Institutes of Health (NIH) is assigned the lead role 
in the research and early development of medical countermeasures to 
prepare for and respond to a biological, chemical, radiological, or 
nuclear threat agents, and in the conduct of research that will expand 
our understanding of the human health impact of these agents. The 
National Institute of Allergy and Infectious Diseases (NIAID) is the 
NIH institute with primary responsibility for carrying out this 
    Thus far, NIAID has used Project BioShield authorities to award 
$35.6 million in grants and contracts. The activities supported by 
these awards will advance development of countermeasures toward 
possible future procurement with Project BioShield funds. Twelve grants 
and two contracts have been awarded to support research for 
therapeutics and a vaccine candidate directed against the CDC Category 
A agents that cause anthrax, smallpox, tularemia, plague, botulism, and 
viral hemorrhagic fevers. NIAID has awarded 4 grants and 3 contracts to 
support research on medical countermeasures against radiological or 
nuclear terrorist attacks, including countermeasures to protect the 
immune system against radiation and improved treatments for the 
elimination of internal radionuclide contamination that can be given by 
mouth rather than intravenously.

Pandemic Influenza Activities

    As you know, last year, the President requested $7.1 billion in 
emergency funding for the National Strategy for Pandemic Influenza, of 
which $6.7 billion was requested for HHS. Congress appropriated $3.8 
billion as the first installment of the President's request to begin 
these priority activities, and of this amount, $3.3 billion was 
provided to HHS. We appreciate the action of Congress on this 
appropriation as it takes us an essential step forward to become the 
first generation in history to be prepared for a possible pandemic.
    Using the first $3.3 billion we received in December, we are 
planning by the end of this year to procure approximately 22-24 million 
regimens of antivirals at the Federal level. The funding we propose for 
fiscal year 2007 will help us come closer to our goal of covering 25 
percent of the American population. This year we will expand our pre-
pandemic stockpile of H5N1 vaccine by 1.7 million courses, and will be 
investing significantly in the domestic development of cell-based 
technology for influenza vaccine. This, and the proposed fiscal year 
2007 funding, is necessary to add additional manufacturers to have the 
domestic capacity to produce enough vaccine for the U.S. population 
within 6 months of the first sign of a pandemic.
    In March 2006, HHS, through CDC, started allocating $100 million to 
help States and other eligible entities enhance preparedness for 
pandemic influenza. Later this year, we will allocate an additional 
$250 million for further State and local preparedness. The Congress has 
specified that the bulk of funding in this area should be based on 
performance. In the near future, HHS will apprise the States as to the 
contractual arrangement whereby they may purchase additional antiviral 
drugs, if they so choose, at a 25 percent subsidy.
    As the next step in these efforts, this year's budget includes a 
$2.3 billion allowance for the second year of the president's Pandemic 
Influenza plan. These funds will enable us to meet several important 
goals, including providing pandemic influenza vaccine to every man, 
woman and child within 6 months of detection of sustained human-to-
human transmission of a bird flu virus; ensuring access to enough 
antiviral treatment courses sufficient for 25 percent of the U.S. 
population; and enhancing Federal, State and local as well as 
international public health infrastructure and preparedness.

Project BioShield

    The Project BioShield Act of 2004 (P.L. 108-276) (``Project 
BioShield'') is a critical part of a broader strategy to defend America 
against the threat of weapons of mass destruction. It provides HHS with 
several new authorities to speed the research, development, 
acquisition, and availability of medical countermeasures to defend 
against chemical, biological, radiological and nuclear (CBRN) threats.
    In exercising the procurement authorities under Project BioShield, 
HHS has launched acquisition programs to address each of the four 
threat agents deemed to be Material Threats to the U.S. population by 
DHS [Bacillus anthracis (anthrax), smallpox virus, Botulinum toxins, 
and radiological/nuclear agents]. HHS has used the Special Reserve Fund 
(SRF) to award two contracts for vaccines against anthrax, one contract 
for a liquid formulation of a drug to protect children from radioactive 
iodine exposure following nuclear events, and one contract for 
chelating agents for countering the effects of internal exposure to 
transuranic radioisotopes.
    In addition, negotiations are underway for the acquisition of 
anthrax therapeutics. With respect to smallpox vaccines, an award will 
be made for the manufacture and delivery of up to 20 million doses of a 
next generation attenuated smallpox vaccine, modified vaccinia Ankara 
(MVA). Additionally, negotiations are underway for procuring 200,000 
doses of botulinum antitoxin.
    These countermeasures are being added to the SNS that currently 
includes vaccines, antibiotics to counter infections caused by anthrax, 
plague, and tularemia, antitoxins, chemical antidotes and radiation 
emergency medical countermeasures.
    However, we recognize that more can and must be done to 
aggressively and efficiently implement Project BioShield. To this end, 
I intend to establish a dedicated strategic planning function in HHS 
that more efficiently integrates biodefense requirements, across the 
full range of threat agents, with the execution of advanced development 
and procurement of medical countermeasures. I will reorganize the 
Office of Public Health Emergency Preparedness (OPHEP) and assign and 
empower it as the responsible office to develop and implement a 
strategic plan for this purpose, and I will ensure that HHS component 
programs and functions are properly aligned, and that their respective 
strengths are leveraged, to support OPHEP's efforts. I will also work 
closely with other departments and agencies to streamline and make more 
effective the current BioShield interagency governance process. We will 
make this process more transparent and work to educate the public and 
industry about our priorities and opportunities. As part of this, HHS 
will convene an outreach meeting with these external stakeholders later 
this year.
    I applaud the committee's efforts to support and promote innovation 
for medical countermeasures, as reflected in S. 1873, the Biodefense 
and Pandemic Vaccine and Drug Development Act of 2006. However, as 
presently drafted, I am concerned that S. 1873 would impose an 
organizational framework on HHS that impairs my ability to implement 
the strategic approach for medical countermeasures development and 
procurement that I have outlined, including the functions to be 
executed by a reorganized OPHEP and a more efficient BioShield 
interagency governance process. I am committed to ensuring that 
advanced development of medical countermeasures is properly supported 
and conducted, and that the procurement and medical countermeasures is 
timely and efficacious. I would therefore appreciate the opportunity to 
work with the committee to further refine S. 1873 to ensure that it 
achieves our mutual objectives of improving processes that expedite the 
availability of promising treatments to naturally-occurring infectious 
diseases or to a chemical, biological, radiological, or nuclear attack.
    As part of this, the administration will work with the committee on 
funding for this effort, while preserving the BioShield Special Reserve 
Fund for medical countermeasures against known and emerging terrorist 
threats. I also note that the administration is requesting $160 million 
in fiscal year 2007 for advanced development.


    Thank you once again for inviting me to testify on this important 
issue. Maintaining a robust national public health infrastructure to 
effectively prepare for all emerging threats requires sound 
collaboration, communication, and clear lines of command and control. 
Although preparedness depends on plans at the local, State, and Federal 
levels, without the exercise of these plans, we will not be able to 
know if we are truly prepared. HHS will continue to lead the way toward 
public health emergency preparedness. As the threat of a pandemic 
influenza clearly shows however, the scope of the Federal Government in 
responding to pervasive public health emergencies such as a pandemic is 
limited. States and localities must be prepared to rise to the 
challenge as well.
    I would be happy to take any questions.

    The Chairman. As to the next panel, Senator Burr wants to 
chair that in its entirety, so he will be here right after the 
vote. So we will have a recess until the vote is completed. We 
will stand at recess.
    Senator Burr. [presiding]. The hearing will come to order.
    Let me thank our witnesses for their patience and 
flexibility. We do know that we are going to start a series of 
votes sometime between 10:30 and 10:45. My hope is that we can 
get all of your testimony in, and potentially give you a short 
break of about an hour and have more members participate in the 
questioning. I hope that works for everybody's timeline. If it 
doesn't, certainly we will try to accommodate. But as has been 
the last 48 hours up here, we could get to 10:45 and have not 
had a vote yet, so we might be able to get the completion of 
the hearing in.
    At this time I would like to recognize Dr. Richard 
Falkenrath, national security expert, a senior fellow at the 
Brookings Institution, the former Deputy Homeland Security 
Adviser to the President. He holds a Ph.D. from the Department 
of War Studies at Kings College in London, as well as degrees 
in economics and international relations.
    Mr. Falkenrath, the mike is yours.


    Mr. Falkenrath. Thank you very much, Senator, for the 
invitation to appear today. I will be very brief and ask that 
my prepared statement be----
    Senator Burr. Without objection, everybody's testimony will 
be made a part of the record.
    Mr. Falkenrath. I was in the White House when the first 
bioterrorism bill was worked on by the Congress and was 
involved in that. I think it made sense at the time, and it 
still makes sense. I think there are certain aspects of it 
which should be modified, and I am going to lay those out.
    First just a general point about the subject you are 
working on. I am concerned with national security. I have 
worked on terrorism for most of the last 5 years of one form or 
another. I will say this, though: that when viewed in 
comparison to all other conceivable threats to U.S. national 
security, in my opinion catastrophic disease is now and for the 
foreseeable future the greatest danger we face. And so I could 
elaborate on that in questions, if you are interested, but let 
me just say that I have looked at this in comparison to lots of 
other threats, and I think it presents the worst combination of 
likelihood, severity of consequences, and poor countermeasures 
and defenses on our part.
    Now, since we are short on time and we need to be brief in 
our opening statement, I am just going to focus on the 
shortcomings that I see in the U.S. response to this threat 
rather than all the things that we have done right, of which 
there are many.
    I believe that we are better prepared for biodefense 
threats than any other country in the world and that we have 
made enormous strides. I think there is no area of national 
security in which we have come further since 9/11, but also no 
area where we have further to go. And so that is the context 
when I now offer some criticisms about how we are doing as a 
    I am going to focus on four areas: first, countermeasure 
availability; second, the National Response Plan; third, State 
and local roles in the National Response Plan; and, fourth, the 
Federal organization.
    On countermeasure availability, this is obviously critical. 
These attacks and diseases, pandemics, are in principle 
treatable. So if we have the right countermeasures, we can make 
an enormous difference.
    Two areas I think are working right. We have a very good 
R&D program for fundamental discovery at NIH. I also think we 
have an appropriately sized effort at HHS to purchase 
countermeasures to known pathogen threats. Everyone agrees, 
including Secretary Leavitt, that that is moving too slowly, 
and I am talking about the BioShield Program, but we do have a 
program to buy countermeasures to known threats, things that 
are already on the CDC list.
    There are four areas where we are not doing so well in 
countermeasure availability:
    First, the pharmaceutical industry has not yet been 
effectively mobilized to this task. Everyone understands that. 
Big PHRMA, the largest pharmaceutical companies with enormous 
resources, are really not involved in the way that we would 
like them to be as a country. We can understand why that is 
economically. It is still an outcome we would like to change.
    Second, the clinical trial process just takes too long. It 
takes too long to get a drug from discovery to manufacturing. 
Everyone is aware of that. I don't have a quick solution to it, 
but it is the sort of thing that we need to keep paying 
attention to.
    Third, we do not have a program to deal with novel 
pathogens. These are pathogens that either emerge newly in 
nature or that are genetically modified by some adversary. We 
have a program to buy countermeasures to known pathogens, but 
not to look over the horizon and figure out how we can fight 
against novel pathogens that come along.
    I would note that the Department of Defense, without 
prompting by Congress or the White House, elected to dedicate 
$1.5 billion over 5 years to this threat. I think that is good. 
I am glad Secretary Rumsfeld decided to do that. But we need a 
program, and I don't really care where it is in the U.S. 
Government, but we need a program, and it should be separate 
from our program to buy countermeasures to known threats. It is 
a fundamentally different task, and they should be 
organizationally distinct.
    A final point on countermeasure availability. As Secretary 
Leavitt said, we need domestic influenza vaccine production 
capacity. We need it here in the country, and we need it now. 
And this is taking a very long time to deal with the vaccine 
manufacturers, but we are trying to bring them along so that 
they will voluntarily build this capacity, which everyone who 
studies this problem knows that we need.
    I am starting to wonder whether they will ever do it and 
whether we need a different approach, whether we should go for 
some sort of Government-owned contract or -operated approach, 
which is a radical departure. But, you know, the definition of 
insanity is to keep repeating the same behavior and expect a 
different outcome, and I am really wondering whether we are 
ever going to bring these companies around to build a plant 
which economically they have yet to feel like is in their 
interest to build. No matter how much incentives, how much tax 
breaks, how much liability relief, they haven't done it in the 
last 5 years. I am not sure they are ever going to do it, 
certainly not in the timetable that we want.
    I would say here as a parenthetical, given the extra--we 
have an enormous foreign dependency on foreign producers of 
vaccine for a pandemic. The relative lack of attention to that 
foreign dependency for a pandemic is, I think, striking when 
you contrast it to the enormous outcry that we had over the 
transfer of six port terminal operators to another company. 
Just think about the security implications of these two things. 
There is no doubt the vaccine production capacity is a far more 
significant security issue.
    The NRP. In my judgment, the NRP is not adequate for 
catastrophic disease contingencies. I was involved in writing 
the NRP. I was involved in writing the Presidential directives 
that called for the NRP. I am very familiar with it. It assigns 
responsibility to HHS for ESF-8, Medical Support, and assigns 
responsibility for implementing the Biological Annex of the 
    There are two big problems. This works fine for routine 
disasters, for routine health problems, for providing discrete 
assistance in the midst of a major disaster. It is, in my 
judgment, completely inadequate and unrealistic for a genuinely 
catastrophic disease contingency--a pandemic or a wide-area 
bioterrorist attack--when you need to distribute life-saving 
medicines to a fearful population over a very large area, 
potentially the entire country, in a very short period of time 
and in which we have reason to believe that the State and local 
agencies will not be able to perform what the Federal 
Government implicitly expected them to do. And we know this 
from exercise after exercise after exercise. We know this.
    So what do you do about it? I think HHS is fine for leading 
ESF-8 routine matters, including medical support in something 
like Katrina. I do not think they are capable of doing what the 
country and the President and the Congress will expect of them 
in a pandemic or a wide-area bioterrorist attack. And, 
therefore, I think that we need to amend the NRP, amend the 
Presidential directives that relate to the NRP, and a number of 
different internal administration documents to allow the 
President to transfer ESF-8 to the Department of Defense when 
he decides it is necessary, and to direct the Department of 
Defense to prepare to assume that responsibility and to assume 
for the incapacitation of State and local and public health 
agencies. This is a major change, but we know from exercise 
after exercise that the current arrangement is not working.
    I am almost out of time. I will say further on State and 
local responsibilities, I think that we give a lot of grants to 
State and local agencies. I think it is very important to build 
this capacity. I supported them before I even entered into 
Government. I think we need to start conditioning them. We need 
to make them powerfully conditional on meeting the certain 
requirements for plans and capabilities that the Federal 
Government expects of State and local agencies in the midst of 
a crisis. This would be a radical change, and this would 
require amendment of Title I of the bioterrorism bill, which 
right now gives the grants out more or less as an entitlement. 
I think they need to be conditioned.
    A final point on organization of the Federal Government. 
There is no one in charge in this area, there is no one person 
in charge beneath the President. It is widely distributed 
across the U.S. Government. That is frustrating. It was 
frustrating when I was on the White House staff. There is no 
single solution to it. You can't just decree that one person is 
in charge. It doesn't work the way our Government is organized. 
I think the only answer is to augment the White House 
coordination staff on which I used to work and also to augment 
the HHS staff. Secretary Leavitt needs a robust and large staff 
under him to coordinate his highly stovepiped agency at HHS, 
which has huge responsibilities. Right now the Assistant 
Secretary for Emergency Health Preparedness has far too small a 
staff for the expectations that we have of it.
    Senator Burr. Thank you very much. You have certainly laid 
on the table in a very short period of time some very meaty 
things for us to weigh, especially a transfer to DOD, which I 
am probably in total agreement with you that that debate needs 
to begin to happen because that is not a transfer that happens 
easily or quickly. And it is time we learn from what we have 
    [The prepared statement of Mr. Falkenrath follows:]
              Prepared Statement of Richard A. Falkenrath


    Good morning, Mister Chairman, Senator Kennedy, and members of the 
committee. I am grateful for the opportunity to be here today to 
provide my views on the reauthorization of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188), 
and biodefense and public health preparedness more generally. I am 
honored to be asked to assist your committee as you discharge your 
vital oversight responsibilities.
    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 was an extremely important bill. It was the first 
of several important steps taken by the United States in the area of 
biodefense after the terrorist attacks of September 11, 2001. The 
direction and authorizations contained with Title I of the Bioterrorism 
Act made sense at the time. Most of them still make sense today, but 
there are certain aspects in which I believe modifications are in 
order. I describe these recommendations in the testimony that follows.
    I would like to commend the members of this committee for holding a 
hearing at this time. Biodefense and public health preparedness is not 
the crisis de jour. Yet biodefense and public health preparedness are 
profoundly important subjects: more important, in my judgment, than 
many of the security issues that have dominated the public debate in 
the last few months. As I know from first-hand experience, it is 
difficult for senior policymakers to devote their time and energy to 
matters of great importance but no immediate urgency.
    I would also like to commend the American and international public 
health community. I am continually impressed by the beneficence and 
selfless dedication of the countless doctors, nurses, scientists, 
technicians, and other public servants who have devoted themselves to 
the fight against infectious disease. Here in the United States, we are 
particularly fortunate to have two individuals of highest possible 
caliber serving as our Director of the Centers for Disease Control 
(CDC) and our Director of the National Institute for Allergy and 
Infectious Disease (NIAID). I have some sense of the enormity of the 
challenges they and others still serving in government face. The 
testimony I have to offer today should in no way be taken as a critique 
of the performance of any individual government official at any level. 
Rather, the criticism I offer today is meant to be constructive and is 
directed at the overall U.S. strategy for dealing with catastrophic 
disease events.
    For the record, my name is Richard A. Falkenrath and I am presently 
a senior fellow in Foreign Policy Studies at the Brookings Institution. 
I am also Managing Director of the Civitas Group LLC, a strategic 
advisory and investment services firm serving the homeland security 
market, and a security analyst for the Cable News Network (CNN). Until 
May 2004, I was Deputy Assistant to the President and Deputy Homeland 
Security Advisor on the White House staff. Previously, I served as 
Special Assistant to the President and Senior Director for Policy and 
Plans within the Office of Homeland Security, and as Director for 
Proliferation Strategy on the National Security Council staff. Prior to 
government service, I was an Assistant Professor of Public Policy at 
the John F. Kennedy School of Government at Harvard University.

The Threat of Catastrophic Disease

    I have studied many different threats to U.S. national security. As 
an undergraduate, I studied the Soviet maritime threat to the United 
States and its European allies. As a graduate student, I studied the 
Soviet conventional forces threat in central Europe. As a postdoctoral 
researcher, I co-authored a book on the threat of fissile material and 
nuclear weapons leaking out of the former Soviet Union's sprawling 
nuclear complex. As a Kennedy School professor, I co-authored another 
book on the threat of mass-casualty terrorism involving nuclear, 
biological, and chemical weapons. As a member of the National Security 
Council staff, I was a voracious consumer of intelligence on the 
extraordinarily wide variety of threats to the United States. After the 
terrorist attacks of September 11, 2001, I became one of the 
President's homeland security advisors; in this capacity, I scrutinized 
not only the never-ending stream of intelligence related to terrorist 
threats against U.S. interests, but also the less accessible body of 
information related to America's underlying vulnerabilities--that is, 
to the plausible scenarios which present the greatest likelihood of the 
greatest harm to the Nation. In previous testimony before the Senate 
Homeland Security and Government Affairs Committee, I have drawn 
attention to some of those vulnerabilities, notably those presented by 
toxic industrial chemicals.
    My years of study and government service have led me to the 
following conclusion. As the prospect of global thermonuclear war has 
faded away, the greatest remaining source of danger to U.S. national 
security in the 21st century--and to mankind as a whole--is disease.
    I reach this conclusion in part because I define the catastrophic 
disease threat broadly, to include both natural and manmade disease 
outbreaks. The pathogens that cause disease range from the viruses that 
cause influenza, smallpox, West Nile, and SARS--to the bacteria that 
cause anthrax, cholera, plague, and tuberculosis--to the parasites that 
cause malaria and sleeping sickness. Some, like smallpox, are recorded 
in earliest human history; others, like the virus that causes SARS, 
have only recently become known to science. Like all living organisms, 
pathogens evolve to adapt to changes in their environment, which in 
most causes is another living organism--a human, a bird, a pig, or a 
mosquito, for instance--with an immune system that seeks to manage the 
host's microbial infections.
    There are three basic categories of the catastrophic disease 
threat. The first are naturally occurring infectious diseases, such as 
influenza, yellow fever, and tuberculosis. Naturally occurring disease 
has profoundly influenced human history, as the scholar William McNeill 
explained in his brilliant 1976 book, Plagues and Peoples, and retains 
the capacity to do so again today despite revolutionary advances in 
public health methods and biomedical science. In the words of Nobel 
Laureate Joshua Lederberg:

        We are engaged in a type of race, enmeshing our ecologic 
        circumstances with evolutionary changes in our predatory 
        competitors. To our advantage, we have wonderful new 
        technology; we have rising life expectancy curves. To our 
        disadvantage, we have crowding; we have social, political, 
        economic, and hygienic stratification. We have crowded together 
        a hotbed of opportunity for infectious agents to spread over a 
        significant part of the population. Affluent and mobile people 
        are ready, willing, and able to carry afflictions all over the 
        world within 24 hours' notice. This condensation, 
        stratification, and mobility is unique, defining us as a very 
        different species from what we were 100 years ago. We are 
        enabled by a different set of technologies. But despite many 
        potential defenses--vaccines, antibiotics, diagnostic tools--we 
        are intrinsically more vulnerable than before, at least in 
        terms of pandemic and communicable diseases.\1\
    \1\ Joshua Lederberg, ``Infectious Disease as an Evolutionary 
Paradigm,'' Emerging Infectious Diseases, Vol. 3, No. 4 (October-
December 1997), at http://www.cdc.gov/ncidod/eid/vol3no4/lederber.htm 
[emphasis added].

    The greatest danger seems to develop when a pathogen shifts 
suddenly from an animal reservoir into an immunologically naive human 
environment (a process called zoonosis), as has happened in Asia and 
Turkey with the H5N1 influenza strain (and happened with the human 
immunodeficiency virus (HIV) in the late 1970s or early 1980s).
    The second category of the catastrophic disease threat are 
naturally occurring disease-causing microorganisms that some State, 
nonstate actor, or individual has deliberately acquired, produced, and 
then somehow disseminated against a susceptible population in order to 
cause harm; this is bioterrorism. In principle, virtually any disease-
causing agent can be used as a weapon, but in practice certain 
characteristics--communicability, lethality, resistance to 
countermeasures, environmental resilience--make some agents far more 
attractive than others.\2\ An essential element of the bioterrorism 
threat is what Richard Danzig, the former Secretary of the Navy and 
noted thinker on bioterrorism and biodefense, calls the ``reload'' 
problem.\3\ Once a State or a terrorist has established an effective 
production process for a biological weapon, there are very few inherent 
limitations on the amount of biological weapon agent that can be 
produced. This is because microbes in proper settings reproduce and 
multiply on their own; time, therefore, is the main constrain on the 
amount of pathogenic agent a terrorist can deploy. The implications of 
this fact are profound and are responsible for putting bioterrorism in 
an altogether separate category from, for instance, nuclear terrorism. 
As Danzig warns us, bioterrorism needs to be thought of not as one or 
more discrete attacks but as a campaign that will continue until the 
attacker calls it off or its production process has been located and 
destroyed. (Nuclear terrorism, on the other hand, is far more likely to 
consist of only one or a few nuclear detonations due to limits 
established by the availability of fissile material).
    \2\ The Centers for Disease Control list of ``Category A'' agents 
include anthrax (Bacillus anthracis); botulism (which is an acute 
intoxication rather than infectious disease, caused by clostridium 
botulinum); plague (Yersinia pestis); smallpox (variola major, which no 
longer exists in nature); tularemia (Francisella tularensis); and 
various viral hemorrhagic fevers (e.g., Ebola, Marburg], Lassa, 
Machupo). See http://www.bt.cdc.gov/agent/agentlist-category.asp#a.
    \3\ Richard Danzig, Towards a Long-Term Strategy for Coping with 
the Risk of Bioterrorism. Washington, DC.: The Defense Science Office, 
October 2005.
    The third are disease-causing microorganisms that a State, nonstate 
actor, or individual has genetically manipulated (or, conceivably, 
produced from scratch) for the purposes of improving their utility as a 
weapon, and then produced and disseminated against a susceptible 
population; this is bioterrorism involving a novel pathogen. As a 
result of revolutionary advances in genomics and microbiology, 
scientists can create new microorganisms that are more communicable, 
lethal, resistant to countermeasures, and/or resilient to the 
environment than naturally occurring pathogens. There is debate about 
the severity of the novel pathogen threat, but the potential dangers 
were graphically revealed in late 2000, when a team of Australian 
scientists inadvertently discovered that they could significantly 
increase the lethality (in rodents) of a relatively benign pox-virus by 
splicing the interleukin-4 gene into the virus. This relatively simple 
genetic modification of an animal pathogen raised serious questions 
about the ease with which a bioterrorist could create novel pathogens 
that would be more dangerous than the likely naturally occurring 
biowarfare agents for use against human beings.\4\
    \4\ Elizabeth Finkel, ``Engineered Mouse Virus Spurs Bioweapon 
Fears,'' Science, Vol. 291, No. 5504 (January 26, 2001), p. 585.
    Infectious disease is, of course, a chronic problem throughout the 
world with particularly devastating manifestations in the developing 
world. My particular focus in this testimony is catastrophic disease 
events in any of the three categories outlined above. A catastrophic 
disease event in an extreme scenario may result when one or more of the 
following three criteria apply.

     First, is the disease characterized by efficient human-to-
human communicability and serious expected health effects due to 
inadequate immunological or likely medical response? The SARS outbreak 
did not meet this criterion because the disease was not particularly 
communicable. Efficient human-to-human transmission is most likely to 
be airborne, involving an invisible respiration of infectious aerosol, 
since the other possible modes of transmission can more effectively 
countered through behavior change. Pandemic influenza is the disease 
most likely to satisfy this criterion in the near term.
     Second, is the outbreak the result of a wide-area release 
of a pathogenic agent deliberately and competently selected for the 
seriousness of its health effects, its resistance to available medical 
treatment, and/or its environmental resilience? The anthrax attacks of 
October 2001, as serious as they were, did not meet this criterion 
because of the relatively small amount of pathogenic agent used. A 
line- or point-release of 100 times as much agent of the same quality 
in a densely populated area would, however, in all likelihood satisfy 
this criterion and qualify as a catastrophic disease scenario.
     Third, is the fear created by the outbreak likely to 
trigger a public response of such scale or character that it damages 
the authorities' ability to manage the initial outbreak and/or its 
follow-on waves, provokes civic unrest, impedes the provision of 
essential services, undermines public trust in government, damages the 
economy, or impairs the Nation's ability to protect its strategic 
interests or fulfill its global responsibilities? These effects seem 
most likely to result from shortages in vital, life-saving medical 
countermeasures to the disease in question. For instance, because of 
the ``reload'' problem noted above, an effective aerosolized anthrax 
attack in a confined area of the country is likely to create enormous 
demand for antibiotic prophylaxis across the entire country (until the 
perpetrator is identified and the anthrax production and weaponization 
facility destroyed). If this demand for antibiotic prophylaxis is 
satisfied, hundreds of thousands, if not millions, of healthy people 
could quickly consume the Nation's entire available supply of effective 
antibiotic--leaving the country acutely vulnerable to a follow-on 

    A catastrophic disease event is admittedly an extreme scenario, 
residing at the very highest end of the threat spectrum. With respect 
to manmade threats--bioterrorism--I am not suggesting that such a 
scenario can be easily effectuated or is imminent. Nonetheless, I do 
not believe that the trends are in our favor. With every passing year, 
the latent technological potential of States and nonstate actors to use 
disease effectively as a weapon rises inexorably. With respect to 
naturally occurring disease threats, no one can estimate precisely the 
likelihood, timing, or consequence of the appearance of a new human 
pathogen.\5\ However, for at least one potentially catastrophic 
disease, even the conservative World Health Organization concludes that 
``the world may be on the brink of another pandemic.'' \6\ According to 
the WHO, a pandemic along the lines of the relatively mild pandemic of 
1957 would result in 2 million to 7.4 million deaths worldwide. A 
pandemic with the death rate of the 1918 Spanish flu--perhaps the most 
extreme human disease event in history--could result in several million 
fatalities in the United States and perhaps over 100 million abroad.
    \5\ Again, in the words of Joshua Lederberg, ``the outcome of 
encounters between mutually antagonistic organisms is intrinsically 
unpredictable. . . . Infectious agent outcomes range from mutual 
annihilation to mutual integration and resynthesis of a new species.'' 
    \6\ http://www.who.int/csr/disease/influenza/pandemic10things/en/
    In sum, when viewed in comparison to all other conceivable threats 
to U.S. national security, the catastrophic disease threat is and for 
the foreseeable future will remain the gravest danger we face. No 
State, no terrorist group, no ideology or system of government, no 
other tactic or target or category of weapons, no technological 
accident, and no other natural phenomenon, presents as terrifying a 
combination of likelihood, poor defenses and countermeasures, and 

Achievements, Shortcomings, and Recommendations

    Since the terrorist attacks of September 11, 2001, there is no area 
of national or homeland security in which the United States has made 
more progress than civilian biodefense, and no area in which the Nation 
has further to go.
    We have launched an extraordinary biodefense research program at 
the National Institutes of Health; improved our domestic and 
international epidemiological surveillance systems, including through 
the deployment of an effective atmospheric sampling system called 
BioWatch; and stockpiled enough smallpox vaccine for every American, as 
well as vast quantities of other pharmaceutical and emergency medical 
supplies that give us dramatically better ability to manage the 
consequences of certain categories of bioterrorist attack. No country 
in the world has attacked the challenges for biodefense more 
aggressively or effectively as the United States, and in my opinion, no 
country in the world is better prepared for a bioterrorist attack.
    There are, however, a number of serious shortcomings in our 
Nation's current and likely future capacity to cope with most 
catastrophic disease scenarios. I will focus on four general areas: 
countermeasure availability; the National Response Plan; local, State, 
and Federal responsibilities in response plan execution; and Federal 
organization for biodefense and public health preparedness.

I. Medical Countermeasure Availability

    The critical difference between pathogens and most other threats 
facing the United States is that disease is, in principal, treatable. 
The right vaccine administered with enough lead time can make a person 
immune to particular pathogen threats. Antibiotics administered quickly 
enough can cure a person of most bacterial threats, or at least those 
which have not acquired antibiotic resistance. Intensive care--
respirators and other methods of treating the acute symptoms of a 
disease--can improve a person's chance of survival dramatically.
    The availability of appropriate medical countermeasures is, 
therefore, a critical element of the Nation's overall biodefense and 
public-health preparedness. As noted earlier, the U.S. Government has 
made some extraordinary strides in acquiring large stocks of certain 
medical countermeasures that, in the certain disease contingency, will 
dramatically improve the Nation's ability to cope with the crisis.
    Two aspects of the U.S. strategy for acquiring biomedical 
countermeasures to pathogen threats seem to me to be essentially sound. 
The first is the multibillion dollar NIAID biodefense research program. 
I believe this program is adequately funded, excellently led, has 
already yielded many important discoveries for reducing the 
catastrophic disease threat, and will continue to do so in the future. 
The second is the Department of Health and Human Service's program for 
procuring proven biomedical countermeasures against known pathogen 
threats, such as ordinary anthrax and smallpox. This effort has been 
funded through the $5.6 billion BioShield advance appropriation as well 
as the annual discretionary budget of the Department of Health and 
Human Services. Most observers would like to see this HHS procurement 
program move more swiftly, but in my estimation it is reasonably sized 
and directionally sound.
    Nonetheless, I see four general problems in the area of pathogen 
countermeasure availability.
    First, I do not believe that the pharmaceutical industry has been 
effectively mobilized to the task. From the perspective of the largest 
pharmaceutical firms, their relatively modest commitment to anti-
infective research, development, and production is economically 
understandable. There is in general less money to be made, and more 
risk incurred, from developing treatments for infectious disease than 
treatments of chronic disease and other ailments. Governments, however, 
cannot shoulder the burden of countering pathogen threats alone, and so 
we must find a way to more effectively marshal the resources of the 
world's leading pharmaceutical firms.
    Second, the clinical trial process for new biomedical 
countermeasures takes too long, often 5 years or more. It is, of 
course, necessary for drug researchers and manufacturers to demonstrate 
the efficacy as well as the safety of new drugs, and for the Federal 
Government to regulate this process. The finalization of the Food and 
Drug Administration's ``animal rule'' for clinical trials of 
countermeasures that cannot be tested on humans was a step in the right 
direction, as was the emergency use authority conferred to the 
Secretary of Health and Human Services in the Bioterrorism Act of 2002 
and BioShield Act of 2004. Even so, the revolutionary advances in the 
biological and computer sciences over the past decade should make it 
possible for the U.S. Government to reduce significantly the length of 
time, and perhaps even the expense, of proving the efficacy and safety 
of all new disease countermeasures.
    Third, the United States needs a discrete program dedicated to 
understanding and, to the extent possible, developing and acquiring 
countermeasures to novel pathogens. As noted earlier, the HHS 
procurement program for the Strategic National Stockpile focuses on 
countermeasures against known pathogen threats--that is, the threat 
agents that appear on one of several official lists maintained by the 
Centers for Disease Control. At the moment, there is no government 
program focused on developing and acquiring countermeasures that will 
be effective against the threat agents that do not exist or are not yet 
known. Given the long-term potential for the genetic manipulation of 
pathogens, the United States should invest in such a capability as part 
of the Nation's overall biodefense effort. In its 2006 Quadrennial 
Defense Review, the Department of Defense has announced its plan to 
reallocate ``more than $1.5 billion over the next 5 years to develop 
broad-spectrum medical countermeasures against advanced bio-terror 
threats, including genetically engineered intracellular bacterial 
pathogens and hemorrhagic fevers.'' \7\ This important initiative, 
which has not yet begun, should be strongly supported by the Congress, 
authorized by statute (perhaps in the reauthorization of Title I of the 
Bioterrorism Act), and fully involve all other agencies with biodefense 
responsibilities. The location of the novel pathogen countermeasures 
program within the U.S. Government matters less than that it exists in 
the first place and that it is organizationally separate from the 
government's program to procure countermeasures against known 
pathogens. This separation is important because novel pathogens are an 
over-the-horizon threat requiring innovative, advanced, high-risk 
countermeasure strategies that are not likely to prosper within a more 
conventional procurement bureaucracy.
    \7\ Quadrennial Defense Review 2006, pp. 52-53.
    Finally, the United States requires a domestic influenza vaccine 
production capacity to produce sufficient vaccine for the entire U.S. 
population within at most 1 year of the onset of a global pandemic. 
According to the estimates of the University of Minnesota's Center for 
Infectious Disease Research & Policy, the current domestic vaccine 
production capacity would allow only 37.5 million U.S. citizens, out of 
a total population of 295 million, to be vaccinated during the first 
year of a pandemic.\8\ The United States has plans to acquire 20 
million doses of ``pre-pandemic'' vaccine--that is, a vaccine that was 
developed against the H5N1 strain that is currently endemic in avian 
populations but not yet communicable between humans. This pre-pandemic 
vaccine stockpile is clearly one critical strategy for ameliorating the 
expected vaccine shortage in the short run. Stockpiling ``pre-
pandemic'' vaccine is not, however, a viable long-term strategy due to 
the uncertain efficacy of pre-pandemic vaccines against pandemic 
strains of the virus.
    \8\ ``In the United States, domestic production was estimated at 50 
million doses of trivalent vaccine during 2004. This would be 
equivalent to about 150 million doses of monovalent standard-dose, 
assuming 15 mcg HA per dose. . . . Two critical caveats need to be 
considered with these types of estimates: (1) it is not clear how many 
micrograms of antigen will be necessary to elicit an immune response to 
a pandemic strain and (2) two doses of vaccine will likely be needed to 
confer adequate protection. For example, recent data from a clinical 
trial of a candidate H5N1 vaccine demonstrated that volunteers required 
two doses of a 30-mcg vaccine to mount an adequate immune response to 
H5N1. If this is the case for a pandemic vaccine, then 60 mcg of 
antigen would be needed per person, which is four times higher than 
that needed per dose to confer protection with current annual influenza 
vaccines. An extrapolation of the current production capacity to this 
antigen requirement per person suggests that only 37.5 million people 
in the United States could be vaccinated during the first year of a 
pandemic (roughly 10 percent of the country's population).'' See 
    Currently, most of the world's vaccine production capacity located 
abroad, mainly in Europe, and relies on a relatively unreliable egg-
based production technique with a rigid production timetable that can 
lead to months of unnecessary delay. CDC Director Julie Gerberding has 
testified that the ``pandemic influenza vaccines produced in other 
countries will likely not be available to the U.S. market as those 
governments may prohibit export of the vaccines produced in their 
countries until their domestic needs are met.'' \9\ The implications 
are obvious: in the event of a global pandemic, thousands to hundreds 
of thousands of U.S. citizens will contract the disease, and some 
fraction of them will die, while the citizens of countries with more 
robust domestic vaccine production capacities--Australia, Canada, 
France, Germany, Italy, the Netherlands, Switzerland, and the United 
Kingdom--will acquire an effective vaccine and survive. Given the 
extreme public and political concern expressed over the security 
implications of Dubai Port World's intended acquisition of operating 
contacts for six container terminal facilities at six U.S. ports, the 
relative lack of concern over this far more significant foreign 
dependency is astonishing. As a matter of great national urgency, 
therefore, the United States should develop a large-scale, domestic 
based vaccine production facility. I urge the Congress to include this 
mandate in its reauthorization of Title I of the Bioterrorism Act. If 
private-sector financing is unavailable or only partially available for 
this project, then it should be paid for from the general revenue. The 
total cost would be a small and an entirely justifiable fraction of 
total U.S. national security expenditures.
    \9\ Testimony of Julie L. Gerberding, MD, MPH, before the 
Subcommittee on Health, Committee on Energy and Commerce U.S. House of 
Representatives, May 26, 2005 .

II. The National Response Plan

    The National Response Plan (NRP) is not adequate for catastrophic 
disease contingencies. The plan assigns responsibility for Emergency 
Support Function #8, ``Public Health and Medical Services,'' to the 
Department of Health and Human Services. The Biological Incident Annex 
to the NRP similarly assigns lead responsibility to the Department of 
Health and Human Services. The NRP's premise is that ``State, local, 
and tribal governments are primarily responsible for detecting and 
responding to disease outbreaks and implementing measures to minimize 
the health, social, and economic consequences of such an outbreak,'' 
\10\ and that HHS's role is to coordinate ``the provision of Federal 
health and medical assistance to fulfill the requirements identified by 
the affected State, local, and tribal authorities.'' \11\ This is a 
perfectly appropriate arrangement for ordinary emergencies, routine 
public health problems, and noncatastrophic disease contingencies. It 
is completely inappropriate and unrealistic for genuinely catastrophic 
disease contingencies, particularly those which will require the 
effective distribution of life-saving medicines to a fearful population 
over very large areas in very short periods of time. In such 
circumstances, we must assume that State, local, and private-sector 
health care capabilities become fully or partially incapacitated, and 
that the Federal Government will need to step in forcefully. A variety 
of recent full-field and tabletop exercises have supported this 
    \10\ National Response Plan, p. 332.
    \11\ National Response Plan, p. 160.
    The Department of Health and Human Services is the locus of most of 
the Federal Government's expertise on the science of disease and 
bioterrorism and should remain so. But HHS does not possess much 
capacity to conduct field operations. The Centers for Disease Control 
(CDC), an agency within HHS, has various operational capabilities at 
its headquarters in Atlanta and in the field, but these are, for the 
most part, optimized for routine public-health matters and 
epidemiological investigations. With its limited organic operational 
capabilities, the Department of Health and Human Services is simply not 
going to be able to meet the American people's expectation of the 
Federal Government in a truly catastrophic disease contingency such as 
a high lethal pandemic or major bioterrorist attack.
    To address this problem, I believe that Homeland Security 
Presidential Directive 5 (HSPD-5 on ``Management of Domestic 
Incidents''), HSPD-10 (``Biodefense for the 21st Century''), the 
National Response Plan, the National Strategy for Pandemic Influenza, 
the HHS Pandemic Influenza Plan, the CDC Smallpox Response Plan, the 
Defense Planning Guidance, and the DOD Contingency Planning Guidance 
should be amended to permit and, indeed, anticipate the assignment of 
ESF #8 to the Department of Defense in a catastrophic disease incident 
at the order of the President. The Department of Defense should be 
directed to plan and prepare for the assumption of the ESF #8 
responsibilities--to include the provision of essential health care, 
distribution of medical countermeasures, rationing of scarce essential 
supplies--and to anticipate the inability of State, local, and private-
sector entities to perform the medical and logistical functions 
expected of them in the National Response Plan. In such a circumstance, 
the Department of Health and Human Services should be assigned 
responsibility for supporting the Department of Defense by providing 
necessary medical advice and personnel, thus essentially reversing the 
roles of the two departments in catastrophic disease situations. In 
ordinary emergencies, noncatastrophic disease scenarios, and 
catastrophic scenarios without a significant medical dimension, the 
Department of Health and Human Services should retain responsibility 
for ESF #8. This can all be effectuated by Executive Order but given 
the significance of this change it would probably be prudent to 
authorize expressly in a statute such as the reauthorization of Title I 
of the Bioterrorism Act of 2002.
    My reason for this recommended change is simple. Only the 
Department of Defense has the planning, logistics, and personnel 
resources needed to conduct nationwide medical relief operations in a 
full-scale catastrophic disease scenario.

III. Local, State, and Federal Responsibilities in Response Plan 

    When Hurricane Katrina hit metropolitan New Orleans, we saw what 
could happen when State and local authorities lack appropriately robust 
contingency plans as well as the operational capability to implement 
those plans (which in some cases they did not even follow); when 
Federal authorities assume incorrectly that State and local authorities 
will perform vital operational tasks in the early stages of the crisis; 
and when the Federal authorities lack real-time situation awareness and 
effective mechanisms for interagency command, control, and 
    I believe that many, if not most, of the problems in the national 
response to Hurricane Katrina were unique to metropolitan New Orleans. 
Most other cities in the hurricane belt are above sea-level, and most 
other cities and States in this region have over the years demonstrated 
an ability to respond to major hurricanes more effectively than New 
Orleans and Louisiana did before, during, and after Katrina. This is 
not to excuse the many failures at the Federal level, but instead to 
make a broader point about the Nation's preparedness for the disease 
equivalent of a Category 5 hurricane--namely, to a catastrophic disease 
scenario such as the onset of pandemic influenza in the United States 
or a major, fully effective bioterrorist attack.
    The Federal Government's strategy for responding to catastrophic 
disease scenarios relies very heavily on State and local authorities. 
The Federal Government expects States and localities to receive 
supplies from the vast Federal stockpile of medical countermeasures--
antibiotics, vaccines, and other pharmaceuticals as well as respirators 
and other essential medical supplies--for use at whatever treatment 
centers the State and local authorities plan to utilize or establish. 
The Federal Government expects State and local authorities to 
communicate with their citizens about when, where, and how they can 
receive necessary treatment. The Federal Government expects State and 
local authorities to ration scarce medicines.\12\ The Federal 
Government expects State and local authorities to develop plans for 
crowd control and security at medical treatment facilities and 
distribution centers, and to execute those plans in a crisis. The 
Federal Government expects State and local authorities to develop plans 
for ``surge capacity''--that is, for the treatment of hundreds, 
thousands, or tens of thousands of people who may require medical 
attention and to execute those plans in a crisis. The Federal 
Government expects State and local authorities to work out appropriate 
operational, legal, and financial arrangements to support all these 
plans with private health-care and logistics providers.
    \12\ On November 20, 2005, Secretary Leavitt even said on Meet the 
Press that, in the event of pandemic, the Federal Government will 
distribute its vital supplies of antiviral medicines and pre-pandemic 
vaccines--supplies which for the next few years will be insufficient 
for the entire U.S. population--to the States for further distribution 
to the citizens. This was also the approach employed by the Department 
of Health and Human Services during the unexpected shortfall of season 
influenza vaccine in 2004-2005 (see Monica Schoch-Spana, et al., 
``Influenza Vaccine Scarcity 2004-05: Implications for Biosecurity and 
Public Health Preparedness,'' Biosecurity and Bioterrorism, Vol. 3, No. 
3, 2005.
    I am not sure that anyone in the country has an authoritative 
document that lays out all of these expectations. I do not think that 
any senior Federal official has bluntly stated them in a public 
setting. In fact, I suspect that many responsible officials at the 
Federal, State, and local level are not even aware that these are the 
expectations of State and local performance in the Federal Government's 
catastrophic disease response plans. I think that many people assume 
that, in the aftermath of a catastrophic disease outbreak, the Federal 
Government will come to the rescue of the affected communities, setting 
up its own treatment, isolation, and pharmaceutical or vaccine 
distribution system. This is not, so far as I am aware, the Federal 
Government's plan, and even if the Federal Government could perform 
this function (realistically, only the Department of Defense has 
capacity to perform such a task on a large scale, and even the 
Department of Defense could not undertake such an effort across the 
entire country), it would take weeks, if not months, to get up and 
    So far as I am aware, there is not a single State or city in the 
entire United States that is currently equipped to fulfill the Federal 
Government's expectations in the event of a catastrophic disease 
scenario.\13\ The implications of this fact are deeply troubling.
    \13\ This is despite the fact that the Federal Government has 
dispersed roughly $14.5 billion in biodefense spending through HHS 
between 2002 and 2005 (allocating about $5.5 billion to CDC 
    This extraordinary national deficiency was first revealed during 
the first TOPOFF exercise in May 2000 at which I was an observer. It 
was revealed again during the May 2003 TOPOFF II exercise, in which I 
played a central role. And, in April 2005, it was revealed again in the 
TOPOFF III exercise at which I was again an observer. It has been 
revealed in a wide variety of smaller scale tabletop exercises and 
simulations. It has been candidly discussed at countless interagency 
meetings, some of which I participated in during my government service. 
The Federal Government, in other words, is fully on notice that a 
series of critical assumptions in its plans for responding to a major 
disease scenario--namely, those related to the effective and timely 
performance of a series of specific actions by State and local agencies 
and their associated private health-care and logistics providers--are 
incorrect. The implication is inescapable: the plans, if put to the 
severe test of a catastrophic disease scenario in the near future, will 
    To deal with this problem, I believe that all Federal homeland 
security assistance--that provided by DHS as well as HHS in the form of 
public health grants pursuant to Title I of the Bioterrorism Act of 
2002--should be made powerfully conditional. In particular, I believe 
that Congress should by statute give the President or his designee the 
authority and mandate to establish baseline requirements for State and 
local governments to conduct emergency medical operations and other 
essential homeland security functions. Every 6 months, Congress should 
require the secretaries of homeland security and health and human 
services to jointly certify to the President and the Congress that 
their requirements are or are not likely, with a high level of 
confidence, to be met by the State and local agencies in question. With 
respect to any State or local agency that the two secretaries certify 
as unlikely to fulfill their requirements in a crisis, the two 
secretaries shall be required to notify the President and the Congress 
of this fact. In addition, they should request that the Director of the 
Office of Management and Budget freeze up to 100 percent of all Federal 
grants, financial transfers, reimbursements, or in-kind assistance 
provided to the agencies in question indefinitely and until such time 
as the two secretaries determine the entity to be likely, with a high 
level of confidence, to meet the appropriate requirements. At this 
time, the Director of the Office of Management and Budget will release 
the funds to the entity in question. Each freeze shall be individually 
reported to the Congress, which may at any time pass an act requiring 
the release of the funds and resources in question.
    The original public health-grant authorization in Title I, Section 
E, of the Bioterrorism Act of 2002 needs to be amended to impose some 
strong form of conditionality along the lines suggested here. Federal 
homeland security and public health grants should not be an entitlement 
but a part of a bargain that requires State and local agencies to 
fulfill their responsibilities under the Constitution, law, and 
national response plans.

IV. Federal Organization for Biodefense and Public Health Preparedness

    During my service on the White House staff, I found biodefense and 
public health preparedness to be one of the most difficult areas in 
which to coordinate interagency policy and operations. The number of 
different departments, agencies, and offices within departments 
involved in biodefense and public health preparedness is astounding. 
The plain fact is that there is no executive branch official beneath 
the President ``in charge'' of all relevant aspects of the Federal 
Government's biodefense and public health preparedness program.
    The President and most of the Federal Government look to the 
Department of Health and Human Services for intellectual leadership on 
biodefense and public health preparedness. But HHS is not a tightly 
integrated department and it pays attention only to certain aspects of 
the biodefense and public health preparedness challenge. Its three key 
agencies--CDC, NIAID, and FDA--are highly autonomous entities with 
their own appropriations and separate lines into the Congress and into 
the White House. These agencies possess deep subject matter expertise 
but, in my experience, have relatively limited interaction with other 
elements of the Federal Government and, at the working level, 
relatively little exposure to national security affairs. The Secretary 
of HHS has a very small staff, led by the Assistant Secretary for 
Public Health Emergency Preparedness established by Section 102 of the 
Bioterrorism Act of 2002, to advise and assist him on biodefense and 
public health preparedness, to run countermeasure procurement programs, 
and to manage the public health grants. I do not believe that the 
staffing and funding of this HHS staff element is commensurate with the 
expectations placed upon it.
    The President's original legislative proposal for the Department of 
Homeland Security sought to give it a substantial role in biodefense 
and public health preparedness. This proposal was essentially rejected 
by the Congress, though the Homeland Security Act of 2002 did transfer 
a few biodefense-related assets and responsibilities to the new 
department. One of these was the Strategic National Stockpile, but this 
was transferred back to HHS in 2004 after much difficulty. Another was 
the Metropolitan Medical Response System (MMRS), which oversees and 
helps support a variety of specialized medical response teams around 
the country. The MMRS is now located within FEMA; the advantages and 
disadvantages of this arrangement are not clear. DHS also runs the 
National Biodefense Analysis and Countermeasures Center at Fort 
Dietrich, Maryland. The most significant DHS responsibility for 
biodefense and public health preparedness relate to the Secretary of 
Homeland Security's role as the principal Federal official in the 
management of all domestic incidents of national significance.
    The Department of Defense also plays an important role in 
biodefense. There are three assistant secretary-level officials within 
the Office of the Secretary of Defense with significant biodefense 
responsibilities: the Assistant to the Secretary for Nuclear, Chemical, 
and Biological Defense Programs; the Assistant Secretary for Homeland 
Defense; and the Assistant Secretary for Health Affairs. There are 
countless research, development, and procurement programs in the 
Department of Defense related to biodefense, and the Northern Command 
engages in extensive planning and exercise related to domestic 
biodefense contingencies.
    Most interagency policy and operational matters are managed out of 
the White House, mainly the biodefense directorate of the Homeland 
Security Council. Given the fragmentation of agency responsibilities, 
this White House staff function is indispensable.
    Within this interagency setting, there are both substantially 
overlapping responsibilities and significant omissions. For instance, 
the Department of Homeland Security and the Department of Health and 
Human Services both make grants to State and local agencies to help 
improve their preparedness; there is little if any real coordination of 
these separately authorized, appropriated, and managed grant processes. 
HHS, DHS, and DOD all conduct research and development on a wide 
variety of biodefense technologies, with only the loosest coordination. 
Each of the three main departments tends to conduct exercises and 
develop plans in relative isolation from the others, leaving it to the 
White House staff to pull them together. A variety of different 
expectations and responsibilities apply to each of the three main 
departments in a crisis, which leads to both unnecessary duplication of 
some efforts and omission of others.
    I have given a great deal of thought to how to improve the 
interagency coordination of biodefense policy and operations. It is 
tempting to simply declare one official to be ``in charge.'' This, in 
my opinion, is unrealistic given the complex and interdisciplinary 
nature of the biodefense challenge and the distribution of statutory 
authorities and operational capabilities across multiple executive 
branch agencies and officers.
    The only realistic option, in my judgment, is to strengthen the 
White House staff element in charge of interagency integration. 
Accordingly, I believe that the President should establish a Deputy 
National Security Advisor for Health Security, with appropriate support 
personnel, within the National Security Council staff, building on the 
existing biodefense directorate within the Homeland Security Council. I 
do not believe, however, that this should be legislated as it pertains 
to the President's personal staff. At most, the reauthorization of 
Title I of the Bioterrorism Act of 2002 should offer a sense of the 
Congress that strong, continuous interagency leadership from the White 
House staff is essential given the statutorily grounded fragmentation 
of biodefense and public health preparedness across the executive 
    I also believe that the Secretary of Health and Human Services 
requires a robust, large, and high qualified staff element to support 
him in discharging the extensive biodefense and public health 
preparedness responsibilities and to conduct intra-agency coordination 
and oversight. I do not have a precise number of the appropriate size 
of this staff, but I know it should be substantially larger than it is 
today. I further believe that it should be led by an Under Secretary, 
not an Assistant Secretary, and thus that Section 102 of the 
Bioterrorism Act of 2002 should be amended accordingly.


    The Bioterrorism Act of 2002 has served the country well. It 
established the basic framework for the country's first serious effort 
to prepare itself for catastrophic disease contingencies. But, in the 
past 4 years, we have learned a great deal about this threat, as well 
as about how the department and agencies of the Federal Government are 
likely to respond to a catastrophic disease contingency. A great deal 
has been accomplished, but there is much more to do. In my opinion, our 
future efforts will be even more successful and efficient if we modify 
certain core elements of our strategy for dealing with the catastrophic 
disease threat, as I have outlined in this testimony.
    Thank you again for the privilege of appearing before you. I will 
try to answer any questions you may have.

    Senator Burr. At this time let me introduce Dr. Leah 
Devlin, who is the State Health Director of my State of North 
Carolina, Department of Health and Human Services. Dr. Devlin 
also pulls double duty as the President of the Association for 
State and Territorial Health Officials. She holds a dental 
degree and a master's degree in public health administration 
from the University of North Carolina at Chapel Hill--one of 
the 64 teams playing in the NCAA, I might add, but only three 
ACC teams, and I think that will take a legislative remedy to 
make sure that never happens again. There should be more. Dr. 
Devlin has led a distinguished 20-year career in public health 
serving in both local and State public health departments since 
    Leah, it is awfully good to have you. You are recognized.
    Dr. Devlin. Thank you, Senator Burr, for having me here 
today. We are very grateful and proud of your leadership role 
here on public health preparedness and response and 
bioterrorism. Thank you, Senator Burr.
    We also want to thank you for the investments that have 
been made in the public health infrastructure since 2002 to 
protect the health of the people of this country from terrorism 
and other public health emergencies. This is essential that you 
continue to make this investment, and here are a few key points 
as to why.
    First, the State and local public health system has made 
enormous progress in strengthening our preparedness 
capabilities. If you boil it all down, it is about early 
detection and rapid response.
    Let me give you a few examples that are concrete from my 
own State, your State. We have knitted all of our hospitals 
together, the emergency departments, to public health and we 
have reduced our opportunity for early detection from 1 month 
to 12 hours. We have created seven regional strike teams that 
provide surge capacity, expertise to all of the counties in our 
State in epidemiology, veterinary medicine, pharmacy, lab, 
environmental. We have embedded public health epidemiologists 
in our 12 largest hospitals, doubled our laboratory capacity. 
Every health department has a full-time person dedicated to 
preparedness. It is their full-time job, planning, exercising, 
reiterating what we learn, train, train, train. And we have 
developed a tiered medical response surge capacity. Our 100-bed 
statewide asset mobile hospital was deployed, as you know, 
Senator, to Mississippi during the Katrina response, served 
over 7,400 people in a 7-week deployment of over 500 
professionals. These are just some concrete examples about what 
we are doing to make progress in our States. Again, our goal, 
early detection and rapid response.
    The role of the State agency in coordinating that whole 
statewide effort is unique, and we also are responsible for 
supporting at the local level the communities, the health 
departments, and knitting together and developing their plans 
and exercising and training, their relationships. So much 
progress is being made.
    Point two, we have established essential partnerships with 
law enforcement, with other first responders, emergency medical 
services, agriculture. These partners expect public health to 
pull their weight, as you have just heard our first speaker 
say. And we are pulling our weight in the States in public 
health thanks to the investments that you have been making in 
public health.
    Point three, many challenges remain, so we have had 
progress, we have the strong partnerships, but we have 
challenges, and these are the challenges very quickly.
    First of all, no community can say they are fully prepared.
    Second, the threats are not going away. We are preparing 
for all hazards every day. We are using this capacity in the 
States, and this work does prepare us for an event that would 
be intentionally delivered as well.
    The biggest challenge probably is sustaining the Federal 
investment that you are making in State and local preparedness. 
I cannot overemphasize how important this is because early 
detection, rapid response will save lives in our communities 
across the State. That investment has eroded over the past 4 
years. We have had a redirection of funds in 2004 of $39 
million into the Strategic National Stockpile. We had another 
year $95 million redirected for the Cities Readiness 
Initiative. The 2007 budget proposes to redirect hospital 
preparedness funds that would normally go locally to other 
initiatives. Now is not the time to be backing up on the 
preparedness investments in State and local health departments. 
And these investments are never--almost never one time. Even 
laboratory equipment requires maintenance; it requires 
reagents; it requires replacement.
    Preparedness at the State and local level is a people 
business. It is an expertise business. Yes, we need 
countermeasures, vaccines, antivirals, equipment, but it takes 
a workforce that will deploy them, and as the Secretary says, 
to put the pill in the palm of the people, that requires a 
workforce. And that is your State and local infrastructure.
    Speaking of the workforce, our workforce is aging. We have 
some States where 45 percent of the workforce in public health 
will be retiring within the next 5 years. We do not see the 
young people coming in to take their places, and we would ask 
and urge you strongly to include in your reauthorization bill 
the Public Health Preparedness Workforce Development Act of 
2005 that is a loan repayment and scholarship program.
    So this is the progress, the challenges that we face. I was 
asked to address two specific issues. One I think we have 
already heard spoken to today, which is how clear are the lines 
of authority, and we do understand what the National Response 
Plan requires of DHHS and Homeland Security. We operate that 
way in North Carolina where public health has the lead for the 
health issues, but very quickly moves into an overarching 
response by our homeland security chief in the States. But 
certainly if there are things that you need to do differently 
here at the Federal level so that the Federal Government is 
clear on how they are going to work together, we would support 
    And, yes, we are accountable and we look forward to 
continuing to work with CDC and our Federal partners to make 
sure that we have performance measures that document the 
progress being made in States in order to come into compliance 
with the national goals and objectives.
    In closing, let me just reiterate that early detection and 
rapid response is the core goal of our public health 
preparedness, and that will save lives back home. And we ask 
that in this reauthorization you continue to sustain the 
Federal investment that you have made in the State and local 
    Thank you very much, Senator Burr.
    Senator Burr. Thank you, Dr. Devlin.
    [The prepared statement of Dr. Devlin follows:]

              Prepared Statement of Leah Devlin, DDS, MPH

    Mr. Chairman and members of the committee, I am Dr. Leah Devlin, 
Director of the North Carolina Division of Public Health and President 
of the Association of State and Territorial Health Officials (ASTHO). 
ASTHO represents the State and territorial public health agencies of 
the United States, the U.S. Territories, and the District of Columbia. 
Our members are the chief health officials of these agencies. It is a 
pleasure to appear before you today to discuss the critical 
reauthorization of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (P.L. 107-188).
    First, let me begin by thanking you for recognizing the need in 
2002 to invest in building our Nation's public health infrastructure to 
deal with terrorism and other public health emergencies and emerging 
threats. In responding to the events of September 11, 2001 and the 
subsequent national anthrax crisis, we realized that many public health 
agencies, a critical piece of our front line of defense, were not fully 
prepared to deal with such threats. We thank you for creating a program 
that has strengthened our laboratory, surveillance and epidemiologic 
capacities, and improved our communications and information technology 
systems. Critically important attention and funding were also provided 
for preparedness planning, readiness assessment, and the education and 
training for public health professionals to respond to bioterrorism and 
other public health threats and emergencies. Public health agencies are 
now recognized as key partners with law enforcement, emergency 
management and health care in preparedness and response.
    My remarks will focus on: (1) what State and local health agencies 
have done to increase their level of preparedness, (2) what challenges 
remain that must be addressed, and (3) what resources are needed to 
sustain a high level of public health security.
    In North Carolina, our new Hospital Emergency Surveillance System 
has dramatically improved our ability to rapidly detect bioterrorism 
attacks, pandemic influenza, and other disease outbreaks. Today, the 
North Carolina Division of Public Health receives real-time electronic 
reports from more than 100 hospital emergency rooms so that we can 
rapidly identify potential disease outbreaks. We now have seven disease 
investigation strike teams that respond immediately to suspicious 
disease reports anywhere in the State. Our three-tiered State Medical 
Assistance Team (SMAT) system provides medical care during emergencies 
and augments our hospital capacity. Investments in our public health 
laboratories have tripled our capacity to test suspicious substances 
and confirm the presence of select biologic and chemical agents. None 
of this existed prior to 2002.
    Real life emergencies such as Hurricane Isabel in 2003 tested our 
ability to protect our citizens. During that hurricane, our regional 
disease investigation strike teams assessed community health needs and 
helped redirect critical resources such as food and water to the most 
vulnerable households. Last fall, following Hurricane Katrina, we sent 
our mobile hospital, ambulatory care clinic, and more than 500 public 
health and medical professionals from our SMAT to Mississippi to 
provide care for more than 7,400 patients over 7 weeks. An effort of 
this magnitude would not have been possible prior to 2002.
    Since passage of the Public Health Security and Bioterrorism 
Preparedness and Response Act, State and local health agencies have 
made real progress in their ability to respond to bioterrorism and 
other threats and emergencies. No single State, and no community within 
any State, has reached a full level of preparedness. The act has made a 
tremendous difference, but the safety of the American public requires 
us to do more.
    The ability of the public health system to respond adequately to 
potential terrorist events, emerging infectious diseases, and other 
public health threats and emergencies depends on a well-trained, 
diverse, and adequately staffed public health workforce at the Federal, 
State and local levels. Recruiting, training and sustaining the public 
health workforce is the preparedness crisis. Some States are 
experiencing retirement rates of up to 45 percent over the next 5 
years. The average age of a State public health professional is 47. The 
current scenario is a rapidly aging workforce that will experience high 
rates of retirement over the next 5 years with no clearly identified 
source of qualified public health professionals to fill the void.
    ASTHO urges you, in the strongest way possible, to include the 
provisions of the Public Health Preparedness Workforce Development Act 
of 2005 (S. 506) in your reauthorization legislation. This bill would 
provide incentives for health professionals to enter the practice of 
governmental public health, ensure these individuals commit to a 
designated number of years of service in public health agencies, and 
help to retain current employees in the field of public health.
    We continue to face new challenges each year, from anthrax to 
smallpox to SARS to pandemic influenza. One of the lessons of Hurricane 
Katrina is that we cannot focus too narrowly on specific threats. 
Instead, an all-hazards approach is needed. We must ensure that 
essential public health resources--personnel, laboratories, 
surveillance systems, communications, well thought out response plans--
are available to address ongoing and new public health threats.
    I cannot emphasize enough how important it is that Federal 
bioterrorism funding to State and local health agencies be predictable 
and sustainable. Recruitment and retention of qualified public health 
professionals is not possible in an environment where there are 
concerns about the future of program funding. There are very few 
examples of one-time preparedness needs. Even expensive laboratory 
equipment must be replaced every few years and requires costly 
maintenance contracts and continuous replenishment of reagents. 
Antibiotics, antidotes and other medical supplies acquired to prepare 
for mass casualty events must be rotated, replaced or replenished.
    Over the past few years, portions of existing preparedness funding 
for State and local programs have been redirected to support other 
Federal preparedness needs. For example, last year the Centers for 
Disease Control and Prevention's (CDC) State and local public health 
preparedness cooperative agreement funds were cut by $95 million to pay 
for an expansion of the Strategic National Stockpile (SNS). Prior to 
that, CDC's State and local public health preparedness cooperative 
agreement funds were redirected to launch the Cities Readiness 
Initiative (CRI). The administration's fiscal year 2007 budget doubles 
the Emergency System for Advance Registration of Volunteer Health 
Professionals (ESAR-VHP) funding. This new funding would again be 
redirected from the Health Resources and Services Administration (HRSA) 
hospital preparedness cooperative agreement.
    While SNS, CRI and ESAR-VHP are all important programs for 
improving our public health and medical response to catastrophic 
events, funding them by redirecting resources from existing State and 
local public health preparedness efforts is wrong. Worthy new 
initiatives and expanded activities should be worthy of their own 
funding. Funding cuts may result in layoffs of highly skilled public 
health professionals, reductions in the number of exercises planned and 
implemented, and delays in upgrading laboratory equipment, surveillance 
technology and surge capacity. We must ensure that all State and local 
health agencies sustain and improve existing public health preparedness 
activities, not cut back on them.
    In your letter of invitation, you asked if the lines of authority 
within the Federal Government are clear during medical and public 
health emergencies. Yes, the National Response Plan (NRP) correctly 
assigns coordination of emergency health and medical functions to the 
U.S. Department of Health and Human Services (HHS) under Emergency 
Support Function 8. It also makes clear that the U.S. Department of 
Homeland Security is the overall coordinating agency for issues 
including and transcending those addressed in ESF-8.
    You also asked if HHS should require more State and local 
accountability and Federal oversight for developing medical surge 
capacity. ASTHO supports the development and implementation of 
performance measures to assess progress in preparedness. Accountability 
is essential and best measured against a limited set of performance 
measures that are evaluated over time and flexible enough to allow 
States to match their individualized strategic plans to national goals.
    In closing, I want to again thank the members of this committee for 
your past commitment to improving public health preparedness. While we 
applaud the accomplishments that this committee has permitted the 
public health community to make, we know that so much more can be and 
must be done to improve our Nation's security. We welcome the 
opportunity to continue to work with you in pursuit of that goal.
    Thank you for your attention. I will be pleased to answer any 
questions you may have.

               PREPAREDNESS AND RESPONSE SINCE 9/11/2001

Strengthening Local Preparedness Statewide

     Established seven Public Health Regional Surveillance 
     Provided local funding and guidance to 85 local health 
departments and the Eastern Band of the Cherokee Indians.

Providing State Level Leadership and Expertise

     Established a State level Office of Public Health 
Preparedness and Response.
     Appointed the Public Health Preparedness and Response 
Advisory Committee.
     Created the Public Health Command Center.

Creating Necessary Legal Authorities

     Sought passage of two new laws (1) reporting by hospitals 
of Emergency Department data (2) extended isolation and quarantine 
     Sought passage of major legislation to require reporting 
of zoonotic diseases from the State veterinarian and improved reporting 
requirements for suspected bioterrorism events.
     Added smallpox, pandemic flu, west nile virus, and 
monkeypox to the NC list of required communicable diseases reports.

Developing and Exercising the Plans

     Developed numerous plans as a part of the NC Emergency 
Operations Plan.
     Developed the first FEMA approved mitigation plan for 
infectious diseases.
     Routinely conducted State, regional and local field 
     Established the Avian Influenza & Human Health Task Force.

Assuring Earliest Detection: Surveillance

     Initiated the development of the North Carolina Public 
Health Information Network which includes the NC-Health Alert Network 
(NC-HAN), the National Electronic Disease Surveillance System (NEDSS), 
the NC Hospital Emergency Surveillance System (NCHESS), a pre-hospital 
emergency medical services data system called PreMIS, the Laboratory 
Information Management System (LIMS), and the NC Immunization Registry.
     Developed the Mobile Data Entry Project--a system for 
collecting electronic data in the field including geocoding for GIS 
     Created the NC Hospital Emergency Surveillance System 
     Embedded Public Health Epidemiologists (PHEs) at the 12 
largest hospitals in NC.
     Established NC-DETECT (North Carolina Disease Event 
Tracking and Epidemiology Collection Tool).

Improving Communications

     Established the North Carolina--Health Alert Network 
     Enhanced the existing NC Medical Communications Network.
     Participated in the development of statewide 
telecommunications partnerships with State and local first responders.
     Established system of communications with the private 
healthcare providers.

Identifying the Agent Early

     Developed the NC Laboratory Response Network (LRN) in the 
State Laboratory of Public Health.
     Created the first statewide registry of biological agents 
in the Nation.
     Developed the white powder protocol used by all first 
responders and law enforcement.

Getting Health Information on Risk to the Public

     Distributed to 1.5 million people an insert into all major 
newspaper publications.
     Provided additional staffing and technology support to the 
Department of Health and Human Services Care Line to answer citizen 
     Established new public information officers in the 
Division and the Department including bilingual (Spanish) expertise.

Implementing Training to Maintain Readiness

     Partnered with the North Carolina Community College System 
and the University of North Carolina to develop educational modules 
that will enhance statewide preparedness and response efforts.
     Developed the first training program in the country for 
how law enforcement and public health work together--Forensic 
     Implemented the NC National Incident Management System 
(NIMS) Training Program.
     Implemented numerous preparedness trainings of the public 
health workforce.
     Conducted in partnership with UNC School of Public Health 
a workforce development survey and learning management system.

Building Surge Capacity for Mass Care

     Partnered with the Office of Emergency Medical Services 
(OEMS) to plan and implement a statewide Hospital Preparedness Program.
     Established the 3-tiered State Medical Assistance Teams 
     Strengthened capabilities at the State Medical Examiners 

Learning From Real Life Experiences

     Established and operated shelters in Wake and Mecklenburg 
counties for hundreds of Hurricane Katrina and Rita evacuees in NC.
     Investigated and contained one of the eight laboratory 
confirmed cases of SARS in the country in 2003.
     Managed the distribution of limited flu vaccine available 
during the 2004 flu season.

    Senator Burr. Dr. Melton, I am going to skip over you, if I 
can. I will give Senator Hatch, who really wants to introduce 
you, every opportunity, but given that I see that the bell is 
going to go off, I doubt he is going to make it. But let me go 
to Dr. Dan Hanfling, the Chairman of the Disaster Preparedness 
Committee of Inova Fairfax Hospital in Falls Church, Virginia. 
He has an extensive background in emergency response. Dr. 
Hanfling is involved with FEMA, USAID, Urban Search and Rescue 
Response, and serves as the operational medical director of the 
Fairfax County Fire and Rescue Department.
    Doctor, it is great to have you here.
    Dr. Hanfling. Thank you, Senator Burr. I am pleased to be 
here this morning on behalf of the American Hospital 
Association's 4,800 hospitals, health systems, and other health 
care organization members, and I appreciate the chance to share 
some thoughts with you.
    This morning I want to talk to you specifically about two 
things related to the reauthorization of this important 
legislation: the need to create health care delivery surge 
capacity and the critical importance of hospital preparedness 
    We are doing perilously little to achieve real surge 
capacity. The goal of any medical response to disaster must be 
to save as many lives as possible and to reduce as much 
suffering as possible. And while the term ``surge capacity'' 
has been used to explain a variety of health care-related needs 
to a variety of constituencies, the way I suggest that we ought 
to define surge capacity is to ask this question: How many 
lives are we going to allow to hang in the balance?
    A natural disaster or a terrorist-related attack may result 
in hundreds, thousands, or more critically ill or injured 
victims, and it goes without saying that the timely provision 
of appropriate medical care will play a key role in decreasing 
morbidity and mortality after such events or, simply stated, 
the delivery of care is going to lessen the burden of pain and 
suffering for those in need.
    A response to surge demand and care cannot be provided 
without substantial planning, and experience has shown that 
hospitals in these situations have limited ability to divert or 
transfer patients to other hospitals in the immediate aftermath 
of such events. The experiences of Katrina and Rita also show 
that a deployable medical team or medical teams of the Federal 
Government will have a limited role in increasing a hospital's 
immediate ability to provide critical care to large numbers of 
victims. As a result, hospitals will need to depend on local 
and State sources and reserves of medications and equipment 
necessary to provide appropriate care for the first 48 or more 
hours following the onset of a catastrophic event.
    Currently, there are significant deficiencies, particularly 
in the ability to provide critical care to those patients who 
may be most severely affected. The HRSA National Hospital 
Preparedness Program and the Department of Homeland Security's 
Urban Area Security Initiative grant program have helped fund 
initial purchases of some basic medical supplies and equipment, 
and they have provided for some health care worker training. 
However, funding has been inadequate to establish the necessary 
all-hazards acute care surge capacity that is really required.
    As a result, only piecemeal solutions have been developed 
to address the problem, meaning the ability to provide acute 
and extended health care delivery in the setting of a surge and 
demand for care remains significantly far behind other elements 
of the Nation's tactical response to creating a secure 
homeland. Consider preparedness efforts underway for the avian 
flu, for example. The amount of available funding for supplies 
and equipment has not been adequate to support the purchase and 
use of items of significant cost. The New York times recently 
reported that the national supply of ventilators, which would 
be critical for caring for patients in a pandemic influenza 
outbreak, falls far short of the estimated need, and even 
considering the number of ventilators that are currently being 
stockpiled by the Federal Government.
    Second, the goal for preparedness funding should be to 
allocate sufficient resources so as to maximize the number of 
lives saved. It is worth noting that the ability to meet these 
added challenges is occurring in a larger context, a context in 
which hospitals face significant increasing financial 
pressures. Today, a third of hospitals lose money on 
operations, with Medicare and Medicaid underfunding being a key 
driver. Hospitals also face other financial pressures, such as 
rising labor costs, uninsured patients, skyrocketing medical 
liability insurance costs, and rising pharmaceutical and 
medical supply costs.
    Hospitals receiving funding under the first Bioterrorism 
Act through the National Bioterrorism Hospital Preparedness 
Program were able to take big steps forward toward increasing 
hospital readiness, and at the time the bill was passed, 
preliminary estimates suggested that hospitals would require 
approximately $11 billion to obtain the necessary levels of 
preparedness. To date, hospitals have been appropriated and 
received approximately $2.1 billion, minus the administrative 
costs taken by HHS and the State governments. While we have 
become smarter and somewhat better prepared with time and 
experience, we still have a long way to go.
    The Federal Government must help to protect the Nation by 
providing greater resources to hospitals to meet the challenges 
of emergency readiness and ensuring that those resources are 
made available in a timely manner.
    So, in conclusion, we urge you to:
    No. 1--reauthorize the Hospital Preparedness Program with 
substantial funding for the next 5 years.
    No. 2--direct program funds primarily to acute care 
hospitals rather than being inappropriately siphoned off.
    No. 3--improve coordination between all Federal 
preparedness programs to avoid confusion and waste.
    And, No. 4--require that State health departments consult 
hospital groups in developing their funding plans.
    Mr. Chairman, thank you for your time, and we look forward 
to working with you and your staff on sharing a goal of 
improving the emergency preparedness of America's hospitals and 
    Senator Burr. Thank you, Dr. Hanfling.
    [The prepared statement of Dr. Hanfling follows:]

        Prepared Statement of the American Hospital Association

    Good morning, Mr. Chairman. I am Dan Hanfling, M.D., a board 
certified emergency physician practicing in the Department of Emergency 
Medicine at Inova Health System (Inova) in Falls Church, Va. On behalf 
of the American Hospital Association's 4,800 hospitals, health systems 
and other health care organization members, and our 33,000 individual 
members, we appreciate this opportunity to present our views on medical 
preparedness as you consider reauthorization of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.
    I am Director of Emergency Management and Disaster Medicine at 
Inova, a six-hospital health system with over 1,500 licensed beds in 
suburban Northern Virginia. In addition, I currently serve as State 
Medical Director for PHI AIR Medical Group--Virginia, the largest 
private rotor-wing air medevac service in the States, and as a Medical 
Team Manager for Virginia Task Force One, a FEMA- and USAID-sanctioned 
international urban search and rescue team. I have extensive experience 
in the delivery of out-of-hospital emergency medical care, including 
disaster scene response, most notably at the Pentagon on September 11, 
2001 and the recent responses to Hurricanes Katrina and Rita. I was 
also intricately involved in the response to the anthrax bioterror 
mailings in the fall of 2001, when two cases of inhalational anthrax 
were successfully diagnosed at Inova Fairfax Hospital.
    Hospitals have long had emergency management plans in place that 
have been carefully developed and tested. These plans are multipurpose 
and flexible in nature because, as we have recently witnessed, the 
number of potential disaster scenarios is large. As a result, hospitals 
maintain ``all-hazards'' plans that provide the framework for managing 
the consequences of a range of events, including natural and man-made 
disasters. The funding provided to hospitals through the National 
Bioterrorism Hospital Preparedness Program (NBHPP), a program 
authorized by the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002, has been a good first step toward increasing 
the readiness of the Nation's hospitals and their communities and 
developing improved strategies for dealing with all kinds of threats 
facing our communities. At the time preliminary estimates suggested 
that hospitals would require approximately $11 billion to obtain a 
basic level of ``all hazard preparedness.'' To date, Congress has 
appropriated approximately $2.1 billion over 5 years for the program. 
The amount that hospitals have actually received is significantly less 
due to dollars taken off the top for the Federal Government's 
administration of the program and overhead allotments that the State 
grantees have retained. As you will hear, we have become smarter with 
time and experience, but we still have a long way to go before we can 
say we are fully prepared to handle disasters that will surely occur in 
the future.

Defining Surge Capacity

    The public looks to hospitals to play a critical role in the event 
of a disaster. As such, hospitals must be able to accommodate the surge 
in demand for care in order to screen, stabilize and provide definitive 
care for affected persons. Traditional disaster planning has largely 
concentrated on ``fixed occurrence'' events, such as those created by 
transportation accidents or the terrorist attacks of September 11, 
2001, in which there are a finite, and usually relatively small, number 
of victims requiring hospitalization. However, the swiftly changing and 
sophisticated nature of terrorism, the growing threat of natural 
disasters such as Hurricanes Katrina and Rita, and emerging infectious 
diseases such as ``avian flu,'' require that hospitals update their 
emergency management plans. Hospitals must be able to effectively 
extend their ability to deliver uninterrupted medical care in the face 
of a prolonged event involving large numbers of victims, such as an 
attack utilizing chemical, biological or radiological (CBR) weapons or 
a pandemic disease.
    Because of the dual nature of disasters--fixed versus prolonged 
events--hospitals and their communities must plan to create surge 
capacity for each of these two distinct types of events. Hospitals can 
increase their patient care capacity in relatively short periods of 
time by ``surging in place.'' This involves rapidly discharging 
existing patients, cancelling scheduled procedures, and taking steps to 
increase the number of patient care staff in the facility in order to 
make additional staffed hospital beds available for incoming disaster 
event patients. In addition, ``surge in place'' includes the creative 
reconfiguration of available space by a health care facility for use in 
the initial management of disaster victims. Many hospitals, in addition 
to creating inpatient availability, have plans to extend emergency 
department capability by using lobby and waiting room areas, as well as 
other patient care areas typically reserved for specialty patients 
undergoing gastroenterology, pulmonary and cardiac procedures, to 
accommodate additional patients.
    Examples of the creation of internal surge capacity abound from the 
experiences of the health care systems most impacted by the attacks in 
New York City and Northern Virginia on September 11, 2001. Upon 
learning of the events that transpired at the Pentagon that day, Inova, 
which has facilities within mere miles of the Pentagon, implemented its 
facility emergency management plan. Patients already designated to go 
home sometime that day and those deemed stable enough for continued 
management of their medical conditions at home were discharged as 
quickly as safely possible. Elective surgeries were canceled, and all 
ongoing surgical cases were completed. As a result, an additional 343 
hospital beds (out of approximately 1500 beds across the health system) 
and 43 operating rooms were made available within 3 hours of the attack 
on the Pentagon.
    While this type of strategy can provide for a temporary ability to 
increase patient care capacity, most hospitals cannot sustain such a 
surge for extended periods of time. Individual facilities would quickly 
become overwhelmed if the disaster involved large numbers of victims 
presenting over a prolonged period of time.
    Prolonged disasters involving large numbers of victims that 
overwhelm the health care system in a community, such as would be seen 
in pandemic influenza, would require the development of ``community 
surge capacity,'' involving the development of alternative care 
facilities. This type of community surge capacity is complicated and 
costly to achieve and involves advance planning for logistical support, 
the development of protocols, and the determination of specific mission 
goals. Communities must plan for this contingency using the advanced 
designation of facilities that can be used to accommodate patients, 
perhaps under more austere circumstances than would be faced in 
everyday medical care.

A Demonstrated Need

    Like the attacks of September 11, 2001, a number of recent man-made 
and natural disasters have also demonstrated the necessity of hospital 
surge capacity. The evacuation of hospitals and nursing homes in 
Louisiana and Mississippi due to Hurricanes Katrina and Rita, and the 
illnesses and injuries resulting from the hurricanes, required that 
thousands of acutely ill and fragile patients be admitted to hospitals 
in surrounding communities and States. Here in the Washington area, the 
delivery of anthrax spores to the Hart Senate Office Building in 2001 
caused a surge in demand for care at Inova. The emergency department of 
Inova Fairfax Hospital diagnosed two confirmed inhalational anthrax 
cases and screened over 1,127 patients with influenza-like symptoms or 
concerns of ``anthrax exposure'' over a 2-week period of time.

Key Assumptions Validated

    Review of these, and other recent disaster events that generated 
definable surges in demand for care, validates a number of important 
assumptions regarding the development of acute care surge capacity. 
First and foremost, the rate limiting step in mounting any coordinated 
response to a surge in demand for care will be the sustained 
availability of medical and nursing staff. Whether the disaster results 
from the use of weapons of mass exposure (WME)--including biological, 
chemical or radiological attacks--a contagious, infectious disease, or 
the widespread disruption in civil order, it must be assumed that 
staffing will be a problem. With the use of WME in particular, 
workforce attitudinal survey suggest that one-quarter to one-third of 
the workforce may be deliberately absent for some period of time. The 
experience of several hospitals, including the Ochsner Clinic in New 
Orleans, during and after Katrina give further credence to the 
importance of adequate planning for workforce reductions in a prolonged 
event. Infectious disease outbreaks would also reduce the workforce if 
caregivers or their family members succumb to the very illnesses they 
    It is also important to note that in planning for surge demand for 
care due to a disaster, decisionmakers must also consider the ongoing 
need to continue to deliver basic health care services. Hospital 
services will be required to maintain routine delivery of emergency 
care, such as delivering babies, dealing with traumatic injuries and 
sudden acute illness. In fact, some researchers have noted that certain 
conditions, particularly those related to cardiovascular events, may 
even increase in times of great stress related to disaster.
    In addition, last year's response to Hurricanes Katrina and Rita 
emphasize the key assumption that the initial forward movement of 
patients is not likely to occur, and that Federal resources could be 
unavailable for up to 3 days following the onset of any disaster event. 
A surge in demand for care is going to have to be handled locally, with 
locally available resources.

Lack of Funding Hindering Readiness

    Emergency readiness requires a significant investment in staff and 
resources. But the ability to meet these investment challenges is 
compromised by the significant financial pressures facing hospitals. 
Today, a third of hospitals lose money on operations--with Medicare and 
Medicaid under-funding being a key driver. On top of under-funding by 
government payors, hospitals face other financial pressures: labor 
costs continue to rise as hospitals increase wages to attract scarce 
workers; the number of uninsured patients also continues to grow, 
contributing to greater levels of uncompensated care; and hospitals 
face skyrocketing costs for medical liability insurance, 
pharmaceuticals and medical supplies.
    A hospital's ability to deliver optimal medical care in the setting 
of any disaster event, regardless of its cause, is in large part 
contingent upon an immediately available supply of key medical 
equipment, supplies and pharmaceuticals, as well as adequate staffing. 
However, due to financial pressures, hospitals have adopted just-in-
time supply chains for their equipment and supplies. As a result, in a 
disaster hospitals would face an almost immediate shortage of critical 
supplies such as ventilators, personal protective equipment for staff, 
drugs and other supplies. In addition, most hospitals routinely operate 
at or near full capacity and have only limited ability to rapidly 
increase their workforce.
    The NBHPP, administered through HRSA, and the Department of 
Homeland Security's (DHS) Urban Area Security Initiative (UASI) grant 
program have helped to fund initial purchases of some basic medical 
supplies and equipment, as well as some health care worker training. 
However, these programs have not provided the level of funding required 
to establish adequate ``all-hazards'' acute care surge capacity. As a 
result of the relative paucity of funding, only piecemeal solutions 
have been developed to address the problem of developing surge 
capacity. The amount of available funding for supplies and equipment 
has not been adequate to support the purchase and use of items of 
significant cost, such as ventilators, intravenous pumps, or cardiac 
monitoring equipment. For example, The New York Times recently reported 
that the national supply of ventilators, which would be critical for 
caring for patients in a pandemic influenza outbreak, falls far short 
of their estimated need, even considering the numbers that are being 
stockpiled by the Federal Government. In addition, the rate limiting 
step in surge capacity planning, namely the ability to recruit, retain 
and deploy staff to the bedside during any given crisis, has not been 
fully and comprehensively addressed, despite some progress in the 
development of systems to identify and register in advance health 
professionals willing to volunteer for service in a disaster.
    As a result, the ability to provide acute and extended health care 
delivery in the setting of a surge in demand remains significantly 
limited. Furthermore, planning and funding for medical surge capacity 
remain far behind the other elements of the Nation's tactical response 
to creating a secure homeland. And given the very real concerns 
regarding an impending influenza pandemic, communities must focus on 
priorities for building such capacity that goes beyond the purchasing 
of beds, a metric which is too simplistic, and of little use, in 
creating the sort of capacity that is truly needed.
    The Federal Government must help protect the Nation by providing 
greater resources to hospitals to meet the challenges of emergency 
readiness and ensuring that those resources are made available in a 
timely manner. In addition, given what Americans need from our Nation's 
hospitals, today is a time for investment, not cutbacks.

Key Principles to Consider Moving Forward

    As Congress prepares to reauthorize the NBHPP, I would like to 
share with you eight key principles the AHA has developed after 
carefully analyzing the program's successes and shortcomings since its 
inception in 2002. We hope that you will take these principles, along 
with the information I have just shared with you on the challenges of 
creating adequate surge capacity, to heart during the reauthorization 
Ensuring Program Sustainability
    First, the AHA supports reauthorizing the program for a full 5, or 
more, years. We urge Congress to continue to include ``such sums as may 
be necessary'' for ensuring consideration of needs during the 
appropriations process. Disaster readiness is an investment that is 
well worth its cost. However, hospitals simply do not have the extra 
funds to pay for what is needed to ensure their readiness to respond. 
As noted previously, hospitals' ability to adequately respond in a 
disaster will depend in large part on the availability of key medical 
equipment, supplies and pharmaceuticals, as well as optimum staffing 
levels. Simply put, to adequately meet the most basic needs of our 
communities in the event of a disaster, more money is needed.
Funding Acute Care Hospitals
    Many in the field believe that too large a proportion of the 
hospital readiness funds have been funneled to nonhospital providers. 
Given the challenges hospitals face in responding to the threats such 
as pandemic influenza and catastrophic natural disasters and the 
significant gaps remaining in hospital preparedness for these threats, 
program funding should be primarily directed to acute care hospitals.
Improving Coordination Between all Federal Preparedness Programs
    Over the last several years, various Federal departments and 
agencies, including HRSA, the Centers for Diseases Control and 
Prevention (CDC) and DHS, have administered funding to enhance health 
care, public health and first responder preparedness. These streams of 
funding have often worked at cross-purposes, including inconsistent 
requirements and redundant purchases. The law must ensure that Federal 
agencies plan in a coordinated way to enhance national preparedness and 
avoid confusion and waste.
Broadening State and Metropolitan Hospital Associations' Roles
    State health departments should continue to be the ``grantees of 
record'' for preparedness funds. However, the AHA strongly recommends 
that State and metropolitan hospital associations be given a more 
substantial role in disbursing funds to the proper recipients. While 
many of these hospital associations have had some level of involvement 
with their State departments of health with regards to this program, we 
are concerned that States have not often permitted their hospital 
associations to have real input into decisionmaking. Therefore, we 
recommend that each State's grantee agencies be required to work with 
the State hospital association (or metropolitan hospital associations 
for city-specific funding) to develop the State's preparedness plan and 
to determine how funds will be disbursed.
Greater Flexibility in Approved Use of Funds
    Under the current legislation, hospitals have been subject to 
myriad Federal and State requirements in order to receive preparedness 
funding. The AHA recommends minimizing the number of Federal/State 
requirements imposed on hospitals as a condition of funding to reduce 
the potential for unfunded mandates. As stated previously, ensuring 
adequate supplies, equipment and staff in the event of a disaster is 
very costly. Placing additional unfunded mandates on hospitals in the 
form of numerous Federal and State requirements further stretches 
hospitals' already scarce resources, limiting their capacity to not 
only respond in the event of an emergency, but to deliver the care 
their communities need every day.
    We also recommend expanding the ``allowed uses'' of NBHPP 
preparedness funds in appropriate areas. For instance, funds should be 
allowed to be used for making facility/security enhancements (i.e., 
allow construction for enhancing ventilation systems, window 
enhancements, etc.). These upgrades are a vital part of ensuring 
hospitals' response capabilities and should be eligible to receive 
funding. The AHA also recommends more comprehensive funding for 
education for hospital preparedness. For instance, permit funds to be 
used to pay for staff to attend education sessions and as ``backfill'' 
for staff who are attending educational sessions.
Reduce Ability to Use Funds to Build State Health Department 
    The AHA recommends Congress take steps to minimize the use of 
hospital preparedness grant funds by health departments for internal 
operations and hiring. While we understand the need for the State to 
have adequate staff and resources to administer their hospital 
preparedness program, we are concerned about reports that some States 
are inappropriately using hospital preparedness money for purposes that 
are more appropriately funded under the CDC's public health 
infrastructure stream of funds. Congress should also make States 
accountable for how they expend funds. Specifically, we recommend the 
creation of ongoing State progress reports.
Maintain HRSA Program Administration
    While we recommend greater coordination between Federal 
preparedness programs, we believe the National Bioterrorism Hospital 
Preparedness Program should continue to be administered by HRSA.


    Hospitals face new and emerging threats--both man-made and 
natural--every day. We have always been ready for the foreseeable. Now 
we must plan for the previously inconceivable.
    Hospitals are upgrading existing disaster plans, and continue to 
tailor their disaster plans to suit the individual needs of their 
communities in the face of new threats. America's caregivers perform 
heroic, lifesaving acts every day. And, in the face of the unexpected, 
they can be depended on to rise to the needs of their communities.
    We look forward to working with this committee and staff to forge 
ahead toward a shared goal of improving the overall preparedness of 
America's hospitals and communities.

    Senator Burr. Clearly, Senator Hatch is probably headed to 
the floor. Let me call on Dr. Richard Melton, the Deputy 
Director of the Utah Department of Public Health. He holds a 
master's degree in public health and laboratory medicine and a 
Ph.D. in public health. While serving as Director of the 
Division of Laboratory Services at South Dakota Department of 
Public Health, Dr. Melton developed a collaborative statewide 
approach to disease outbreak investigation and has been an avid 
proponent of health information technology. Dr. Melton also 
played a vital role in the preparations for the 2002 Salt Lake 
Winter Olympic Games.
    On behalf of Senator Hatch, especially, Dr. Melton, 
    Mr. Melton. Thank you. Good morning, Senator Burr. I am 
grateful for the opportunity to be here. It is hard for me to 
add too much to what has already been said. My specific task 
was to talk a little bit about how preparations for the 
Olympics helped us in using the funds and preparing for what we 
have been talking about today.
    One of the greatest things that we got out of preparation 
for the Olympics was our ability to work with other agencies, 
particularly with Federal and State law enforcement. One of the 
most interesting things we developed was with the Department of 
Energy wherein we started using the instrumentation that is now 
utilized for BioWatch. We are not a BioWatch State, but we 
gained a lot of experience out of that, including one of the 
most exciting times Secretary Leavitt talks about when a sample 
returned a positive result from the airport and we considered 
closing the airport for a while until we finally got a 
confirmatory report that said that was negative. But the 
interesting thing that we got from that was that the plans that 
we had prepared, while they did not exactly work--and no plan 
ever exactly works--was able to get us through what was then an 
exciting time.
    We developed during the Olympics a coalition of hospitals 
in the Olympic footprint where we talked about surge capacity 
particularly, in that we arranged for some long-term care 
facilities in the area who were not utilizing all of their 
beds, we would be able to utilize those in case of a disaster. 
Since then, those beds are no longer available to us, and we 
continue to work with a statewide coalition of hospitals on 
surge capacity, which is, as mentioned, a vital element.
    We still do not have, very frankly, a very good surge 
capacity plan. It is very difficult. Staffing is one of the 
biggest concerns that we have with surge.
    Disease surveillance, as Dr. Devlin has talked about, is 
one of the main things that we were concerned about during the 
Olympics as well. We decided to utilize a real-time outbreak 
detection system that the University of Pittsburgh was 
utilizing at the time, and we tied together three emergency 
rooms in the Salt Lake area at that point and were able to look 
at the major complaints that were coming into those facilities 
and were able to look at the disease. We currently are looking 
at trying to expand this from emergency rooms to primary care 
physicians as an extension of our monitoring of disease in the 
    We had a contingent of the Strategic National Stockpile 
that was stationed in Salt Lake City during the Olympics and 
developed for the footprint of the Olympics a very good 
distribution system for the Strategic National Stockpile. It 
has been far more difficult to develop distribution systems 
statewide, however, and that still is an ongoing task for us.
    We worked with the Denver regional office of the Department 
of Health and Human Services, and they were very beneficial. We 
believe that Health and Human Services is the correct place for 
medical response.
    Let me share with you in the last minute that I have a 
couple of concerns. In the past few years, we have seen a 
reduction in the amount of funding that is coming to State and 
local government for preparedness, and in Utah, in the 2007 
year, we will see about 50 percent of the funds that were 
originally put in Utah. And while it will allow us to continue 
to make progress, progress will be significantly slower.
    Another issue that I would like to address is disease 
reporting, and I have in my testimony a couple of instances 
that point out that response is, in fact, a local issue. One of 
those was a smallpox scare where we had a hospital that had 
smallpox. And we were able, with our current ability, to 
resolve that within a few hours. But it is a local issue, and 
disease reporting and surveillance should be at the local 
    We also support the Public Health Preparedness Workforce 
Development Act language. We believe that that is essential.
    We also believe, as Senator Dodd was talking about, that we 
do need a regional training program for disaster preparedness. 
Right now in Utah, if we need good training, we must go to the 
East Coast, and we believe that we need to develop that. The 
University of Alabama, Yale University, and University of Utah 
are working on developing a regional plan. We would like to see 
that kind of language placed in this reauthorization as well.
    With that, I thank you very much for your time and 
    [The prepared statement of Mr. Melton follows:]

            Prepared Statement of A. Richard Melton, Dr.P.H.

    Mr. Chairman and distinguished committee members, it is an honor 
for me to address you today. I hope you will find the information I 
share both interesting and informative. My name is Dr. A. Richard 
Melton. I served as the laboratory director for the State of South 
Dakota for about 12 years followed by about 5 in Utah before being 
appointed as the Deputy Director for the Utah Department of Health 
(UDOH) about 14 years ago. One of my assignments as Deputy Director is 
to administer the Public Health Security and Bioterrorism Preparedness 
and Response Act funds from both HRSA and CDC. I was also involved 
along with Dr. Scott Williams as we prepared for the Salt Lake 2002 
Winter Olympics. I have been asked to share with you how these Olympic 
preparations influenced our use of funds provided under this act.
    Salt Lake City was named as the host city for the 2002 Olympics in 
June of 1995. We watched with interest as the 1996 Atlanta games 
unfolded, but had no real understanding of what preparations we would 
need to make for our upcoming event. We finally started to consider 
seriously what was involved during the 1998 Nagano games. It was at 
that time we started to develop the coalition of partners we felt would 
be necessary to assure the public's health during the 2 months 
surrounding the 17 days of the 2002 games. While these considerations 
provided a strong base for cooperation and planning, and an alliance 
was formed around public health issues, it was not until we sent a 
representative to the 2000 Sidney games that we fully understood the 
extent of the challenge that lay ahead. I have provided the staff with 
some documentation of what was done and what we learned. Time only 
permits me to touch briefly on our experiences which provided an 
extraordinary foundation for what we have been able to accomplish with 
the funds provided by this act.
    One of the foremost benefits the preparation and games provided was 
the close working relationship that we developed not only with agencies 
with whom we normally work such as local and Federal public health 
partners, but we developed such relationships with local, State and 
Federal law enforcement agencies, fire agencies and interestingly the 
Department of Energy (DOE).
    The DOE approached us early in our preparations about testing some 
experimental equipment that could sample air in selected Olympic venues 
for the presence of biological agents. We agreed to work with them and 
began our introduction to the technology now used in BioWatch. We are 
now able to use the analysis part of the system daily in our 
surveillance activities. The actual instrumentation provided by the DOE 
was removed after the games and Utah is not a BioWatch State, but our 
laboratory staff developed expertise using this technology and since 
have been able to easily implement the testing procedures now used for 
biological agents. The DOE instrumentation monitored such locations as 
the airport and the medals plaza. The one exciting experience we had 
with the system is one to which then Governor Leavitt often refers. A 
sample from the airport returned a presumptive positive result. On 
confirmatory testing, the sample was not a bioagent. The experience 
provided a live, real time test of our plan and processes. Frankly, the 
plan did not work as outlined, but the underlying process did. The key 
to the effective use of this technology, either as used by DOE during 
the Olympics or as implemented in BioWatch, and the most difficult to 
get right, is a well thought through and well defined response when a 
positive result is reported.
    It was important as we prepared for the Olympics that we take an 
all-hazards approach, for there is no way of predicting whether a 
disaster will be from a terrorist or if it will be a natural disaster, 
whether an incident will be an explosion in a single location, or a 
disease across the entire population or within a selected group. Our 
preparation following the Olympics has continued to address all aspects 
of preparedness--all-hazards.
    Our Olympic planning concentrated on five areas of preparedness 
that represent this all-hazards approach.

        1. EMS and Hospital Preparedness (Surge Capacity)
        2. Environmental and Food Safety Regulation
        3. Disease Surveillance and Outbreak Response
        4. Public Information and Health Promotion
        5. Event Operations and Disaster Preparedness

    We did make statutory and regulatory changes, during Olympic 
preparation that gave the UDOH clearer authority for all aspects of 
medical and public health response. I could speak at some length on 
each of these issues, but I will just mention an item or two for each 

1. EMS

        In order to increase the number of ambulances available for the 
        venues, vehicle replacement was planned for 2 to 3 years in 
        advance and staged to create a period of service overlap where 
        both new and aging vehicles were used. Additional emergency 
        technicians were recruited from other areas to staff the needed 
        response capacity.

        To provide surge capacity for major hospitals, arrangements 
        were made with large long-term care facilities nearby that had 
        a low occupancy rate and thus beds available for use. We 
        developed a coalition of all of the hospitals in the Olympic 
        footprint to plan with us all aspects of medical response 
        outside the actual Olympic medical responsibility. The Olympic 
        medical service was awarded to the Intermountain Health Care 
        system. They were, of course, also a part of our planning 

2. Environmental and Food Regulation

        An estimated 150,000 meals per day were prepared and served in 
        the Olympic venues. The safety and security of these meals had 
        to be assured. Also drinking water and solid and sanitary waste 
        disposal was a problem especially for the mountain venues. 
        Processes and staffing were developed and implemented with the 
        cooperation of the local health departments, the Utah 
        Departments of Environmental Quality and Agriculture as well as 
        the USDA.

3. Disease Surveillance and Outbreak Response

        Traditional disease surveillance for this event was clearly not 
        sufficient. The typical disease report often takes 2 weeks to 
        make it to public health. The need to see potential terrorism 
        agents or natural disease outbreaks for the games demanded real 
        time monitoring. The DOE system provided one real time 
        detection system. Collaboration with the University of 
        Pittsburgh using a system called Realtime Outbreak Detection 
        System (RODS) reported and evaluated major complaints in the 
        emergency room of LDS hospital or what is referred to as 
        syndromic surveillance. Collaboration with the University of 
        Utah reported syndromic information from the University of Utah 
        Medical Center emergency room and the Olympic village. These 
        systems were effective in monitoring disease in the population. 
        It is unclear if they really would have detected a bioagent 
        because seasonal influenza peaked in Utah during the games. I 
        have included, on the following pages, 3 charts outlining the 
        data which was produced over the 17 day period of the games. We 
        continue to use the RODS system and are working to expand the 
        number of health care providers report through it.

4. Public Information and Health Promotion

        It is not uncommon in the Salt Lake Valley to have temperature 
        inversions that increase air pollution. The UDOH along with the 
        Utah Department of Environmental Quality developed pre-written 
        statements that were used when levels of pollutants were high. 
        These included recommendations for at-risk populations. Many 
        other pre-written press statements were prepared for issues 
        that might present during the games. All of the public 
        information processes were coordinated across all agencies.

5. Olympic Operations and Disaster Preparedness

        Table top training and exercises in public health were 
        conducted in the 2 years preceding the games. These covered 
        almost 20 topics and included in excess of 40 agencies and 
        organizations. The topics ranged from mass gathering issues 
        through medical management to fatality management. During the 
        games we did experience incidents that tested the system. These 
        included the airport incident mentioned earlier and a chemical 
        incident in downtown Salt Lake. Because of the preparation, 
        these were handled ``without incident.''

    I would comment that while we had good cooperation from the Salt 
Lake Organizing Committee command system and other partners on general 
public health issues such as sanitation and health preparedness, with 
the exception of the Department of Energy, no one took our concern for 
bioterrorism seriously until after the 2001 Anthrax attacks. Following 
those attacks, HHS agreed to station a contingent of the National 
Pharmaceutical Stockpile (NPS) (now called the Strategic National 
Stockpile) in Utah during the games and other assistance became more 
generous. Our preparations during the Olympics had included our Federal 
partners at the regional level (Denver Regional Office), and they were 
very good at responding to our needs where they had the resources. 
Since the NPS was not something they could just call in for us in the 
absence of a declared disaster we made the request to the Secretary. 
Our current planning assumes that in a disaster, we could make requests 
through the Denver Office and it would be forthcoming. Following the 
Salt Lake City tornado of 1999, our requests through Denver brought the 
needed response. We have no reason to believe, even in light of the 
experience of Katrina, that this processes would not continue to work.
    The attacks of September 11 and the following Anthrax attacks 
focused our Olympic preparations. As stated previously, our planning 
took an all-hazard approach. We had planned for bioagents. With the 
attacks of late 2001 our focus on terrorism became more intense. We 
also finally had the attention of all of our partner agencies, both 
State and Federal. There were discussions of canceling the Olympic 
games entirely. After reviewing our preparations, we all concluded the 
games should go on. By the time the games started, Federal resources on 
the ground included; the DOE detection system, National Guard Civil 
Support Hazmat Teams, Urban Search and Rescue Teams, Disaster Medical 
Assistance Teams, National Medical Response Teams, Disaster Mortuary 
Assistance Teams and the National Pharmaceutical Stockpile. IOC 
president Jacques Rogge summarized the impact that these attacks had on 
the games when he said ``No major sporting event will ever be the same 
because of heightened security concerns following the terrorist attack 
in the United States . . . because, of course, when it comes to 
security, everything has changed since Tuesday.''
    Let me move to the impact this experience had on our use of the 
HRSA and CDC funding provided by this act. We had, of course, received 
a small amount of preparedness funding through CDC prior to the 
Olympics which were very helpful in our preparations. During the 
preparation and games, many of our staff along with those of the other 
agencies involved assumed double duties, preparing for the games as 
well as whatever duties were normal. There was little funding provided 
by the SLOC, the State or Federal Government. We could accomplish what 
we did only because it was seen as a short, 2 year, defined period. 
This also highlights the advantage of having to meet a set preparedness 
deadline. We knew when this disaster would occur. We recognized that we 
could not maintain this level of expectation after the games. Following 
the games then we searched for ways to take advantage of what we had 
accomplished. With the funds that became available later in the year 
through this act we were not only able to maintain but to build on our 
    One challenge that the Olympic experience did present early in our 
use of the CDC funds surrounded the limited footprint of the Olympic 
games. The Olympic preparations had included only 7 counties and 6 
local health departments of the 29 counties and 12 local health 
departments that make up Utah. I have included a map on following pages 
that shows the Olympic footprint. The challenge we faced was how to 
continue the progress with the 6 LHOs who had worked closely with us 
for 4 years and yet bring the other 6 up to the same level of 
preparedness. Does one distribute the funds disproportionately to those 
who have not been involved or equally to all based on some formula. 
There was no choice but to spend some additional resource on the 
nonOlympic venue departments. That then caused concerns from those who 
had been working with us so long that they were being ``punished'' for 
having already done so much. Over time we have resolved the issue, 
though the nonOlympic venue departments are still not quite to the 
level of those who experienced the Olympics. We also had to bring the 
nonOlympic hospitals (mostly rural) our medical response coalition 
hospitals. We had somewhat the same dilemma with hospitals and our 
expenditure of the HRSA funds.
    Let me share with you in the limited time left to me, just two of 
many recent experiences that demonstrate how much these funds have 
changed how public health operates in Utah and how preparedness is a 
local issue.
    At 6:00 one morning, a long haul truck driver who had just arrived 
in Salt Lake Valley from Seattle, having stopped at a number of truck 
stops along the way, presented at an emergency room with skin lesions 
and fever. The attending ER physician determined that the appearance of 
the lesions were compatible with smallpox. She immediately recognized 
the complexity of the situation and called the Salt Lake Valley Health 
Department. The emergency room was also immediately closed and all of 
those who were there were isolated and not allowed to leave. After 
consulting with the UDOH and CDC a sample was taken to the UDOH 
laboratory and tested. It was quickly determined that the man had 
atypical chicken pox and not smallpox. Everything went, well not quite 
like clockwork, but within about 7 hours the people in the emergency 
room were released and the emergency room was reopened. What really 
made this happen was that the people were trained to communicate with 
the local health department and the Utah laboratory had the technology 
to do the diagnosis within a couple of hours. Had this happened 1 year 
before, the sample would have been sent to CDC for testing and would 
have taken at least a couple of days if not more. In Utah we can now 
test, within a few hours, for all of the BT agents and our local health 
departments have a working relationship with the hospitals in their 
    Another recent event took place in a remote part of Utah near one 
of our beautiful national parks. A lodge--Ruby's Inn--had a chemical 
irritant intentionally introduced into the air handling system, 
exposing a large number of visitors. These guests were quickly 
transported to the small local hospital not far away. The hospital had 
a decontamination tent, provided with HRSA funds, and were trained in 
its use. Though, as it turned out, the agent was not life threatening, 
the visitors were all appropriately decontaminated and treated. 
Interestingly, just 2 weeks prior to this event, the hospital 
administrator had complained that he didn't know why he had to store 
one of those tents, no one would ever use it in such a remote area. The 
fallacy of course is that the risk of such events is limited to large 
metropolitan areas.
    I could detail for you many such incidents we now manage, in Utah, 
almost daily, which we would or could not easily have managed before. A 
SARS case in Saint George, a chemical explosion at Thiakol in remote 
northern Utah, a meningitis outbreak at a Job Corps site, and last 
summer we efficiently received and cared for 600 evacuees from Katrina.
    Each year we continue to build our level of preparedness. We have 
recently implemented a radio system we believe to be unequaled anywhere 
in the Nation. We do not have statewide coverage of 800 mhz radio 
service. However, through a system called Omnilink, we can set up radio 
communication with all emergency providers in the State, regardless of 
the frequency they use, and make on-the-fly bridges to connect groups 
as required by the situation. All local health departments, ambulances 
and emergency rooms, fire and law enforcement agencies and the national 
guard are a part of this system so we can link to them as needed. We 
are now working on adding wireless data service to this same system. 
This system was tested during a recent military exercise when one of 
the coordinating 800mhz towers was struck by lightning. Radio dispatch 
saw the tower service go down and used Omnilink to reroute the signals 
to another tower and no one on the ground knew the tower was lost. We 
also have a notification system, called UNIS (Utah Notification and 
Information System) that is statewide and can be used to send automated 
notifications to all emergency personnel, including primary care 
physicians who sign up for the service. This also includes reverse 911 
capacity across the State. We hope to add primary care physician 
disease reporting to the syndromic surveillance system within a year or 
    Our legal review of the Utah health statutes recently found that 
our quarantine and isolation laws still would not allow us to deal with 
large groups of ill or exposed populations such as one might have with 
terrorism in a large office building or an airplane landing at one of 
our airports, and certainly not the numbers expected if we have an 
influenza pandemic similar to 1918. Our legislature just passed and the 
Governor signed a revision to our enabling statute that now allows us 
to address such situations. It is clear that the Executive Director of 
the UDOH has the legal authority as well as the networks to deal with 
all medical and public health situations that may arise.
    I am sure that most States can give you similar information about 
how much the CDC and HRSA funding has helped and how wisely we have 
expended the funds--how many epidemiologists and laboratorians have 
been added and how much training has been provided to health and public 
health professionals. They will also assure you that continuation of 
this funding is vital to our continued preparedness and to test those 
preparations. They will tell you that Biosurveillance should include 
all levels of government and that disease reporting should be through 
the local and State health agencies and not directly to Federal 
Agencies. They will also encourage you that it is vital that we begin 
training a new generation of public health leaders by enacting language 
proposed for the Public Health Preparedness Workforce Development Act. 
All of these things are true for us to continue strengthening the local 
and State health response and should be included in the 
    I appreciate the opportunity to share with you these thoughts and 
our thanks for the vital funds that have allowed us to become more 
prepared. I have listed for you, on the last couple of pages some of 
the many things we accomplished with these funds in just the last year. 
I also want to emphatically State that we are far from fully prepared. 
I could give you another list of the things that we yet need to do and 
I assume others who address you will do so. I would like only to say 
that it is vital that these funds continue to come to us to maintain 
what we have and to assist us in making further progress toward 
preparedness. Thank you for your time and attention.
 health and public health planning organizations for the 2002 olympics

Utah Olympic Public Safety Command (UOPSC)

        Unified command of local, State and Federal public safety 
        agencies involved in Olympic security.

Environmental & Public Health Alliance (EPHA)

        3 State agencies (UDOH, UDEQ, UDAF)
        6 local health departments
        Coordination with Federal agencies (EPA, FDA, CDC, HHS)

Salt Lake Organizing Committee (SLOC)

        SLOC Medical Services
Utah's Public Health Preparedness & Response Grant

Accomplishments: Grant Year 2004
     A major response exercise conducted by the University of 
Utah and 10 of the major Salt Lake County hospitals allowed SNS and 
notification systems to be further tested. The exercise was held May 
11, 2005.
     SNS training has been provided to UDOH and local health 
department staff members. Training has included attendance to SNS 
courses in Atlanta, Georgia for local health emergency response 
     Pandemic Response Plan has been developed and includes 
information about immunization.
     Pediatric considerations in emergency response were 
developed and presented at the Health Resources Services Administration 
(HRSA) trainings throughout Utah.
     The Utah Smallpox Response Plan was revised to include the 
National Response Plan and the National Incident Response Plan as well 
as updated information.
     Development and implementation of the Adult Immunization 
Management System (AIMS) is continuing. Significant progress was made 
this year.
     Lessons learned from participation in mass vaccination 
clinic exercises or real events were included in the mass vaccination 
and medication plans.
     UDOH has implemented two data management tools called: 
SERPH (Surveillance and Epidemiological Response for Public Health), 
which provides a single web-based tool supporting surveillance and 
outbreak investigation, linking UDOH and the 12 local health 
departments; and RODS (Real-time Outbreak and Disease Surveillance), 
which provides early warning of outbreaks or bioterrorism through 
monitoring emergency department visits and sales of over-the-counter 
     UDOH has hired four skilled epidemiologists (disease 
experts) to work in different parts of the State. The epidemiologists 
strengthen Utah's ability to detect and respond to diseases.
     In partnership with Utah's local health departments, a 
workgroup has been formed to coordinate and improve laboratory testing 
and disease outbreak detection and response.
     A system has been established to assure 24/7 response to 
urgent reports of diseases or outbreaks across Utah, including 
procedures for testing and improving the system.
     The UDOH State public health laboratories had developed 
testing capabilities for most of the bioterrorism agents and other 
emerging infectious disease agents. They train weekly to stay current 
in running the tests.
     This past year, the laboratory developed testing 
capability for avian influenza, a disease of concern around the world. 
The laboratory's ability to test for this particular disease will allow 
for rapid public health intervention to stop the spread of the 
     The lab began the implementation of a new Laboratory 
Information Management System. This new system allows the laboratory to 
collect, manage and report data used for making rapid and informed 
public health decisions by local, State and Federal public health 
workers. The laboratory had been using a data management system that is 
over 15 years old.
     The microbiology laboratory purchased leading edge 
equipment that significantly decreases the time needed to identify the 
organisms that cause infectious diseases.
     Microbiologists from the public health laboratory provided 
regular training to community and hospital clinical laboratory staff, 
emergency first responders, local health departments and other 
interested parties on bioterrorism organisms, diseases, and how to 
handle and pack specimens safely for delivery to the lab for testing.
     The UDOH public health laboratory has achieved proficiency 
to detect and confirm 12 heavy metals in urine and cyanide in blood 
samples. The laboratory is one of 37 laboratories in the country deemed 
proficient by the CDC for detecting these chemicals in response to a 
chemical emergency incident.
     UDOH took the lead in identifying various problems with 
the cyanide analytical method. The experience reported to CDC was made 
available by CDC to all 50 States to raise awareness of data quality 
and of potential problems that could arise with cyanide testing.
     A Round Robin study to test the efficiency of field 
testing equipment was conducted. Findings of the study will help Utah 
better characterize contaminants of concern in a bio/chem-terrorism 
     Training was provided to hospitals and clinics to ensure 
safe packaging and shipping of samples to the State health lab. 
Training included how to safely package and ship blood and urine 
samples exposed to chemical agents.
     A laboratory response plan for a chemical terrorism 
incident is in place. Follow-up training is planned.
     The Utah Notification and Information System (UNIS) is 
being used on a regular basis. UNIS is a statewide, integrated, web-
based information and communications system serving as a platform for 
distribution of alerts, dissemination of guidelines and other 
information to local, State and Federal partners. Various enhancements 
to improve the system have been developed and implemented during the 
past year. Numerous additional users statewide have been enrolled in 
the system.
     The UDOH has partnered with other State agencies to 
purchase and implement the Utah Wireless Integrated Network (UWIN)--
OmniLink. This system allows agencies in the State to patch together 
various communication channels on one frequency. Various types of 
radios as well as cell and land lines can be connected to facilitate 
emergency communications.
     Application, Database, and Web servers have been added to 
increase the redundancy, efficiency and capacity of the network. This 
will also allow bioterrorism applications and databases to be 
integrated with each other. In some cases, data can be reused instead 
of gathered multiple times.
     New server room chillers have been purchased and 
installed. These chillers maintain a constant, safe operating 
temperature for all bio-terrorism and UDOH systems.
     The UDOH developed a public service campaign that 
encouraged action from the public. The campaign's primary goal was to 
provide Utahns with the tools needed to develop emergency plans and 
emergency kits. The highly successful campaign focused its efforts on 
two primary tools to reach Utahns: a video documentary and an emergency 
planning guide brochure. Research performed after the campaign showed 
that the UDOH was successful in reaching its audience and prompting 
     From July 2004 to July 2005 approximately 3,208 public 
health and health care professionals and emergency response partners 
were reached through the implementation of a Statewide Public Health 
Preparedness Training Plan. A wide range of delivery methods were used 
to implement training and exercises in areas across the public health 
preparedness spectrum. Some highlights were a Suicide Bombing 
Conference (471 people trained), Bioterrorism Track at the Utah Public 
Health Association Conference 2005: Making Public Health Visible! (203 
people trained) and ongoing distance learning outreach (837 people 
     Emergency Preparedness in the Healthcare Setting: 
Bioterrorism and other WMDs (weapons of mass destruction). From May to 
September 2005, hospitals and clinics were provided with a 2-day train-
the-trainer course in hospital bioterrorism preparedness. Eight 
locations throughout the State received this training, with a total 
attendance of 247 people. The target audience was primarily the 
healthcare setting. Additionally, key partners from the community, such 
as emergency management services (EMS), military medical centers, 
surgery centers, emergency management, local health departments, 
convalescent care managers/staff and public health officials, were also 
encouraged to attend.
     Local Health Department partnerships and reporting. The 
UDOH worked closely with 12 local health departments to implement and 
report on the status of the Statewide Public Health Preparedness 
Training Plan. Utah has put a major focus on training partnerships, 
guidance, and reporting tools with local health departments. Each local 
health department was very responsive with their reporting and 
coordination with UDOH. This mutual effort has made reaching our 
preparedness goals attainable.
     Countering Bioterrorism 2005: Breaking New Ground. UDOH 
sponsored and facilitated the implementation of a regional conference 
titled Countering Bioterrorism 2005: Breaking New Ground. This year we 
partnered with the Department of Public Safety and presented both the 
Public Officials Conference and the Countering Bioterrorism Conference. 
Over 400 people attended this conference and learned from many national 
experts in preparedness. The combination of these two conferences 
strengthened ties and coordination between all parties involved in 
emergency response.
     Utah expanded bioterrorism response capabilities through 
the stockpiling of N95 Masks, gloves, gowns, and 500,000 3-day 
antibiotics to prevent the spread of disease. This is a solid 
beginning, with plans to expand the medication cache to include 
antidotes for Acute Radiation Sickness and increased personal 
protection equipment.
     A comprehensive Emergency Operations Plan for the UDOH was 
developed and implemented. The plan includes the National Incident 
Management System. This plan has been exercised, and continued 
exercises will need to be conducted to assess for shortfalls.
     Legislation was passed to allow hospitals to expand beds 
20 percent beyond licensure without seeking permission from UDOH, and 
to protect medical volunteers from lawsuits through expansion of the 
Good Samaritan Act. These actions will enhance the ability of 
healthcare facilities to meet surge needs during a Mass Casualty 

    Senator Burr. Dr. Melton, thank you so much. As one who had 
the great fortune or misfortune to be involved in the Russell 
Building nerve gas evacuation of several weeks ago, I 
understand how vital detection is, but more importantly, the 
distinction between a positive and a negative detection. But it 
taught us firsthand up here the progress we have made, when you 
compare it to the anthrax evacuation of several years ago, 
where the response was to run, and there was never any thought 
process to figure out who was in the building before it was 
evacuated, and potentially who might have been contaminated. It 
made the back end of it, the response end, very difficult in 
that case. Though it was inconvenient, all individuals who 
might have been affected were accounted for, and more 
importantly, they were not released until we knew exactly 
whether it was negative or positive. So we have learned from 
past experiences.
    It is unfortunate that we are going to have to break at 
this time for votes on the floor. My intention is to reconvene 
this hearing at 11:45. That would be 55 minutes from now, a 
great opportunity to take a break or grab some lunch. I am 
going to ask my staff to get with all of you. If there are 
inconveniences, we understand. My hope is that all of you will 
be able to come back for a short period of time for questions 
from members.
    At this time we stand in recess until 11:45.
    Senator Burr. Let me once again thank all four of you for 
your patience, your flexibility and your willingness to share 
with us your information.
    Dr. Melton, Senator Hatch sends his regrets that he is 
already scheduled to be somewhere else, but did want me to, on 
his behalf, welcome you here.
    Richard, I have to go to your comment on DOD, which I think 
probably should already be a debate in this country. Probably 
framed from the standpoint of when does a disaster, a 
catastrophe, reach a level where potentially you would 
automatically go to Federal assets because you know that it has 
now reached a level that is overwhelming to a State and 
locality. How do we define what that level of catastrophe is?
    Mr. Falkenrath. I do not think you can define it for the 
whole country all the time. I think it will vary with the 
contingency, the type of scenario it is, the scale of it, the 
severity, and also the capabilities that we find at the State 
and local level, wherever it happens to happen.
    Looking at that, then you can decide, are the local assets 
going to be overwhelmed to the point that a Federal assumption 
of responsibility is necessary? Take hurricanes, for instance. 
As far as I can tell, many States in the government are 
perfectly capable of dealing with major hurricanes hitting 
their cities, and there is no need for the Federal Government 
to step in in a more forceful way. What we saw in New Orleans 
was a city below sea level, a Cat 5 hurricane direct hit, and 
where the municipal authorities really were overwhelmed very 
quickly. And that, I think, in hindsight, shows us the Federal 
Government should have been stepping in.
    On bioterrorism----
    Senator Burr. Let me stop you if I can though, and Dr. 
Hanfling referred to this, that we are sort of geared at the 
local and regional level today to be prepared for the first 48 
hours. The difficulty comes from the length of time that it 
takes, and it took in the Gulf Coast case, for all three 
parties, local, State, Feds, to come to a conclusion that 
Federal assets were needed. Unfortunately, that decision was 
made after the 48 hours. Then it took an additional 48 hours 
minimum to accumulate all the assets, aircraft, pilots, 
maintenance crews, fuel, food, because we knew enough by then 
to know that to move people in, they had to be self-sufficient. 
And to some degree, I think it was miraculous that within 48 
hours, and at the far end of it, 72 hours, all those assets 
were on the ground.
    But what I am hearing the local folks say is that that is a 
decision that has to be made at the beginning, not after 48 
hours, because 48 hours becomes 96, and at 72 we have chaos 
that breaks out, if in fact the local resources are 
overwhelmed. How do we establish some criteria?
    Mr. Falkenrath. Well, on the timeline issue, and the lag 
time, let me first offer this comment. I actually think the 
decision to prepare for this has to be made long in advance. 
And at the Federal level, you want to have planning assumptions 
that are realistic, given your contingency, so you can get 
ready, and so it does not take you 48 hours or 72 or 96 to come 
in in the way that you will, in fact, be expected to come in in 
the contingency at hand.
    To my point in my testimony was, we need to tell some 
competent agency of the Federal Government to be ready to do 
this if necessary, if called upon. And by ``do this'' I mean 
something very, very specific, which is to prepare to 
distribute life-saving medicines to extremely large 
populations, very, very quickly, when they are afraid, because 
there is a communicable disease out there that they do not know 
how to deal with. And this is something that we have never 
asked our State and local agencies to do for real. We have only 
done it in exercises, and we have had a lot of these exercises 
in the Federal Government, and the exact same thing happens 
every time, which is they cannot do it fast enough. They cannot 
do it in the way that the President and the people will expect 
them to do it in the sort of extreme contingencies that we are 
talking about, and I am talking about the very high end, the 
most extreme contingencies, not the routine ones.
    Therefore, what is our approach as a Federal Government? Is 
it just to keep replaying this situation again and again and 
again in exercise until it happens in reality, and we 
experience in reality what we know will happen in a simulated 
way, or do we adopt a different approach?
    Senator Burr. I think we have some constitutional issues 
with those Federal assets and how quickly they could trump, for 
the lack of a better word, a State request, but clearly, the 
Governors in this country could have a compact with the Federal 
Government that triggers something. I think the key thing is 
figuring out how to stimulate that debate, and establishing 
what that criteria is for the trigger.
    You talked about research and development of 
countermeasures, the lack of big pharma participation. I think 
to a large degree, in the current world of vaccines and 
antivirals, academia is cut out of it. There is some basic 
research that goes on that is funded from numerous different 
Federal sources and some private.
    What does it take for us to have the level of advanced 
development of countermeasures that would create a framework 
that could address the threats we know of today, but also could 
serve as a sufficient blueprint for threats that are going to 
come that we do not know about today?
    Mr. Falkenrath. It is going to take a lot of things, and 
some of them are already in place. I mean I think we have a 
pretty sound fundamental R&D effort in the country now for 
basic discovery. The harder part is development, to take a 
discovery and actually do all the work needed to bring a drug 
online. There, there is no one single answer, but what you do 
need is a very well-staffed, professionally led program at the 
Federal level, and probably located in HHS, to take care of 
every little detail that needs to be dealt with as you bring 
countermeasures along.
    As I said, I think the effort to deal with countermeasures 
to known pathogens, the ones that are out there today, like 
ebola or anthrax or smallpox, should be separate from the ones 
that do not exist yet, or that we do not know about, because I 
think they require a very different approach, a different 
mindset, as it were.
    But you need a well-funded, well-staffed program at the 
Federal level that has responsibility for this effort from soup 
to nuts to bring these things along. I think the embryo of it 
exists at HHS today, but I think as Secretary Leavitt 
acknowledged this morning, even it, there is not enough people 
with not enough resources and not enough flexibility to do all 
the things they need to do.
    Senator Burr. As I shared with the Secretary before I left, 
BioShield really has become a procurement tool for 
countermeasures. We have played with advance development, but 
usually it involved a request to another agency that happened 
to have some available money, and they became a venture capital 
fund almost for whoever reached that advanced research stage 
and needed further development. This might work, but I think 
you alluded to the fact, if I remember, that we have a problem 
with the length of clinical trials.
    I guess my question is this: is it not impossible for us to 
layer clinical trials, if in fact, we do not have some third 
party group that can see the data in real time? It is really 
unacceptable to believe that we cannot shorten that clinical 
trial period?
    Mr. Falkenrath. I think that is probably right, Senator, 
and I speak as a sort of former policy official and expert, not 
as a technician. I have never done this. I am not a scientist. 
But there is no question that we have for clinical trials, a 
process which is largely sequential, one step follows another, 
follows another, and we need to make it massively simultaneous 
and to find a way to do all the different things we need to do 
in as great a degree simultaneously as we can.
    I think it is good that we have emergency use authority 
already conferred through the first bioterrorism bill and then 
the BioShield bill to the Secretary of HHS. We need that. But 
we need the ability, somehow, to more quickly find out if the 
countermeasure will be effective and safe for use in a general 
    I will say on BioShield, I was involved in this in the 
White House. There is a theory behind BioShield, which is, if 
you create an advance appropriation, a pot of money that is out 
there and available, they will come. The industry will come and 
say, ``We see the money to buy the stuff in the end, and 
therefore, we are going to produce it.'' That assumption 
probably is not, as I think we have learned, is not entirely 
right. They are not going to come. They need a lot of hand-
holding and bringing along, and it tends to be the small and 
mid-cap companies, not the largest ones, that are willing to do 
    Senator Burr. I think to some degree that period between 
identification and development might also share additional 
information where one, in hindsight, might look and say, 
``Well, I am not really sure this is necessarily a stockpile 
item,'' but you have already got the commitment out there to 
purchase it, and that is a troubling thing, not necessarily for 
what we know today and what we are after as far as the 
countermeasure, but for tomorrow, not knowing what to develop 
in time, not knowing the specificity of the countermeasure that 
we are looking for, and not knowing how long that threat might 
exist. It could be that the threat is gone by the time you get 
the countermeasure, but you are still obligated to the purchase 
for the stockpile.
    As I have just raised on the Senate floor, we have a 
fiduciary responsibility to the taxpayers to make sure that 
what we do is not throwing money down a black hole, but is 
truly an expenditure on behalf of their protection.
    I am going to ask you one last question, and then I would 
open that up to anybody else that would like to comment as 
well. I asked the Secretary, while he was here, specifically as 
it related to masks, because HHS made a proposal or suggestion 
to the American people this week that canned meat, canned milk 
were probably good things to store. I think the comments were 
targeted at avian flu. The Secretary, wisely, this morning, 
expanded that to any potential disaster or threat that might be 
out there, and certainly it is appropriate for us to suggest to 
the American people, and remind them that there are 
preparations they can make on their own.
    But there is an issue on masks, and there may be other 
products that go into the category of, you know, it would be 
good for the American people to have this from a standpoint of 
prevention. The marketplace will be flooded with them. Not all 
of them will necessarily be ones that will be sufficient to 
protect somebody from contracting the flu.
    Is it possible for us to negotiate with the appropriate 
manufacturers to approve the appropriate masks, and either 
directly from that manufacturer or through somebody they choose 
to use as a marketer of their product, have an official 
Government Web site that would suggest to people, here are the 
masks that are approved for avian flu. Here is the price that 
the Federal Government negotiated for every person that would 
like to purchase. All you need to do is go on the Internet and 
purchase those for yourself. Is that reasonable?
    Mr. Falkenrath. Yes. It is. They should be able to do that. 
But I would probably take it one step further, which says, if 
the Department of Health and Human Services is not capable of 
protecting the population medically from a particular disease, 
like pandemic, or we just do not have the vaccines or the 
antivirals to do it, they better have another answer, and masks 
are suboptimal. They are not ideal. It would be much better to 
vaccinate everyone.
    But if you have no vaccine and you have insufficient 
antivirals and you expect every single hospital to be flooded 
with sick people, and so you are not going to be able to get 
proper medical care, you need an alternative idea about how you 
are going to protect people and slow the velocity of viral 
transmission among each other. And that say, you are going to 
have to do something to protect the respiratory system.
    I came back from Asia 2 days ago. In Asia people routinely 
walk around and take subways with masks on. It looks kind of 
odd, but in every Asian country I have been to, you see people 
walking around with masks on. I am not an expert on which mask 
would be effective against which particular pathogen, but 
science should be able to figure that out, and in addition to 
making that information available and allowing people to 
purchase them on their own, if I were HHS or whatever 
responsible agency in the Federal Government, I would think 
about stockpiling them myself to distribute if we do not have a 
medicine to distribute.
    Senator Burr. I do not disagree with you on that, but at 
some point you and I are going to have a discussion then about 
how you distribute them to the American people, because 
ultimately, they need to make it to people across the country. 
I will get to you, Dr. Melton. You said we pre-positioned the 
national stockpile in Utah, and still today you are sitting 
there going, if we had needed it, how would we have gotten it 
to the population of Utah? The distribution link is something 
that has been way down on our list of things to think about in 
a realistic way. I know from a modeling way, we have looked at 
    Mr. Melton. We had plans for a six-county area. Beyond 
that, it would have been far more difficult. In the rural 
areas, it is a different issue in rural Utah than it is urban 
Utah, to develop plans for distribution. We are still working 
on some of the rural areas as we speak, how to get a 
distribution system we feel is comfortable in the rural area. 
Urban Utah, we believe we could distribute most anything in the 
urban areas of Utah with the organizations that we currently 
have developed within a 24-hour period.
    Senator Burr. Leah, let me ask. You talked about the 
partnership with local law enforcement. Why is that so 
    Dr. Devlin. Well, we found out in 2001 when the first 
anthrax person actually got sick in North Carolina, and we 
ultimately knew he contracted his infection in Florida. But 
right away, this was a partnership then with law enforcement 
because we knew that if this was pulmonary anthrax, which it 
turned out to be, that it was intentionally delivered. So we 
moved from there into the white powder incidences, and we are 
front-line first responders with law enforcement in North 
Carolina on a consistent basis since then. We are part of the 
national security.
    If I might go back and talk just a little bit about some of 
the all-hazards approach, would that be acceptable to you, 
Senator Burr?
    Senator Burr. Yes, ma'am.
    Dr. Devlin. Thank you. You can be very proud that in North 
Carolina, the first hurricane to come ashore after Katrina was 
Ophelia, and in planning for a hurricane, there is a lot you 
can do ahead of time. And we had forward placement of Federal 
assets. We had over 400 people from FEMA positioned in North 
Carolina, and we were ready. We had a U.S. Coast Guard, the 
highest level official in our emergency operations center, and 
he stayed there from Sunday to Thursday, ready to assume 
responsibility if the State and local response was not adequate 
in his judgment. And when he left Thursday night, he said in 
his 32 years of service, this was the best run operation that 
he had seen.
    Now, luckily, Ophelia was not a category 5, but the pre-
positioning of assets in that kind of situation works. In a 
communicable disease outbreak or an act of terrorism, all 
communities have to be prepared on an ongoing basis, and we 
have to have the capacity in the State and local level to be 
responsive at early detection and rapid response. We have never 
been resourced until 2002 to really step up to the plate and be 
partners with law enforcement, agriculture and first 
    So we have this all-hazards approach. It is every day in 
North Carolina, and it is real. So something big, we will all 
have to be ready, is the point that I wanted to make.
    Senator Burr. I remember in the months after 9/11, on the 
House side on the Commerce Committee, as we began to look at 
our public health infrastructure, the amazement of Congress to 
find that a third of our public health infrastructure in this 
country was only connected to CDC via telephone. It was not the 
Internet, it was not a fax, but it was a telephone. For a 
health threat, in order to notify that public health entity, 
CDC had to rely on somebody actually answering a telephone. And 
I think the initiative at that time was to make sure that 100 
percent of our public health infrastructure was electronically 
connected so that in real time we could transmit information. I 
am still not sure that we are at 100 percent yet, and that is 
something that we are going to look at as we get ready for this 
    How important is it that we exhaust every possibility from 
a surveillance standpoint to understand what is going on across 
this country? We have some Federal programs that are 
specifically designed to detect some of the chemical, 
biological, and radiological threats that exist. We have had 
available for quite some time, the ability as the Federal 
Government, via CDC and a connection to the public health 
entities, regardless of what community they were in, to plug in 
prescriptions that were written the day before across this 
country because we have the capabilities now to look at about 
95 percent of all the scrips that were filled. Yet today, we 
still do not plug into that, and were CDC to contract for that, 
every public health entity across the country could plug into 
their area of jurisdiction and look at the scrips.
    Now that would not be specifically just things limited to 
anthrax or just things limited to our host of chemical, 
biological or natural threats, but the communicable diseases 
that public health is really charged with being on the front 
line, how valuable would that be to a local public health 
    Dr. Devlin. Thank you, Senator Burr. I do think that we 
have to take advantage of existing systems that are already 
electronically capturing data that can be of use to public 
health. I think we have to get as near real time data as we can 
so that we have ongoing situational awareness, and certainly, 
plugging into hospital emergency departments, moving from there 
to urgent care centers and primary care centers, bringing those 
into contact with the public health system to get as near real 
time as we can is important, and certainly, the data that you 
are talking about from the pharmacies, is data that is not 
quite as real time, but it is low-hanging fruit, if you will, 
and it does add value. So I think we have to get clear on what 
our priorities should be as we roll out, and what can we get in 
a timely fashion that will move us forward.
    Senator Burr. I think it is safe to say we do not mine that 
data very well today, in part because we do not have all the 
pieces electronically connected, but that has to be a goal, and 
I think our answer is we have to do it all, and that anything 
short of that would be a mistake.
    As we look at the progression of avian flu around the 
world, I think it is safe to look at this morbidity rate of 50 
percent, and say, you know, this is probably not accurate. It 
is 50 percent of the people who are actually walking in so sick 
that they are staying in a hospital. And when we look back at 
1918, the morbidity rate was 2 percent, huge difference. So I 
think we have to look at avian flu and ask ourselves, do we 
have only a gap in surveillance? Or do we have a problem with 
the ability to identify everyone who is ill? Do we have a gap 
in the surveillance just simply because of the multiple places 
that people are going such as drug stores and clinics, and we 
do not identify it as bird flu?
    Dr. Hanfling, you talked about medical surge. You talked 
about the specific needs for surge in ventilators and other 
supplies. I do not disagree with you. The difficulty that I 
have is that we could bring 10 times the number of ventilators 
online that are currently available across the country. All it 
would take is appropriations.
    Dr. Hanfling. Good to hear it is that simple.
    Senator Burr. But we do not have the medical staff 
available today or in the foreseeable future to actually take 
care of the patients on the ventilators.
    Dr. Hanfling. It is an important point, and I am glad to 
hear that it is as simple as just asking for an appropriation 
and getting it, and I urge you and your colleagues to consider 
doing that, because I think it will make a huge difference in 
terms of providing for the care, the availability and the 
resources that will be required to care for the American people 
should something as drastic as avian influenza come across our 
    But it speaks to a broader point that I think you alluded 
to in the Secretary's comments about how the American people 
can be prepared and take preparations under their own wing so 
to speak, and I would suggest that that conversation needs to 
be broadened out to include the recognition that there may be--
there may come a time in the most catastrophic of situations 
where we are discussing and need to discuss and need to put in 
place and legislate altered standards of care that allow for 
what we call the graceful degradation of care, that we will not 
be delivering health care in the context or to the level that 
we are used to delivering it today.
    And in that setting then, begin to also recognize that 
there will be a need to train health care workforce and 
nonhealth care workforce to take a role in the delivery of some 
degree of care, and we have looked at the issue of the 
shortfall in the way of trained critical care intensivists and 
respiratory therapists and so on, and, you know, have some 
recommendations in terms of providing for a real training 
capability that will identify a cohort of folks who could step 
into those roles, either under direct supervision--in other 
words, I would be responsible for the three others at this 
table, to show them things to look out for. And then beyond 
that, really to go back to the family side and to give the 
families some role in the provision of health care.
    Senator Burr. I think it certainly gets back to Mr. 
Falkenrath's comments about, you know, there needs to be a Plan 
B. If you have not got the vaccine, if you have not got the 
antiviral, then at some point we are going to know what the 
right morbidity rate is, and if it is a full-scale pandemic, we 
are going to know what we are dealing with from the standpoint 
of the affected population, what percentage of those likely 
will not make it through, and what percentage we are going to, 
to some degree, have in some type of medical care.
    I think the challenging thing for me is the reality that 
every week when I go back to North Carolina, and we are 
spitting out nurses just as fast as we can educate them, and we 
are doing it in 4-year programs and 2-year programs, and 6 
months before they graduate, they have got a work contract for 
twice as much money as they made before they went in the 
nursing program. They are excited. They are interested, and we 
cannot even fill North Carolina's needs.
    And the problem is, not that we cannot increase the size of 
the class, we could do that tomorrow. The problem is we do not 
have the clinical space to take them through the program, and 
in some cases, we are running three nursing programs where they 
are doing clinical work at some point 24 hours a day in the 
hospitals, but you just do not have enough capacity to jet them 
out--we can do it much faster on teachers than we can on nurses 
because of the clinical side of it.
    So there are some realities out there that I hope you 
understand. I would expect you to say exactly what you did. I 
hope you would expect me to say there are some limitations 
where you have to be realistic about this that we cannot do.
    Dr. Hanfling. Just to follow up on that though, I think 
that there is, somewhere between the sun and the shadow lies 
the middle ground, and in that middle ground is not the worst, 
worst, worst case scenario, which we just discussed, but there 
are many, many other scenarios and many, many communities right 
now that cannot even mount a basic response to what I would 
consider to be a small to moderate size scale disaster. In 
other words, in Northern Virginia, in our health care system, 
where we have about 250 ventilators spread amongst our 
hospitals, you know, 80 to 85 percent of them are already in 
use. I mean they are in place already. So there is a role to 
supporting some degree, I think, of local cache capability.
    I would go back to Dr. Falkenrath's point that, yes, there 
is some threshold at which with preplanning you will call in 
the cavalry, but even in calling in the cavalry, it will take 
some time, and that is why I go back to the point that I made, 
which is that how are we going to answer to the American people 
when lives are hanging in the balance? I think that that is the 
question that I suggest we put ahead of us as we discuss surge 
capacity, and then in the context of staffing, surge 
capability, which is the complement to capacity.
    Senator Burr. Richard.
    Mr. Falkenrath. Senator, on this question of surge 
capacity, I think it is very important, and we need some manner 
of surge capacity in this country. I would just say though, I 
think it is very multidimensional. It is not just about 
equipment. It is also about plans, personnel, physical space, 
communication systems, and it is multiyear, so it is not a 
matter of a single appropriations. You can spend the 
appropriations 1 year, and it might get you something that is 
useful in some circumstance, but it does not give you across-
the-board surge capacity.
    The dilemma we face at a national level, as you well know 
from your committee, health care is incredibly expensive. I do 
not know what part of the economy is devoted to health care, 
very high percentage, and it is rising very fast. The implicit 
policy direction of both Republican and Democratic 
administrations, for quite a while, has been to reduce health 
care costs, to keep it in check and to squeeze out excess 
capacity. So you have a collision of the national economic 
imperative of squeezing out excess capacity for the purpose of 
saving money, versus the homeland security imperative of 
preparing for calamity, in which case you need the excess 
capacity. So that is a real dilemma that we in the White House 
wrestled with and I know you in the Congress still have to 
wrestle with.
    On grants, I will say, when I was in the White House, in 
the beginning I was a very strong proponent of both the 
homeland security and the public health grants. I supported 
them very strongly. I have come to be very concerned about the 
value that we are getting for those investments for 
catastrophes, for the highest-end scenarios, not for the middle 
tier and lower-end scenarios, where I know they are very useful 
out there in America, but for the highest end, I am not sure 
that we are getting a whole lot of additional capacity, a 
delta, to deal with the extreme sorts of contingencies that we 
could have.
    I think--and this is not an indictment of any particular 
entity--my understanding is that every agency--we have a 
problem nationwide with the recipients of grant assistance of 
essentially sort of defraying other operating costs with them. 
So we are not getting a delta, we are not getting a bump up so 
much as budgetary support for the grant recipients. I know the 
recipients of the grants do not like to hear that, but I will 
say, as someone who reviewed the sort of audits of what we were 
getting for the grants, no agency was able to come to the White 
House and say with great certainty that they knew the money 
that they were handing out was being used only for new and 
additional capabilities, as opposed to paying for things that 
already were planned for.
    Senator Burr. I might say that in a meeting that we had 
last week on the reauthorization, it made me stop and think 
that for the last several years, in an effort to try to lower 
the health care costs overall, we have suggested, to some 
degree, national policy. You know, you get a cold, go to the 
drugstore, do not go to the doctor, go to your cold medicine. 
Now, all of a sudden, we are sitting here going into a period 
where there may be bird flu. Do we still continue the policy 
of, if you get the sniffles, if you get the fever, if you feel 
like you are getting the flu, go to the drugstore, get this, or 
is it go to the hospital?
    We have to figure out what our message is going to be, 
because if not, we either overreact one way or we under react, 
and the consequences are much greater as are the challenges.
    Leah, did you have something you wanted to say?
    Dr. Devlin. Well, I have a couple of things I would like to 
say. Thank you very much, Senator Burr.
    Just in response to your thinking, and yours about 
workforce issues related to surge capacity, that is there for 
that IT question that you asked also. We have to have people in 
public health that can bring that data in, make sense of it, 
get the medical record, read it, and still put the medical 
epidemiologist, the nurse, the environmental specialist out 
there in the field. So I just wanted to hold that thought too, 
that with these new technology systems, that is also a 
workforce issue, as is true of many other aspects of public 
    An interesting twist on the issue of supplanting that has 
been raised, actually, what we have seen in our State is that 
the Federal investment in public health preparedness, which 
really is central to our mission if you know the history of 
public health, we have been about the business of communicable 
disease control since the inception. Strengthening that 
function--and we have led a road for the past 30 years--has 
actually resulted in our State, and probably is true in other 
States, of strengthening other parts of the public health 
infrastructure as well because we are visible now for the first 
time, and people understand more what the role of the local, 
State health department, the Federal role is as well.
    So actually it has not been supplanting, but it has been a 
strengthening that has brought additional opportunities to 
public health, which gets to that larger issue of controlling 
health care cost, because we really need to invest in 
prevention in many ways, not just in preparedness, but in all 
aspects of our health behaviors and health policies if we are 
going to be able to control cost.
    Senator Burr. Should every public health entity in America, 
regardless of the jurisdiction that they are in, be exactly the 
    Dr. Devlin. Well, we have a local system and a State system 
and a Federal system, but we all work together toward the same 
end. And the needs of the communities are different. We have 
the rural parts of our State. We have some urban area. We have 
the mountains with their separate air quality issues, and so 
each State is different.
    Senator Burr. Let me explain why I asked the question. 
Today you can go into a community where the primary care 
provider for an at-risk income group could be the health 
department, could be public health. You could go 30 miles down 
the road and go to the public health department there, and find 
that the extent of what they offer is vaccinations for low-
income children. There is a problem with that, in my 
    I guess my question is, as we go through this 
reauthorization, I think it is vitally important that we define 
what our expectations are from public health entities. How much 
flexibility, if any, should exist from one to the other, based 
upon the State they are in, based upon urban versus rural? How 
much of it needs to be really a uniformity from place to place 
to place to place?
    Dr. Devlin. We are working for our performance indicators 
from CDC, and we welcome these performance measures, and we 
have been--they have been changing on us since 2002, when the 
funding first started to come. So we would like to get clear on 
that with the Federal Government on what is expected county to 
county to county, and we want to meet those deliverables.
    Senator Burr. Dr. Melton.
    Mr. Melton. We need to be careful though not to mix 
function. We are talking here about preparedness for disaster 
and for communicable disease. At least in Utah, most of the 
local health departments that provide primary care are not 
doing so with the dollars that we are talking about here. They 
are doing so with either local dollars provided by their 
government to provide primary care for their citizens, or they 
are getting it through third-party payers as the only primary 
care provider in the area, because we also do not standardize 
our health care system. So in some areas public health is the 
only health care system available, and in those, we cannot say 
you cannot do that because you are public health.
    So we cannot function. Public health has an assurance 
function. In some areas they do not need to assure health care, 
primary health care.
    Senator Burr. So we need to possibly legislate a floor but 
not a ceiling?
    Mr. Melton. That may be correct, yes. There is a minimum 
number of things that we need to do for public health, and 
those are the kinds of things that Dr. Devlin has been talking 
about and that we need to talk about here. What should we do 
with the Federal dollars we are getting? There should be a 
floor on that, and there should be a thing required. And there 
probably should be a set of things that we should not expend 
our money for. I cannot talk about other States, where they may 
have put some money into primary care, but we in Utah have not 
used any of these funds for things that we had otherwise 
planned to do.
    Senator Burr. Dr. Devlin addressed some of the things that 
I think North Carolina does well. We do them well for two 
reasons. One, we have a plan. Two, every year, multiple times, 
we get an opportunity to execute that plan, and we are just 
fortunate location-wise, that like Florida, we get an 
opportunity to play it out.
    Utah is one of the few, if not the only other place, where 
you have an opportunity to actually create a plan, bring the 
assets in, and have to think about it from a standpoint of how 
do we actually implement it?
    One of the things you said was the importance of 
coordination with other agencies. I am just curious if you 
would comment how easy it was or how difficult it was to seek 
the level of coordination of different agencies that you had to 
    Mr. Melton. Utah has, I think, a culture that makes it a 
little easier for us to coordinate. That may be an underlying 
statement. However, it was not easy for public health to insert 
itself in a lot of the planning. Other than food, sanitation 
and some medical coordination, it was not easy for us to get 
across the idea that there were other things that they needed 
to be thinking about as well, until the anthrax attacks. And 
then all of a sudden the surveillance activities that we had 
been talking about previously became very important subjects. 
Until that, it was not easy to get them to think about 
surveillance as one of the underlying pieces that had to be 
done for the Olympics.
    Let me add one other thing that is true about the Olympics 
that is not true about what we are talking about here. We knew 
when that disaster would occur and what we were expecting. What 
we are talking about here, with the exception of a few days, 
perhaps, with a hurricane, we do not know when an earthquake is 
going to take place, and that is one of the things we prepare 
for, earthquakes. We do not know when a terrorist might attack, 
so it is a little harder for us as a Nation to maintain the 
level of preparedness that Utah was able to get to when we knew 
when the disaster would take place.
    Senator Burr. I thought during the days and weeks and now 
months after Katrina, that--Dr. Devlin, correct me if I am 
wrong--this year we will put the last individuals who were 
displaced in the eastern North Carolina floods from a hurricane 
into permanent housing. This year, I think 5 years later, the 
last group of individuals will be moved from temporary housing 
to permanent housing. We had flooding on a geographical area 
that exceeded the city of New Orleans, certainly not a 
population the size of New Orleans that was affected, but in 
some ways, a greater challenge from a standpoint of rebuilding. 
It is a reminder that the challenge in front of us is not one 
that is going to be done overnight. We have lived it firsthand.
    What I think, in many cases, is that it was the level of 
our plan that was written, and our ability to respond even to 
something we never dreamed could happen in North Carolina, that 
enabled us to get by that particular catastrophe, disaster. We 
were able to do it. New Orleans was not. I think to some 
degree, the difference is the fact that we actually got the 
opportunity to implement our plan so often, that even though it 
was not perfect and we learned from it, our ability to respond 
to it when it did happen enabled us to have a little different 
    Richard, if I could ask you just one last thing. The White 
House after-action report on Katrina recommends NDMS to move to 
HHS. Do you have any comments on that? And if I could, let me 
expand that as well to say, are there other areas of health 
care response that still are at DHS that you would say, you 
know, you ought to look at moving this over?
    Mr. Falkenrath. I think it makes sense to move it back. The 
history of this is that in the President's initial proposal for 
DHS, there was a whole bunch of biodefense capability that he 
wanted to move in, not just NDMS, also the stockpile, also the 
R&D stream at NIH, also the public health grants. Congress at 
the time did not go along with that. That was the one area of 
the proposal actually they rejected. And so only a few things 
were moved in. Plum Island was moved from USDA, NDMS into FEMA, 
and the stockpile into FEMA. The stockpile was transferred back 
in 2004. That did not work. It was the legislative language 
that authorized the transfer divided up responsibilities where 
it was just too complicated. And so Secretary Ridge and 
Secretary Thompson agreed to move it back, and Congress 
concurred in that in the appropriations rider.
    I think this will be the sort of same arrangement. You 
know, the two secretaries are in agreement, the White House is 
in agreement. If all relevant interested Members of Congress 
are okay with it, I think it should be pretty easy to effect a 
transfer back.
    Senator Burr. You know as well as I do how difficult it is 
sometimes to move things from one agency to the other, because 
there is a budget that follows it. I hope it is as easy as 
maybe what you have suggested.
    Mr. Falkenrath. I hope so. I guess it is true, I did spend 
a lot of time on the stockpile issue, but once the decision was 
made, it moved pretty easily.
    I think it does not make sense to--it made sense to move 
the biodefense capabilities from HHS to DHS when DHS was 
getting them all. But that did not work. Congress did not 
concur, and maybe the idea was not well conceived enough, and 
so there ended up being a division, where a lot of 
responsibilities stayed at HHS and a little bit went to DHS, 
and so it was sort of complicated.
    DHS does not have a whole lot of medical expertise, 
frankly, and the ability to manage things, and HHS retains 
responsibility for ESF-8 under the NRP. So if they have ESF-8 
under the NRP, why not have the NDMS, which is one instrument 
for executing the responsibilities in ESF-8?
    Senator Burr. Dr. Hanfling, Secretary Leavitt said earlier 
that significant moneys, 27 million per year, have been spent 
on medical preparedness. Do you think we have sufficiently 
established the national standards for a variety of the health 
care workers to establish a floor for medical preparedness?
    Dr. Hanfling. Let me answer that question, and then if I 
may, I would like to go back to address on of the other issues 
that was on the table.
    Senator Burr. Absolutely.
    Dr. Hanfling. You know, this is a marathon, and so we are 
talking about being in the front end of a long race toward 
getting a degree of competency-based training in place amongst 
the full spectrum of health care workforce staff, and I would 
go so far as to tell you that it is not just doctors and nurses 
anymore, we need our housekeeping staff, we need our cafeteria 
staff, we need our clerical staff and so on. We are a complex 
community, if you will, all of whom have to receive some 
training, and I think that there has been a lot of work, 
particularly put forth by a number of academic institutions to 
really begin to shed light on what those competencies ought to 
    And I think that one of the problems that we faced in the 
first go-around of the HRSA grant funds was that we could not 
pay for our staff to attend training, so there was a mandate to 
receive training, but we could not actually pay them to do 
that, and I think that that is something that has to be looked 
at in the reauthorization.
    If I may, sir, I would like to just go back to address the 
issue about the role of public health vis-a-vis the hospitals 
in delivery of basic care needs, because the public health 
community does a tremendous job, in some places better than 
others, but the emergency departments and our hospitals are the 
safety net for delivery of heath care to those who are 
disenfranchised or underprivileged or have no place else to go. 
And I can tell you that from firsthand experience because I 
take care of the public health patients on the weekends and at 
night when there is no place else for them to turn.
    So I think it is important, again, for the discussion about 
the delivery of care, to come back, not to the public health 
community, but to the hospitals and the health care community. 
And in that context, I would also remind you, as I am sure you 
are well aware, that in this year's budget that the President 
submitted for review, there is an elimination of a number of 
programs that have been funding key elements of the delivery of 
health care, particularly as it relates to trauma care. The 
trauma and EMS program, budgeted for no dollars in fiscal year 
2007. The children's EMS program, budgeted for no dollars. The 
Preventative Health and Health Services Block Grant, budgeted 
for zero dollars.
    So here we are on the one hand talking about how we are 
going to create surge capacity and surge capability, but on the 
other hand, we are taking it away. I think that you and your 
colleagues have to give strong consideration to the successes 
of those programs and the importance that they plan.
    Another one, the traumatic brain injury program, I mean 
here is a place where we have made tremendous strides in the 
last few years, and now we are taking moneys away from these 
programs. Are they important? Sure, they are important, because 
whether it is a low, moderate or large-scale disaster event, 
all of those elements are going to need to come together to 
provide for a response.
    Senator Burr. I appreciate that input, and Congress, in its 
own way has an ability to sort of shrug off budget resolutions 
and presidential budgets, because we know that at the end of 
the day under the umbrella, under the cap, we are the ones 
charged with making sure that we put the money where it serves 
the most good for the population, and I think we will do that 
again, and the likelihood is that many of those areas that you 
just talked about will receive funding, so I am fairly 
confident we will see some things that we have seen in the 
    Having said that, I think it was stated earlier that we are 
challenged every year with a larger share of the GDP going to 
health care, and the question is, when does it pop? To me, I 
look at Medicaid in the United States, and I seriously do go to 
bed at night and wonder why is it not mandatory that every 
Medicaid beneficiary be assigned a primary care provider? How 
do you educate a population on taking care of their health if 
they do not have a relationship with a health care 
professional? And this is an explosion of the Federal 
Government's budget, an explosion of State budget, regardless 
of which State it is. Medicaid is out of control. We are doing 
some very creative things in North Carolina. I actually think 
more about how we take that population and set a precedent that 
if it is not an emergency, the last place you are coming to is 
the hospital. Why is it the primary care provider today? 
Because we have not forced a relationship with a primary care 
entity, be that a doctor, be it a rural health clinic, be it a 
community health center. And until we do that there is no way 
for us to have that educational link for disease management or 
for prevention.
    I think at the end of the day, putting aside the subject 
matter that we are here to talk about today, if we cannot find 
a way to build wellness and prevention into the health care 
model in America, Richard, we do not have a prayer turning 
around the percentage. At some point, the difference is, we are 
going to choose between children's health insurance for low-
income children and seniors' participation in Medicare, and 
then you start ratcheting it down, and every choice is winners 
and losers versus trying to figure out a strategy where 
everybody wins.
    Now, there is one thing that I can promise you, if that day 
comes, I will not be up here. You may still be in your 
profession, but I will not be up here making the choices. I 
think that is one of the reasons that as we go through the 
choices that we have on making, creating the availability of 
countermeasures, and how we restructure or reauthorize the 
bioterrorism bill, that we do not do it in a way that picks 
winners and losers. The objective here is to create an 
infrastructure that can withstand anything that is thrown at 
it, and to some degree, when you get behind the eight-ball, 
like we are in avian flu, where there is a time constraint that 
you are dealing with, you are forced to pick winners and 
losers. It may solve that one problem, but the problem down the 
road is how you have an infrastructure that can handle it all, 
and that is truly what we are trying to grapple with as we do 
both of these bills. I think there is a way to do it. It is not 
going to be easy, as I learned last year, but I also have 
learned that big things do not happen up here in Washington 
    Dr. Hanfling. And your point about accountability, which is 
really what we are talking about in sort of the broadest terms, 
is a very good one, because what we are saying and what I think 
the Secretary said and what others on the panel have said, is 
we need our citizens to take some accountability. Well, you 
know, that goes so far as to if you are a Medicaid signatory, 
figure out who your doctor is going to be. Do not always come 
to the emergency room in the middle of the night, because, yes, 
I will be there, but let's build systems, I think is really 
what we are talking about.
    And I would agree with you that this bill, although 
focusing on disaster preparedness and the sorts of things that 
we have been discussing, really is the opportunity to continue 
to build this platform upon which we are looking at the 
delivery of health care at all times, and the kinds of 
communications and linkages that we have to build amongst the 
    Senator Burr. Every step in the right direction enables us 
to achieve a higher level of preparation and response. I am not 
sure when we get to the ultimate plateau at the top where we 
can all look back and say we are there. I am not sure we ever 
will be. This will be a process that will continually challenge 
us to figure out where it is we need to be.
    I cannot thank all of you enough for your flexibility 
today. I have kept you 30 minutes past what Bob told me your 
timelines accommodated, but, literally, this is invaluable to 
us as we start this process.
    I would ask unanimous consent--and since I am the only 
member here, I am going to get it.
    That the record be left open for 10 days to accommodate the 
other members who might have questions or statements for the 
record. As well, I would ask all of you that if you have 
additional information that might have been stimulated in this 
hearing, if you would share it with us in writing. It will 
certainly be useful to us as we begin to craft this 
    Once again I thank you for the input, thank you for the 
wisdom, and thank you for the flexibility.
    This hearing is adjourned.

                          ADDITIONAL MATERIAL

       Questions of Senator Clinton to Secretary Michael Leavitt

    Question 1. We cannot respond to any public health emergencies--
biological attacks, pandemic influenza, and naturally occurring 
disasters like Hurricane Katrina--unless we have a strong public health 
infrastructure that is effective in day to day operations. It is 
particularly important to invest in ``dual use'' mechanisms--such as 
the vaccine tracking system proposed in the Influenza Vaccine Security 
Act, legislation I introduced with Senator Pat Roberts--that can be 
used to address the public health needs that we face every year, but 
can also be used in emergency situations. The benefit of ``dual use'' 
systems is that they allow our public health professionals to become 
comfortable with something they're using every day, so that it's second 
nature to them in times of emergency, and I believe that the mechanisms 
set up in our legislation are ones that HHS should support.
    How will you ensure that the steps we take in preparing for 
pandemic flu are ``dual use,'' and can help strengthen both our 
traditional public health infrastructure and our ability to respond to 
bioterrorism or other public health emergencies? I am particularly 
interested to learn of any efforts to establish tracking and 
distribution systems for vaccines, antivirals, medical supplies, and 
other items that are needed during our annual flu season and will be 
necessary for pandemic influenza or other emergencies.

    Question 2. Stewart Simonson, Assistant Secretary for Public Health 
Preparedness at HHS, submitted his resignation to the President last 
week. As the Associated Press reported, ``. . . [he] told the president 
. . . that he had accomplished what he had set out to do, and it was 
time to move on.'' Yet the hearing before the HELP Committee 
highlighted multiple concerns--lack of coordination, no clear 
authority, the need for additional resources and guidance--with our 
Federal response to bioterrorism preparedness. Could you please 
elaborate how the Department will address these remaining concerns? 
What is the timeline for doing so?

    Question 3. In your testimony, you noted that you are considering a 
reorganization of the role of the Assistant Secretary for Public Health 
Preparedness. Could you please explain how your plans for 
reorganization would take into account the need to increase 
coordination both within HHS and with other Federal agencies like the 
Department of Homeland Security? How would the Assistant Secretary of 
Public Health Preparedness coordinate with the Assistant Secretary of 
Health, and what roles would be assigned to each individual?

    Question 4. In an appearance on CNN earlier this year, you said:

        ``Don't count on Washington, D.C. to manage your pandemic 
        because it will be about your schools, it will be about your 
        parades, it will be about your businesses. And you need to have 
        the ability to be knowledgeable and to respond when--if your 
        hospital were to surge and need to have three to four or five 
        times the capacity that it currently has. You need a plan.''

    Could you please explain in greater detail how HHS is taking 
responsibility to ensure that States, local public health departments, 
local governments, and health care have adequate resources to plan and 
prepare for an all-hazards response to all emergencies, not just 
pandemic influenza?

    Question 5. States, local health departments, and hospitals have 
raised significant concerns over the use of CDC's and HRSA's critical 
benchmarks in evaluation of funding allocations. Specifically, there 
are concerns that these benchmarks do not adequately measure bioterror 
preparedness. How does HHS plan to address these concerns in the 
revision of these indicators? How will HHS take these comments into 
account when developing indicators to measure use of the $350 million 
in pandemic flu funding that will be given to States and localities?

    Question 6. We are aware of multiple exercises to help both health 
officials and other Government agencies prepare for emergencies. The 
Department of Homeland Security has engaged in its TOPOFF exercises in 
cooperation with several States. High-level officials within the 
administration have engaged in both pandemic influenza and smallpox 
planning scenarios, and in your recent pandemic flu update, you have 
indicated the intent of HHS to assist with both State exercises and 
spearhead a national pandemic exercise. Could you explain how these 
drills are being evaluated and used to inform both your agency and 
State and local preparedness efforts? What changes have occurred in 
operations as a result of the lessons learned through these exercises?

    [Editor's Note--The repsonses to the above questions were not 
available at time of print.]

    [Whereupon, at 12:50 p.m., the committee was adjourned.]