[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
   REAL-TIME ASSESSMENT OF THE FEDERAL RESPONSE TO PANDEMIC INFLUENZA
=======================================================================

                                HEARING

                               Before The

                        SUBCOMMITTEE ON EMERGING
                        THREATS, CYBERSECURITY,
                       AND SCIENCE AND TECHNOLOGY

                                 Of The

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 27, 2009

                               __________

                           Serial No. 111-41

                               __________

       Printed for the use of the Committee on Homeland Security
                                     

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  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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                               __________



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                     COMMITTEE ON HOMELAND SECURITY

               Bennie G. Thompson, Mississippi, Chairman
Loretta Sanchez, California          Peter T. King, New York
Jane Harman, California              Lamar Smith, Texas
Peter A. DeFazio, Oregon             Mark E. Souder, Indiana
Eleanor Holmes Norton, District of   Daniel E. Lungren, California
    Columbia                         Mike Rogers, Alabama
Zoe Lofgren, California              Michael T. McCaul, Texas
Sheila Jackson Lee, Texas            Charles W. Dent, Pennsylvania
Henry Cuellar, Texas                 Gus M. Bilirakis, Florida
Christopher P. Carney, Pennsylvania  Paul C. Broun, Georgia
Yvette D. Clarke, New York           Candice S. Miller, Michigan
Laura Richardson, California         Pete Olson, Texas
Ann Kirkpatrick, Arizona             Anh ``Joseph'' Cao, Louisiana
Ben Ray Lujan, New Mexico            Steve Austria, Ohio
Bill Pascrell, Jr., New Jersey
Emanuel Cleaver, Missouri
Al Green, Texas
James A. Himes, Connecticut
Mary Jo Kilroy, Ohio
Eric J.J. Massa, New York
Dina Titus, Nevada
Vacancy
                    I. Lanier Avant, Staff Director
                     Rosaline Cohen, Chief Counsel
                     Michael Twinchek, Chief Clerk
                Robert O'Connor, Minority Staff Director
                                 ------                                

   SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND 
                               TECHNOLOGY

                 Yvette D. Clarke, New York, Chairwoman
Loretta Sanchez, California          Daniel E. Lungren, California
Laura Richardson, California         Paul C. Broun, Georgia
Ben Ray Lujan, New Mexico            Steve Austria, Ohio
Mary Jo Kilroy, Ohio                 Peter T. King, New York (Ex 
Bennie G. Thompson, Mississippi (Ex      Officio)
    Officio)
                      Jacob Olcott, Staff Director
       Dr. Chris Beck, Senior Advisor for Science and Technology
                          Ryan Caldwell, Clerk
               Coley O'Brien, Minority Subcommittee Lead
                            C O N T E N T S

                              ----------                              
                                                                   Page

                               Statements

The Honorable Yvette D. Clark, a Representative in Congress From 
  the State of New York, and Chairwoman, Subcommittee on Emerging 
  Threats, Cybersecurity, and Science and Technology:
  Oral Statement.................................................     1
  Prepared Statement.............................................     2
The Honorable Daniel E. Lungren, a Representative in Congress 
  From the State of California, and Ranking Member, Subcommittee 
  on Emerging Threats, Cybersecurity, and Science and Technology.    12
The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Chairman, Committee on 
  Homeland Security..............................................    14
The Honorable Laura Richardson, a Representative in Congress From 
  the State of California:
  Prepared Statement.............................................    15

                               Witnesses

Dr. Alexander Garza, Chief Medical Officer and Assistant 
  Secretary for Health Affairs, Department of Homeland Security:
  Oral Statement.................................................    16
  Joint Prepared Statement.......................................    18
Dr. Nicole Lurie, Assistant Secretary for Preparedness and 
  Response, Department of Health and Human Services:
  Oral Statement.................................................    23
  Prepared Statement.............................................    25
Mr. Richard Serino, Deputy Administrator, Federal Emergency 
  Management Agency, Department of Homeland Security:
  Oral Statement.................................................    30
  Joint Prepared Statement.......................................    18
Ms. Marcy Forman, Director, Intellectual Property Rights 
  Coordination Center, Department of Homeland Security:
  Oral Statement.................................................    32
  Joint Prepared Statement.......................................    18

                                Appendix

Questions From Chairwoman Yvette D. Clarke for Alexander Garza, 
  M.D., Chief Medical Officer and Assistant Secretary for Health 
  Affairs, Department of Homeland Security.......................    51
Questions From Chairwoman Yvette D. Clarke for Nicole Lurie, 
  M.D., Assistant Secretary for Preparedness and Response, 
  Department of Health and Human Services........................    55
Questions From Chairwoman Yvette D. Clarke for Richard Serino, 
  Deputy Administrator, Federal Emergency Management 
  Administration, Department of Homeland Security................    62
Questions From Chairwoman Yvette D. Clarke for Marcy Forman, 
  Director, Intellectual Property Rights Coordination Center, 
  Department of Homeland Security................................    63


   REAL-TIME ASSESSMENT OF THE FEDERAL RESPONSE TO PANDEMIC INFLUENZA

                              ----------                              


                       Tuesday, October 27, 2009

             U.S. House of Representatives,
                    Committee on Homeland Security,
      Subcommittee on Emerging Threats, Cybersecurity, and 
                                    Science and Technology,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 2:05 p.m., in 
Room 311, Cannon House Office Building, Hon. Yvette D. Clarke 
[Chairwoman of the subcommittee] presiding.
    Present: Representatives Clarke, Richardson, Lujan, 
Thompson (ex-officio), Lungren, and Broun.
    Also present: Representative Jackson Lee.
    Ms. Clarke. Good afternoon. I would like to thank our 
witnesses for appearing before us today.
    The Homeland Security Committee has long been concerned 
with the state of our preparedness to deal with pandemics. 
Today, our subcommittee turns its attention to the Federal 
response to the reemerging threat of pandemic influenza.
    Over the weekend, President Obama declared a National 
emergency with respect to the 2009 H1N1 influenza pandemic. 
This action underscored the gravity of the situation.
    Although we went into this pandemic better prepared than we 
had been in the past, we were not fully prepared to meet the 
pandemic when it started this year. Going into this pandemic, 
we knew that, No. 1, our early warning and detection systems 
were inadequate; No. 2, some key planning activities were 
incomplete; No. 3, we didn't have a good approach to provide 
health care under pandemic conditions; and, No. 4, our levels 
of preparedness for pandemic influenza were unclear.
    Unfortunately, our failure to develop these systems, 
activities, and policies cost us during the response. For 
instance, the pandemic started in North America, the one place 
we were not looking for it. We did not have an early warning. 
The alarm sounded only when people started to die. We did not 
have the luxury of time to observe the virus before the 
pandemic started; and, to the surprise of the community, the 
virus turned out to be H1N1, not the H5N1 virus that causes 
avian influenza.
    We have made it through the first phase of our pandemic and 
are now entering the second. The Department of Homeland 
Security, the Department of Health and Human Services are our 
leading Federal response efforts. It is clear that DHS 
Secretary Napolitano and HHS Secretary Sebelius have set the 
tone for responding to the pandemic with their strong 
leadership and commitment to the Nation. We commend them, and 
we commend you.
    But the pandemic has shown us where our public health 
security infrastructure is weak in the same way that the 
natural disasters show us where our physical infrastructures 
are vulnerable. The pandemic has shown us that we need to 
improve biosurveillance, pandemic disaster assistance, real-
time recording of lessons learned, public messaging, and the 
security of our pharmaceutical system.
    In these areas, I believe that the National Biosurveillance 
Integration Center needs more information and participation. 
The FEMA disaster assistance policy on pandemic human influenza 
needs to be updated. The DHS lessons learned information 
sharing system needs to be better utilized. Influenza messaging 
needs to be deconflicted and clear, and our pharmaceutical 
system needs to be better secured against the introduction of 
counterfeits.
    Our Federal departments and agencies should be commended 
for positive steps forward. Indeed, our system improvements 
have already been made, communication between and among 
countries have improved, and I am pretty sure that the United 
States knows more about what is going on in Mexico and Canada 
now than it did before, and vice versa.
    Communication between and among agencies have improved. For 
example, the Department of Health and Human Services is not 
putting out guidance on school closures without first 
consulting with the Department of Education. More guidance 
regarding personal protective equipment, school closures, and 
high-risk groups needing vaccination has been provided. Some 
additional plans, particularly response plans, have been 
finalized and communicated.
    The H1N1 vaccine has been developed, and what we have been 
able to produce of it is beginning to be distributed. The DHS 
lessons learned information sharing system has shifted from 
gathering information, from exercises, to collecting some real-
time information; and law enforcement agencies are specifically 
addressing the threat of the H1N1-related counterfeit 
pharmaceuticals through such entities as the Intellectual 
Property Rights Coordination Center.
    But we still have work to do. We now have the obligation to 
strengthen at least some of the weaknesses in our National 
response. To do that, we in Congress need concrete information 
from you. We need information from your departments and 
agencies and need concrete recommendations and resources--that 
need concrete recommendations and resources from us. The 
Legislative and Executive branches must work together to 
improve our response efforts and save as many lives as we can 
during this pandemic.
    I will be submitting a longer statement for the record; and 
I look forward to hearing from you, all of you, our witnesses 
here today.
    [The statement of Ms. Clarke follows:]
                Statement of Chairwoman Yvette D. Clarke
                            october 27, 2009
                            i. introduction
    Although the United States became acutely aware of the incidence of 
H1N1 cases in April 2009, the disease was already present in other 
parts of the world. Outbreaks were soon noted in many countries, 
creating epidemics. Subsequently, the World Health Organization 
declared an influenza pandemic in July 2009, when Phase 5 was attained 
(see Figure 1 below). To date, cases of the disease have been reported 
by every U.S. State and territory, and in many countries throughout the 
world.


A. Data Lacking, But H1N1 Assumed to be Everywhere
    It is likely that every country in the world has cases of H1N1 
occurring within their borders, but difficulties in testing, diagnosis, 
and reporting prevent us from knowing for sure. When influenza 
pandemics occur, we move away from laboratory testing of all suspected 
cases, and instead, assume that everyone that is presenting with 
influenza-like-illnesses (ILI) are infected with the pandemic strain of 
the disease--in this situation, H1N1 influenza. Laboratory testing does 
continue in those countries (such as the United States, Canada, 
Australia, the United Kingdom, many of the countries in the European 
Union, and Russia, that possess sufficient laboratory capacity and 
capability to test various groups of patients to determine with what 
disease they are afflicted. To-date, the vast majority of patients 
presenting with ILI in the United States and worldwide are indeed 
infected with H1N1.
B. 2009-H1N1 Disease is Widespread, But Not as Severe as 1918-H1N1
    The severity of the current pandemic is clearly not as bad as it 
was in 1918. There are a number of theories about why this may be the 
case. First, levels of health and hygiene are better now than they were 
in 1918. Second, public health, medicine, and health care delivery are 
all much more advanced. Third, although the strains of influenza are 
the same--H1N1--there may be differences in the way genetic components 
are behaving and expressing themselves.
    However, despite the overall lower severity, people with certain 
underlying conditions are developing very serious illnesses. As of 1 
October, 28 pregnant women have died, and the rate of pediatric (under 
the age of 18) deaths is rising, 86 having died to date. We also still 
do not understand exactly why H1N1 caused so many deaths in Mexico.
C. We Will Never Know Exactly How Many People Were Exposed to H1N1
    We have questions about the disease--why it causes severe illness 
and death in some but not in others, exactly how many people were and 
are being exposed, how fast it spreads, the nature of our immune 
response, etc. These questions will need to be answered by 
scientifically valid data. However, as stated above, laboratory, 
diagnostic, and reporting capacity differs in countries around the 
world and in States and territories throughout the United States. We 
went into this pandemic lacking in these areas, and as a result, we 
will never have an entirely accurate picture of what is happening and 
what will happen in the future.
             ii. weaknesses revealed by pandemic influenza
    One of the characteristics of large-scale disasters is that they 
reveal weaknesses in society and its critical infrastructures. Disaster 
management theory suggests that these weaknesses should be strengthened 
in order to mitigate the effects of the next disaster before it occurs.
    The same holds true for a large-scale disease event such as 
pandemic influenza. Since April 2009, the pandemic caused by the H1N1 
influenza virus has revealed a number of weaknesses in the 
infrastructures affecting public health, safety, and security. Many 
were identified by committee staff previously in a report, entitled 
``Getting Beyond Getting Ready for Pandemic Influenza,'' issued in 
January 2009.\1\
---------------------------------------------------------------------------
    \1\ The report can be found on the committee website at: http://
www.homeland.house.gov/SiteDocuments/20090114124322-85263.pdf.
---------------------------------------------------------------------------
A. Early Warning and Detection Inadequate
    Biosurveillance efforts are lacking throughout the United States 
and the world. Committee staff identified three deficiencies in 
January: (a) Information used to inform U.S. decisions was not 
uniformly collected or derived; (b) integration of biosurveillance 
information from throughout the Government was insufficient; and (c) 
biosurveillance early warning was unsatisfactory.
    Biosurveillance information in the United States comes from a 
variety of sources, such as hospitals, physician's offices, 
pharmaceutical companies, drug stores, and clinics. However, the 
collection of this information is not uniformly collected or derived. 
This means that information is collected from and reported by some 
organizations and not others, and that derivative products from that 
information vary according to local and State needs for those products. 
As a result, we do not have a complete or entirely accurate picture of 
what is happening with any disease occurring in the United States, 
unless the number of people becoming ill is very low and the disease is 
of such great interest that there are mandatory reporting requirements.
    States also have the right to determine which diseases are of 
greatest interest to them, and add some additional reporting 
requirements as they see fit. Further, although some reporting 
requirements are mandatory, there are few penalties for not reporting 
and the requirements are not vigorously enforced. Lastly, information 
coming from the States to various Federal departments and agencies has 
never been integrated sufficiently, despite the creation of the 
National Biosurveillance Integration Center (NBIC) at DHS.
    As a result of these deficiencies here in the United Sates and 
throughout the world, we did not have early warning of the H1N1 
outbreaks. The United States only started paying significant attention 
after cases began to appear in California and Texas, belatedly 
realizing that the virus causing disease in these cases and those in 
Mexico was the same--the H1N1 influenza virus. We could have known 
sooner, had we been: (a) Paying more attention to what was occurring, 
particularly in our neighboring countries of Mexico and Canada; (b) 
implementing long recommended systems to collect and analyze 
information from all our health care delivery, military, and diplomatic 
establishments; and (c) integrating what information the Federal 
Government did manage to collect. We did not detect this disease as 
soon as we could have.
B. Execution of Key Planning Activities Incomplete
    Key planning activities were not executed, or were executed 
incompletely or improperly prior to the beginning of the pandemic in 
April 2009. Committee staff identified five deficiencies in January: 
(a) Key stakeholders were not consulted when the National Strategy for 
Pandemic Influenza and its Implementation Plan were developed; (b) 
synergies between and among the National Strategy for Pandemic 
Influenza and the other National strategies were not identified; (c) 
planning guidance given to the States and territories was inadequate; 
(d) evidence of pandemic influenza planning for the Federal departments 
and agencies was scant; and (e) private sector continuity of operations 
plans were lacking. As a result, when the pandemic started in April, 
public and private sector entities were not able to respond efficiently 
and effectively because many did not have plans to execute in the first 
place.
    The Bush administration had not identified synergies between and 
among the National strategies, and it is unlikely that the Obama 
administration has had time to do so, yet. If a terrorist event were to 
occur during this pandemic, we would not know how these strategies 
should be applied simultaneously, when one takes precedence over 
another, etc. This of particularly concern if the terrorist event is an 
act of bioterrorism. Resources that may ordinarily have been available 
if such an event were to occur in non-pandemic conditions are now 
becoming scarce.
    When the H1N1 pandemic began in April 2009, many Federal 
Departments and agencies had not completed their plans for responding 
to pandemic influenza. Some, like DHS, had attempted to complete their 
planning, but their plans were hung up in review processes that 
occurred too close to the change in administration. As a result, many 
of these Federal plans were incomplete, unapproved, or altogether 
missing as late as July 2009. The strategy for DHS itself was only 
finalized in October.
    Some strategies for the Federal departments and agencies are 
available at Flu.gov (and previous to the inception of that site, 
PandemicFlu.gov). However, many are not posted there. Some are not yet 
completed--others are done, but not posted. Some (among them, DHS) make 
the argument that the information to be found in these plans is too 
sensitive for public release, but the argument lacks validity when one 
sees that the Department of Defense has posted its plan there. There 
are two reasons it is important for these Federal plans to be posted: 
(a) Doing so is part of Government accountability; and (b) access to 
these plans allows non-Federal Governmental entities as well as the 
private sector to understand what the Federal Government has planned to 
do during a pandemic, thereby allowing them to establish realistic 
expectations.
    The Federal Government still has not comprehensively posted its 
plans, nor did it issue adequate guidance in advance of the pandemic. 
As a result, States, territories, Tribes, localities, and the private 
sector were not able to complete the best plans possible. They did not 
and do not know what all to expect from the Federal agencies regarding 
Federal activities and which resources could be made available. As of 
now, they are doing the best they can with the planning and resources 
information they do have at their disposal. This accounts for at least 
some of the incongruity in Federal and non-Federal response efforts to 
date. Although everyone understood that some guidance could not be 
issued until the pandemic started (needing to be based on the exact 
virus, for example), other guidance could and should have been 
developed in advance (such as that regarding the distribution of 
pandemic vaccine). Planning efforts continue in the midst of responding 
to this pandemic in both the public (including Federal) and private 
sectors.
C. Challenges Posed By Key Medical Response Requirements Partially 
        Addressed
    Pandemics challenge the ordinary practice of medicine, particularly 
in the most developed countries in the world, where medicine is also 
highly developed and expectations exist for the best possible care at 
all times and in all circumstances. Committee staff identified four 
deficiencies in January: (a) Difficult issues (such as the need to 
establish a different standard of care under pandemic conditions) were 
identified but left unaddressed by the Bush administration; (b) 
hospital resource and priority management (including triage) was 
problematic; (c) pharmaceutical interventions were limited; and (d) 
recommendations for non-pharmaceutical interventions were lacking or 
confusing.
    As hospitals and other health care delivery establishments are 
rapidly running out of medicines, equipment, space, and time to treat 
those suffering from the H1N1 disease--as well as those that are ill or 
injured otherwise--they are put in the extremely difficult position of 
having to try to deliver the highest level of health care. This is 
becoming increasingly difficult, and soon will be impossible. Some 
States, for example, are running out of hospital space altogether. For 
them, it is impossible to deliver the highest level of care if doing so 
requires a patient to be in a hospital. In order for doctors and other 
medical personnel to not be held liable for providing what would be 
considered substandard care under ordinary circumstances, it is 
necessary for a different standard of care to be developed quickly and 
communicated to providers throughout the country.
    Related to this is the need to triage patients differently as they 
come into health care establishments--how they are physically handled 
(to minimized exposure to others and themselves), where they are 
treated and in what order they are treated are all different under 
pandemic circumstances. This was completely foreseeable, but never 
addressed in advance. To date, the only guidance that has come out 
regarding both resources and triage is that those patients that present 
with influenza-like-illness (ILI) should be assumed to have been 
infected with H1N1.
    Unless the pandemic was caused by a strain of influenza that also 
happened to be part of the seasonal influenza targeted virus group--
thereby allowing the seasonal vaccine to confer some amount of partial 
immunity--we knew that we would have to develop the pandemic vaccine 
after the virus had been identified. Attempts had been made to create 
broad-spectrum vaccines, and vaccines that were termed pre-pandemic 
vaccines (created by guessing that H5N1/avian influenza variants would 
cause the pandemic). Additionally, funding has been provided to create 
new vaccine technologies (e.g., cell-based instead of egg-based), but 
those technologies were not and still are not available. So going into 
the pandemic, we did not have H1N1 vaccine (having guessed incorrectly 
that H5N1 would cause the pandemic).
    We also did not have a sufficient supply of antiviral medications, 
because we did not have enough stockpiled and because H1N1 was found to 
be resistant to two of the four antivirals that had been effective in 
the past in treating influenza. Insufficient supplies also further 
exposed the Nation to the threat of counterfeit pharmaceuticals and 
medical equipment.
    There are two main types of non-pharmaceutical interventions that 
are applicable to pandemics: (a) Protective equipment, and (b) 
protective actions. In the case of protective equipment, Members of the 
committee are well aware of what happened in terms of guidance and 
availability. If guidance was developed in advance, it was not 
communicated adequately to the American workforce (including that at 
DHS). There is no reason this should have occurred. Regardless of the 
exact genetic composition of an influenza virus, physical properties 
are similar enough to have been able to create guidance for the use of 
personal protective equipment for any of these viruses. The same can be 
said for protective actions. Shortfalls also occurred when guidance 
regarding what to do in particular situations and places by particular 
professions had not been developed in advance.
    The blame cannot be placed entirely on the shoulders of the CDC 
(specifically the National Institute for Occupational Safety and 
Health, part of the CDC) or the Occupational Safety and Health 
Administration (OSHA). All agencies should have taken what guidance was 
available from the CDC and OSHA and applied it to their own personnel 
and circumstances. Neither the DHS Office of Health Affairs nor the DHS 
Office of Safety and Environmental Protection (part of the DHS 
Management Directorate) tailored CDC guidance to the specific worksite 
requirements of the DHS components in advance of the pandemic.
D. Levels of Preparedness for Pandemic Influenza Unclear
    As we went into the pandemic, we were not sure as a Nation how 
prepared we were. Committee staff identified four deficiencies in 
January 2009: (a) Measurement of and reporting by the Executive Branch 
was not altogether suitable; (b) reporting under the Bush 
Administration was inconsistent; (c) the Federal priority on pandemic 
influenza preparedness had been lowered; and (d) the example set by 
Executive Branch Departments and agencies working together poor.
    Although not all planning was completed for all levels of 
Government and the private sector in advance of the pandemic, some 
planning had occurred. For example, the Implementation Plan for the 
National Strategy for Pandemic Influenza contained hundreds of actions, 
accompanied by conditions and standards for completion. Unfortunately, 
not all of the conditions and standards matched the actions, some 
standards were impossible for responsible agencies to meet on their 
own, some conditions were based on a different type of situation (a 
pandemic caused by avian influenza and starting somewhere other than 
North America), and some standards were not even provided (for example, 
there were no deadlines associated with the tasks assigned to the non-
Federal governmental and private sector entities responsible for 
executing them). As a result, it was not been possible to accurately 
measure how prepared we were for a pandemic. Although the Bush 
administration had been reporting that most and then all of the Federal 
activities had been completed or on-going, there was no way to really 
be sure because of the Implementation Plan was inherently flawed.
    Even if we accepted that the all of the conditions and standards 
matched the activities perfectly, the Bush administration had not been 
reporting activity status periodically or according to a schedule. 
After two reports, priorities were changed and the Bush administration 
chose to focus its efforts on addressing other threats, delegating more 
of the responsibility for pandemic influenza preparedness to the 
Federal departments and agencies. Unfortunately, the Bush 
administration's White House had been monitoring task completion, and 
they neglected to delegate the responsibility for this monitoring to 
another Federal entity. As a result, we became less--not more--sure of 
how prepared we were. The Obama administration was left with a flawed 
system, poor measurement, and delayed monitoring when it took over. It 
also eradicated the Office of Health and Biodefense, eliminated the 
position of Special Advisor to the President that had headed this 
office and decided to rely entirely on Federal detailees to address 
pandemic preparedness. Shortly thereafter, the pandemic started.
    Prior to the beginning of the pandemic, it was clear that some of 
the Federal departments and agencies were not working together to 
prepare for such a large-scale disease event. This carried on for 
months, requiring additional leadership from President Obama to 
overcome. A glaring example was that of the Department of Education 
having not worked significantly with the Department of Health and Human 
Services (HHS) on school closure guidance. It was only after the CDC/
HHS issued guidance that recommended school closure without the benefit 
of input from the Department of Education regarding county funding 
mechanisms (where counties receive funding on the basis of how many 
children actually show up to school) and the behavior of children when 
they are not in school (continuing to congregate elsewhere in the 
community) that these Federal agencies realized they had to work 
together.
               iii. systemic improvements in the response
A. Communication Between and Among Countries and Agencies Improved
    When the H1N1 outbreaks were occurring in Mexico in the Spring, the 
United States was not very aware of what was going on. Part of this was 
due to an administrative situation, in which Canada was testing 
specimens for Mexico (the Canadian Centers for Disease Control and 
Prevention in many ways have capacities equivalent to that of the U.S. 
CDC, but were charging Mexico less for the service of laboratory 
testing). There was no reason or mechanism in place for information to 
be reported to the United States about what was going on in a different 
country. However, it rapidly became clear to all three countries that 
some amount of information needed to be shared in order to protect the 
citizenry of North America. Since then, there has been greater 
information sharing, and it is likely that after the pandemic, these 
information-sharing mechanisms will remain in place. This is what 
occurred between Canada and the United States during the SARS epidemic 
of 2002-3.
    Communications and information sharing has also improved between 
and among various U.S. and international agencies. Many of these 
organizations learned the hard way that creating guidance or policy in 
a vacuum very quickly resulted in outcry from others in the community 
or those in the community that were on the receiving end of conflicting 
or incomplete guidance. Although it is still tempting for Federal 
departments and agencies to issue guidance and policy on their own--in 
order to make decisions and provide information as quickly as 
possible--most seem to have learned that either time needs to be 
invested in advance or more time will be spent subsequently in adding 
additional information and fixing problems. The best examples of this 
are the much-improved communications between the Department of 
Education, HHS, and DHS.
B. Additional Guidance Provided
    Although there were many pieces of guidance missing when the 
pandemic started in April 2009, the Federal Government was (relatively) 
quick to identify those needs and fill them as quickly as possible. In 
some case, it was necessary to wait for research or testing to be done, 
but on the whole needed guidance was developed and distributed. 
Additionally, some guidance was also modified as time went on and more 
was learned about the H1N1 disease--how it spread, what underlying 
conditions were exacerbating the illness, etc. For example, although 
there were initial difficulties in understanding what personal 
protective equipment was necessary for those DHS personnel working on 
the border and ports of entry (e.g., CBP and TSA) that came in contact 
with many people entering and exiting the country, the need for 
tailored guidance seems to have been resolved. It is important to note, 
however, that the tailored guidance was developed mostly by the CDC 
working directly with the component agencies in DHS--as opposed to the 
DHS Office of Health Affairs or the DHS Office of Safety and 
Environmental Programs.
    More guidance has been, and continues to be, provided to the 
States, territories, and private sector by the Federal Government. 
Where the Federal Government failed to provide adequate planning 
guidance, it is providing more now in the way of guidance for response. 
In some cases, where the Federal Government has still not provided 
guidance--such as that regarding different standards of care or how 
best to conduct triage under pandemic conditions, the States, 
territories, and private sector are slowly developing their own 
criteria and are not allowing themselves to be paralyzed by the lack of 
Federal guidance.
C. Some Additional Plans Finalized and/or Posted
    Since April 2009, more Federal plans have been posted on Flu.gov. 
Before April 2009, the Department of Defense, HHS, and the Department 
of Veterans Affairs had posted their departmental strategic plans for 
pandemic influenza. Since April 2009, the following Department and 
agencies have also posted plans regarding pandemic influenza in general 
or H1N1 specifically (although none are strategic plans): Department of 
Education (re: pandemic emergency planning guidance), DHS (re: critical 
infrastructure), Department of State (re: international assistance), 
Environmental Protection Agency (re: EPA actions to prepare), OSHA (re: 
workplace infection control), U.S. Fire Administration (re: planning 
guidance to first responders), and the National Highway Traffic Safety 
Administration (re: planning guidance for EMA and 9-1-1). DHS has also 
supposedly finalized its 2009-H1N1 Influenza Implementation Plan, but 
it has not yet been forwarded to the committee.
D. Vaccine Developed and Distribution Beginning
    HHS, working with its subordinate agencies [CDC, the Food and Drug 
Administration (FDA), and the National Institutes of Health (NIH)] and 
private sector vaccine manufacturers has developed H1N1 vaccine and 
began distribution of the vaccine to central distribution points in 
October. While the pandemic justified fast tracking the vaccine's 
development and use (via the FDA Emergency Use Authorization), NIH 
simultaneously has been conducting the studies one would hope and 
expect to see with any new vaccine. For example, one such study 
addressed simultaneous inoculation with both the seasonal influenza and 
H1N1 vaccines (finding that full immune response occurred to both 
immunizations and that there were no additional ill effects). The 
ordering system for the vaccine seems to be working well and the States 
and territories have not yet reported any problems. The only problem 
noted so far is that the predictions for how much vaccine would be 
available by this time were off, but it was expected that the 
predictions would more than likely were not going to be exact, given 
the inherent vagaries of egg-based vaccine production.
E. Lessons Learned Information Sharing System in Place
    The Lessons Learned Information Sharing (LLIS) \2\ system is under 
the direction of the National Protection and Programs Directorate at 
DHS. The purpose of the secure website is to collect lessons learned, 
after-action reports, etc., from exercises and actual events and foster 
communication among the first responder community that is its primary 
audience. LLIS has been in place since 2004, and pandemic influenza 
information was added to the site in 2007. LLIS conducts research and 
provides information regarding those aspects of previous influenza 
pandemics, other infectious disease outbreaks, and bioterrorism 
preparedness and response that would be applicable to the problem of 
pandemic influenza. Some lessons learned, best practices, good stories, 
practice notes, and other information that would be useful in 
preventing, detecting, preparing for, responding to, and recovering 
from pandemic influenza can be found here. However, the system is 
limited in its dependence on input from organizations outside of the 
standard first responder community and does not have medical personnel 
on staff. LLIS is currently does not possess a truly medical platform.
---------------------------------------------------------------------------
    \2\ See www.llis.gov.
---------------------------------------------------------------------------
F. Anti-Counterfeiting Activities Occurring
    A number of Federal agencies are responsible for addressing the 
threat from counterfeit pharmaceuticals and medical equipment, 
including the Federal Bureau of Investigation (FBI), the FDA, and U.S. 
Immigration and Customs Enforcement (ICE). Where there is a border 
connection, however, ICE has the lead, with broader jurisdiction than 
their other Federal law enforcement counterparts. Additionally, due to 
lack of funding, the FDA often hands cases over to ICE for the agency 
to investigate. ICE has taken a significant leadership role in the 
arena, creating the Intellectual Property Rights Coordination Center 
(IPR Center) under its auspices. Personnel from ICE and a number of 
other Federal agencies, including but not limited to Customs and Border 
Protection (CBP), FBI, and FDA are present there with full-time and 
some part-time representation. Shortly after the pandemic began in 
April 2009, leadership at the IPR Center decided to expand some of its 
on-going efforts to stem the tide of counterfeit pharmaceuticals into 
the United States, and included the requirement that investigators and 
officers look for counterfeit antivirals and vaccine as part of these 
operations. Since the summer, CBP, ICE, and the FDA--under the auspices 
of the IPR Center or as part of their individual agency activities--
have seized H1N1-related counterfeits.\3\
---------------------------------------------------------------------------
    \3\ Investigations regarding these counterfeits are on-going. 
Therefore, no further specifics are available at this time regarding 
quantities and value seized.
---------------------------------------------------------------------------
            iv. weaknesses in the current pandemic response
A. Biosurveillance Remains Weak
    Going into the pandemic, the public and private sectors were well 
aware of the flaws and deficiencies in our National biosurveillance 
efforts. We have hundreds of different public health and health care 
systems reporting on any number of diseases, events, types of 
laboratory data, types of epidemiological data, etc.--as well hundreds 
of other systems reporting biological and medical intelligence, 
bioterrorism and biocrime law enforcement information, and military 
weapons and material-related information. The problem is not that we 
lack information and data. The problem is that we lack the ability to 
gather/collect, combine/integrate, and analyze the enormous amount of 
information to which we could or do have access.
    The DHS National Biosurveillance Integration Center (NBIC) was 
established by this committee to address the need for integration, but 
it is up to the Federal departments and agencies to gather/collect and 
in some cases, analyze this information in advance of sending it on to 
DHS. However, NBIC has not provided products of value to the Department 
or to the rest of the Federal Government. Funding has not been high 
enough (about $8 million over fiscal year 2009 and again over fiscal 
year 2010), because NBIC has not performed well since its inception and 
appropriations has not been willing to provide additional funding.\4\ 
The committee must seriously consider the notion that if NBIC could not 
provide value during this pandemic, it would not be able to provide 
value during a bioterrorist event.
---------------------------------------------------------------------------
    \4\ Some estimate that NBIC will not be able to do what it needs to 
do unless it is funded at ten times the current level.
---------------------------------------------------------------------------
    The CDC has demonstrated another major weakness in biosurveillance. 
Although it has gathered what information it can from a variety of 
sources, none of its products provide an accurate picture of what is 
truly going on with the disease in the United States. In some cases, 
they reported information but did not take immediate action to fill 
gaps revealed by that information. For example, the CDC produces a map 
of the United States in their FluView system (see Figure 2 below). This 
map shows how the disease is spreading geographically in the States and 
territories, as reported by sentinel epidemiologists.
    Notice how the U.S. Virgin Islands (USVI) is shown not to be 
reporting. After weeks of committee staff asking why this was the case 
(when the USVI was reporting data for other charts within the CDC 
FluView) it was ascertained that the USVI lacked an epidemiologist who 
could do the sentinel reporting required for the map. Subsequently, the 
CDC decided to send one of their own Federal epidemiologists to the 
USVI to make these reports (and hopefully train others from within the 
USVI in epidemiology as well). However, as you can see from this most 
recent map, as of 10 October, almost 6 months after the start of the 
pandemic, the USVI still was not reporting.


B. FEMA Disaster Assistance Policy on Pandemic Influenza Not Yet 
        Updated
    The Robert T. Stafford Disaster Relief and Emergency Assistance Act 
authorizes Federal assistance to public and private not-for-profit 
entities affected by catastrophes following a Presidential declaration 
of an emergency. The Stafford Act is administered by FEMA, which can 
draw from a Disaster Relief Fund to provide assistance for eligible 
activities. The Stafford Act's applicability to infectious disease 
threats--whether natural (such as an influenza pandemic) or intentional 
(such as a disease caused by an act of bioterrorism) has been a matter 
of debate. CRS concluded that emergency assistance under the Stafford 
Act could be provided if a major disaster is declared as a result of a 
pandemic. There is no precedent for such a declaration.
    FEMA issued Disaster Assistance Policy 9523.17 Emergency Assistance 
for Human Influenza Pandemic (DAP 9523.17P), that describes Stafford 
Act assistance that may be provided during an influenza pandemic.\5\ 
The committee sent a letter to the Department, suggesting that DAP 
9523.17 be updated and that various aspects be revisited and clarified. 
First, DAP 9523.17 used avian influenza predictions as the basis for 
its policy. Second, reimbursement for such activities normally 
associated with natural disasters (such as search and rescue 
operations) are included but it is hard to imagine pandemic 
circumstances that would warrant search and rescue. Third, there is 
confusion between lack of reimbursement for increased administrative 
costs associated with medical surge and the reimbursement for temporary 
medical facilities that would only be necessary if there was a need for 
medical surge, carrying with it administrative costs. The letter was 
sent to the Department on 13 August 2009. Committee staff has 
communicated with various entities (such as FEMA and the Office of 
Health Affairs) within DHS on numerous occasions since then, but DAP 
9523.17 has yet to be updated. Some hospitals throughout the country 
are running out of hospital space now. It is necessary to get this 
policy updated well before the President declares emergencies due to 
pandemics, so that States and territories know in advance what they can 
expect to get reimbursed.
---------------------------------------------------------------------------
    \5\ FEMA, ``Emergency Assistance for Human Influenza Pandemic,'' 
Disaster Assistance Policy 9523.17, March 31, 2007. See: http://
www.fema.gov/government/grant/pa/9523_17.shtm.
---------------------------------------------------------------------------
C. DHS Lessons Learned Information Sharing System Underutilized
    The Pandemic All-Hazards Preparedness Act of 2006,\6\ required the 
creation of LLIS-Health, recognizing that there was a need for public 
health and medical lessons learned, after-action reports, etc. should 
be collected and provided in a secure area for emergency medical and 
health professionals. HHS was given the responsibility for gathering 
and providing information for the site, and it was supposed to have 
been built on the same platform as the existing LLIS site. LLIS-Health 
has not been created to date. DHS has added some health and medical 
information to the site (such as the pandemic influenza page referred 
to above). However, there is not a large amount of information 
currently present.
---------------------------------------------------------------------------
    \6\ Public Law No. 109-417.
    
    
    Committee Members have made many comments about the need for 
lessons learned from infectious disease events, including but not 
limited to pandemic influenza, to be collected and centralized in a 
site such as LLIS. Although DHS is to be commended for obtaining and 
putting what information it can into the existing system, HHS should 
follow through and either create LLIS-Health or add to the information 
already present in LLIS currently. We do not want to miss the 
opportunity to identify and record lessons learned from this pandemic 
as it is occurring. We will need this information when it comes time to 
update (and in some cases complete) the pandemic preparedness plans 
that were and should have been used to respond to this pandemic.
D. Influenza Messaging Confusing
    Although some thought had been given to public messaging regarding 
pandemic influenza, and some messages were developed by the Federal 
Government (most by HHS, with some by DHS), it appears that little 
thought was given to the possibility of having to issue messages 
regarding seasonal influenza occurring at the same time as pandemic 
influenza. There is a great deal of confusion regarding simultaneous 
vaccination with both the seasonal vaccine and the H1N1 vaccine. It may 
have been necessary to conduct studies to determine whether the vaccine 
developed for the pandemic would interact adversely with the seasonal 
vaccine, but there are only so many outcomes--either there is no 
problem (which would have resulted in a set of messages stating exactly 
that and encouraging people to get both simultaneously if necessary), 
or there is a problem (which would have resulted in a set of messages 
warning people not to take both at once, and providing strict guidance 
as to how long to wait in between, which to get first, etc.).
    The Federal Government has not engaged in a significant public 
information campaign, using messages and a particular spokesperson 
(such as the U.S. Surgeon General). As a result, localities and their 
businesses are providing whatever information they have about vaccines, 
school closures, personal protective equipment, etc., to prevent the 
spread of the H1N1 virus. 


    Although the need for coherent, comprehensive, and unified 
messaging has been discussed for years regarding these and other 
aspects of pandemic influenza, disasters, and other events for which 
the public would require information in order to take the best possible 
actions, very little seems to have been implemented. The public must be 
considered a partner in the endeavor to prevent illness and death due 
to pandemic influenza. The public cannot do so, however, if it is not 
armed with the right information.
E. Pharmaceutical System Vulnerable to Counterfeiting
    Federal law enforcement agencies (such as ICE, CBP, and the FBI) 
and agencies with small contingents of law enforcement personnel (such 
as FDA) have indeed expanded on-going operations to look for and seize 
H1N1-related counterfeit medications (such as antivirals and vaccine). 
However, high demand and desperation drive criminals to produce more 
counterfeit pharmaceuticals and consumers to seek pharmaceuticals 
outside of normal sources if they are not available when and where they 
think they should be.
    Many illegitimate on-line pharmacies look very legitimate, and fool 
consumers into purchasing pharmaceuticals that are counterfeited but 
often look like the real thing. The FDA recently issued a warning to 
the Nation, urging people to be very cautious about ordering H1N1 drug 
products over the internet and telling the public that these were 
unapproved and/or illegal. ICE has been investigating the use of the 
internet for crime, and these investigations have included ordering 
counterfeit pharmaceuticals on-line, bringing pharmaceuticals over the 
border illegally, etc. However, the proliferation of websites has 
outpaced the ability of ICE and other Federal law enforcement agencies 
to check each site and what it is selling. 

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    More must be done to protect unsuspecting consumers from ordering 
or otherwise obtaining counterfeit pharmaceuticals, knowingly or 
unknowingly. It is one thing to purposely obtain pharmaceuticals using 
illegal practices--this is a crime that should be stopped, and both 
dealers and consumers must be investigated and prosecuted. It is 
another to unknowingly obtain pharmaceuticals that are believed to be 
real, either over the internet or introduced into pharmacies that we 
believe to be secure. The pharmaceutical supply chain, wholesaler 
systems that are not regulated and monitored as closely as they should 
be due to lack of State and local personnel and funding, and the 
internet are all vulnerable. These vulnerabilities allow criminals to 
sell counterfeit pharmaceuticals, taking advantage of both demand and 
desperation during this pandemic.
                             v. conclusion
    We have the opportunity to strengthen at least some of the 
weaknesses in our National response. To do that, we need concrete 
information and your departments and agencies need concrete 
recommendations and resources. The Legislative and Executive Branches 
must work together to improve our response efforts and save as many 
lives as we can.

    Ms. Clarke. The Chairwoman now recognizes the Ranking 
Member of the subcommittee, Mr. Lungren of California.
    Mr. Lungren. Thank you very much, Chairwoman Clarke, and a 
welcome to our witnesses.
    In this second hearing of our committee on the subject of 
pandemic influenza, I do look forward to hearing about the 
challenges we have encountered thus far and our Federal 
response to this pandemic influenza, what gaps we have 
discovered, what steps you have taken to correct them, and what 
corrective strategies will be needed in the future. It would be 
a great benefit to us to have that in as much detail as 
possible.
    At our July 29 meeting, we examined the near-term outlook 
for the developing national response to pandemic influenza. 
Today, we have a chance to see how well we have performed thus 
far in meeting the challenges and overcoming many of the 
obstacles that were forecast at that earlier meeting.
    I believe I can speak for all of us here today to say the 
illness and the fatality numbers are very disturbing, with the 
CDC reporting more than 1,000 people in the United States 
having died from the 2009 H1N1 influenza, with more than 100 of 
them being children. At the same time, I recognize how many we 
have that die on an annual basis from regular flu strains, and 
I think we ought to put that into context and not forget that 
as well.
    I also recall when I was a member of the executive branch 
in the State of California how different it is from being a 
Member of the legislature where we often come up with great 
ideas and then kind of wipe our hands and go off to solve 
another problem and don't realize perhaps some of the 
ambiguities, uncertainties, and nuances of what we have asked 
the Executive branch to do. So I do understand why it is not as 
easy as putting it on paper for those of you to go forward and 
actually perform your duties.
    Nonetheless, we have an obligation to have serious 
oversight, and that is what this committee and subcommittee is 
doing. Going forward, I think we would all agree that we must 
develop safe and effective vaccines in a timely manner and 
generate confidence in their use. We must enhance research on 
vaccines for at-risk populations such as pregnant women and 
young children, and there is always the cry to correct the 
delays in the supply chain that have been witnessed I think 
just about every time and even now.
    I would ask this question: A decade into the 21st century, 
how is it acceptable that we have not commercialized advanced 
non-egg-based manufacturing for these vaccines? Is there 
something that I don't understand? Is there something we can do 
on the Congressional side? Is there a need for great resources 
to be directed for that? All of this, no matter what your 
answer, would require resources and commitment from the 
administration, the Congress, and the private sector.
    We should also be concerned about developing significantly 
better diagnostic technologies for the detection and tracking 
of these novel flu strains. So I look forward particularly Dr. 
Lurie's testimony to learn why H1N1 vaccine production has been 
delayed and why it is still such a challenge to accurately and 
quickly diagnose influenza strains, whether at the doctor's 
office or our Nation's ports of entry.
    I welcome the Department of Homeland Security's newly 
appointed Chief Medical Officer, Dr. Garza. Now that the 
President has declared the H1N1 outbreak a National emergency, 
I am looking forward to hearing from Dr. Garza on how well DHS 
is protecting its own workforce and how DHS and the Department 
of Health and Human Services are coordinating their influenza 
prevention efforts.
    In addition to the human element of any disease, a sick 
population is a burden on our entire medical system. High 
workforce absenteeism slows business productivity and impacts 
the availability of critical State and local government 
services and this at a time when our economy is at a very, very 
delicate position.
    This pandemic is now a declared National emergency, and I 
look forward to hearing from today's witnesses what challenges 
they had to overcome, the lessons they have learned in 
addressing this H1N1 influenza outbreak, and what advice and 
counsel they can give us as to how we can work even more 
closely together in the future to overcome some of the 
obstacles that remain.
    I thank you, Madame Chairwoman, for this hearing.
    Ms. Clarke. Thank you, Mr. Lungren.
    The Chairwoman now recognizes the Chairman of the full 
committee, the gentleman from Mississippi, Mr. Thompson, for an 
opening statement.
    Mr. Thompson. Thank you, Madame Chairwoman, for convening 
this hearing to assess the Federal response to pandemic 
influenza.
    Pandemic influenza is not a new phenomenon. Historically, 
there have been others; and by the time H1N1 pandemic began 
this year, we were well overdue.
    Although the disease caused by the H1N1 strain of influenza 
is not as severe as it could have been, we remain concerned. It 
is already infecting human beings. Pediatric deaths are 
increasing. Pregnant women are also dying. We realize that if 
further mutations occur, as often happens with influenza 
viruses, the death rate could become much higher. As it is, 
every country in the world has been affected, and global 
society has changed.
    Prior to April 2009, work was on the way to prepare for 
pandemic influenza. However, even though we knew that an 
influenza pandemic was coming and that we feared the 
consequences of such a disease, we were not prepared as a 
Nation. This committee knew that pandemic influenza would 
greatly affect the security of our Nation and homeland. It is 
for this reason that I made oversight of the pandemic 
preparedness a priority and the oversight of pandemic response 
a requirement.
    Coming into this pandemic, it was clear to the committee 
that early warning, detection, and biosurveillance were 
inadequate. Execution of key pandemic planning activities was 
incomplete. A different standard of care under pandemic 
conditions had not been identified. Triage rules under pandemic 
conditions had not been modified. Pharmaceutical interventions 
were limited. Recommendations for the use of personnel, 
protective equipment, and other nonpharmaceutical interventions 
were lacking. Pandemic preparation preparedness was poorly 
measured, and the Federal departments and agencies were not 
working together as well as they could have been.
    However, the pandemic did start in April. No matter how 
prepared we were or were not, the Nation and the world stopped 
preparing and started responding.
    In January of this year, before the pandemic started, I 
instructed the Majority staff of this committee to release a 
report: ``Getting Beyond Getting Ready for Pandemic 
Influenza.'' In that report, we made a number of key 
recommendations for the Nation to become prepared. Some of them 
have been implemented. For example, we have seen Federal 
departments and agencies work better together to respond to 
this pandemic. The CDC is issuing new health care delivery 
guidance, and a number of response plans have been completed.
    However, we are also seeing predictable problems occur 
during the pandemic response. Many public and private-sector 
entities are having difficulty reporting how the disease is 
affecting them or what resources they need. We do not have a 
truly accurate picture of how the disease is affecting the 
Nation or the world. Coordination between and among agencies 
still need to occur, even within the Departments such as 
Homeland Security and the Health and Human Services. Hospitals 
are still determining what the acceptable level of care should 
be under pandemic conditions. We are still hobbled by the 
limitations of an egg-based vaccine production. Criminals are 
infiltrating the pharmaceutical system and trying to sell 
counterfeit antivirals and vaccine, and confusing messages are 
still going out to the public.
    The Obama administration is working to address these 
shortcomings while the response to H1N1 pandemic is occurring. 
We know how hard this is to do, and this committee stands ready 
to work with the administration in this important endeavor. As 
leaders, we all share the responsibility to address this threat 
and fight this pandemic. I, again, as Chairman of the 
committee, look forward to working with all of the departments 
as well as other Members of the committee on addressing this as 
best we can, but we need to do it in a planned, coordinated 
fashion.
    I yield back.
    Ms. Clarke. Thank you, Mr. Chairman.
    My colleagues on the subcommittee, we have been joined by 
the gentlelady from Texas, Ms. Sheila Jackson Lee, a Member of 
the full committee; and I am asking unanimous consent for her 
participation here today.
    Seeing no objection, so ordered.
    Other Members of the committee are reminded that, under the 
rules, opening statements may be submitted for the record.
    [The statement of Hon. Richardson follows:]
                Statement of Honorable Laura Richardson
                            October 27, 2009
    Mister Chairman, thank you for convening this very important 
hearing today focusing on the Federal response to the pandemic 
influenza. I appreciate your commitment to this very important and 
timely issue. I would also like to thank our witnesses for taking the 
time to appear before Congress today.
    This is a very timely topic given the recent announcement that 
vaccines for the H1N1 virus will not be ready as soon as expected. We 
have all read the local newspaper reports, both in Washington and our 
respective districts, with stories of people waiting in line for hours 
to receive vaccines that quickly run out in the face of high demand.
    For example, let me tell you about a case in my home State of 
California. Cindy Nexon Filsinger of San Fernando Valley says she has 
not been able to obtain flu shots for her two young children. She has 
driven around fruitlessly to local pharmacies and called her family's 
pediatrician repeatedly, only to be told, ``We are out,'' and ``We 
don't know when to expect the next shipment.'' Mister Chairman, this is 
simply unacceptable. Worried families deserve answers and peace of mind 
about the health of their children.
    In the spring, this subcommittee convened a panel about 
preparations for a pandemic. It is clear that we still have some 
lessons to apply to the current situation with regard to the H1N1 virus 
and its rapid spread around the country.
    The 37th Congressional District of California, which I am 
privileged to represent, is one of the most diverse districts in the 
country. My district is located in Southern California, home to 
Samoans, Cambodians, Hispanics, and countless other ethnic groups. 
While we are dealing with a shortage of vaccines all over the country, 
it is important that we do not overlook minority communities as well. I 
hope to hear from our witnesses on the protocols in place for outreach 
and education. Minorities need to have equal access as well to vaccines 
and other health information.
    But the time for action is certainly sooner rather than later. 
According to the CDC, H1N1 is present in all 50 States, but widespread 
in 46 States, including California. But in California, just 1.7 million 
doses of H1N1 inoculations have been delivered out of 20 million 
expected this season. It is clear that despite the advance warning and 
early calls to action, we are still under-prepared for the H1N1 virus. 
And it is chilling to think what would happen in the event of a bio-
terrorist attack, which would certainly come with little to no warning.
    I am pleased that this hearing will focus on the efforts to 
strengthen the weaknesses in public health, safety, and security 
revealed by this virus. Clearly, the Federal Government still has work 
to do in terms of preparation and coordination. I look forward to 
bringing back positive information and answers to the worried families 
of my district, as well as hearing from our distinguished panel of 
witnesses on public outreach with regard to education about the virus, 
vaccine availability, and basic tips on containing the spread of this 
virus.
    Thank you again, Mr. Chairman, for convening this hearing. I yield 
back my time.

    Ms. Clarke. I welcome the panel of witnesses.
    Our first witness, Dr. Alexander Garza, I understand likes 
to be called Alex--or doesn't mind--is the Assistant Secretary 
of the Health Affairs and Chief Medical Officer of the 
Department of Homeland Security. Welcome.
    Prior to joining DHS, Dr. Garza spent 13 years as a 
practicing physician and medical educator. He most recently 
served as the Director of Military Programs at the ER-1 
Institute at the Washington Hospital Center and has served as 
the Associate Medical Director of EMS for the State of New 
Mexico and the Director of EMS for the Kansas City, Missouri, 
Health Department. He is a war veteran, and we commend him for 
his service in Senegal and Iraq.
    Our second witness is Dr. Nicole Lurie. Dr. Lurie is the 
Assistant Secretary for Preparedness and Response for the 
Department of Health and Human Services. The subcommittee is 
well familiar with the work she did at the RAND prior to 
returning to HHS, where she served previously as the Principal 
Deputy Assistant Secretary of Health.
    Welcome.
    Our third witness is Mr. Richard Serino, Deputy 
Administrator for the Federal Emergency Management Agency. Mr. 
Serino brings over 35 years of experience in State and local 
emergency management and EMS to FEMA and the Department. Prior 
to coming to FEMA, Mr. Serino was Chief of Boston EMS and 
Assistant Director of the Boston Public Health Commission.
    Our fourth witness is Ms. Marcy Forman, Director of the ICE 
Intellectual Property Rights Coordination Center. Prior to 
taking on this directorship, Ms. Forman was the Director of the 
ICE Office of Investigations, overseeing the largest 
investigative arm of the Department of Homeland Security. Ms. 
Forman was responsible for spearheading a number of important 
initiatives, including Operation Cornerstone and Operation 
Community Shield.
    We thank all four of our witnesses for their service to the 
Nation and for being here today.
    Without objection, the witnesses' full statements will be 
inserted into the record. I now ask each witness to summarize 
his or her statement for 5 minutes, beginning with Dr. 
Alexander, Alex, Garza.

 STATEMENT OF ALEXANDER GARZA, M.D., CHIEF MEDICAL OFFICER AND 
ASSISTANT SECRETARY FOR HEALTH AFFAIRS, DEPARTMENT OF HOMELAND 
                            SECURITY

    Dr. Garza. Thank you.
    Good afternoon. I want to thank Chairman Thompson, 
Chairwoman Clarke and Ranking Member Lungren and the 
distinguished Members of the subcommittee for the opportunity 
to testify before you today.
    As you know, this is my first testimony before the 
committee as the Department of Homeland Security Assistant 
Secretary and Chief Medical Officer. I welcome the opportunity 
to address this body, and I am pleased to be here alongside Dr. 
Lurie from HHS as well as my colleagues from the Department of 
Homeland Security.
    The current H1N1 pandemic is unique in that there is no 
Ground Zero, no city or State where it is most likely to make 
landfall, and no discrete beginning or end. It will not destroy 
buildings, but its effect will be widespread, prolonged, and 
have the potential to disrupt the normal functioning of 
communities. To this end, DHS and OHA have focused our efforts 
on protecting the people and the country from the ramifications 
of the H1N1 pandemic.
    The principal tasks of the Office of Health Affairs 
regarding the current pandemic are providing information, 
analysis, and advice in support of Secretary Napolitano, co-
leading the DHS H1N1 planning effort, helping ensure that the 
DHS workforce is protected, and serving as the lead 
representative of DHS in the interagency coordinating bodies.
    DHS has a dual mission intersecting at National security. 
While we are intimately involved with National planning and 
response efforts, we are also internally developing policies 
and procedures to protect our workforce so they may continue to 
safeguard our country. Together with our interagency partners, 
DHS has led a strong Federal response. We have learned from our 
experiences and have implemented changes to improve our 
response for the Fall wave and in the future.
    The key lessons observed and learned that I would like to 
highlight are interagency coordination, planning, workforce 
protection, and communications. The Spring outbreak illustrated 
the necessity of a strong interagency coordination. We have 
worked closely with our Federal partners, including my 
colleague, Dr. Lurie, at ASPR, the Department of Health and 
Human Services, the Centers for Disease Control and Response, 
and the Department of Education, as well as the White House.
    In addition to working horizontally, we have integrated 
vertically by working with our State, local, Tribal, and 
territorial governments, as well as the private sector and 
faith-based communities in providing guidance. Our Office of 
Intergovernment Programs conducts weekly calls and meetings 
with the homeland security advisers across the country. Our 
National Protection Programs Directorate coordinates with 
critical infrastructure representatives. This, just to name a 
few. We will continue to collaborate and push information 
across at all levels.
    As my experience in the Army has taught me, plans must be 
flexible enough to adapt to the tactical reality on the ground. 
The Department has learned this as well from the H1N1 pandemic. 
While we originally planned for a worst-case scenario, that 
being a pandemic influenza originating outside of the 
continent, we realized the situation was different and were 
able to adapt and maneuver to the challenges of the current 
reality. We tested our internal coordination and planning by 
conducting tabletop exercises with DHS senior leadership, 
including the Secretary and the deputy secretary. This provided 
an opportunity for the Department to identify how to meet our 
mission-critical functions while protecting employees during an 
influenza pandemic outbreak.
    As I mentioned earlier, we have a dual mission where one 
complements the other. The Department of Homeland Security has 
over 200,000 personnel, of which 80 percent are operational. 
The size of our operational force is second only to the Defense 
Department and equivalent to the size of the Marine Corps. OHA 
and DHS have acted aggressively through several different 
mechanisms to ensure that our forces are protected. We have 
disseminated evidence-based guidance directly to the employees 
and posted this on our internet. In addition, we spearheaded 
the acquisition of personal protective equipment and antiviral 
medications. By performing these functions, we are helping 
assure that the threat of the current pandemic will not 
influence the security posture of the Nation.
    Because our job at DHS is to ensure a coordinated Federal 
response, information sharing is essential. Our National 
Biosurveillance Integration Center provides situational 
awareness via the biosurveillance common operating picture to 
State and local fusion centers. We integrate and disseminate 
critical information to our law enforcement and emergency 
managers across the country. As we move forward through the 
Fall flu season, we continue to build on the strong 
relationships we have formed across all levels of Government 
and the private sector.
    Again, I would like to thank you for the opportunity to 
testify before you today, and I look forward to any questions 
that you may have. Thank you.
    [The joint statement of Dr. Garza, Mr. Serino, and Ms. 
Forman follows:]
Prepared Joint Statement of Alexander Garza, Richard Serino, and Marcy 
                                 Forman
    Chairwoman Clarke, Ranking Member Lungren and Members of the 
committee. The Department of Homeland Security (DHS) thanks you for 
taking the time today to discuss the National response to 2009-H1N1 
flu. The DHS Office of Health Affairs (OHA), the Federal Emergency 
Management Agency (FEMA) and Immigration and Customs Enforcement (ICE) 
are key players in DHS efforts to ensure the Nation is prepared for the 
effects of 2009-H1N1 influenza.
    At this time, the Nation has a solid idea of the scope and severity 
of the outbreak. However, we are still watching to see what changes 
will occur during regular flu season, if any, as the seasonal flu 
strains circulate concurrently with the 2009-H1N1 virus. DHS has worked 
in close collaboration with the Department of Health and Human Services 
(HHS) and other agencies to lead a strong response since the initial 
appearance of 2009-H1N1 flu in the Spring, and we have implemented 
changes to continually improve our response now and in the future.
                  lessons learned and accomplishments
    As a result of what we learned in the spring about H1N1, the 
Federal Government has updated its response plans, enhanced our 
community mitigation planning and guidance, and improved a range of our 
abilities. We have effectively pre-deployed antiviral medications, and 
we have created and disseminated messages that help the public 
understand what the Nation is facing. These improvements are not only 
critical to our H1N1 response, but are also critical to responding to 
future pandemics when they occur.
    Specifically, the Department and other Federal agencies had been 
planning for an influenza pandemic for many years, and especially since 
2005. However, we learned this past Spring that much of what actually 
occurred in the H1N1 outbreak did not align with prior avian flu 
planning. Since the spring, DHS has led interagency efforts to develop 
and implement H1N1-specific preparedness and response planning 
activities. On Aug. 25, 2009, the Secretary of Homeland Security signed 
the DHS 2009-H1N1 Influenza Implementation Plan, which identifies 
specific component roles and responsibilities, and directs all DHS 
components to develop plans that address key preparation and response 
actions, performance of mission essential functions, workforce 
protection, continuity of operations, and communications with key 
stakeholders during the H1N1 influenza outbreak. We also worked with 
the Department of State to clarify the status of international border 
operations under provision of the Security and Prosperity Partnership 
of North America's Plan for Avian and Pandemic Influenza.
                        interagency coordination
    Throughout the response to H1N1, DHS has engaged closely with 
Federal interagency partners, including the Department of Health and 
Human Services (HHS) and its Centers for Disease Control and Prevention 
(CDC), the Department of Education, the Department of State, and the 
White House. DHS has also worked with State, local, Tribal, and 
territorial governments and with the private sector to help mitigate 
and monitor the spread of this illness.
    Our partnerships with HHS, including the HHS Assistant Secretary 
for Preparedness and Response (ASPR), and other Federal departments and 
agencies continue to play a critical role in our efforts. The National 
2009-H1N1 Summit, held on July 9, 2009, brought together the 
Secretaries of DHS, HHS, and Education, other Federal officials and 
experts, staff from Governors' offices, State, Tribal, and territorial 
health, education, and emergency management/homeland security 
officials, and National organizations to discuss H1N1 response 
realities and potential Fall scenarios. The summit was condensed into a 
webcast for city, county, and local officials and released on Aug. 4, 
2009, to update local officials on the status of H1N1, resources 
available and expectations going forward.
    In addition, DHS, HHS, and CDC to provide updated guidance to help 
multiple segments of the private sector and academic community prepare 
for and respond to 2009-H1N1. DHS, HHS, and the Department of Education 
released updated guidance for the K-12 education community on Aug. 7, 
2009; updated business guidance from DHS, HHS, and the Department of 
Commerce followed on Aug. 19, 2009; and guidance for higher education 
institutions came the following day. In conjunction with the business 
guidance, DHS, HHS, and the Small Business Administration also produced 
a small business guide on H1N1 preparedness.
                       guidance to dhs employees
    DHS has one of the largest operational workforces in the Federal 
Government. The health and safety of this workforce continues to be a 
primary priority of DHS leadership. Therefore, OHA stockpiled personal 
protective equipment (PPE) and antivirals in advance of any influenza 
outbreak. Currently PPE is pre-positioned at over 120 DHS locations and 
field offices Nation-wide. Our antivirals are stored in a 
pharmaceutical warehouse, fielded across the operational workforce 
sites, and are prepared to be deployed as required by DHS components.
    Throughout the H1N1 response, the Management Directorate and OHA 
provided DHS employees with new and updated guidance on a number of 
topics. This guidance has been disseminated to components, is available 
to all employees on the DHS intranet, and includes information on 
seasonal influenza and 2009-H1N1 vaccines, influenza antiviral 
medications, low- and medium-exposure risk occupations, mandatory use 
of respirators for high- and very high-exposure risk occupations, fit 
testing and fit checking of respirators, and human resources 
flexibilities for employees as well as supervisors and managers. We 
will continue to provide our employees with guidance based on the best 
science available.
                      the office of health affairs
    For the past 3 years, OHA has led the Department's pandemic 
preparedness activities, placing it in a position to assume an 
appropriate leadership role when the pandemic occurred. OHA stood up a 
Decision Support Cell at the first reports of an outbreak, and worked 
directly with our interagency partners to provide information needed by 
DHS leadership to coordinate the Federal response. OHA also serves as 
the DHS representative to interagency coordinating bodies focused on 
2009-H1N1.
    OHA is co-leading the DHS 2009-H1N1 planning effort in cooperation 
with the DHS Office of Operations Coordination (OPS). The office also 
plays a critical role in protecting the DHS workforce, particularly 
higher-risk employees. OHA provides health and medical guidance to 
operational components, and has stockpiled PPE and antivirals for DHS 
employees. To test our internal coordination for workforce protection, 
OHA conducted an Assistant Secretary level 2009-H1N1/Pandemic table top 
exercise on Sept. 10, 2009. The exercise was designed to provide an 
opportunity for DHS offices and components to identify how they will 
continue to meet their essential functions while protecting employees 
during an influenza pandemic event. The forum validated operational 
relationships, the soundness of Secretarial decision-making processes, 
and roles and responsibilities of DHS components, confirming that DHS 
must continue to confront long-term pandemic-related continuity issues 
head on.
                            biosurveillance
    OHA, through the National Biosurveillance Integration Center 
(NBIC), integrates and analyzes biological surveillance information 
from multiple Federal, State, local, and private sector partners. NBIC 
provides senior DHS leaders a clear, comprehensive picture of on-going 
incidents and/or outbreaks, both domestically and overseas, and 
provides the continuing capability to maintain cross-domain analysis 
and impact assessments of the novel 2009-H1N1 influenza pandemic.
    Recognizing the potential consequences of 2009-H1N1 infections on 
multiple critical infrastructure areas of the United States, NBIC 
engaged with the National Infrastructure Simulation and Analysis Center 
(NISAC) to assess potential outbreak characteristics and infrastructure 
impacts of a resurgent novel-H1N1 virus. The results of the assessment 
effort were analyzed and reviewed by an aggressive and thorough 
interagency process that engaged all NBIC Member Agencies and 
additional Federal participants (including the Departments of Energy, 
Education, and Labor). The assessment was based on the best scientific 
snapshot of the outbreak in June and assumed no mitigation efforts. 
NBIC is now working with HHS and other departments and agencies to 
conduct an updated assessment that takes into account updated 
assumptions and mitigation strategies. DHS will use this information to 
continue to inform Federal Government planning and preparedness.
                          incident management
    DHS has taken an aggressive, proactive approach to 2009-H1N1 
incident management operations. FEMA has staffed and trained 56 
Incident Management Assistance Teams--Advance (IMAT-As) to provide 
direct Federal support to any State or territory upon a Governor's 
request. The primary mission of an IMAT-A is to rapidly deploy to an 
incident or at-risk venue, provide leadership in the allocation and 
provision of Federal assistance, and to coordinate and integrate an 
inter-jurisdictional response in support of the affected State(s) or 
U.S. territory(s). The IMAT-As will support efforts to meet the 
emergent needs of State and local jurisdictions; possess the capability 
to provide initial situational awareness for Federal decision-makers; 
and support the initial establishment of a unified command. In 
addition, last month, FEMA activated the National IMAT East to provide 
a dedicated coordination cell for the 2009-H1N1 national response. This 
cell coordinates with the DHS National Operations Center and the HHS 
Secretary's Operations Center, facilitates information collection and 
dissemination; is prepared to receive and evaluate requests for 
assistance from States and other Federal agencies; and is ready to 
expand as needed.
    For the 2009-H1N1 influenza pandemic, Secretary Napolitano elected 
to replace the National Pandemic Influenza Principal Federal Official 
(NPI-PFO) field teams with reconfigured 2009-H1N1 Regional Coordination 
Teams (RCTs). Secretary Napolitano has outlined clear missions for the 
2009-H1N1 RCTs, which will:
   Serve as a conduit between the many Federal agencies engaged 
        in the 2009-H1N1 response efforts and our various partners in 
        the States;
   Identify and, through the established incident management 
        architecture, respond to the Secretary's critical information 
        requirements, enabling the Secretary to make decisions related 
        to her role as the Principal Federal Official for the 2009-H1N1 
        Pandemic;
   Serve as the Secretary's primary source in the field for 
        awareness of strategic issues related to the 2009-H1N1 pandemic 
        and help broker resolution of significant disputed issues;
   Report through the FEMA Regional Administrator and the 
        Federal Coordinating Officer (FCO). This will ensure that the 
        FEMA Regional Administrators can focus on emergency management 
        and regional administration functions and the FCOs can focus on 
        and lead the administration and coordination of relief at the 
        operational and tactical levels as required by law;
   Assist DHS Component and other Federal interagency leaders 
        in the field to coordinate and collaborate to achieve 
        Nationally directed strategic objectives, including those 
        related to entry and exit screening, quarantine, isolation, 
        vaccination, continuity of operations, and continuity of 
        Government.
             federal emergency management agency activities
    In addition to establishing the IMAT-A teams, FEMA is identifying 
and addressing potential gaps in Federal response plans, and is 
providing critical preparedness and response assistance to States and 
localities.
    As a proactive measure at the Federal level, FEMA has shared with 
HHS a number of Pre-Scripted Mission Assignments (PSMAs) to expedite 
potentially necessary support to States. In the absence of a 
declaration under the Robert T. Stafford Disaster Relief and Emergency 
Assistance Act, Pub. L. 93-288, the PSMAs provide an advance 
architecture for the scope and cost of Federal support that HHS can use 
to develop Interagency Agreements (IAAs) between HHS and the Emergency 
Support Function Departments and Agencies. For example, PSMAs have been 
established to outline how HHS will seamlessly integrate with the IMAT-
A teams, FEMA's Regional Response Coordination Centers and the National 
Response Coordination Center.
    FEMA is also taking the lead in the effort to ensure that the 
Federal Government can continue operating in the event of significant 
absenteeism in a major outbreak. The agency's National Continuity 
Programs (NCP) Directorate has developed and tested its Continuity of 
Operations for Pandemic to ensure the relevant Federal departments and 
agencies have the capability to continue supporting disaster activities 
if pandemic conditions warrant social distancing. NCP has developed 
planning guidance to address differences in pandemic continuity 
planning and traditional continuity planning. For example, unlike more 
traditional continuity planning scenarios, pandemic influenza may be 
widely dispersed geographically and could arrive in waves that could 
last several months at a time.
    To ensure that all of these Federal planning efforts are well 
coordinated across all agencies, FEMA has incorporated lessons learned 
in the Common Operating Picture (COP), within the Homeland Security 
Information Network (HSIN). The COP is a web-based tool that collects 
information and provides data to our partners in the Government and in 
the private sector. To continue updating and improve planning efforts, 
FEMA provides the DHS Deputy Secretary status updates on a select 
number of action items, which are included in the Department of 
Homeland Security Weekly Situation Report. The DHS Situation Report 
(SitRep) is uploaded to the COP by DHS OPS each week. The DHS weekly 
SitRep, which provides updated information from responding Federal 
Departments and Agencies, including HHS, specifically highlights 
information such as:
   Stafford Act emergency declarations and requests for Federal 
        assistance (to date, there have not been any Stafford Act 
        declarations or requests of DHS pertaining to H1N1);
   Status of Federal-State coordinating elements (e.g. RCTs, 
        ESFs, and IMAT);
   Status of reported school closings;
   Updates from all Federal departments and agencies;
   Impacts, if any, on critical infrastructure and key 
        resources (i.e. absenteeism, operational impact, 7-10 day 
        concerns, mitigation measures, and unique concerns);
   Any specific department or agency updates regarding planning 
        or operational capacity within the four national framework 
        pillars: Mitigation, surveillance, communication, and 
        vaccination.
    FEMA is also playing a key role in proactively assisting State and 
local governments with their H1N1 preparedness and response efforts. 
For example, the agency's Mass Care Unit is working with State, 
regional, and other Federal agencies and non-governmental organization 
partners in the development of a Mass Care (ESF6)/Emergency H1N1 
Planning Guidance Template that will assist States with planning for 
sheltering, feeding operations, and donations management within an H1N1 
environment. The Mass Care/Emergency Assistance Planning Guidance 
Template provides guidelines for the FEMA regions to support States in 
their planning efforts for either a pandemic or a pandemic combined 
with a natural or man-made disaster. Some of the functions included in 
the template are sheltering, feeding, providing emergency supplies, 
supporting mass evacuations, facilitating unification, and supporting 
household pets.
    FEMA's National Preparedness Directorate's Center for Domestic 
Preparedness (CDP) revised the Pandemic Influenza Planning and 
Preparedness (PIPP) course to reflect new information about the 2009-
H1N1 strain along with updated planning considerations. This course is 
available to State, territory, local, and Tribal homeland security and 
emergency management professionals.
    FEMA's Individual Assistance's Crisis Counseling Program (CCP) is 
also working with HHS' Single State Medicaid Agencies (SMSA) to develop 
a contingency plan for administering CCP technology in the event of a 
mass infectious disease outbreak.
    Finally, FEMA's Disaster Assistance Directorate has developed 
procedures and criteria, under the authority provided in the Stafford 
Act for requesting assistance from the Federal Government. The 
President approves all Stafford Act emergency and disaster declaration 
requests (DAP 9523.17). The Disaster Assistance Directorate has 
developed guidance titled ``Procedure for Evaluating State Requests for 
Emergency Disaster Declarations for Pandemic Influenza,'' which is 
designed to provide States information on factors considered in 
evaluating State requests for emergency assistance declarations for a 
pandemic influenza. In addition, FEMA Public Assistance is developing a 
Disaster Assistance Fact Sheet, entitled ``2009-H1N1 Influenza 
Frequently Asked Questions.''
     ice national intellectual property rights coordination center
    Immigration and Customs Enforcement places a significant emphasis 
on reducing the threat to health and safety posed by the trafficking of 
counterfeit, unapproved, and substandard pharmaceuticals. Due to the 
current 2009-H1N1 threat, this emphasis now includes efforts to 
identify and interdict counterfeit 2009-H1N1 vaccines and other 
influenza treatment products, such as counterfeit antiviral 
medications. In addition to the investigative resources of the ICE 
Office of Investigations, and the Office of International Affairs, ICE 
spearheaded the establishment of a new National Intellectual Property 
Rights Coordination Center (IPR Center). The IPR Center now includes 
representation from all Federal agencies with enforcement jurisdiction 
over intellectual property (IP)-related crime, including U.S. Customs 
and Border Protection (CBP), the Federal Bureau of Investigation (FBI), 
the Food and Drug Administration (FDA)--Office of Criminal 
Investigations, the U.S. Postal Inspection Service (USPIS), the 
Department of Commerce, and the Department of Justice Computer Crimes 
and Intellectual Property Section (CCIPS). Of particular significance 
is the recent inclusion of Mexico Customs as a partner agency, 
providing ICE and the IPR Center with the ability to more effectively 
address cross-border commercial fraud issues between our two countries.
    With the reorganization and restructuring into the IPR Center, we 
have created a true task force environment, bringing together the 
statutory authority of the partner agencies for a more focused approach 
to addressing pharmaceutical-related IP crime. The IPR Center develops 
and receives actionable leads; generates intelligence, seizures, 
investigations, and initiatives; and conducts outreach and training. 
One of the primary missions of the IPR Center is the analysis, 
deconfliction, and coordination of leads received from private 
industry, counterpart law enforcement agencies, and public avenues. 
This is accomplished through the sharing of all lead information with 
agency partners for review and vetting, and is vital to the 
identification and coordination of existing investigative or 
interdiction overlaps. To maximize its investigative capabilities, the 
IPR Center is conducting ongoing investigations of subjects, 
organizations, and networks exploiting the internet to facilitate the 
sale and distribution of counterfeit, tainted, and substandard 
products.
    As previously noted, ICE places specific focus on products that 
present a threat to the health and safety of the U.S. public, which 
currently include 2009-H1N1 and antiviral medication counterfeit 
pharmaceuticals. In 2004, ICE developed and implemented Operation 
Apothecary, which specifically focuses on international mail and 
express courier services that facilitate the importation of counterfeit 
and unapproved pharmaceuticals. Operation Apothecary generates 
information about, and conducts investigations of, subjects and 
websites involved in the sale and importation of suspect 
pharmaceuticals.
    With the outbreak of 2009-H1N1 earlier this year, ICE and its 
partners at the IPR Center projected a potential influx of counterfeit 
influenza products. In response, the IPR Center proactively initiated 
undercover activity targeting individuals and websites that were 
offering potential counterfeit influenza treatment products for sale. 
Even with heightened vigilance, close attention, and thorough 
investigation, to date ICE has found no evidence of the illicit 
production or dissemination of counterfeit antiviral medications in the 
United States. While we have not encountered any counterfeit vaccines 
or medicines to date, we recognize the potential for the emergence of 
this threat. ICE will remain diligent in coordinating with our domestic 
and foreign partners and counterparts on this issue, and will continue 
to conduct investigative and interdiction activity targeting 
counterfeit 2009-H1N1 vaccines and other associated pharmaceuticals.
                               conclusion
    In closing, DHS is continuing to address 2009-H1N1 influenza 
aggressively, as it has since the first appearance of this virus in the 
Spring. Since that time, we have strengthened our plans and our 
response capacity as we have learned more about 2009-H1N1, and we have 
built a strong, coordinated, and effective response. Again, thank you 
for inviting us to testify on this important issue, and we are happy to 
answer any questions you have.

    Ms. Clarke. We thank you, Dr. Garza, for your testimony.
    I will now recognize Dr. Nicole Lurie to summarize her 
statement for 5 minutes.

   STATEMENT OF NICOLE LURIE, M.D., ASSISTANT SECRETARY FOR 
   PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Lurie. Thank you, Madame Chairwoman, Chairman Thompson, 
Ranking Member Lungren, and other distinguished Members and 
guests.
    I am Dr. Nicole Lurie. I am the Assistant Secretary for 
Preparedness and Response. I brought with me for your reading a 
series of updates on the situation and guidances that have been 
put out just for your reference.
    I thought I would start by describing ASPR's role in 
general and then move on to talk about what we have been doing 
with H1N1. So, in general, the role of my office is to 
coordinate across HHS response and work with the interagencies 
throughout this pandemic. It is also to stimulate the 
development of and contract for vaccines and antivirals that 
have been so essential at combating this pandemic. In addition, 
we must ensure that we backstop States and communities if they 
get overwhelmed and request our help. Finally, we have to stay 
prepared for any other emergency. I will remind you that just a 
couple of weeks ago we helped out in American Samoa when they 
were overwhelmed with their tsunami.
    H1N1 has been really a public-private partnership from the 
get-go in response, and I want to give you examples. We have 
vaccine today because, thanks in large part to the foresight of 
Congress, we had invested in rebuilding the vaccine 
infrastructure in the United States. As a result of our avian 
flu planning, we were able to get out of the blocks quickly, 
with preexisting contracts with manufacturers already licensed 
in the United States.
    As you know, we have bought enough vaccine for anyone who 
wants it. While we all know that the vaccine is later than we 
want it to be, this is a global problem; it is not just a U.S. 
one. The good news is that at the end of last week States had 
16 million doses available to order, and today they have 22 
million doses available to order, and there will be more coming 
every day.
    We have stimulated the development of antivirals and have 
just issued an emergency use authorization for the first-ever 
intravenous antivirals, and we stockpiled antivirals and 
personal protective equipment in the Strategic National 
Stockpile. In the Spring, when the virus first hit, we released 
about one-quarter of the antivirals from the stockpile as well 
as N-95 masks to the States. We have replenished that supply, 
and in the last few weeks we have released about 300,000 
treatment courses of liquid pediatric Tamiflu from the 
stockpile as well as more N-95.
    We have partnered closely with the private-sector health 
care system. Investments in the hospital preparedness program 
have meant that most health care facilities had exercised all 
hazards plans, including influenza plans. We have already seen 
it pay off with places activating disaster procedures, setting 
up temporary facilities, including tents outside of their 
emergency rooms. You know, while we first felt scared about 
that, that is exactly what is supposed to happen in an 
emergency, and that preserved their emergency rooms for people 
with true emergencies.
    Putting in place a way to pay for vaccine administration 
has been another accomplishment; and we have partnered very 
successfully with health insurers, pharmacists, big box stores, 
the American Medical Association, and public health agencies to 
get this done. The goal is to be sure that cost is not a 
barrier for anyone who wants to get vaccinated.
    We are working hard in partnership with State and local, 
Tribal, and territorial agencies on surveillance, on vaccine 
administration, and on educating the public and working with 
community groups to get the message out. We talk all the time, 
formally at least twice a week, with them; and their 
representatives now are embedded in the Emergency Operations 
Center of the CDC.
    We have also partnered very effectively across the Federal 
Government, and I would like to highlight just a few of those.
    As Dr. Garza said, we work now very closely with DHS. We 
talk all the time and have coordinated a lot on both the 
Federal emergency response as well as working with private-
sector entities. Similarly, as you pointed out, Madame 
Chairwoman, we have worked very effectively with the Department 
of Education around guidance for schools. I would also like to 
recognize our partnerships with VA and DOD around medical surge 
and around monitoring vaccine safety.
    Let me move on for a minute to lessons learned. In addition 
I want to say a couple things. The first and most important 
lesson, chronic underinvestment in public health, whether at 
the Federal, State, or local level, has real-world 
consequences; and we can't afford to let this happen again. 
While surveillance, either about the disease or the status of 
the health care system, may not always have been as timely as 
we would like, we have been able to enhance surveillance 
quickly by collaboration with the health care system and 
leveraging capabilities of new information technologies.
    There is a lot of future promise in those approaches; but, 
at the same time, biosurveillance, more computers, and fancy IT 
cannot replace the work of human beings, clinicians, public 
health scientists, and others who need to track the virus and 
investigate what is going on on the ground.
    Communication remains a challenge; and while it is 
certainly much better across the interagency, the challenges 
and speed of the internet means that we need to communicate and 
respond in new ways tracking down rumors, et cetera.
    We are not done with the science, either, in advanced 
development related to vaccines or building manufacturing 
capacity in the United States. My fear is that when this is 
over we will just check the box and decide we don't need to 
worry about a pandemic for another 30 years.
    [The statement of Dr. Lurie follows:]
                   Prepared Statement of Nicole Lurie
                            October 27, 2009
    Good afternoon Chairwoman Clarke, Mr. Lungren, and Members of the 
subcommittee. I am Dr. Nicole Lurie, the Assistant Secretary for 
Preparedness and Response (ASPR) at the U.S. Department of Health and 
Human Services (HHS). As Secretary Sebelius emphasized in her testimony 
before the Senate last week, slowing the spread and reducing the impact 
of 2009 H1N1 is a shared responsibility and we all need to plan for 
what would need to be done when the flu impacts our communities, 
schools, businesses, and homes this fall. I appreciate the opportunity 
today to discuss our role in response efforts as well as some of the 
challenges and successes we have encountered in responding to the 2009 
H1N1 influenza outbreak.
                        overview of the outbreak
    Since the initial spring outbreak of 2009 H1N1 influenza, this 
virus has triggered a worldwide pandemic, and was the dominant flu 
strain in the southern hemisphere during its winter flu season. Data 
about the virus from around the world have shown that the circulating 
pandemic H1N1 virus has not mutated significantly since the Spring. The 
virus remains similar to the virus chosen for the 2009 H1N1 vaccine, 
and remains susceptible to the antiviral drugs oseltamivir (Tamiflu) 
and zanamivir (Relenza), with rare exception. As with seasonal 
influenza, persons with some chronic health disorders and pregnant 
women have a higher risk of severe disease. In contrast to seasonal 
influenza, elderly persons have proven less likely to contract the 
virus; nevertheless, many elderly persons who do contract the virus 
have had serious complications, so early treatment with antivirals is 
recommended for them, as it is for pregnant women and others at high 
risk for complications, and for anyone who becomes seriously ill.
    Unlike our typical seasonal flu, we continued to see flu activity 
in the United States over the summer, notably among school-aged 
children and young adults. More recently, we have seen widespread 
influenza activity in almost all States. Visits to doctors for 
influenza-like illness are much higher than levels expected for this 
time of the year. We are already observing that more communities are 
affected than those that experienced outbreaks this past Spring and 
Summer, reflecting wider transmission and potentially causing greater 
impact. For example, as of October 10, 2009, 86 pediatric deaths 
related to 2009 H1N1 flu have been reported to the Centers for Disease 
Control and Prevention (CDC) since April 2009, a level that has only 
been seen at the peak of past influenza seasons. During the week of 
October 4-10, 2009, 11 deaths were reported. In each of the past 3 
years, between 46 and 88 children died from seasonal influenza.
    Over the next several months, seasonal influenza viruses may 
circulate along with the 2009 H1N1 influenza virus, and it will not be 
possible to determine quickly if ill individuals have 2009 H1N1 
influenza, seasonal influenza, or other respiratory conditions based on 
symptoms alone. Because of this, close monitoring of viruses in the 
United States will be critical to ensure that the best guidance about 
treatment and prevention of influenza can be provided.
Office of the Assistant Secretary for Preparedness and Response (ASPR)
    The Pandemic and All-Hazards Preparedness Act (the Act) designated 
the HHS Secretary as the lead Federal official for public health and 
medical response to public health emergencies and incidents covered by 
the National Response Plan developed pursuant to section 502(6) of the 
Homeland Security Act of 2002, or any successor plan, and created the 
Assistant Secretary for Preparedness and Response. Under the Act, ASPR 
plays a pivotal role in coordinating emergency response efforts across 
the various HHS agencies and among our Federal interagency partners.
            2009 H1N1 Task Force
    In July 2009, the White House National Security Staff (NSS) 
released the National Framework for 2009 H1N1 Influenza Preparedness 
and Response (National Framework) to ensure a coordinated and focused 
National strategy. In response, ASPR created the 2009 H1N1 Task Force 
to: Coordinate and consolidate H1N1 strategic program activities; serve 
as the focal point for policy coordination; and ensure that HHS's 
National Framework activities and accomplishments are reported to DHS 
according to NSS timelines.
    The Task Force addresses the National Framework's four key 
capability ``pillars'': Surveillance, mitigation measures, vaccination, 
and communication and education. The Task Force meets daily with me and 
the HHS Chief of Staff to review on-going activities to ensure our 
successful execution of the National Framework strategy. The Task Force 
has closely collaborated with DHS to establish a Common Operating 
Picture (COP) for 2009 H1N1, a single display of relevant information 
to facilitate collaborative planning and to achieve situational 
awareness.
            ESF No. 8 Response Activities
    Under the National Response Framework, ASPR is responsible for 
coordinating the Emergency Support Function (ESF) No. 8 response--
Public Health and Medical Services. ASPR provides the mechanism for 
coordinated Federal assistance to supplement State, local, territorial, 
and Tribal resources in response to public health and medical care 
needs during an emergency.
    Specifically with regard to the 2009 H1N1 influenza outbreak, ASPR 
coordinates the interagency public health and medical response 
activities through a series of twice-weekly Emergency Support Function 
No. 8 calls. During these calls, HHS regional health administrators and 
regional emergency coordinators report updates on their regions' 
pandemic influenza preparedness and response activities. Federal 
interagency partners, including DHS, also report their activities for 
group discussion and integration.
    Other coordination activities include weekly calls between ASPR and 
the State health departments to discuss any challenges and issues that 
might necessitate Federal assistance. ASPR has also conducted calls 
with intensive care physicians to better understand the clinical 
picture of patients requiring extensive care in hospitals and to share 
information and experience to help identify best practices to improve 
patient outcomes.
            Hospital Preparedness
    Since its inception in 2002, ASPR's Hospital Preparedness Program 
(HPP) has provided more than $3 billion to fund the development of 
medical surge capacity and capability at the State and local level. HPP 
funds are awarded to State and territory departments of public health, 
which in turn fund projects at hospitals and other health care 
entities. As a result, hospitals can now provide more beds; actually 
communicate with other responders through interoperable communication 
systems; track bed and resource availability using electronic systems; 
protect their health care workers with proper equipment; decontaminate 
patients; train their health care workers on how to handle medical 
crises and surges; develop fatality management, hospital evacuation, 
and alternate care plans; and coordinate regional training exercises. 
Over the past 3 years, HPP awardees have been required to conduct at 
least one pandemic preparedness exercise each year.
    Congress's investment in the Hospital Preparedness Program has 
resulted in our hospitals being better prepared to respond to the 
current 2009 H1N1 outbreak. In 2007, $75 million was awarded to States 
and territories specifically for pandemic influenza planning, including 
pandemic exercises and purchases of equipment, such as ventilators, 
that would aid in their response to a pandemic. Of the grantees 
receiving these funds, 79 percent conducted pandemic influenza 
exercises to hone their preparedness capabilities. In 2009, $90 million 
was awarded for purchase of personal protective equipment, such as N-95 
masks and ventilators. Each program recipient also was required to 
develop plans for alternate care sites. Pandemic influenza preparedness 
and development of alternative care sites have been two priorities of 
the HPP program since the inception of funding.
    HPP has required recipients to implement a system of bed counting, 
called the ``Hospital Available Beds in Emergencies and Disasters'' 
(HAvBED). This system requires reports of available beds, including a 
count of available adult and pediatric general beds and ICU beds, to 
State and HHS emergency operations centers within 4 hours of request. 
For the past 6 weeks, HAvBED has been operational and collecting 
information from States about hospital status that has enhanced our 
2009 H1N1 medical surge response needs.
    Furthermore, based on the lessons learned from the Spring 2009 H1N1 
response, HAvBED was modified to also collect information on emergency 
department stress and hospital stress. ASPR worked with the HPP 
grantees, the American Hospital Association and private vendors to 
develop a core set of measures (including daily census counts and 
equipment shortages) for the level of stress on the health care system. 
Within 48 hours of receiving information, we have senior ASPR experts 
discuss the analyzed data to determine if any hospitals are showing 
signs of stress or if there are indicators of equipment shortages. On 
occasions where the data indicates stress, we engage our Regional 
Emergency Coordinators to work with State health departments in 
conducting an investigation. To date we have not uncovered any 
instances of additional stress due to 2009 H1N1, but we remain vigilant 
and are prepared to act should the need arise.
            Other Activities
    ASPR has worked with CDC and Emory University to develop a web-
based triage algorithm that enables people with flu symptoms to 
determine if they need to seek medical care and where this care should 
be sought. This tool is currently posted on the flu.gov website for 
public use.
    ASPR also worked with the American College of Emergency Physicians 
(ACEP) to develop 2009 H1N1 influenza guidance for emergency 
departments and emergency physicians. This tool is available on the 
ACEP website. (http://www.acep.org/WorkArea/
DownloadAsset.aspx?id=46870)
    ASPR is working with the Society for Critical Care Medicine and is 
conducting a ventilator survey that will enable HHS to understand how 
many ventilators are available and where any regional shortages might 
exist. We are also working with professional organizations to train 
physicians in taking care of patients on ventilators.
    The National Disaster Medical System (NDMS) is training personnel 
to become vaccinators to assist State and local jurisdictions in that 
activity. Additionally, NDMS teams have received training on the 2009 
H1N1 outbreak and are standing by ready to assist States/locals in the 
delivery of care to pandemic influenza patients.
                           responding to h1n1
    Responding to 2009 H1N1 influenza has provided challenges and 
valuable lessons that will assist our response efforts going forward. 
As this emergency unfolded it became clear that significant resources 
would be necessary to respond to the pandemic with potentially large 
impacts. Further, based on a number of factors such as State readiness 
and vaccine effectiveness, we would not be able to plan response 
requirements with certainty and thus, how resources would need to be 
allocated. As a result, we greatly appreciated the flexible funding 
that the Congress provided for these efforts.
    As we learn from the experiences of 2009 H1N1, we look forward to 
working with you to improve strategies to ensure that our Nation has 
the right assets at the right time to minimize the health impacts of an 
influenza pandemic, hurricane, or bioterrorism event. The timely access 
to a flexible response fund has provided us with a nimbleness to 
quickly augment capabilities--such as hiring personnel on the front 
line of public health--where the speed of our response translates to 
lives saved.
    Now, I will briefly discuss a few of the challenges we encountered 
in our biosurveillance efforts, vaccine research and development, 
antiviral stockpiling, situational awareness, private sector 
collaboration, and international assistance.
Biosurveillance Efforts
    Several additional systems have been put in place or modified to 
more closely monitor data on the impact of 2009 influenzas. These 
changes include the following:
   Enhancing Hospitalization Surveillance.--Using the 198 
        hospitals in the Emerging Infections Program (EIP) network and 
        six additional sites with 76 hospitals, CDC monitors a 
        population of 25.6 million to estimate hospitalization rates by 
        age group and to monitor the clinical course among persons with 
        severe disease requiring hospitalization. The EIP sites also 
        track vaccine effectiveness.
   Expanding Testing Capability.--HHS continues to support all 
        States and territories with test reagents, equipment, and funds 
        to maintain laboratory staff and ship specimens for testing. 
        CDC serves as the primary support for public health 
        laboratories around the globe and has provided test reagents to 
        295 laboratories in 147 countries. Accurate testing is 
        essential for monitoring any changes in the virus that may 
        indicate increases in severe infection, resistance to antiviral 
        drugs or a decrease in the match to circulating vaccine 
        strains. To further enhance availability of testing, FDA has 
        evaluated and provided emergency use authorization for several 
        diagnostic tests specific for the 2009 H1N1 virus.
   Monitoring severe illness and mortality of women who are 
        pregnant.--Pregnant women are at higher risk of severe disease 
        and death from the 2009 H1N1 influenza virus. CDC is in the 
        process of implementing a new system to collect data on severe 
        illness (intensive care hospitalization) and mortality among 
        pregnant women, which will improve our ability to monitor this 
        group.
   Aggregate Hospitalizations and Deaths Reporting Activity 
        (AHDRA).--Initiated on September 1, 2009, AHDRA collects 
        information from all 50 States to identify hospitalizations and 
        deaths due to influenza or influenza-like-illness (ILI) 
        Nationally and within each State. This new collection activity 
        will contribute to a more complete picture of the burden of 
        serious influenza and pneumonia illness and deaths during the 
        pandemic and let each State examine trends in the course of the 
        pandemic in their areas.
Vaccine Research and Development
    ASPR's investment over the past 6 years in medical countermeasure 
advanced research and development enabled the Department to complete 
2009 H1N1 vaccine development with unprecedented speed. ASPR's 
Biomedical Advanced Research and Development Authority (BARDA) has 
worked with industry to build and sustain a domestic manufacturing 
infrastructure. Under the HHS Pandemic Influenza Plan (November 2005), 
the Department's key goals for vaccine preparedness were:
   Stockpile enough pre-pandemic influenza vaccines to cover 20 
        million persons in the critical workforce;
   Develop sufficient domestic manufacturing capacity to 
        produce pandemic vaccine for the entire U.S. population of 300 
        million persons within 6 months of pandemic onset.
    To establish domestic pre-pandemic influenza vaccine stockpiles, 
BARDA supported the development and manufacture of vaccines against 
different H5N1 avian virus strains. Today, BARDA continues to support a 
secure supply of raw materials, including eggs for domestic 
manufacturing of seasonal and novel influenza vaccines and the 
development and manufacturing of novel influenza vaccine candidates for 
clinical evaluation. BARDA also provided cost-sharing support to expand 
the domestic influenza vaccine manufacturing infrastructure by 
retrofitting existing vaccine manufacturing facilities and building new 
cell-based influenza vaccine manufacturing facilities. Additionally, 
FDA was fully engaged with industry to substantially increase the 
number of U.S. licensed seasonal influenza vaccine manufacturers and 
their overall production capacity, a necessary infrastructure for 
pandemic vaccine development and production. It was through the 
licensed seasonal influenza vaccine framework that we were able to 
license and rapidly make available H1N1 vaccine.
    The rapid responses of HHS agencies, including CDC, the National 
Institutes of Health, and the Food and Drug Administration, in terms of 
surveillance, viral characterization, pre-clinical and clinical 
testing, and assay development, were greatly aided by preparedness 
efforts for influenza pandemics set in motion by the H5N1 outbreak in 
2003. Stockpiling for pandemic preparedness began in 2004, with H5N1 
vaccine (23 million doses). In 2005 and 2006, the first six contracts 
for cell-based vaccines were initiated with two manufacturers at a cost 
of $1.3 billion. In 2007, two manufacturers were contracted for work on 
adjuvants, which are vaccine-boosting compounds ($137.5 million). 
Throughout, clinical studies have been supported by ASPR/BARDA and the 
National Institutes of Health/National Institute on Allergy and 
Infectious Diseases (NIH/NIAID).
    These initial activities to prepare for H5N1 provided valuable 
lessons that have informed our efforts to respond to the current 2009 
H1N1 outbreak. For example, we learned that coordination between ASPR/
BARDA and NIH/NIAID was necessary to learn about the immunogenic 
properties of the virus and to conduct clinical trials. Working with 
our industry partners, we learned that, just as for seasonal influenza 
vaccines, one dose of the H1N1 vaccine induces a response that is 
likely to be protective in adults and older children. We also learned 
that vaccine distribution through Points of Distribution (POD) should 
not be the only option. Instead, we need to develop our planning and 
contractual relationships to allow for flexible distribution--in this 
case, through a third-party--to 150,000 State-specified locations.
Antiviral Stockpiling
    Under the HHS Pandemic Influenza Plan, HHS was required to:
   Establish National influenza antiviral drug stockpiles to 
        treat 25 percent of the U.S. population during a pandemic, plus 
        an immediate readiness cache of 6 million treatment courses for 
        containment at pandemic onset;
   Support the advanced development of new and promising 
        influenza antiviral drugs toward U.S. approval; and
   Boost U.S.-based production of antiviral drugs.
    To accomplish these mandates, ASPR awarded contracts in 2004-2007 
totaling more than $924 million to establish and coordinate the Federal 
and State pandemic stockpiles of antiviral drugs. We procured 50 
million treatment courses for storage in the Strategic National 
Stockpile (SNS) by the end of 2007, completing the Federal contribution 
to the antiviral goal. Additionally, using funding provided by 
Congress, ASPR subsidized States in their purchase of 22 million 
treatment courses of antivirals towards the 31 million treatment course 
goal for State stockpiles.
    To support antiviral development and manufacturing ramp-up 
activities, BARDA awarded a contract in 2007 for $102.7 million for 
advanced development and domestic industrialization of a new influenza 
antiviral drug. Beginning in 2008, BARDA also solicited and awarded 
additional contracts for new and combination influenza antiviral drugs. 
These efforts directly benefited pediatric and critically ill 
populations.
    We know that antiviral resistance is a threat. So our acquisition 
strategy for additional antivirals needed to be flexible. A lesson 
learned from the 2009 H1N1 outbreak is that rare cases of H1N1 have 
been Tamiflu resistant. As a result, ASPR has increased efforts to 
stockpile an alternative antiviral, Relenza. We also know from this 
outbreak that children are disproportionately affected by 2009 H1N1 
influenza, leading us to procure more pediatric courses of antivirals.
    Another challenge presented by 2009 H1N1 influenza is the treatment 
of critically ill individuals, who potentially may require an 
intravenous antiviral formulation that requires an Emergency Use 
Authorization (EUA) from the FDA. Since January 2007, HHS has supported 
the advanced development of a new antiviral drug, Peramivir, which may 
be administered intravenously to hospitalized influenza patients. On 
October 23, an Emergency Use Authorization was authorized by the FDA 
for the utilization of Peramivir to treat critically ill patients with 
H1N1 virus infections. In addition, the emergency use of intravenous 
formulations of two other antiviral drugs, approved already for other 
indications, is under evaluation.
Situational Awareness
    Situational awareness is an essential component of any incident 
response. During the 2009 H1N1 influenza response, HHS worked very 
closely with the Department of Homeland Security (DHS) to develop a 
National Situation Report (SitRep) which is then inserted into the 
Homeland Security Information Network (HSIN). Working cooperatively, 
DHS and HHS have modified the SitRep to accurately reflect public 
health and medical issues. HHS has also been working with DHS to enable 
State and local public health officials to gain access to the HSIN so 
they can maintain their situational awareness.
Private Sector Collaboration
    HHS has engaged many private sector partners in a series of 
problem-solving dialogues related to the vaccine dispensing program. 
The Association of State and Territorial Health Officials (ASTHO) 
worked with ASPR to convene a series of meetings with America's Health 
Insurance Plans (AHIP), individual insurers, American Pharmacists 
Association, retail pharmacy chains, American Medical Association 
(AMA), National Vaccine Safety Program, and other State and Federal 
partners. The private sector demonstrated a firm commitment to working 
through complex issues of vaccine administration, billing processes, 
and other policy issues that would facilitate a successful vaccine 
campaign with the goal of providing easy access to the 2009 H1N1 
influenza vaccine for every person in the United States who wants it.
    Many issues related to vaccine administration, including billing 
and payment issues, were raised and partnerships with the HHS Centers 
for Medicare & Medicaid Services and the AMA yielded the development of 
specific vaccine codes, and unique vaccine administration codes for 
both Medicare recipients and the privately insured. In addition, the 
health insurers and pharmacies agreed upon a set of principles for 
billing practices and payment procedures and developed associated draft 
templates to support State vaccine program consistency.
International Assistance
    There is broad international recognition that the 2009 H1N1 
pandemic is a global health challenge. Millions of people around the 
world have been affected, thousands have died and the virus continues 
to spread across international borders. Recognizing that 2009 H1N1 
infection, like most diseases, knows no borders and that the health of 
the American people is inseparable from the health of people around the 
world, President Obama committed to make 10 percent of the U.S. 2009 
H1N1 vaccine supply available to other countries through the World 
Health Organization (WHO). Vaccine will be donated on a rolling basis, 
as it becomes available, in order to assist countries that will not 
otherwise have direct access to the vaccine. We are taking this action 
in concert with international partners: Australia, Brazil, France, 
Italy, New Zealand, Norway, Switzerland, Japan, Germany, and the United 
Kingdom.
    On October 5, we met with the Governments of Mexico and Canada to 
review current 2009 H1N1 efforts and decided to re-institute the North 
American Plan for Avian and Pandemic Influenza Coordinating Body to 
ensure continued international coordination in the areas of human 
health, animal health, border issues, and emergency management.
                               conclusion
    I want to assure the subcommittee that the administration is taking 
the public health challenges of 2009 H1N1 seriously and is implementing 
a comprehensive strategy to monitor and address this influenza outbreak 
throughout this Fall and Winter. HHS continues to work in close 
partnership with virtually every part of the Federal Government under a 
National preparedness and response framework for action that builds on 
the efforts and lessons learned from this spring.
    Working together with Governors, mayors, tribal leaders, State, and 
local health departments, the medical community, and our private sector 
partners, the Federal Government has been actively implementing a 
vaccination program and continues to revise and refine our pandemic 
influenza plans and activities based on new data and information.
    It is important to reiterate that our current level of preparedness 
and subsequent ability to respond is a direct result of the investments 
and support of Congress; the hard work of State, local, Tribal, and 
territorial public health officials; and our partners in the private 
and not-for-profit sectors. Building strong systems to track and 
monitor seasonal influenza has allowed us to closely monitor the impact 
of this novel virus on our communities.
    Our Nation's investment in public health infrastructure, 
particularly at the State and local levels, remains a critical 
challenge that has real life consequences in peoples' lives. Today, 
these consequences are impacting our communities, our schools, our 
workplace, and our homes.
    Investments in science and the public health infrastructure will 
enable us to better prepare and respond to threats, such as 2009 H1N1, 
that arise in the future. For instance, the President's 2010 budget 
includes funding for advanced development of antiviral drugs and 
invests in new vaccine technology. These investments are critical to 
building the resilience needed to better prepare for a flu pandemic or 
other public health emergency before it occurs. Moreover, these 
investments require our continuing attention and commitment over the 
long-term and should not depend solely on the occurrence of a public 
health emergency.
    Building resilience makes us more secure from a number of public 
health emergencies--from the current 2009 H1N1 pandemic, to chemical, 
biological, radiological, or nuclear threats and natural disasters.
    Our experience with 2009 H1N1, and the lessons we have learned, 
demonstrate a need to examine new paradigms for leveraging the public 
health infrastructure to facilitate proper preparedness, recovery, and 
response to future disasters.
    Thank you for your time and interest. I am happy to answer any 
questions.

    Ms. Clarke. We are going to have to probably get the rest 
of your testimony through the questioning. We want to make sure 
that we get the other witnesses in. But thank you.
    I thank you for your testimony, and I would like to now 
recognize Mr. Richard Serino to summarize his statement for 5 
minutes.

  STATEMENT OF RICHARD SERINO, DEPUTY ADMINISTRATOR, FEDERAL 
  EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY

    Mr. Serino. Chairman Thompson, Chairwoman Clarke, Ranking 
Member Lungren, and Members of the subcommittee, thank you for 
the opportunity to testify on behalf of the Federal Emergency 
Management Agency.
    The issue that we are discussing today is timely and 
extremely important. As the President indicated on Saturday 
with his declaration of a National emergency, this 
administration is taking the H1N1 threat seriously. Even before 
this declaration, the strong Federal team led by the Department 
of Health and Human Services assembled to address an outbreak 
of H1N1.
    As a member of this team, FEMA is doing its part to 
ensuring our communities are prepared. The drive behind this 
effort is clear: We care deeply for all those who we serve and 
protect, and our hearts go out to the families of those who 
have suffered or lost a loved one as a result of H1N1. I want 
to ensure all of them and all Americans that the Federal 
Government is working hard to protect them.
    As you know, this is my first appearance on Capitol Hill 
since I was sworn in as Deputy Administrator last week. Prior 
to my swearing in, I served as both Chief of the Department for 
the City of Boston EMS but also as the Assistant Director of 
Health in Boston. I was proud that Mayor Menino entrusted me to 
be part of the team to lead the city's effort in preparing for 
H1N1. I am now looking forward to bringing that experience to 
bear at a National level.
    What we are doing in Boston is similar to what many cities 
all across America are doing right now. The key to our efforts 
in Boston was community outreach. We used partnerships with 
schools, churches, synagogues, temples, businesses, and unions 
to spread the message of personal protection from the H1N1 
virus. We emphasized the simple things but critically important 
things that you have all heard, but it bears repeating, like 
washing your hands, covering your cough with your arm, getting 
vaccinated, and staying home when you are sick. I know that is 
hard for all of us, but it is important.
    We established a medical intelligence center in Boston last 
year that became a central hub of our efforts. It brought 
hospitals, EMS, community health centers, law enforcement, 
businesses into our facility to foster and create cooperation 
and to build upon the strengths that each member of the team 
had to offer. For instance, when we were looking to expand our 
outreach efforts in several neighborhoods, the Boston police 
who were there were able to assist by using their relationships 
with dozens of community crime watch groups.
    Boston's faith-based community also assisted in our efforts 
to sponsoring vaccination clinics throughout the city. We used 
Facebook, Twitter, and other innovative ways to get the message 
out to the public.
    While I am proud of what we were able to accomplish in 
Boston, I am also now humbled by the responsibilities that I 
now have as FEMA's Deputy Administrator. Much has already been 
done, but I am anxious to contribute to the efforts ahead.
    In the weeks since my swearing in, I have spent much time 
studying the plan and efforts that are already under way; and 
next week I will be traveling to Atlanta with Dr. Garza to meet 
with the CDC officials. What I have observed so far, the 
Federal approach to H1N1 is similar to our approach in Boston. 
Through close coordination and cooperation, we are using unique 
expertise of numerous Government agencies to respond again as 
one team.
    HHS is the lead agency in the Federal team, but FEMA is 
playing an integral part. FEMA is assisting State and local 
governments with their H1N1 planning efforts by developing 
clear guidance on how to structure emergency mass care 
operations within an H1N1 environment. We are providing 
guidance through procedures and criteria for requesting 
emergency assistance under the Stafford Act, if necessary, the 
fact sheet that we are sending out to all States and localities 
for them to know what guidance is available and what they need 
in case they need to use the Stafford guide.
    FEMA is also working to expand and improve coordination 
between all levels of Government. We created 56 Incident 
Management Assistance Teams--Advance, or IMAT-As, that can be 
deployed at the request of a Governor to assist in coordinating 
Federal assistance during H1N1 emergency. We have developed a 
number of pre-scripted mission assignments that provide 
detailed script on how different agencies will interact if 
called upon in H1N1 emergency. In addition, FEMA has developed 
and tested a continuity of operations plan to ensure that even 
during an H1N1 outbreak that the Federal Government still has 
the capability to support disaster response and recovery 
activities.
    Madame Chairwoman, these are just some of the examples of 
how FEMA is working with the Department of Health and Human 
Services in our State and local departments to plan and prepare 
for an outbreak of the H1N1 virus. It is with my experience in 
Boston the key to our effort is coordination and cooperation. 
We are building upon our strengths and expertise of each of our 
partners to form one unified response. I am looking forward to 
be part of this Federal team.
    I am anxious to work with you, Madame Chairwoman, and the 
other Members of Congress to ensure that the Federal Government 
can do all it can do to protect the American people. Thank you 
for the opportunity to appear before you today.
    I am prepared to answer any questions the committee may 
have.
    Ms. Clarke. We thank you for your testimony.
    I now recognize Ms. Marcy Forman to summarize her statement 
for 5 minutes.

  STATEMENT OF MARCY FORMAN, DIRECTOR, INTELLECTUAL PROPERTY 
  RIGHTS COORDINATION CENTER, DEPARTMENT OF HOMELAND SECURITY

    Ms. Forman. Chairman Thompson, Chairwoman Clarke, Ranking 
Member Lungren, and distinguished Members of the subcommittee, 
I appreciate the opportunity to appear before you today.
    I currently serve as the Director of the Intellectual 
Property Rights Coordination Center led by ICE. Prior to me 
coming to the Center, as noted by the Chairwoman, I served as 
the Director of the Office Investigations for ICE. During that 
time, I oversaw the largest investigative arm of the Department 
of Homeland Security for more than 8,000 employees, to include 
over 6,200 special agents assigned to 26 Special Agent-in-
Charge field offices and 181 suboffices.
    It was during my tenure as the Director of the Office of 
Investigations that I established the current National 
Intellectual Property Rights Center to stem the flow of 
counterfeit and tainted goods that were entering the commerce 
of the United States. This multi-agency IPR coordination 
center, through its shared law enforcement and regulatory 
partnerships, targets intellectual property crimes globally 
with a focus on health and safety and a special focus on 
pharmaceuticals, counterfeit pharmaceuticals.
    Because Dr. Garza has provided the committee with a written 
statement on behalf of all the DHS witnesses before you today, 
I will forego making a formal statement at this time.
    I look forward to answering any questions. Thank you very 
much.
    Ms. Clarke. I thank all the witnesses for their testimony.
    I will remind each Member that she or he will have 5 
minutes to question the panel. I will now recognize myself for 
questions.
    Dr. Garza and Dr. Lurie, we knew about H1N1 prior to the 
outbreaks occurring elsewhere in the world before 2009. How 
much did we know and how far in advance did we know it, and who 
do you think--and why do you think, rather, why do you think 
that we didn't act faster?
    Dr. Garza. Let me make sure I understand what you are 
asking. Are you asking about when did we find out about the 
first cases of H1N1?
    Ms. Clarke. Well, we knew about H1N1 prior to the 
outbreaks.
    Dr. Garza. Yes.
    Ms. Clarke. Because they were occurring elsewhere in the 
world before April 2009. That is correct.
    Dr. Garza. I believe they were first discovered in Mexico. 
Correct.
    Ms. Clarke. Do you know how much we knew and how far in 
advance we knew it, about that outbreak in Mexico or elsewhere?
    Dr. Garza. I am not familiar with the outbreak information.
    Ms. Clarke. Dr. Lurie, do you have any sense of that?
    Dr. Lurie. I don't have specific dates. But it is fair to 
say that, as soon as it was clear that outbreaks of a yet 
unnamed respiratory disease were going on in Mexico, there was 
a fair amount of sample sharing, as you know, and the virus was 
identified. Shortly thereafter, cases were identified in the 
United States. As you may know, interestingly, it was actually 
an investigational rapid diagnostic test that was being 
supported as part of our pandemic planning that helped to pick 
up one of those very first cases.
    Ms. Clarke. Well, if you look at the timeline, it would 
seem to me that there would have been a number of steps that we 
would have taken as a Nation, given our proximity to Mexico, to 
try to mitigate as much as possible any outbreak here in the 
United States. Perhaps it could have been happening 
simultaneously. I really don't know. I don't know what sense 
you have. I guess that is sort of what I am trying to get at, 
is what sense do you have of the occurrence that took place 
basically right next door, how quickly it would spread in the 
United States? Do you think that we acted fast enough, given 
what we knew?
    Dr. Lurie. Well my sense is--and I wasn't in the Department 
at the time, but my sense from following this very closely was 
that we acted on it really as soon as we knew it. As soon as we 
knew there was a new virus, we were very vigilant. We 
recognized first cases in the United States early in Texas and 
in California and with the tragic death of the Texas child. At 
that time, it was fairly clear that the virus was already 
likely to be widespread, and that turned out to be the case. 
You will recall that within a few days many more cases were 
noticed. So by that time it was also felt to have sort of 
crossed the border, as it were, and that border closures and 
other sorts of things would not really have been appropriate 
under the circumstances.
    We did look very carefully at the mitigation measures being 
imposed by Mexico. We did enhance surveillance very rapidly. As 
you know, we learned a lot about the virus as it moved around 
the country and particularly then when it hit pretty hard and 
forcefully in New York City.
    Ms. Clarke. Let me ask you, Dr. Lurie. As you know from the 
CDC FluView presentation of influenza data, epidemiologists are 
providing reports of how widespread H1N1 is in the States and 
the territories. Although we have reported cases of H1N1, the 
map shows no report coming from the U.S. Virgin Islands. We 
understand that this is because the U.S. Virgin Islands did not 
have an epidemiologist in the territory that can provide the 
necessary sentinel reporting. Is that true?
    Dr. Lurie. I would have to confirm that fact about the U.S. 
Virgin Islands.
    But one of the things that I think has really challenged 
everybody in this pandemic has been the status of State and 
local public health. You know, there has been serious 
underinvestment there for many years. Throughout this pandemic 
we are in touch with State, local, Tribal, and territorial 
health departments that are laying off people as we are trying 
to cope with this epidemic; and so it wouldn't surprise me in 
the least to hear that there wasn't an epidemiologist there.
    Ms. Clarke. I am sure that you will agree that sending 
Federal personnel to States and territories to do the jobs that 
should be done at their level by their own employees is 
probably not a long-term strategy. What do you think should be 
done to remedy this problem? This is not the first time that a 
lack of expertise in the U.S. territories has presented a 
problem for public health reporting.
    Dr. Lurie. That is absolutely right; and I think one of the 
very important lessons that we are reminded of throughout this 
pandemic is that a chain is as strong as its weakest link, that 
we really need to have very strong public health on the ground 
in States, territories, communities to do the surveillance, to 
do the epidemiology, to do disease control, and to respond. I 
think part of the problem is that public health has become kind 
of invisible over the last several decades.
    Ms. Clarke. Dr. Lurie, I am going to have one of my other 
colleagues follow up on that question. My time has expired.
    I now want to recognize the Ranking Member of the 
subcommittee, the gentleman from California, Mr. Lungren, for 
his questions.
    Mr. Lungren. Thank you very much, Madame Chairwoman.
    Being Ranking Member gives you a lot of things to do, and 
one of them I didn't realize I was going to have, but my 
friend, Mr. Broun, turned over to me when Mr. Serino was 
testifying and he said, what language is he talking?
    Ms. Clarke. Boston, similar to Brooklyn.
    Mr. Lungren. But I have got a guy from Georgia asking me to 
interpret a guy from Boston. Thank God I am from California 
where we have no accents whatsoever.
    Dr. Lurie, as I said in my opening statement, maybe there 
is something I don't fully understand. But aren't we using 50-
year-old technology with respect to producing viruses by way 
of--flu virus in chicken eggs? I remember visiting the CDC 
several years ago, and there was an indication there that they 
thought we were developing a new technology that showed promise 
that would allow us to produce vaccines in the future on a much 
shorter time schedule. What is the state of that? What do we 
need to do? Where are we?
    Dr. Lurie. You are absolutely right. In fact, we are in 
year 3 of a 5-year strategic plan to support the development 
and large-scale manufacturing of vaccines using some of these 
newer technologies like cell-based technology and recombinant 
technologies; and, at the same time, we are continuing to 
invest in even more advanced technologies that hopefully can 
bring vaccines to market much sooner than that.
    Mr. Lungren. But where are we on the course? I know we are 
3 years through 5 years, but that just tells me we have still 
got a program going. What is the promise? What do we think we 
are going to see when?
    Dr. Lurie. We do have a program going. You are absolutely 
right. In November, I think the first U.S.-based cell-based 
facility will, in fact, open in North Carolina. Unfortunately, 
it wasn't open in time to make vaccine there for this pandemic. 
But that is part of the strategy, is both to move toward some 
mix of egg-based technologies and newer technologies, as well 
as to have manufacturing capacity in the United States that is 
robust.
    Mr. Lungren. Let me ask you about that last part, and this 
goes to the question that the scheduled H1N1 vaccine production 
has slipped to 25 percent below the initial Government 
projections, as I understand it.
    On Friday, October 23, only the 14.1 million doses were 
available to the States. By the end of October, it is estimated 
that 28 million doses will be ready. But that is falling short 
of the predicted 40 million. Why were we overly optimistic 
about how much we would produce? I understood at one time we 
had certain manufacturers producing the vaccine for regular 
type of flu that had to move to the other. Is that part of the 
problem, or is it something else?
    Dr. Lurie. Well, I think it has been a series of 
challenges. We have been working in very close collaboration 
with the manufacturers throughout this, and we rely on their 
estimates and what they are able to do to make projections of 
how much vaccine are available. There have been a couple 
problems. One has been the amount of vaccine that they have 
been able to--or virus that they have been able to grow quickly 
in the eggs. As I think you know, all of the manufacturers 
really experienced fairly low yield in the beginning, which set 
back these projections.
    At the same time, some of the manufacturers, as they got 
further on into the manufacturing process, were standing up new 
filling and finishing lines to put the vaccine from a big vat 
into syringes or vials to ship out. Some of those had problems 
in the beginning. They didn't get them up and running as 
quickly as they thought, even with conservative estimates.
    I think the good news now is I think we are through those 
problems and we are back on track, but no doubt vaccine has 
been late.
    Mr. Lungren. Are those problems unique to this 
circumstance? Are those problems that we would anticipate we 
would have in the future if we had to respond in the same way 
using egg-based as opposed to new technologies?
    Dr. Lurie. Great questions.
    First, I should say these are problems that we encounter 
every single flu season. In fact, even growing the seasonal 
vaccine for this year's flu season one of those three strains 
was slow to grow and is late, and so the manufacturers were 
manufacturing seasonal late into the flu season. We hope that 
with cell-based and with recombinant technologies the idea is 
to get there faster with more vaccine.
    Mr. Lungren. Dr. Garza, this may be slightly outside your 
realm. But I saw a GAO report that had a different slant on the 
influenza pandemic, believe it or not. It said that concerns 
exist that a more severe pandemic outbreak than this year's 
could cause large numbers of people staying at home to increase 
their internet use and overwhelm the internet providers' 
capacity. The reason I mention that is that could go 
specifically to our critical infrastructure in any number of 
areas, and one of the responsibilities of DHS is to ensure that 
critical telecommunications infrastructure is protected. So any 
conversation you have with your operation with the critical 
infrastructure protection operation of DHS on this question, 
and is there any insight into what we do in that kind of a 
situation?
    Dr. Garza. Well, absolutely. That is a serious concern, 
with absorbing the bandwidth, people who were staying home.
    As you know, before the H1N1 pandemic came along, we were 
planning for a much more serious pandemic in prior years. One 
of the elements of planning for that pandemic was, of course, 
anticipating the second and third order effects. One of those 
was if we have a large amount of absenteeism, if we have a 
large amount of people staying at home, that they will absorb a 
majority of the bandwidth and thus make it difficult for the 
economy to move as well as security. So there has been a lot of 
effort within DHS at infrastructure protection. We, of course, 
lended our subject medical expertise to those discussions, and 
I believe they are actively working on a draft report right 
now. But it is a little bit outside my expertise.
    Mr. Lungren. That might be the subject of another hearing. 
Because those second- and third-level effects could be as 
devastating to our overall economy as the immediate effect.
    Ms. Clarke. Thank you very much, Mr. Lungren. We will 
certainly follow up and look into that.
    But, at this time, I would like to recognize the Chairman 
of the full committee, the gentleman from Mississippi, Mr. 
Thompson.
    Mr. Thompson. Thank you very much, Madame Chairwoman. I 
appreciate this hearing which, obviously, is perhaps on the 
hearts and minds of a lot of people, the subject matter we are 
talking about.
    One of the issues that continue to confront us is, even 
though we knew certain things around this H1N1 was happening, 
whether or not as a Government we were prepared. That is still 
the subject of a lot of discussion. Mr. Serino, let me give you 
a good example of what I am talking about; and since this is 
your maiden voyage to the committee, I will kind of give you 
some future expectations.
    FEMA has a policy that has been in place since 2007 with 
respect to disaster assistance and communities being reimbursed 
with respect to human influenza pandemic. It is my 
understanding that we have not updated this policy since 2007. 
Am I correct?
    Mr. Serino. Well, from what I understand is this fact 
sheet, that was distributed to all the States, essentially will 
be the policy. Everything that is in the new policy is in the 
fact sheet, and we wanted to get this out to the States and to 
all the regions so they are familiar with all the--that this 
was--I believe this was brought up to you earlier today and was 
shared again with all the States and the Governors and the 
emergency managers throughout the country who, if they needed--
--
    Mr. Thompson. Good point. How old is that fact sheet?
    Mr. Serino. I believe this fact sheet is just within the 
last week.
    Mr. Thompson. So you understand what I am saying.
    Mr. Serino. I understand very much what you are saying.
    Mr. Thompson. We have a policy from March 2007 that just 
got updated recently with respect to this. So that is an issue, 
and one of the concerns that we have is: How much planning are 
we really putting into what we do in the event of another 
situation like this? If you came from Boston, you can imagine 
how you felt on the other end waiting for word from Washington 
that was 2007 didn't really reflect what you were addressing.
    My concern and a concern of this committee is that, as we 
go forward, we would like your agency to take particular note 
of situations like this because of the pivotal role that you 
play, hospitals, public health entities, a lot of those 
entities, in the event that something really bad happens, the 
first line of defense in so much of what we do. But on the back 
side, we have to reimburse those agencies. I think what you 
need to look at is whether or not the reimbursement to those 
State and localities is current. I can tell you that most of it 
is geared towards hospitals and not toward other things, and 
that is probably something from a policy standpoint that you 
need to look at because we now know there are more players in 
this scenario than just hospitals.
    Ms. Forman, counterfeit drugs, we have heard the story of 
Tamiflu being ordered and God knows what comes back. What can 
we assure the public in that these counterfeit drugs somehow we 
are doing our best to prevent that from getting into our 
system?
    Ms. Forman. Mr. Chairman, what we can represent to you is 
that ICE and their law enforcement partners, to include the 
Food and Drug Administration, Customs Border Protection, the 
FBI, the Postal Service, and Department of Justice in 
conjunction with the private sectors, the manufacturers of 
these true and legitimate pharmaceuticals are working very 
proactively to target internet sites, to conduct operations 
within our mail and courier facilities, and to work with our 
foreign partners to identify the illegitimate manufacturers of 
these goods so they do not enter the commerce of the United 
States.
    Mr. Thompson. So to what degree have you been able to 
measure success in stemming the flow of these counterfeit 
drugs?
    Ms. Forman. We believe as a U.S. Government we have made 
impact and inroads within identifying the manufacturers of many 
of these pharmaceutical goods, the counterfeit pharmaceutical 
goods, but there is much work to be done.
    Mr. Thompson. So what other kind of work do you suggest 
that we do?
    Ms. Forman. As counterfeit pharmaceuticals and counterfeit 
goods in general is a global problem, we must work with our 
foreign counterparts, especially in those countries that are 
manufacturing a majority of these goods, to work together to 
identify the manufacturers, to disrupt, dismantle, and 
prosecute the violators, both foreign and domestic, on those 
individuals who are penetrating all our borders.
    Mr. Thompson. So are we doing that?
    Ms. Forman. Yes, we are doing that.
    Mr. Thompson. Just for the sake of this committee's 
information, give me the two top violators of this country.
    Ms. Forman. Probably the two top violators on counterfeit 
pharmaceuticals are, No. 1, China and, No. 2, primarily India 
and countries in Southeast Asia.
    Mr. Thompson. We are entering a dialogue with those 
countries to try to prevent it?
    Ms. Forman. Yes, we are entering in dialogue; and we are 
working joint operations with both these countries and other 
countries worldwide to identify, disrupt, and take down the 
violators.
    Mr. Thompson. Thank you.
    Ms. Clarke. Thank you, Mr. Chairman.
    The Chairwoman will now recognize other Members for 
questions they may wish to ask the witnesses. In accordance 
with our committee's rules, I will recognize Members who were 
present at the start of the hearing based on seniority on the 
committee, alternating between the Majority and the Minority. 
Those Members coming in later will be recognized in order of 
their arrival.
    Having said that, I now recognize the gentleman from 
Georgia, Mr. Broun, for his questions at this time.
    Mr. Broun. Thank you, Madame Chairwoman.
    I am pleased the committee is meeting to review and assess 
the status of H1N1 readiness and prepare for and respond to the 
pandemic flu. If you all need somebody to interpret, Mr. 
Lungren has said that he would be glad to. Down in Georgia, I 
don't have an accent, you all do, and so anyway--but I thank 
you all for being here.
    The DHS national preparedness guidelines and the companion 
target capabilities list both identify ``mass prophylactics 
capabilities'' as one of the core capabilities that 
communities, the private sector, and all levels of Government 
should collectively possess in order to respond effectively to 
a disaster. At the Federal level, the United States has 
purchased its allotment of antivirals called for by the 
National Strategy on Pandemic Influenza. I am told that some 
States have purchased all of their allocations and still have 
some of that on hand. Several States have purchased far less 
than would be needed to protect 25 percent of the population, 
which is the benchmark that was set by NSPI. I am also told 
that some States have used antivirals from their State 
stockpiles and have not replenished those supplies.
    The target capabilities list suggest that States take 
several actions to protect the health of the U.S. population by 
developing procedures for the distribution and dispensing of 
mass prophylactics and developing processes to ensure that 
first responders, public health responders, critical 
infrastructure personnel, and their families receive 
prophylactics.
    For the panel, do you know how many States have established 
these procedures; and, No. 2, what do you see as the roles of 
DHS and HHS in encouraging incorporation of these procedures 
for a public health emergency?
    We will start on this end and go down.
    Dr. Garza. Sure. Thank you, sir.
    As far as the stockpile of antivirals go, that is mostly 
regulated by the SNS stockpile at the CDC.
    I would hope that a lot of the State and local public 
health officials would be following the guidance that is set 
forth by the CDC on when to use antivirals. As we all know, not 
every situation is the same. Had this pandemic turned out to be 
a much more virulent or different strain of virus, then I am 
sure that the CDC and other folks would have taken that into 
consideration on recommendation on when to use the antivirals.
    I am afraid I cannot speak to the different plans that the 
States have for replenishing their stockpiles, but I would hope 
that we would all be prudent in following the best advice that 
the science can give us.
    Dr. Lurie. Sure. Thank you for that question.
    I think both vaccines and antivirals are certainly kind of 
targets for talking about the distribution system; and I think 
throughout this pandemic the decision was made to get 
antivirals out--I am sorry--vaccines out as well as antivirals 
out largely in the way that people access them normally through 
usual flu season, which is through their private providers, 
through the health care system, through community clinics, and 
then to be sure that, in addition, we had places stood up by 
public health departments that people could go both to get 
vaccines and antivirals. That is turning out to be the case 
with the vaccine distribution system.
    With regard to antivirals, you are correct that not all 
States originally stockpiled enough antivirals for 25 percent 
of their populations. But it is also the case right now that 
the priority is to keep people from getting sick and dying. So 
the Strategic National Stockpile initially distributed 25 
percent of the allocations to the States in a pro rata 
allocation, and it is responding to State requests as they come 
in. The goal is to be sure that no child dies or nobody dies 
because antivirals were not released from the stockpile and 
made available to people who need them.
    Mr. Broun. Thank you, Dr. Lurie.
    My time is about expired. I have more questions that I will 
submit, but thank you, Chairwoman Clarke, for the time. I yield 
back.
    Ms. Clarke. I now recognize the gentlelady from Texas, Ms. 
Sheila Jackson Lee, for her questions.
    Ms. Jackson Lee. Madame Chairwoman, let me thank you very 
much for your kindness and that of the Ranking Member and the 
full committee Chairman and my colleagues as well.
    I know that the Obama administration, the administration is 
committed; and I want to thank the witnesses that are here and 
try to see if we can all get on the same page and be part of 
the same team.
    I want to follow the line of questioning that my colleague, 
Chairman Thompson, did on the data and the resources or the 
materials and facts that we have. I am reading from a FEMA 
disaster assistance policy dated March 31, 2007, so I would 
commend the Assistant Administrator to have as one of his first 
tasks, his staff--and I know that you--is the updating of this 
document. But let me just read these numbers:
    It has been estimated that in the United States a Medium 
Level pandemic could cause 89,000 to 207,000 deaths, 314,000 to 
734,000 hospitalizations, 18 to 42 million outpatient visits, 
and another 20 to 47 million people being rendered sick. The 
economic impact could range between $71.3 billion and $166.5 
billion in damage. But this document was written in 2007.
    Another document that I would like to show indicates--and 
this may be a little earlier. It looks as if it has the picture 
which shows that H1N1 or influenza is widespread, which I 
assume led to the President's announcement. So I have the 
following concerns:
    Yesterday, we had a congressional briefing in Texas, in 
Houston, and it was entitled H1N1. Texas may be the epicenter 
of the H1N1 virus pandemic, a very large State, a State a year 
or so ago that had some of the early deaths along with New 
York, my colleague's State. But to refer you to a direct 
question, we had an example of a 33-year-old languishing in his 
apartment for a week and may have gotten Tamiflu but wound up 
dying after being admitted to the hospital, which reflects on 
the lack of health care insurance but still it reflects on I 
think the lack of information.
    So I raise these points, and I will ask two questions.
    There is some representation by the persons who 
participated with us yesterday that they need FDA to expedite 
approval of the PER tests. In our State alone, we do not have 
enough vaccines; and the question was being asked, when will 
they get them? So I invite the Assistant Administrator--I would 
like him to dispatch to Texas as one of the States that you are 
visiting because of its size.
    Pediatricians--private pediatricians, who were also part of 
this briefing, said they have a spray, but they do not have a 
vaccine. In the news wire services there is an indication that 
one out of five children in America will be impacted by 
influenza. I assume that would include H1N1. Our hospitals are 
seeing very, very sick children; and there is a CDC DHS rule 
that nurses cannot come back before 7 days. So let me pose 
these questions:
    Can I have an answer about what you are doing to actually 
hit home about the seriousness of knowing when to get to the 
emergency room? Because I think people are dying right now, and 
I think that we have not coordinated sufficiently so that 
people can stop dying. I would like to know what you are doing 
to coordinate.
    I would like an answer to the FDA expedite of the PER test 
as I understand it and the question of the return of health 
professionals now required to be 7 days. My doctors and 
hospitals say that they will be completely empty of physicians 
if they do that.
    I will start with Dr. Lurie, and I only have 57 seconds, 
and then I will go to the Assistant FEMA Administrator. Thank 
you.
    Dr. Lurie. Sure. I think you raised some very important 
points.
    First, let me assure you now that Texas has allocated to it 
not only the nasal mist vaccine but also injectable vaccine, 
and injectable vaccine is on the way.
    With regard to the messaging about this, I think your point 
is extremely important. We have been really using all channels 
to see if we can get the message out that people, particularly 
who are in high-risk groups and who are sick, need to get 
treated early with antivirals. That information is on flu.gov. 
It is in Flu Essentials. All of the State and local health 
departments are messaging to this. We have been working to 
outreach to the clinical communities.
    In addition, there are several assessment guidelines 
available on flu.gov and other websites to help people 
understand that they need to get antivirals early if they are 
in high-risk groups and what the warning signs are so that we 
don't have the kinds of tragedies like the ones you mentioned. 
Some of that material is actually in the Flu Essentials that I 
provided here.
    With regard to the PER test, I think I will have to get 
back to you about this. But, in general, the guidance is that 
people should not wait to be tested if they are in a high-risk 
group. If they are pregnant, if they have underlying chronic 
conditions, they need to get antivirals and to get them early.
    Ms. Jackson Lee. Did the administrator finish the questions 
I posed to you? I think the outreach--you are the 9/11 man, if 
you will. What are you doing to be 9/11? Because people are 
dying.
    Mr. Serino. There are a number of things that FEMA has 
done, but I also think it is important to realize that the case 
you mentioned is really for people--I think you hit the nail on 
the head. It is about the messaging; and it is also about--it 
is part of the team, that FEMA is a member of the team and 
public health is a member of the team, but the citizens are a 
critical part of the team. One of the key messages I think is 
for people to check on their neighbors as well. When people--
when somebody is home especially by themselves, especially the 
elderly or somebody has young children in a single-parent 
family, is to make sure that they check on other people as 
well.
    In addition to that, some of the things that FEMA has been 
doing is FEMA is able--has worked a number of plans to help 
throughout the continuity of Government here with all the 
Federal agencies but also the ability that if needed, and the 
Government were to request, FEMA is there to add a number of 
things that are consistent with what I mentioned earlier as 
well.
    Ms. Jackson Lee. Thank you, Madame Chairwoman.
    Ms. Clarke. I now recognize Mr. Lujan of New Mexico for his 
questions at this time.
    Mr. Lujan. Madame Chairwoman, thank you very much and thank 
you very much for this hearing to you and to our Ranking 
Member.
    I heard early on, Dr. Lurie, that we have enough vaccine, 
that we purchased enough vaccine for what we need right now, 
that anyone that wants it can get it.
    I just want take share a couple of things about New Mexico. 
The most recent release from New Mexico from our Secretary of 
the Department of Health, H1N1 influenza is the predominant 
strain of flu in New Mexico at this time. Visits to health care 
providers for influenza-like illness increased to approximately 
20 percent this week up from approximately 16 percent last 
week. This is compared to the peak of last year's flu season of 
3 percent of all visits to providers. We have had 16 deaths, 
468 hospitalizations related to novel H1N1 influenza. When 
asked what more we need in New Mexico, he said we can always 
use more vaccine.
    So with that being said, in response to that, Dr. Lurie, is 
it fair to share with my Secretary and the State of New Mexico 
and the Department of Health that if more is needed more is 
available for him to bring in?
    Dr. Lurie. So what we anticipate is the vaccine will be 
available for everybody who needs it. It is not now. As I think 
everyone is aware there have been delays in getting vaccines 
from the manufacturers out to States. But now there is a pretty 
steady pipeline of vaccine coming out. Each State gets a share 
of vaccine based on its population, and New Mexico has been 
getting doses allocated to it, has ordered doses and is able to 
vaccinate, and we will keep making vaccine available for as 
long as people want it.
    In the mean time, until vaccine is available, there is a 
lot people can do. As we were reminded still, the public health 
messages, wash your hands, cover your cough, stay home if you 
are sick, terribly important. In addition, the comment I had 
made to Ms. Jackson Lee about antivirals and getting treated 
early still stands.
    Mr. Lujan. Thank you very much, Dr. Lurie.
    Dr. Garza, can you tell me what is being done specifically 
to reach out to tribal leaders across the country? My district 
in New Mexico, we are home, I believe, to more nations, Tribal 
nations than any other district in the country, second in 
population across the United States. What can be said to me to 
assure me that our tribal leaders are being reached out to?
    Dr. Garza. Yes, I am very familiar with the Indian Tribal 
country in New Mexico, having traveled from Albuquerque to 
Santa Fe almost every day to work at the health department in 
New Mexico. So, a very fast highway, lots of open land, and 
certainly a lot of Indian Tribes.
    So what we have done is our intergovernmental partners have 
been reaching out to our State, territorial, as well as our 
Indian health people throughout Government, as well as down to 
the local level; and they do this by doing weekly phone calls 
to these leaders. I know that they have also been working with 
Health and Human Services, specifically with Indian Health 
Services, to get that message out. I believe they were--if I 
remember correctly, they were planning to go to the conferences 
that the major Indian Tribes have every year in order to 
reinforce that message.
    So, in addition to our State and locals, we are making a 
concerted effort to reach out to the territories and Tribal 
leaders.
    Mr. Lujan. Thank you very much.
    Looking, Dr. Lurie, back to you, in reading some of the 
information that was provided to us by staff as well there 
appears to be a concern with our ability to be able to get the 
data that is being put together to be able to harness that data 
from a biosurveillance perspective and being able to bring that 
together to share the latest information so we can stay on top 
of that. Can you talk about what is being done with the 
coordination from Health and Human Services and how maybe we 
can improve that?
    Dr. Lurie. Sure. I think that is a very accurate 
perception.
    As you know, surveillance really depends both on systems 
set up by the CDC but the surveillance systems that are 
available in States and in local governments. It is fair to say 
that at the outset of this pandemic, and, frankly, throughout 
it, there are often times that we would like to have 
information in real time and we don't, whether it is 
information about how the disease is progressing or how our 
health care system is doing.
    We have very rapidly expanded a lot of on-the-ground 
surveillance through influenza-like illness reporters on the 
ground. We have collaborated with the private-sector health 
care system so that we have now close to real-time surveillance 
from many emergency rooms throughout the country.
    In addition, on the health care system side, we have begun 
having weekly reports from a system from my office called 
HAvBED in which hospitals report on a weekly basis their bed 
availability, how crowded their ICUs are, whether they have 
ventilators available.
    That said, there is a lot more to do. As I said in my oral 
testimony, I think this has really shown us, No. 1, that 
harnessing the power of IT and working with a number of 
private-sector partners we can get a lot further than we have 
been. But, at the same time, it is not going to replace human 
beings on the ground, the clinician calling with something 
funny or needing to track down an outbreak.
    Mr. Lujan. Thank you very much.
    Madame Chairwoman, if I may ask a quick yes-or-no question 
to Ms. Forman along the lines of the questioning from Chairman 
Thompson. Have we found that there are counterfeit H1N1 vaccine 
out there right now?
    Ms. Forman. No, we have not, but we continue to search.
    Mr. Lujan. Thank you.
    Thank you, Madame Chairwoman.
    Ms. Clarke. I now recognize the gentlelady from California, 
Ms. Richardson, for her questions at this time.
    Ms. Richardson. Thank you, Madame Chairwoman.
    Dr. Lurie, are you familiar with the case of the nurse who 
died in Sacramento who they believe contracted H1N1 from her 
work environment?
    Dr. Lurie. I am not familiar with the details.
    Ms. Richardson. Well, ma'am, I think it would be important 
to do so.
    If you read my local paper, which is the Press Telegram, 
the nurse was in Sacramento, I believe Mercy hospital. We can 
supply you the information. She was 51 years old, and her name 
was Karen Anne Hayes. It is believed that she contracted H1N1 
in her work occupation and died several days later.
    Are you aware that in California the nurses are planning on 
striking on Friday due to this, of not everyone having masks 
and so on?
    Dr. Lurie. I am aware of that. That is a really tragic 
situation, yes.
    Ms. Richardson. So what are you doing about it?
    Dr. Lurie. First and most important thing we are doing is 
encouraging health care workers to get vaccinated. As you know, 
they are in one of those very highest priority groups to get 
vaccinated. Unfortunately, every year only about 40 percent of 
health care workers make a choice to get seasonal flu vaccine; 
and we are hoping that nurses and other health care workers 
will decide to get vaccinated now.
    As you know, there is also a shortage of N-95 masks. The 
CDC has put out guidance for how to use those N-95 masks most 
judiciously, how to set up a hospital or health care 
environment with other kinds of controls to minimize the risk 
of infection, and in addition is releasing more N-95 masks from 
the stockpile.
    Ms. Richardson. When do you anticipate having all the 
health care workers have the ability to have an N-95 mask?
    Dr. Lurie. I can't tell you exactly. But what I can tell 
you is that there is a National, in fact, a worldwide shortage 
of N-95 masks and so----
    Ms. Richardson. So--I apologize, ma'am, but I only have 3 
minutes left. So if you don't know when, how are you going to 
figure it out? Are we going to get something else in lieu of 
it? What steps do you plan on taking to ensure that our health 
care workers are in a healthy environment? Because if we have 
an epidemic and more people begin to contract this, if we 
expect people to be cared for, we have to ensure that those 
health care workers are cared for as well so they can care for 
us.
    Dr. Lurie. You are absolutely right. First of all, that is 
why vaccination is so important, because vaccination is the 
best protection. Similarly, treatment of antivirals for people 
who get sick and are in a high-risk group is important. 
Thirdly, as I said, the CDC has put out a fair amount of 
guidance now about the health care environment, how to work on 
the ventilation----
    Ms. Richardson. Ma'am, my question was, when are we going 
to ensure that the health care workers have N-95 masks? If we 
don't have those, when are they going to get some other masks? 
That is my question. I heard you twice now on the other points.
    Dr. Lurie. N-95 masks are being shipped from the Strategic 
National Stockpile to States this week. I am not sure when they 
are slated to arrive in California. People who are priority 
users of N-95 masks certainly include health care workers and 
particularly those health care workers at the highest risk of 
exposure.
    Ms. Richardson. So can you provide to this committee a 
rollout plan of how you expect the N-95 mask to be delivered 
throughout this country? For those that are not going to 
receive it, what is the plan? Beyond vaccination, beyond all 
that, do you have another mask that you recommending? Is 
someone else making the mask? What are you going to do, besides 
the vaccinations? We get that. But my question is specifically 
regarding the mask.
    Dr. Lurie. We would be happy to provide you information 
about the National supply, what is in the stockpile, and what 
has been shipped.
    Ms. Richardson. What is the alternative?
    Dr. Lurie. What is the alternative? Absolutely.
    Ms. Richardson. Okay. Ma'am, my other question has to do 
with when you talk about if I am in a community where people 
are potentially striking. We also had a situation. I sit on the 
Transportation Committee, and TSA was not properly advised of 
when they could begin to wear the mask, and that was the whole 
discussion. What have you put in place to assist them as well?
    Dr. Lurie. Let me go back and say, first of all, with 
regard to the health care workers, we believe that for most 
health care workers that surgical masks provide quite good 
protection as well. So there are surgical masks also available 
in hospitals and surgical masks likely to be shipped from the 
stockpile.
    At the current time, TSA and other workers are not in the 
highest priority groups to receive the limited supply of masks 
that we have. There are some people with very high-risk 
exposure who indeed need them. I would refer this question to 
Dr. Garza, who I know has spent a lot of time working on 
keeping the DHS workforce healthy in this situation in terms of 
their purchases of N-95s and their recommendations for their 
workers.
    Dr. Garza. Yes, ma'am. We have issued guidance to all of 
our workforce employees about when it is appropriate to wear a 
mask. We are following along the CDC OSHA guidelines with the 
high, medium, and low risk.
    In addition to that, we have stockpiled N-95 respirators as 
well as surgical masks for our different components; and so we 
feel at this moment--and, of course, this is a very fluid 
situation--and so at this moment, though, we feel like we have 
adequate supplies to meet our components' needs.
    Ms. Richardson. So when is the TSA person allowed to put on 
a mask?
    Dr. Garza. A TSA person is allowed to put on a mask--we 
recommend if, following along CDC OSHA guidelines, if they are 
in close proximity to someone with a known influenza-like 
illness, then we recommend the N-95 mask. If they are in close 
proximity to the public where they are going to be interacting 
a lot and they feel justified to wear a mask being that they 
are in close proximity, they are certainly welcome to use that 
and address it with their supervisor.
    Ms. Richardson. I will ask further questions. My time has 
expired.
    Ms. Clarke. My colleagues, I know that we all have 
additional questions to ask. It is being said that we are going 
to be having votes probably within the next 15 minutes. So what 
we will do is just quickly, if there is a burning question for 
you, have you do your questions as quickly as you possibly can.
    Let me just take this time to ask a question to Dr. Lurie 
about the spreading and the vaccine production. It just seems 
like the H1N1 is spreading, but the vaccine production and the 
distribution is lagging behind. Epidemiologically speaking, 
what will the impact be on the epidemic curve here in the 
United States, you know, with this disparity?
    Let me just add to that that I just wanted to get a sense 
of--maybe, Dr. Garza, you would have this information. How is 
it determined what parts of the Nation received the vaccine at 
what point in time?
    I know that New York City, for instance, is just beginning 
its vaccination process for children; and it was one of the hot 
spots very early on. But then I land here in Washington, and 
the children have been receiving their vaccines for quite some 
time. So if you can just explain that, why that occurred, and 
also how what that curve is going to look like if we don't 
catch up with our production capabilities?
    Dr. Lurie. Sure. Well, we certainly are eager to get 
vaccine out as quickly as possible. The way this works is that 
every week, depending on how much vaccine has been made and is 
ready to be shipped to States, it is allocated to States on a 
pro rata basis according to their population size. Within the 
States, the State Health Department decides where, in fact, the 
vaccine needs to go first to get to priority groups; and then 
it is shipped to over 150,000 sites in the country according to 
those priorities.
    Because in the first couple of weeks only the nasal spray 
was available and the nasal spray can only be given to certain 
populations, State and local Health Departments made decisions 
about how to reach those priority populations, often health 
care workers or children or college students, by how they could 
reach the most people quickly. Now that injectable vaccine is 
available, it, too, is coming out on a pro rata share.
    Ms. Clarke. Have we found any counterfeits in this process, 
any counterfeit antivirals?
    Dr. Lurie. I would let my colleague, Ms. Forman, speak to 
the counterfeit antivirals.
    Ms. Forman. Today we have not found any pure counterfeit 
Tamiflu antivirals pertaining to the flu. What we have found is 
something referred to as the ``gray market'', which is 
legitimate Tamiflu that comes into the United States. However, 
it was made for a foreign market. It is, in itself, a 
legitimate product.
    Ms. Clarke. It is our understanding that the FDA did find 
some counterfeit antiviral. Are you aware of that?
    Ms. Forman. We have an FDA representative at the IPR 
Center, and my understanding is what they located was a product 
that was not counterfeit and did not represent itself to be 
Tamiflu. It represented itself to treat the flu, which is a 
fraudulent representation and not a violation per se of 
counterfeit law.
    Ms. Clarke. Thank you.
    Let me recognize the Ranking Member, Mr. Lungren, for his 
questions.
    Mr. Lungren. Thank you very much, Madame Chairwoman.
    My colleague from California mentioned this case that 
occurred actually in my district at the Mercy San Juan Medical 
Center in Carmichael where an otherwise healthy nurse--she was 
actually a triathlete--died within a few days of contracting 
the disease, which brings this question. To me, it sounds--and 
I don't want to misstate this for the record so, Dr. Lurie, if 
you could respond, it sounds to me as if you believe the best 
prophylactic is receiving the vaccine. So I would have two 
questions.
    One is, has there been much resistance in the health care 
industry about this? I know there was a command in one 
jurisdiction, and I believe it was the nurses association or 
health representatives fought that, so they countermanded that.
    Do we have sufficient vaccine for our health care workers 
so that if, in fact, they wished to receive it, we could say to 
them today, if you wish to have it, and we recommend strongly 
that you have it, and give at least an example of this one 
terrible case in my district, we have it readily available to 
you? Can we say that?
    Dr. Lurie. What we can say right now is that vaccine is 
coming out every day. Health care workers are among the highest 
priority groups for vaccine, and as soon as it arrives in their 
community the very best way to protect themselves is through 
getting vaccinated.
    I point out that health care workers generally have a 
pretty crummy track record of getting vaccinated, and so I 
would hope that they would do better.
    Mr. Lungren. We have the situation, as I understand it, 
where we have, as this lady was, otherwise healthy individuals 
who are contracting it in very serious ways with very serious 
episodes of the illness or death, which is very different than 
the model that we have had before; and that, in the past, the 
normal course is that, with flus, the highest percentage of 
people dying are those 65 and older, and now we find the 
highest percentage of those dying are 25 and under.
    I believe that is the case. Correct me if I am wrong.
    Dr. Lurie. Yes.
    Mr. Lungren. If that is the case, what does that mean for a 
different strategy, if it does, for how we respond to this with 
these various prophylactics that we have and with the 
antivirals?
    Dr. Lurie. It is a great question.
    One of the things that characterizes a pandemic and why we 
worry about pandemics such as this is because the population 
affected doesn't have immunity because it is a new virus or new 
strain that has shown up. That is exactly what makes a pandemic 
so dangerous and so scary. Almost every pandemic, it kills 
younger people disproportionately to older people.
    So you are quite right. Seasonal flu most often affects 
older people. This pandemic strain and other pandemic strains 
most often affect younger people.
    So that is why it is so important for us to be able to get 
to the point where we can manufacture vaccine quickly, to your 
comments before about the new technologies and get vaccine out 
quickly. In the meantime, the public health measures, you know, 
the hand washing and those things and the antivirals, are the 
most important things that we can do.
    Mr. Lungren. I know you have been doing this, but it seems 
to me the message needs to be repeated. This is different from 
what we usually expect so that the average person may 
understand, hey, maybe it is more important for my child to get 
vaccinated than before, and the average healthy health care 
worker will understand it is more important that they get 
vaccinated than before, as opposed to them saying, well, we see 
this every year. The flu comes along, and the older people die, 
and I am healthy, and it doesn't bother me.
    I know you have said it, but I guess we need to help you 
repeat it as well.
    Dr. Lurie. The more of us that can repeat it together--I 
very much appreciate the help. It is a terribly important 
message. It is very important for young people, for health care 
workers to get vaccinated. It is often hard to talk them into 
it. I am a physician. I still see patients. It is hard for me 
to talk my patients into it. It is hard for me to talk the 
residents that I practice with into it; and yet, at the same 
time, many people are getting vaccinated, taking steps to 
protect themselves.
    Mr. Lungren. Young mothers and pregnant women particularly.
    Dr. Lurie. Young mothers and pregnant women, parents of 
children.
    I also want to just say, health care workers have a very 
special obligation not only to protect themselves but to 
protect their patients from getting infected when they get 
sick; and that is a really, really important reason to get 
vaccinated.
    Ms. Clarke. Let me just--a point of clarification. Ms. 
Forman, we have recent information from the FDA that warns 
consumers to use extreme care when purchasing any products over 
the internet that claim to diagnose, prevent, treat, or cure 
the H1N1 influenza virus. It came because the FDA recently 
purchased and analyzed several products represented on-line as 
Tamiflu which may pose risks to patients. Were you aware of 
what the FDA found out?
    Ms. Forman. Yes, I am, ma'am.
    Ms. Clarke. What is your take on it? What would you say to 
the American people, given what we know about counterfeit 
pharmaceuticals?
    Ms. Forman. I would advise the American public to apply due 
diligence, especially when making purchases over the internet. 
As we know, the internet has been our friend since inception, 
but it has also been an enemy. Because you don't see the 
opposite side of those who are selling these products. These 
individuals--the American citizens need to be aware that there 
are fraudsters out there who are trying to sell them a product 
to make a dollar, and it is all about the money for these 
individuals and not the health and welfare of our citizens.
    Ms. Clarke. Thank you, Ms. Forman.
    I now acknowledge the gentlelady from California for her 
question at this time.
    Ms. Richardson. Dr. Garza, I want to come back to the TSA 
questions that I was asking you. As I understood you quoting 
the rules, if a person knows that a person is infected, then, 
obviously, they can wear the mask. But the TSA worker, nine 
times out of ten, is not going to know if a person is infected. 
You said if they feel that they need to, then they are allowed 
to.
    If I am not mistaken, back when this whole thing started, 
some TSA workers asked to wear masks and were discouraged by 
their supervisors saying, oh, if you wear a mask you will make 
other people feel afraid and they won't want to travel and so 
on.
    So what have you done to address that issue of the workers 
feeling comfortable that if today they want to put on a mask 
that their superior or no one else is going to say or put them 
through the wringer because they feel uncomfortable and want to 
be protected?
    Dr. Garza. Yes, ma'am. You are absolutely right.
    During the initial phases of the pandemic, when there 
wasn't a lot of information out there, there were some issues 
with allowing workers to wear masks. Since then, we have 
updated our guidance to allow them to wear the mask if they 
feel like they need to.
    I would point out, though, that most of our TSA workers are 
in a low-to-medium-risk category. When I say high-risk, being 
around somebody who is infected, I realize that you can be 
around somebody who is infected without the visible signs, but, 
typically, those are safe for health care workers, EMS workers, 
and those sorts of populations. But the fact still remains that 
the guidance that has been issued to DHS would allow a TSA 
worker to wear a surgical mask if they felt like they need to.
    Ms. Richardson. So if I were to walk up to my local airport 
and say can I see the masks that you have available for 
workers, there would be sufficient masks for folks to use and 
that the workers have been communicated to that they can use 
them?
    Dr. Garza. I can tell you that we have issued the guidance, 
that we have sent it out Department-wide, and it is up on the 
internet. As far as individual airports and their procedures 
and where the masks are, issues like that, I can't speak to 
that. But we have provided both the information and the 
material to our component services.
    Ms. Richardson. Would you follow up with those airports and 
I will follow up to this committee?
    Dr. Garza. Absolutely.
    Ms. Richardson. Three very quick questions.
    Dr. Garza, have you agreed to provide to this committee an 
update and clarify the FEMA Disaster Assistance Policy 9523.17 
Emergency Assistance for Human Influenza Pandemic and 
communicate the updated policy to this subcommittee within 30 
days?
    Dr. Garza. Yes, ma'am.
    Ms. Richardson. Dr. Lurie, have you agreed to provide to 
this committee a LLIS-health or use of the capacity in LLIS to 
gather and display H1N1 lessons learned within 30 days?
    Dr. Lurie. Yes.
    Ms. Richardson. Finally, Ms. Forman, have you agreed to 
provide to this committee within 30 days a report regarding the 
IPR Center programs to investigate H1N1 related to counterfeit 
pharmaceuticals and equipment and monthly thereafter until the 
pandemic is over?
    Ms. Forman. Yes.
    Ms. Richardson. Thank you very much. I yield back.
    Ms. Clarke. Well, I want to thank all of our witnesses.
    I think that Congresswoman Richardson has raised in her 
final line of questioning of the documents that we would like 
to make sure that we are receiving from you, just that lays out 
some of the concerns that this committee has about where we are 
in the state of the build-out of your capacities.
    I think you made it pretty clear, Dr. Lurie, that there are 
some areas that you feel need to be much more robust and you 
kind of found flatfooted.
    Certainly the Ranking Member has talked about the new 
technologies that we would like to see put forth in terms of 
production of vaccine. As he has quite rightly said, this is 
the 21st century. I would like to say we are in the new 
millennium. The egg-based vaccine production has to be 
outmoded, and I know that there are technologies already 
available that should make it possible for us to create vaccine 
without that sort of antiquated process.
    So, having said that, I want to thank you all for being 
here and for sharing with us your insights into what is taking 
place. This is real-time assessment of what is happening with 
this pandemic influenza. Our concern is that we are ready, that 
we are ready for anything, whether it is H1N1 or anything else 
that may accompany it, any type of permutation of it or 
mutation of it or anything that may be detrimental to the 
preservation of life on our homeland. You are all on the 
frontline of that. So anything that this committee can do to be 
partners with you in reaching those goals we are certainly 
there to be helpful to you.
    To everyone, thank you very much for attending. My 
colleagues thank you very much.
    This hearing is adjourned.
    [Whereupon, at 3:45 p.m., the subcommittee was adjourned.]


                            A P P E N D I X

                              ----------                              

 Questions From Chairwoman Yvette D. Clarke for Alexander Garza, M.D., 
   Chief Medical Officer and Assistant Secretary for Health Affairs, 
                    Department of Homeland Security
    Question 1. In your testimony, you stated that the Office of Health 
Affairs ``spearheaded the acquisition of personal protective equipment 
and antiviral medications'' for the Department of Homeland Security. 
How did the Office of Health Affairs spearhead this?
    Answer. OHA has provided oversight and direction for the DHS Fiscal 
Year Pandemic Emergency Supplemental (Pub. L. 109-148) since it was 
appropriated in fiscal year 2006. Much of that appropriation was 
identified to provide for the protection of the DHS workforce. Personal 
protective equipment (PPE), including respirators, surgical masks, 
disposable gloves, garments, hand sanitizer, and splash goggles, was 
purchased and distributed to the DHS components for pandemic 
stockpiles. Furthermore, 258,400 courses of antiviral medicine were 
purchased and stockpiled in a secure pharmaceutical warehouse location 
for future needs.
    In addition to purchasing and stockpiling the PPE and antivirals 
above, OHA has spearheaded establishing large procurement vehicles that 
will serve all DHS Components. This will include blanket purchase 
agreements (BPA) and indefinite delivery indefinite quantity (IDIQ) 
contracts, which will be pre-negotiated and competed in advance. This 
will ensure quick, efficient means for the Components to acquire these 
critical items.
    Currently, 15 BPAs are in place for the use by the DHS Components, 
to purchase surgical masks, hand sanitizer, splash goggles, disposable 
gloves and disposable garments. Additional DHS-wide contract vehicles 
are currently in the procurement process for the purchase of 
respiratory protection devices.
    Question 2. In your testimony, you stated that you would follow up 
with airports throughout the United States regarding sufficient 
availability and numbers of masks that TSA employees could wear 
voluntarily. What were the results of your following up with these 
airports?
    Answer. TSA received 600,000 N-95 respirators/surgical masks in 
2007 as part of its pandemic planning stockpile allocation from OHA. In 
2008, TSA received another 400,000 N-95 respirators/surgical masks. In 
2009, at the request of OHA, a contract for 7 million surgical masks 
was awarded on May 1, 2009, at the beginning of the H1N1 outbreak. Of 
that quantity, 1 million was allocated and delivered to the TSA 
distribution center for allocation among its locations. The sum total 
of masks and respirators delivered is 2 million. In September 2009, TSA 
ordered an additional 5.4 million surgical masks. TSA has allocated 
these items to its personnel as directed by TSA's Acting Administrator.
    TSA pre-positioned N-95 respirators at 148 airports and TSA Field 
Offices. Many of these airports serve as ``hubs'' in the ``hub and 
spoke family'' of airports. A hub may serve 10 or more smaller spoke 
airports. Airports receiving respirators allotments include locations 
in all 50 States and Guam, Puerto Rico, and the Virgin Islands. 
Allotments were distributed by TSA in accordance with the personnel 
count at each location.
    All TSA airports were sent a 14-day supply of PPE. If airports 
require additional PPE, they can request it and it will be shipped from 
the TSA warehouse in Springfield, VA. OHA has regular communications 
with the TSA health and safety department, and TSA has not reported any 
shortages of respirators or requested additional PPE.
    Similar quantities of respiratory protection (masks and 
respirators) have been issued to CBP and ICE personnel, many of whom 
also serve in airports around the Nation.
    Question 3. What can be done to improve communications and 
information exchange between the United States, Canada, and Mexico 
regarding important public health security issues? What is the role of 
the Office of Health Affairs' Office of International Affairs and 
Global Health Security in this regard?
    Answer. ``Diseases do not honor international borders,'' is a long-
standing public health axiom that has recently been validated yet again 
in the novel 2009 H1N1 pandemic. The United States, Canada, and Mexico 
are acutely aware of this principle and have worked together to develop 
an integrated approach to public health security.
    The most visible product of this collaboration is the August 2007 
North American Plan for Avian and Pandemic Influenza (NAPAPI), 
originally developed as part of the Security and Prosperity 
Partnership, but now continued under the auspices of the North American 
Leadership Summit (NALS). NAPAPI provides a framework for emergency 
communications among the three countries. It creates a multi-
disciplinary coordinating body with representatives from human and 
animal health, foreign affairs, and security agencies. This body is 
charged to meet and communicate regularly on important issues 
surrounding avian and pandemic influenza.
    On October 5, 2009, the DHS Deputy Secretary led a U.S. delegation 
to a trilateral meeting of the United States, Canada, and Mexico. The 
purpose of the meeting was to focus on the security issues brought 
about by the present H1N1 pandemic. The NAPAPI coordinating body was 
relatively dormant during the change in administrations, and one of the 
key results of this meeting has been to reinvigorate both the plan and 
the coordinating body.
    The Office of International Affairs and Global Health Security 
(OGHS) within the Office of Health Affairs (OHA) for DHS maintains an 
active and vibrant relationship with the DHS attaches, the HHS Liaison 
Officer, key international contacts within HHS, health officials in 
DOS, and selected health policy individuals in the governments of 
Canada and Mexico. During the Spring wave of the pandemic, OGHS gleaned 
important health information from these various sources and then worked 
with other resources within OHA to shape this information into a 
context that assisted our Assistant Secretary in his role of advising 
the DHS Secretary and the FEMA Administrator. We were able to glean 
subtle health information and translate that into impacts on aspects 
such as work absenteeism, critical sector functionality, and impact of 
community mitigation measures, which proved to be valuable facts for 
our Secretary and the FEMA Administrator to use in their decision-
making process for the domestic emergency response.
    Question 4. Which Federal Departments and agencies participating in 
the National Biosurveillance Integration Center (NBIC) are providing 
detailees who work at the NBIC on a full-time or part-time basis? How 
many are working on H1N1 currently?
    Answer. The U.S. Department of Agriculture (USDA) is the only 
Department that continues to provide one full-time equivalent (FTE) 
detailee to NBIC. The USDA-assigned detailee supports 2009-H1N1 and all 
other biosurveillance-related taskings on behalf of NBIC and in 
coordination with USDA. The Department of Health and Human Services 
(HHS) Centers for Disease Control and Prevention (CDC) provided a 
detailee to NBIC in the past. No HHS/CDC detailee has been provided 
since March 2009.
    Question 5. Are all participating Federal departments and agencies 
providing surveillance information to the NBIC--on H1N1 and/or other 
diseases? Which departments and agencies are providing H1N1 
information?
    Answer. Agencies providing H1N1 information (as well as information 
on other diseases and events) to NBIC on a non-routine basis are:
   Department of Agriculture;
   Department of Health and Human Services;
   Department of State;
   Department of Defense.
    All of the reports provided to NBIC are finished products.
    The H1N1 Operational Planning Team (OPT) receives H1N1 information 
from the following sources:
   Department of Health and Human Services;
   Department of Agriculture;
   Department of State;
   Department of Defense;
   Department of Education;
   Department of Labor;
   Department of Transportation;
   Veterans Affairs;
   Treasury Department;
   American Red Cross.
    An NBIC analyst participates in the OPT's daily operations and 
therefore has access to the information provided directly to the OPT.
   The following agencies are not National Biosurveillance 
        Integration System (NBIS) member agencies. Their data is shared 
        with NBIC via the OPT: Department of Education, Department of 
        Labor, and the Department of Treasury.
   The Department of Transportation (DOT) is an NBIS 
        participant, but does not have a signed NBIC Memorandum of 
        Understanding. DOT data is shared with NBIC via the OPT.
   The following organizations are not NBIS member agencies but 
        may still be data sources of H1N1 biosurveillance related 
        information. If such information is shared with the OPT, the 
        NBIC-OPT analyst has access to that information. These 
        organizations include: The American Red Cross.
    Question 6. What do you think can be done right now to improve NBIC 
performance while the H1N1 pandemic is occurring?
    Answer. To improve the performance of the National Biosurveillance 
Integration Center (NBIC) during the current 2009-H1N1 pandemic, NBIC 
Member Agencies (NMAs) should expeditiously assign detailees. In 
addition, NBIC should have unfiltered access to the NMAs' 
biosurveillance source data and access to appropriate subject matter 
experts that support 2009-H1N1 analysis. With direct access to such 
information, NBIC capability to provide cross-domain integrative 
analysis and critical infrastructure impact assessments would 
immediately increase.
    The following Federal agencies are providing 2009-H1N1 information 
(as well as on other diseases and events) to NBIC:
   Department of Agriculture;
   Department of Health and Human Services;
   Department of State;
   Department of Defense.
    Question 7. What is the current budget of NBIC? What is the budget 
for fiscal year 2010? How much would you estimate is going towards H1N1 
biosurveillance efforts?
    Answer. Congress appropriated $8 million for the National 
Biosurveillance Integration Center (NBIC) in fiscal year 2009, and $8 
million for fiscal year 2010. NBIC funding supports a number of 2009-
H1N1 efforts, including surge support as well as staffing for the DHS 
2009-H1N1 Operational Planning Team. Additionally, NBIC has funded the 
National Infrastructure Simulation and Analysis Center (NISAC) to 
conduct modeling of economic and infrastructure impacts of the 2009-
H1N1 pandemic.
    NBIC estimates costs of on-going 2009-H1N1 biosurveillance efforts 
for fiscal year 2009 and fiscal year 2010 at $2.0 million.
    Question 8. How does the DHS Office of Health Affairs work with the 
DHS Office of Intelligence and Analysis on public health security 
issues, including the H1N1 influenza pandemic, if at all?
    Answer.
   The Office of Health Affairs (OHA) is actively supporting 
        DHS Office of Intelligence and Analysis (I&A) on the Health and 
        Medical Intelligence/Information Sharing program. OHA has 
        detailed personnel to I&A, provides subject matter expertise, 
        and provides support through a network of health and medical 
        professionals in the public health and health care community.
   I&A works closely with the 72 designated State and large 
        urban area fusion centers and has 60 officers in processing or 
        deployed to these fusion centers, which creates an information-
        sharing environment that serves stakeholders' information needs 
        and builds interoperability. By partnering with I&A, OHA has 
        been able to leverage those relationships and formulate 
        policies, guidance, and strategies to provide outreach, 
        advisory services, training, and a variety of coordination and 
        education activities. This partnership allows for a 
        maximization of OHA efforts to enhance existing relationships 
        with the health community and promote the appropriate exchange 
        of health security information and intelligence between all 
        homeland security partners. Additionally, OHA has detailed an 
        individual to DHS I&A's State and local program office to 
        develop this program, which emphasizes the strong and effective 
        partnership between OHA and I&A.
   OHA is also partnering with I&A to develop mechanisms to 
        share appropriate WMD and health-related threat information 
        with fusion centers and partners in the health community. The 
        intelligence and analytic products produced by I&A and the 
        National Center for Medical Intelligence (NCMI) are 
        particularly important to fusion centers, State and local law 
        enforcement, and other public safety partners, as well as their 
        public health and health care partners. I&A's Chemical, 
        Biological, Radiological, Nuclear and Health (CBRNH) Branch's 
        health security team is a founding partner, co-located with the 
        Deputy Director of Homeland Security at NCMI. I&A/CBRNH and 
        NCMI provide individual and co-authored all-source intelligence 
        analysis for medical intelligence threats to the homeland, and 
        are able to disseminate them as appropriate to Homeland 
        Security partners. OHA also embedded an I&A/CBRNH intelligence 
        analyst within OHA's 2009 H1N1 Flu Incident Management Cell 
        (IMC). This afforded OHA senior leadership prompt access to 
        intelligence and analytical products concerning the H1N1 
        outbreak.
   OHA has worked closely with I&A's CBRNH Branch on the 
        Homeland Security Presidential Directive (HSPD)--21 to fulfill 
        paragraphs 34 and 35. OHA and CBRNH worked collaboratively on 
        HSPD-21 paragraph 34 by producing an unclassified briefing for 
        non-health professionals that outlines public health risks 
        posed by catastrophic health events (including WMD attacks). 
        OHA and CBRNH also worked with HHS on HSPD-21 paragraph 35 to 
        initiate the appropriate step necessary for qualified State and 
        local health officials to obtain security clearances, which 
        will allow them to receive access to classified threat 
        information when applicable.
   To prepare for the start of the 2009-2010 flu season and to 
        address several of the flu vaccine issues currently in the 
        media, OHA and I&A coordinated with each of the I&A deployed 
        regional managers to hold a series of conference calls for 
        officials from across the country--to include law enforcement, 
        emergency services, fusion center directors, and public health. 
        During these regional conference calls, DHS health experts from 
        OHA and I&A's Health Intelligence team provided an update on 
        H1N1 and the Health Security Intelligence Enterprise (HSIE) and 
        Medical Intelligence, and answered local-level questions.
    Question 9. Please describe how the NBIC has been obtaining 
information and data to create its products, including the Biological 
Common Operating Picture (BCOP)? How is H1N1 addressed in the BCOP?
    Answer.
   NBIC collects reported information from a variety of sources 
        using a tool called the Biosurveillance Common Operating 
        Network (BCON). BCON pulls information from open-source media 
        and Government reports that are sent to NBIC.
   After internal evaluation, information is then presented to 
        the interagency at 1300 on a daily basis for review, further 
        conversation, and analysis by subject matter experts from all 
        member agencies.
   After a concurrence is reached on the information, it is 
        then combined into a report by the NBIC analysts and geo-
        located on the Federal BCOP and the NBIC portal on the Homeland 
        Security Information Network (HSIN). The Federal BCOP is 
        accessible only to NBIC's Federal partners and contains 
        information on H1N1 and other worldwide biological events of 
        interest.
   This process is echoed for the State, local, Tribal, and 
        territorial BCOP, which focuses solely on H1N1 at this time. 
        Each report of significance is posted on the BCOP. This version 
        of the BCOP will be made available to the H1N1 Operational 
        Planning Team (OPT) to post on its HSIN portal to provide 
        information to individuals across the Government as well as to 
        State, local, Tribal, and territorial entities.
   NBIC generates a separate report for each H1N1 item of 
        interest. Examples of past reports include the following:
     Reports of co-infections with H1N1 and dengue;
     An overview of H1N1 in the Ukraine;
     Descriptions of H1N1 mitigation measures;
     Reports of H1N1 in animals worldwide;
     Reports of resistance to antiviral drugs.
    Question 10. Should mobile hospitals (made of tents, vehicles, or 
otherwise) be used to help hospitals overwhelmed by H1N1? What advice 
has the Chief Medical Officer given to the Secretary of Homeland 
Security and/or the FEMA administrator in this regard?
    Answer. Given the nature of a pandemic, the need for surge capacity 
due to hospital overload could be expected to impact all hospitals in a 
given region, possibly even at the National level. Planning for 
hospital surge falls within the jurisdiction of the Department of 
Health and Human Services (HHS). However, the Chief Medical Officer of 
DHS provides advice to the Secretary and FEMA administrator on a range 
of pandemic preparedness and response issues, and keeps DHS leadership 
informed of health and medical critical infrastructure and key 
resources impacts.
    Many States have purchased mobile field hospital units based upon 
the scenario of an unanticipated disaster or incident that would 
require a rapidly assembled platform upon which to care for ill or 
injured citizens. These field hospitals could provide additional bed 
space to assist in the relocating of hospital inpatients, especially 
those less acutely ill. We have seen some successful deployments of 
these units scattered around the Nation during this pandemic. Mobile 
medical units can offer another option, and as they were specifically 
designed with providing patient care in mind, they are often better 
suited physically and ergonomically for this function than retrofitting 
a lecture hall to serve as a patient care area.
    Question 11. How will lessons learned that address many areas 
relevant to H1N1 be identified, collected, recorded, and communicated 
to the many customers seeking that information? How do you recommend 
this occur? How will this information be added to the DHS Lessons 
Learned Information Sharing system, if at all?
    Answer. DHS has already recorded lessons learned and is working to 
implement changes to enhance our pandemic response now and in the 
future. DHS will collate, report, and record the information using the 
DHS Lessons Learned Information Sharing system and the H1N1 Common 
Operating Picture. DHS will work with the National Security Staff, the 
Department of Health and Human Services, and other departments and 
agencies to coordinate and encourage participation in the interagency 
lessons learned effort.
    Question 12. How does DHS identify vulnerabilities in the 
pharmaceutical supply chain? Is the NBIC gathering any information 
relevant to H1N1-related pharmaceuticals in the supply chain? If not, 
why not, and how would you go about giving NBIC such a mission?
    Answer. The National Biosurveillance Integration Center (NBIC) 
utilizes reports issued from the Department of Homeland Security (DHS) 
National Operations Center (NOC), intelligence sources, and open 
sources that detail existing threats to the Nation's transport, 
storage, and delivery of pharmaceuticals. Drawing information from 
these reports, NBIC monitors for signs of distress resulting from the 
2009-H1N1 pandemic--including perceived shortages of desired supplies. 
Although NBIC does not currently have the capability to monitor 
specific supply chain vulnerabilities, NBIC regularly scans open-source 
materials and U.S. Government contacts for indirect evidence of 
pharmaceutical supply chain dysfunction.
    The present NBIC mission--to provide early cueing on biological 
events of National significance--is sufficiently broad to permit NBIC 
to examine supply chain vulnerabilities in cooperation with DHS 
component offices, sector-specific agencies and other relevant 
Government agencies, specifically DHS Office of Infrastructure 
Protection (IP), and the Departments of Health and Human Services 
(HHS), Transportation (DOT), Commerce (DOC), and Justice (DOJ). NBIC 
does not have authority to require agencies to respond to NBIC queries 
regarding either surveys of vulnerability status or to perceived 
threats to these vulnerabilities, but this information can be shared on 
a cooperative request basis. Since the production, transportation, and 
consumption of pharmaceuticals are all ``lagging-indicators'' of a bio-
related event, NBIC's current resources and capabilities have been more 
intensely focused on precursor biosurveillance data-streams and 
indicator analysis. NBIC successfully executes all statutory functions 
with regards to cross-domain biosurveillance analysis and assessments. 
Planned improvements to interagency information sharing technology such 
as the National Biosurveillance Information Sharing Environment (NB-
ISE) will span lingering capability gaps that limit NBIC's ability to 
fully engage with National Biosurveillance Integration System (NBIS) 
Federal partners and will empower NBIC and NBIS engagement with State, 
local, Tribal and territorial agencies and entities as well as private 
sector participants.
    IP assesses vulnerabilities in the pharmaceutical and other 
critical supply chains through the Critical Foreign Dependency 
Initiative (CFDI). CFDI identifies foreign infrastructure critical to 
the public health or economic and National security of the United 
States through an inter-agency process led by DHS, working in close 
collaboration and coordination with the Department of State, the 
intelligence community, and public and private infrastructure 
protection community partners. CFDI is the international component of 
the Department's larger National Critical Infrastructure Prioritization 
Program (NCIPP), which identifies and prioritizes nationally and 
regionally critical infrastructure.
  Questions From Chairwoman Yvette D. Clarke for Nicole Lurie, M.D., 
Assistant Secretary for Preparedness and Response, Department of Health 
                           and Human Services
    Question 1. In your testimony, you stated that, ``investments in 
the hospital preparedness program have meant that most health care 
facilities had exercised all hazards plans, including influenza 
plans.'' What data do you have to back up this observation?
    Answer. Cooperative agreement funding made through the Hospital 
Preparedness Program (HPP) to State/territory departments of public 
health to improve surge capacity and enhance community and hospital 
preparedness for public health emergencies has improved the ability of 
participating health care facilities Nationally to conduct drills and 
exercises, test HPP funded sub-capabilities, and participate in State-
wide and regional exercises. We measure their progress every year. 
Nationally, 4,541 hospitals participated in an exercise or incident 
during the fiscal year 2007 reporting period, and 3,975 hospitals 
developed improvement plans based on after-action reports.
    Question 2. In your testimony, you stated that you would have to 
confirm that the U.S. Virgin Islands (USVI) had not been reporting 
information expressed in the CDC FluView map regarding how widespread 
the H1N1 disease was because the USVI did not have an epidemiologist 
that could do such reporting. Have you confirmed this was and/or is the 
case? Has the CDC provided an epidemiologist of their own to provide 
such reporting from the USVI? Has that epidemiologist been replaced, 
and if so, why? What is the long-term plan to help the USVI and other 
U.S. territories establish and maintain long-term, resident, 
epidemiological capacity?
    Answer. Due to lack of a robust surveillance system in the U.S. 
Virgin Islands (USVI), it is difficult to collect data that can be 
loaded into FluView. CDC deployed a public health advisor to the USVI 
the second week of September and a second epidemiologist was sent the 
last week in October, and has been reporting since November 16. The 
staff is expected to stay for 4 to 6 months, or until they have trained 
others.
    USVI has been able to define its current outbreak as ``sporadic'' 
and this status was included in FluView, beginning Monday, November 23. 
USVI also now is able to collect lab-confirmed flu data from St. Croix, 
which will include both inpatient and outpatient information. It is 
expected that they will begin reporting on a weekly basis. Until 
recently, USVI did not have adequate manpower to conduct surveillance 
activities; they are still limited in what they will be able to 
accomplish due to manpower and system limitations.
    In addition to deploying the epidemiologist and public health 
advisor, staff from CDC's Influenza Coordination Unit has provided 
technical assistance to the USVI health department. This technical 
assistance began prior to the 2009 H1N1 outbreak and will continue 
after the resolution of the event to ensure that USVI is able to build 
its surveillance capacity for influenza and other diseases.
    Question 3. In your testimony, you stated that you would provide a 
roll-out plan to the committee regarding N-95 mask delivery throughout 
the United States, the plan for those that are not slated to receive N-
95 masks, whether HHS is recommending another type of/alternative mask, 
whether other manufacturers are making N-95 masks, information about 
the National supply of N-95 masks, what masks are in the stockpile and 
how many, what has been shipped. Please provide this information to the 
committee.
    Answer. On October 19, 2009, the Secretary approved the Strategic 
National Stockpile Release Strategy for N-95 Respirators. The Strategic 
National Stockpile (SNS) contacted all 62 project areas to determine 
each one's desire and readiness to receive its pro rata allocation of 
75 percent of the remaining N-95 respirators held in the SNS. Fifty-
nine project areas requested their pro rata allocations. Three project 
areas were not ready to receive their pro rata allocations; SNS will 
hold their N-95s in inventory. Including the spring deployment for the 
H1N1 response, SNS has shipped 84.5 million N-95 respirators and has 20 
million N-95 respirators remaining in inventory.
    The commercial, national supply chain of N-95 respirators is unable 
to keep up with current demand. Reports received from N-95 
manufacturers and distributors indicate that product from current 
production cycles is committed, and suppliers report significant 
difficulty filling new orders. As a result, manufacturers and 
distributors have been forced to implement allocation strategies to 
attempt to meet new demand. It is unclear at this time if demand for N-
95 respirators is due to increased use of products or due to facilities 
increasing inventory in anticipation of need.
    Other classes of disposable respirators (e.g., N-99s, N-100s), 
which are similar in appearance to N-95s, can be considered for use by 
health care workers. Alternatives to disposable respirators, such as 
powered air purifying respirators (PAPRs), or elastomeric half-mask and 
full face piece respirators, also can be considered, especially in 
settings such as procedure rooms (e.g. bronchoscopy suites) where 
higher-risk activities such as aerosol-generating procedures are 
intermittently performed, and in facilities that have prior experience 
with these respirators. More information on respiratory protection 
associated with pandemic H1N1 influenza is available at: http://
www.cdc.gov/h1n1flu/masks.htm.
    To most effectively reach respirator users, CDC's National 
Institute for Occupational Safety and Health (NIOSH) has developed a 
web-based clearinghouse of respirator information, in conjunction with 
the October 14, 2009 release of the CDC Interim Guidance on Infection 
Control Measures for 2009 H1N1 Influenza in Healthcare Settings, 
Including Protection of Healthcare Personnel, which is available at 
http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm. The 
purpose of this web page is to provide NIOSH-verified information to 
help facilities identify suppliers of respiratory protective equipment 
and dispel user confusion due to misinformation and lack of knowledge 
on performance, selection, acquisition and use of various respirator 
types.
    Question 4. What can be done to improve communications and 
information exchange between the United States, Canada, and Mexico 
regarding important public health issues such as the H1N1 influenza 
pandemic?
    Answer. The outbreak of novel influenza A/H1N1 in North America in 
April 2009 provided a real world test of the preparedness work of 
Canada, Mexico, and the United States, including efforts under the 
North American Plan for Avian and Pandemic Influenza and the precepts 
of the revised 2005 International Health Regulations (IHR's). In this 
regard, rapid information sharing among the trilateral partners 
occurred early in the event and was maintained. Under the IHR (2005), 
all countries are obligated to notify the World Health Organization 
(WHO) of all events that may constitute a public health emergency of 
international concern (PHEIC), including human influenza caused by a 
new subtype. A simultaneous notification process has been established, 
requiring Canada, Mexico, and the United States to simultaneously 
notify their trilateral partners when they notify the WHO of a 
potential PHEIC under IHR (2005). All three countries met this 
obligation during the H1N1 event. In addition to this initial, formal 
information sharing, the United States hosted conference calls with 
Canada, Mexico, the Pan American Health Organization (PAHO) and the WHO 
to exchange epidemiological and other public health information during 
the H1N1 event.
    Currently, we are in the process of establishing an HHS and Inter-
Agency Health Working Group under the aegis of the North American 
Leaders Summit and, as mentioned in my testimony, re-instituting the 
North American Plan for Avian and Pandemic Influenza (NAPAPI) 
Coordinating Body. As we continue to strengthen our collaborations 
against emerging infections with pandemic potential (particularly with 
H1N1 and other potential novel influenza virus outbreaks), we will be 
focusing on further enhancing trilateral North American communications 
and information with our partners in Canada and Mexico by:
    (a.) Reviewing existing emergency coordination and communication 
        mechanisms and enhancing the exchange of detailed operations 
        plans;
    (b.) Identifying opportunities to exercise trilateral or bilateral 
        pandemic influenza preparedness and response planning to 
        include information-sharing strategies and communication 
        planning that would strengthen the broader emergency response 
        and contingency plans;
    (c.) Establishing and testing mechanisms for communication among 
        institutions according to specific functions for exchanging 
        epidemiological information;
    (d.) Strengthening operating procedures/processes for the sharing 
        of laboratory information before and during an emergency;
    (e.) Establishing public health liaison exchange with Mexico (Note: 
        We already have exchanged public health liaison officers 
        between HHS and the Public Health Agency of Canada); and
    (f.) Enhancing information-sharing on stockpile planning.
    Additionally, we intend to continue to engage in discussions with 
Canada and Mexico to enhance trilateral and cross-border communication 
among agencies and jurisdictions to improve emergency coordination 
regarding risk communications, public messaging, and health alert 
notifications.
    Question 5. Do you agree that laboratory testing for H1N1 is 
necessary--that if we had the additional capacity to test more 
specimens, we should, in order to better characterize the spread of the 
disease, how it mutates (if at all), etc.?
    Testing for 2009 H1N1 is desirable but is not necessary for all 
specimens if it is known that the strain is circulating in the 
community. In epidemic or outbreak situations, testing is usually 
confined to specimens from severe cases or high-risk individuals to 
determine the best course of treatment. The type of testing done at the 
State and territorial laboratories only identifies the virus and does 
not yield information about mutation. Full virus characterization to 
detect antigenic or genetic variation is only conducted in reference 
laboratories such as CDC that are equipped to do this sort of high 
complexity testing. In clinical settings, testing is most important 
when it changes clinical treatment, such as in hospitalized patients.
    Question 6. If you agree that if we had more lab capacity we should 
use it to test for H1N1, then why are we not using available labs such 
as the NIH-funded Regional Biocontainment Laboratories and other 
available labs to test until they, too, are testing at full capacity?
    Answer. In addition to the test developed by the CDC, the FDA has 
issued Emergency Use Authorizations for an additional nine tests for 
the detection of H1N1, including those developed by the DoD, large 
clinical reference laboratories, and commercial companies. This greatly 
increased testing capacity has eased the surge in demand on the CDC and 
public health laboratories and allowed them to concentrate on 
surveillance rather than diagnostic testing for H1N1 infection. CDC is 
in the process of setting up increased testing capacity at the Regional 
Biocontainment Laboratory located at the University of Texas laboratory 
in Galveston. In addition, the CDC Dengue Branch in San Juan, Puerto 
Rico now has now been equipped and trained to do real-time PCR 
diagnostic testing for influenza, allowing it to serve as a resource in 
emergency situations for Caribbean Territories and Nations.
    Question 7. What can be done now to improve collection, analysis, 
and reporting of H1N1 biosurveillance information at HHS?
    Answer. CDC has a long history of collecting robust data to monitor 
and understand the spread of influenza. CDC continues to collect, 
analyze, and report data from various sources. As a result of the 2009 
H1N1 pandemic, several new systems or enhancements to existing systems 
also have been put into place. These include:
   Enhancing Hospitalization Surveillance.--CDC has greatly 
        increased the capacity to collect detailed information on 
        patients hospitalized with influenza. Using the 198 hospitals 
        in the Emerging Infections Program (EIP) network and six 
        additional sites with 76 hospitals, CDC monitors a population 
        of 25.6 million to estimate hospitalization rates by age group 
        and monitors the clinical course among persons with severe 
        disease requiring hospitalization. The EIP sites also track 
        vaccine effectiveness.
   Expanding Testing Capability.--Within 2\1/2\ weeks of first 
        detecting the novel 2009 H1N1 virus, CDC had fully 
        characterized the new virus, disseminated the information to 
        researchers and public health officials, and developed and 
        begun shipping to States a new test to detect cases of 2009 
        H1N1 infection. CDC continues to support all States and 
        territories with test reagents, equipment, and funds to 
        maintain laboratory staff and ship specimens for testing. In 
        addition, CDC serves as the primary support for public health 
        laboratories around the globe and has provided test reagents to 
        295 laboratories in 147 countries. It is vital that accurate 
        testing continue in the United States and abroad to monitor any 
        changes in the virus that may indicate increases in severe 
        infection, resistance to antiviral drugs, or a decrease in the 
        match to circulating vaccine strains.
   Monitoring severe illness and mortality of women who are 
        pregnant.--Pregnant women are a group known to be at a higher 
        risk for seasonal influenza. Similarly, data indicate that 
        pregnant women also are at higher risk of severe disease and 
        death from the 2009 H1N1 influenza virus. CDC is in the process 
        of implementing a new system to collect data on severe illness 
        (intensive care hospitalization) and mortality among pregnant 
        women, which will improve our ability to monitor this group.
   Aggregate Hospitalizations and Deaths Reporting Activity 
        (AHDRA).--To supplement several well-established influenza 
        surveillance systems, CDC introduced an interim data collection 
        activity to augment information on hospitalizations and deaths 
        in 2009. This supplemental activity collects information from 
        all 50 States to identify hospitalizations and deaths due to 
        influenza or influenza-like-illness (ILI) Nationally and within 
        each State. Jurisdictions now can report to CDC either 
        laboratory-confirmed or clinical pneumonia counts of 
        hospitalizations and deaths. Initiated on September 1, 2009, 
        this new collection activity contributes to a more complete 
        picture of the burden of serious influenza and pneumonia 
        illness and deaths during the pandemic and lets each State 
        examine trends in the course of the pandemic in their areas.
   Health Care System Readiness.--HHS is also using multiple 
        systems to track the impact of the 2009 H1N1 pandemic on our 
        health care system. The HHS Assistant Secretary for 
        Preparedness and Response (ASPR) and CDC are in constant 
        communication with State health officers and hospital 
        administrators to monitor stress on the health care system and 
        to be prepared in case Federal medical assets will be necessary 
        to augment State and local surge capabilities. To date, State 
        and local officials have been able to accommodate the increased 
        patient loads, but this is something we need to monitor very 
        closely, and we need to be prepared to respond quickly if the 
        situation warrants.
    Question 8. How will lessons learned that address many areas 
relevant to H1N1 be identified, collected, recorded, and communicated 
to the many customers seeking that information? How do you recommend 
this occur?
    Answer. ASPR is currently collecting lessons learned and best 
practices from the entire Department and once collected, will begin 
processing them through the HHS Corrective Actions Program (CAP) which 
will conduct a thorough root cause analysis and identify specific 
actions necessary to improve response plans and operations. To date, we 
are in the final stages of an H1N1 reconstruction based on a wide 
variety of information reporting products (e.g., situation reports, 
briefings, separate reports and incident action plans) and in-person 
interviews with HHS personnel who were actively engaged in the initial 
H1N1 response operation. HHS will write a report that includes a 
narrative of the reconstruction and an analysis of key issues. We are 
investigating scope, scale, and feasibility of conducting a formal 
After-Action Conference with applicable stakeholders that would include 
State and local representation (currently this is unfunded). At the 
conclusion of this we will conduct an HHS Corrective Actions Program 
Working Group to address identified issues and develop an improvement 
plan. Based upon the outcomes of the work group, we will look to 
identify best practices and lessons learned that capture expertise and 
innovation in the H1N1 response and post them to the Federal Emergency 
Management Agency's (FEMA) Lessons Learned Information Sharing (LLIS) 
website.
    Question 9. In your testimony, you promised to provide to this 
committee the status of LLIS-Health (which was mandated in the Pandemic 
All-Hazards Preparedness Act) or use of the capacity of the DHS Lessons 
Learned Information Sharing system within 30 days of the hearing. What 
is the status of LLIS-Health or the use of DHS-LLIS capacity?
    Answer. Supporting the LLIS-Health/DHS-LLIS capacity, HHS/ASPR has 
responded to the PAHPA requirements through the following:
    The LLIS was established as a vehicle to provide an on-line 
clearinghouse for best practices related to exercises and events.
   Vast numbers of awardees have supplied promising practices 
        in this area to the Lessons Learned Information Sharing (LLIS) 
        secure portal through DHS.
   HPP has access to LLIS to view awardee submissions.
   While several submissions for health care exist, there is a 
        relative paucity of entries on emergency preparedness, 
        especially from the public health and health care systems 
        perspective.
   Health care is supported on DHS-LLIS with over 20,000 
        entries.
   Currently there are:
     7,720 entries for public health;
     1,605 entries for medical surge;
     7,851 entries for medical;
     1,649 entries for vaccinations.
   Since PAHPA legislation in 2006, up through the present, HPP 
        has been collecting data related to:
     Exercises/Drills;
     Corrective Actions/Improvement Plans;
     Executive Summaries.
   HPP will continue to encourage LLIS submissions:
     DHS and HHS have been collaborating through the DHS-HHS 
            Coordinating Committee to get AARs for health care loaded 
            into LLIS and allow awardees more access and increase 
            transparency.
    Question 10. When did the FDA start addressing the potential for 
H1N1 antivirals, vaccines, and other related medicines and equipment to 
be counterfeited and tainted? How did the FDA change its operations to 
accommodate this particular threat?
    Answer. When the H1N1 virus first emerged as a public health threat 
and the Secretary of Health and Human Services declared a public health 
emergency at the end of April, FDA immediately put a proactive strategy 
in place to actively and aggressively target, investigate, and take 
enforcement action against counterfeit products, as well as products 
FDA has not approved or cleared, that falsely claim to diagnose, 
prevent, treat, or cure the H1N1 flu virus. In addition, FDA put 
measures in place to inform the public about its efforts in this area 
so that consumers could protect themselves and report suspect products 
to the agency.
    To achieve its objective to combat fraudulent H1N1 products, FDA 
has, to date:
   Issued more than 80 Warning Letters to more than 85 websites 
        covering about 145 products via the internet with a 48-hour 
        response time. These warnings are the result of frequent 
        internet surfs conducted by staff across FDA's product Centers, 
        the Office of Criminal Investigations (OCI) and the Office of 
        Enforcement (OE).
   Achieved a compliance rate of approximately 80 percent, 
        meaning that the violative H1N1 claims that appeared on the 
        websites have been modified or removed, that the website no 
        longer exists, or that the violative product with fraudulent 
        claims is no longer offered for sale to the public.
   Established a single H1N1 reporting form for the public to 
        report fraudulent products, websites, or suspected criminal 
        activity.
   Posted a searchable database on FDA's website which includes 
        a list of all websites that received Warning Letters and the 
        products covered by those warnings.
   Initiated further investigations for possible civil or 
        criminal enforcement actions when appropriate.
   Analyzed several products purchased over the internet that 
        purported to be anti-viral treatments for the H1N1 flu virus. 
        Worked with Internet Service Providers (ISP) to shut down 
        websites that illegally offered fraudulent H1N1 products for 
        sale to the public. Launched an H1N1 Fraudulent Reporting 
        Widget.
   Conducted numerous interviews with the print, radio, and 
        broadcast media, and issued four press releases, to inform the 
        public about FDA's efforts in this area.
    Question 11. What else can and should be done to counter the threat 
from H1N1-related counterfeit and tainted pharmaceuticals right now?
    Answer. FDA remains vigilant in its efforts to counter the threat 
from H1N1-related counterfeit and fraudulent products and continues to 
use civil and criminal enforcement and communication as effective tools 
to protect the public health, achieve credible deterrence and prevent 
illegal H1N1 products from proliferating throughout the marketplace.
    Question 12. How does HHS determine the authenticity and integrity 
of medicines and medical equipment in the National stockpile?
    Answer. The Strategic National Stockpile (SNS) consults with FDA 
regarding the regulatory status of products proposed for procurement, 
as well as on issues affecting products currently in the SNS, including 
storage, labeling, and shelf life. The products in the SNS are 
manufactured and stockpiled in accordance with current Good 
Manufacturing Practices. There are quality control procedures in place 
to ensure that the Division of Strategic National Stockpile's receipt, 
handling, and storage of drugs, vaccines, and devices meet these 
defined standard practices.
    Question 13. How does HHS identify vulnerabilities in the 
pharmaceutical supply chain?
    Answer. FDA, including its Office of Criminal Investigations (OCI), 
in collaboration with the Assistant Secretary for Preparedness and 
Response (ASPR) and CDC, identifies vulnerabilities in the 
pharmaceutical supply chain through various sources, including 
information gathered from domestic and international law enforcement 
partners, industry, consumers, health care professionals and our 
regulatory counterparts.
    Question 14. What impact would the release of large quantities of 
substandard counterfeit pharmaceuticals (such as substandard 
antivirals) to the public have during an influenza pandemic when there 
is not yet enough vaccine available?
    Answer. Substandard, counterfeit, or fraudulent products present a 
significant threat to the public health. They may not prevent the 
transmission of the virus or offer effective remedies against 
infection. Likewise, they could give consumers who unknowingly take 
them a false sense of protection and cause them to delay or fail to 
seek legitimate medical care. More seriously, they put consumers at an 
increased risk of suffering life-threatening adverse events from 
possible dangerous drug interactions or from contaminated, impure, 
super-potent, or sub-potent ingredients.
    Question 15. Once information has been obtained by FDA that 
counterfeit or tainted pharmaceuticals have been found in the system, 
how is that information communicated to the public health community? 
How is this information communicated to other Federal agencies that may 
be investigating or could come across counterfeit pharmaceuticals in 
the course of their own investigations or activities?
    Answer. FDA uses a variety of communication tools to disseminate 
important information to the public. These include press releases, 
consumer updates and many different ``List Serves'' and ``RSS Feeds'' 
through which stakeholders who are interested in specific public health 
topics can receive timely, regular updates when the agency issues 
information in their areas of interest.
    FDA will also distribute information about counterfeit drugs 
through the agency's Counterfeit Alert Network (CAN), a network of 
National organizations, health professionals, consumer groups, and 
industry representatives. The goal of this network is to disseminate 
alert messages to a wide audience about specific counterfeit drug 
incidents in the United States and measures that can be taken to 
minimize exposure. In the event of a confirmed counterfeit case in the 
United States, FDA will send an alert to these partners. The agency 
also will send partners a notice if a counterfeit incident is confirmed 
elsewhere in the world that could affect U.S. partners.
    FDA's Office of Criminal Investigations (OCI) is responsible for 
liaison contacts with all local, State, and Federal law enforcement 
agencies on matters related to FDA-regulated products, including 
counterfeit, adulterated, or misbranded drugs and vaccines. All 
questions from law enforcement counterparts concerning fraudulent and/
or counterfeit H1N1 countermeasures can be directed to OCI Headquarters 
for assistance and further investigation.
    In addition, FDA has established a single reporting form whereby 
any member of the public can report suspected fraudulent/counterfeit 
products or criminal activity associated with H1N1. This form is 
available at the following link: http://www.accessdata.fda.gov/scripts/
email/oc/oci/flucontact.cfm.
    Question 16. In your testimony, you state that HHS is `` . . . in 
year 3 of a 5-year strategic plan to support the development and large-
scale manufacturing of vaccines using some of the newer technologies 
like cell-based technology and recombinant technologies . . .''. Please 
provide this strategy to the committee.
    Answer. The U.S. pandemic preparedness strategy for establishing a 
domestic manufacturing surge capacity to produce sufficient pandemic 
vaccine for the entire United States within 6 months of pandemic onset 
involves an integrated approach utilizing vaccine development and U.S.-
based manufacturing facility building. Advanced development of new 
influenza vaccines using tissue culture, recombinant DNA, and molecular 
technologies is the foundation for providing more flexible and robust 
ways to manufacture influenza vaccines. Further advanced development of 
antigen-sparing technologies for existing and new influenza vaccines 
using adjuvants provides opportunities to expand the vaccine supply at 
different points towards the final surge capacity goal. Coupling the 
enhancement of existing U.S.-based manufacturing facilities that 
produce egg-based influenza vaccines with the building of new domestic 
facilities that will manufacture cell-, recombinant-, or molecular-
based influenza vaccines is the natural extension of vaccine advanced 
development that achieves the U.S. pandemic vaccine surge capacity 
goal.
    Question 17. We know egg-based vaccines experience varying levels 
of ability to grow. How is the need for new technology to develop 
vaccine being addressed at HHS? What else needs to happen? What else 
does BARDA need? How much longer do you think it will be before we have 
better, non-egg-based technology to produce vaccines?
    Answer. At the present rate of vaccine development and building of 
new vaccine manufacturing facilities as described strategically above, 
the U.S. pandemic preparedness vaccine goal may be reached in 2012. In 
2005-06 HHS supported advanced development of six cell-based programs. 
In 2009 a down selection of contractors was planned due to lack of 
performance or inconsistency with the manufacturers' business models. 
Presently, three of the original six contracts remain active and 
continue to make progress. Two of these vaccines are nearing completion 
of final clinical testing and are expected to seek U.S. licensure in 
2010-11. One of these two companies has started to build a plant for 
the production of cell-based vaccines here in the United States with 
assistance from HHS. This facility may be available for vaccine 
production in less than 2 years in a pandemic emergency. Other cell-
based vaccine candidates are earlier in the development pipeline.
    In June 2009, HHS made its first award for advanced development of 
a recombinant vaccine. Recombinant and molecular technologies are not 
dependent on the ability to grow the virus in an egg or a cell to 
manufacture vaccine and thus may be available much sooner after 
pandemic onset. It is projected that this first program will be 
licensed for use in the United States in 3 years. A second request for 
proposals (RFP) was released in September 2009 to support additional 
recombinant and molecular influenza vaccine candidates; multiple 
proposals were received for review with contract awards expected early 
in 2010.
    In early 2007 HHS made awards for three antigen-sparing technology 
programs. These technologies reduce the amount of vaccine needed to 
vaccinate a person and thus increase the total supply. These 
technologies are in late stage development with H1N1 vaccines and are 
expected to seek U.S. licensure in 2010.
    As part of our efforts to augment existing and nearly completed 
influenza vaccine manufacturing facilities, HHS plans to issue a RFP in 
early 2010 to further support construction of a U.S. vaccine 
manufacturing facility implementing new cell-, recombinant-, or 
molecular-based technologies. Additionally, we plan to pursue new 
vaccine production technologies and technologies that expedite the 
vaccine production and delivery process, such as new and faster ways to 
measure vaccine potency that will provide better estimates of vaccine 
production. Together, these programs of advanced development and 
building domestic manufacturing infrastructure will enable the United 
States to meet its pandemic preparedness vaccine goals in the next 3 
years.
    Question 18. How has new information on how the H1N1 vaccine is 
growing in eggs modified projections of how much vaccine will be 
available, and by when?
    Answer. Prior to the release of materials for vaccine testing, the 
estimates of vaccine production were based on experience with viruses 
that grow poorly for vaccine production, like H5N1, and feedback from 
the manufacturers from alternative assays they were using to gauge the 
productivity over the summer. After the FDA/CBER released the materials 
for vaccine testing in mid-August, accurate numbers for what was being 
produced became available. These results showed the poor growth of the 
initial virus seeds and therefore reduced the projections for the 
amount of vaccine that was produced over the summer. Projections for 
the number of doses that could be available during the early stages of 
the immunization campaign were reduced to reflect this realization. The 
manufacturers have now made improvements in their production process 
for H1N1 vaccine and production is now meeting the initial estimates.
    Question 19. Should HHS have told everyone that so much vaccine was 
going to be available by mid-October? What should HHS have done 
differently?
    Answer. While firmly based in both scientific information from the 
vaccine manufacturers and experience in making influenza vaccines, the 
initial projections and statements on the vaccine supply raised public 
expectations too high. The poor growth of the virus contributed to a 2- 
to 3-fold reduction in the number of doses received early in the 
vaccination program. Other unforeseen factors including a prolonged 
seasonal influenza vaccine manufacturing campaign by 40 days, home 
countries taking priority for vaccines, and start-up delays in new 
vaccine production lines caused delays in vaccine availability in 
October and November 2009.
    HHS strives to meet the public's need for transparency and 
expectations with available facts. HHS has asked manufacturers to 
publicly disclose their projections, and is posting them on flu.gov.
    Question 20. Has influenza vaccine production reached maximum 
capacity? If so, and the virus mutates, how would the current 
production apparatus be modified? What would the Nation do for new 
vaccine? Would the currently produced seasonal and H1N1 vaccines 
provide any partial immunity?
    Answer. All manufacturers are at or near their maximum production 
capacity for influenza vaccine production.
    If the virus were to mutate significantly, a new virus seed would 
need to be generated and shared with the manufacturers so they could 
produce a matched vaccine. We would work with manufacturers to dedicate 
their production and filling lines to this new vaccine. Once this new 
vaccine was produced and released for use it could be used to immunize 
the public.
    Sera from recently immunized subjects can be studied to see if the 
seasonal and H1N1 vaccines offer any partial immunity. This should also 
include sera from clinical studies in which subjects received H1N1 
vaccines with adjuvants. Adjuvants are additives that can be added to 
vaccine to increase the body's immune response and may broaden the 
immune response to afford protection against related influenza viruses 
that an unadjuvanted can not or can only partially protect against.
 Questions From Chairwoman Yvette D. Clarke for Richard Serino, Deputy 
Administrator, Federal Emergency Management Administration, Department 
                          of Homeland Security
    Question 1. What is the status of updating FEMA Disaster Assistance 
Policy 9523.17 for Human Influenza? The committee understands that 
guidance was released in October, but that this guidance does not 
replace this policy. During the hearing, the committee asked that the 
updated and clarified policy be communicated to the committee within 30 
days of the date of the hearing. Please provide this to the committee 
within the requisite time frame.
    Answer. FEMA is currently in the process of updating FEMA Disaster 
Assistance Policy 9523.17 for Human Influenza and expects to have it 
completed as soon as possible; however, appropriate agency and 
Departmental review is necessary. FEMA has the support of DHS and the 
administration in this effort.
    In the interim, on October 27, 2009, FEMA issued a fact sheet with 
guidance on the available assistance and guidelines for requesting that 
assistance. FEMA has shared that document with Congressional Members 
and staff.
    We are working as quickly as possible to finalize the policy, but 
must ensure agency and Departmental review.
    We will issue it as soon as possible, and will ensure the committee 
receives a copy of the finalized policy.
    Question 2. What is the total amount of tentage that FEMA 
possesses? How much is being used for other emergencies and disasters 
currently?
    Answer. Total--4280.
   Distribution Centers (DCs) within the contiguous United 
        States--0.
   DCs outside the contiguous United States--4,280.
     DC Pacific-Guam--1,411 (types: Yurts, Disaster Relief 
            Shelters and Catomas).
     DC Pacific-Hawaii--2,869 (types: Colemans and Catomas).
     DC Caribbean-Puerto Rico--0.
    Recently, 1,300 tents were sent from DCs Pacific to support 
American Samoa.
    Question 3. What is the specific status of the tents in storage in 
Maryland? How much tentage is resident there? Have any of those tents 
been used since they were produced and stored during the previous 
administration?
    Answer. FEMA does not have any tents in storage in Maryland. Tents 
are only stored outside the contiguous United States as previously 
shown in the answers to prior questions.
    Question 4. What do you think of the use of mobile hospitals (made 
of tents, vehicles, or otherwise) when hospitals are overwhelmed by 
disease events such as the H1N1 pandemic? How many mobile hospitals 
does FEMA own?
    Answer. The Department of Health and Human Services is the 
appropriate agency for recommending the protocol, if any for using 
mobile hospitals.
    FEMA has maintained a Federal Medical Contingency Station (FMCS) 
since January 2007 when the National Disaster Medical System (NDMS) 
returned to the Department of Health and Human Services. Although FEMA 
expended resources to manage this medical asset, the FMCS was never 
used.
    There is a Memorandum of Agreement between FEMA's FMCS and the 
North Carolina Department of Human Services to transfer FEMA's FMCS to 
North Carolina. FEMA Region IV and the States within that Region have 
developed a plan to incorporate the FMCS by assigning it to North 
Carolina, and making it available to other States via the Emergency 
Management Assistance Compact. North Carolina accepted the FMCS when it 
was delivered in Spring 2009.
    Question 5. How will lessons learned that address many areas 
relevant to H1N1 be identified, collected, recorded, and communicated 
to the many customers seeking that information? How do you recommend 
this occur? How will this information be added to the DHS Lessons 
Learned Information Sharing system, if at all?
    Answer. DHS has already recorded lessons learned and is working to 
implement changes to enhance our pandemic response now and in the 
future. DHS will collate, report, and record the information using the 
DHS Lessons Learned Information Sharing system and the H1N1 Common 
Operating Picture. DHS will work with the National Security Staff, the 
Department of Health and Human Services, and other departments and 
agencies to coordinate and encourage participation in the interagency 
lessons learned effort.
Questions From Chairwoman Yvette D. Clarke for Marcy Forman, Director, 
    Intellectual Property Rights Coordination Center, Department of 
                           Homeland Security
    Question 1. In your testimony, you promised to provide to this 
committee a report regarding Intellectual Property Rights Coordination 
Center programs to investigate H1N1-related counterfeit pharmaceuticals 
and equipment--within 30 days of the hearing and monthly thereafter 
until the pandemic is over. Please provide this information in the 
requisite time frame.
    Answer. The National Intellectual Property Rights Coordination 
Center provides as an attachment its report (as of November 20, 2009) 
regarding its operational activities that investigate all counterfeit 
pharmaceuticals and equipment, including those related to H1N1. Reports 
will be provided monthly thereafter until the pandemic is over.
    [The information follows:]
                   ipr center report on h1n1 efforts
Background
    This report sets forth the information requested by the U.S. House 
of Representatives Subcommittee on Emerging Threats, Cybersecurity, and 
Science and Technology, from the National Intellectual Property Rights 
Coordination Center (IPR Center) during the October 27, 2009, hearing 
on the topic of ``Real-Time Assessment of the Federal Response to 
Pandemic Influenza.'' This report was to be submitted within 30 days of 
the hearing, with additional monthly reports until the pandemic threat 
is over. The information below is the initial report regarding the IPR 
Center's programs that investigate H1N1-related counterfeit 
pharmaceuticals and equipment.
    Since the inception of the H1N1 pandemic during the spring of 2009, 
the IPR Center partner agencies \1\ have coordinated three different 
initiatives to address the threat posed by the potential importation 
and distribution of counterfeit H1N1 antiviral and vaccine products, as 
follows:
---------------------------------------------------------------------------
    \1\ Partner Agencies: U.S. Immigration and Customs Enforcement; 
U.S. Customs and Border Protection; Federal Bureau of Investigation; 
Food and Drug Administration; Department of Commerce; Department of 
Justice Computer Crime and Intellectual Property Section; U.S. Postal 
Inspection Service; Mexican Revenue Service.
---------------------------------------------------------------------------
    1. Operation Apothecary.--The IPR Center coordinates monthly surge 
        inspection operations under Operation Apothecary, which targets 
        subjects and organizations utilizing international mail to 
        facilitate the importation and distribution of counterfeit 
        pharmaceuticals. The latest operations have focused directly on 
        counterfeit H1N1 antivirals and vaccines.
    2. Undercover Operations.--The IPR Center mobilized the 
        capabilities of its certified undercover operation to identify 
        internet-based websites and individuals involved in the sale of 
        purported anti-viral products (Tamiflu). Purchases of these on-
        line Tamiflu products were conducted in an undercover capacity 
        to determine their authenticity and identify any health and 
        safety concerns, as well as identify investigative and 
        enforcement targets.
    3. Partnership with the Industry.--The IPR Center continues to 
        coordinate with industry partners who are involved in the 
        manufacture of antivirals, such as Tamiflu, to identify all 
        viable leads that may assist in a criminal investigation or 
        interdiction effort.
Monthly Report to Congress
    Operation Apothecary:
   Packages Examined--460.
   Antiviral Found--0.
   Counterfeit Antiviral Found--0.
    Undercover Operation:
   Counterfeit Antiviral Received--0.
    Referrals From Industry:
   Counterfeit Antiviral Leads--0.
    Question 2. To what degree and how has ICE been able to measure 
success in stemming the flow of counterfeit pharmaceuticals?
    Answer. Operation Apothecary is an ICE-led interagency health and 
safety initiative with U.S. Customs and Border Protection (CBP) and the 
U.S. Food and Drug Administration (FDA) that targets counterfeit 
pharmaceuticals that are purchased on the internet and imported into 
the United States via international mail branches and express 
consignment couriers (e.g. FedEx, UPS, etc.). ICE measures the success 
of Operation Apothecary through the utilization of metrics designed to 
track arrests, indictments, convictions, and seizures as a result of 
reactive and proactive cases initiated. Since inception in 2004, 
Operation Apothecary has resulted in 1,205 seizures of counterfeit 
pharmaceuticals valued at more than $2.2 million and initiated 229 
investigations that have resulted in 68 arrests, 99 indictments, and 67 
convictions.
    Operation Guardian is an ICE-led interagency health and safety 
initiative that targets substandard, tainted, and counterfeit products 
imported into the United States that pose health and safety risks to 
the American public. During fiscal year 2009, Operation Guardian 
generated 394 seizures of harmful products valued at more than $3.3 
million and initiated 166 investigations that have resulted in 26 
arrests, 22 indictments, and 23 convictions.
    In addition, ICE, through the National Intellectual Property Rights 
Coordination Center (IPR Center), works with various interagency 
partners engaged in the targeting and interdiction of counterfeit 
pharmaceuticals including the Federal Bureau of Investigation, CBP, 
FDA, and U.S. Postal Inspection Service. ICE and its partners collect, 
analyze, and reconcile data associated with seizures and discoveries at 
U.S. ports of entry and in locations away from the U.S. border, as well 
as information from State and local law enforcement and prosecutorial 
agencies concerning investigations and prosecutions. As an example, the 
IPR Center leverages criminal enforcement authorities under the 
jurisdiction of FDA to help ICE, FDA, and CBP in surges under Operation 
Apothecary and other health and safety investigations involving 
counterfeit, substandard, and unapproved pharmaceuticals. In these 
surges, ICE and its partner agencies conduct operations at ports of 
entry, international mail facilities, and express courier consignment 
hubs in which they search packages to secure intelligence and 
investigate leads.

    Question 3. Should lessons learned regarding H1N1-related 
counterfeit pharmaceuticals be identified, recorded, and added to the 
DHS Lessons Learned Information Sharing system or some other system? If 
the latter, which system? How will these lessons learned be identified, 
collected, recorded, and communicated to the many customers seeking 
that information? How do you recommend this occur?
    Answer. The ICE-led Intellectual Property Rights Coordination 
Center (IPR Center) is dedicated to sharing lessons learned through a 
number of different mechanisms. As a multi-agency effort, the IPR 
Center oversees and participates in criminal and civil investigations. 
ICE and the IPR Center utilize a vast network of established law 
enforcement and regulatory contacts that are involved in criminal 
enforcement and targeting to further identify, record, and share H1N1-
related counterfeit pharmaceuticals information. Although the vast 
majority of the information received by the IPR Center is deemed law 
enforcement-sensitive, the IPR Center has also created a mechanism to 
document and respond to leads provided by private industry and the 
public.
    In addition, the IPR Center also has a robust training and outreach 
program, focused on domestic and international training initiatives for 
our law enforcement and regulatory partners. ICE's Outreach and 
Training Unit at the IPR Center coordinates domestic and foreign 
training efforts with the U.S. Patent and Trademark Office, the 
Department of State, the Department of Justice, and the World Customs 
Organization. This training allows for enhanced information sharing 
between law enforcement and the private sector.
    The information learned regarding counterfeit pharmaceuticals 
should not be included in the DHS Lessons Learned Information Sharing 
system as this would not be the best way to share information with 
other Federal, State, and local agencies in the United States, or with 
agencies throughout the world. The IPR Center believes it is using the 
best mechanisms to share information.
    Question 4. How does ICE draw upon medical and public health 
information it might need as it investigates cases involving 
counterfeit or tainted pharmaceuticals? Is this different than with 
other types of cases?
    Answer. ICE and the IPR Center leverage all available resources to 
identify appropriate subject matter experts to facilitate and support 
lines of inquiry and investigation that involve elements of medical and 
public health information. The IPR Center works with the ICE National 
Incident Response Unit (NIRU) and other ICE programs to consolidate and 
share information concerning interdicted and seized counterfeit or 
tainted pharmaceuticals and their possible impact on the public health. 
Additionally, the IPR Center utilizes NIRU to facilitate interaction 
with the Department of Homeland Security's Office of Health Affairs 
(OHA) and the U.S. Department of Health and Human Services Centers for 
Disease Control and Prevention.
    The efforts that ICE and the IPR Center put forth in leveraging all 
available resources are recognized in standard operational protocols 
that the IPR Center utilizes for all investigations.
    Question 5. Please explain how the Intellectual Property Rights 
Coordination Center addresses counterfeit pharmaceuticals, grey market 
pharmaceuticals, etc. What other resources does the Center need to 
execute these missions?
    Answer. The National Intellectual Property Rights Coordination 
Center (IPR Center) addresses counterfeit pharmaceuticals in a variety 
of ways, including the following:
    Operation Apothecary.--Operation Apothecary is a health and safety 
initiative that targets counterfeit pharmaceuticals that are purchased 
on the internet and imported into the United States via international 
mail branches and express consignment couriers. Under Operation 
Apothecary, IPR Center partner agencies conduct monthly surge 
inspection operations at targeted facilities looking for commercial 
quantities of counterfeit product. Information is gathered from the 
surges for use in targeting websites, international shippers, and drop-
shippers (individuals who receive large amounts of contraband and 
distribute it in smaller amounts) operating in the United States.
    Leads.--The IPR Center partners with industry and National and 
international law enforcement counterparts to generate leads targeting 
subjects, organizations, and networks involved in the manufacture, 
sale, smuggling, and distribution of counterfeit pharmaceuticals. Upon 
receipt of viable leads, the IPR Center deconflicts the target 
information among all partner agencies, coordinating investigative 
overlap to ensure a focused and effective approach to disrupting and 
dismantling the criminal activity. The leads are then distributed to 
the appropriate agency or ICE field office for investigation.
    Investigations.--The IPR Center also has the capability to conduct 
undercover investigations targeting subjects, organizations, and 
networks that exploit the internet to facilitate the sale of 
counterfeit pharmaceuticals. Through these efforts, the IPR Center 
generates and enhances leads for investigative action in the field 
either by ICE or partner agencies, or retains viable lead information 
for investigations. The IPR Center investigates violations and utilizes 
Department of Justice Computer Crime and Intellectual Property Section 
attorneys to prosecute cases in the Northern District of Virginia.
    Relative to gray market pharmaceuticals, the IPR Center does not 
conduct enforcement actions to address the importation of these 
products; however, these products are subject to seizure based on not 
being approved by the FDA for consumption in the United States. Gray 
market pharmaceuticals are produced abroad without authorization and 
payment but are imported into unauthorized markets. In either 
circumstance, the product does not present a counterfeit, substandard, 
or tainted threat.
    Question 6. When did the Intellectual Property Rights Coordination 
Center start addressing the potential for H1N1 antivirals, vaccines, 
and other related medicines and equipment to be counterfeited, tainted, 
entered into the grey and black markets, etc.? How did the Center 
change its operations to accommodate this particular threat?
    Answer. During Spring 2009, in concurrence with the increased 
concern over the potential H1N1 pandemic, the National Intellectual 
Property Rights Coordination Center (IPR Center), in conjunction with 
our partner agency the Food and Drug Administration--Office of Criminal 
Investigation (FDA-OCI), initiated efforts to address the potential 
threat of importation and distribution of counterfeit, tainted, and 
unapproved H1N1 antivirals, vaccines, and related medicines. The IPR 
Center mobilized the capabilities of its certified undercover operation 
to identify internet-based websites and individuals involved in the 
sale of these violative products. Through these efforts, the IPR Center 
identified numerous websites offering antivirals through outside of the 
legitimate pharmaceutical supply chain, in particular Tamiflu. 
Purchases of these questionable Tamiflu products were conducted in an 
undercover capacity to determine their authenticity and identify any 
health and safety concerns.
    In addition, the IPR Center and its partner agencies coordinated a 
surge inspection operation at the JFK International Mail Facility to 
target counterfeit antivirals. The IPR Center partner agencies reviewed 
the efforts of their field components to identify any investigations or 
enforcement actions relating to this area of concern. These surge 
operations are continuing on a monthly basis to identify the presence 
of antivirals entering the United States via the mail/express 
consignment environment. No counterfeit Tamiflu was found during the 
operation. Additional interdiction and undercover investigative efforts 
have been made to identify any counterfeit H1N1 vaccines entering the 
United States, with negative results.
    Although there have been no counterfeit antivirals discovered since 
the emergence of H1N1, there are other products that have been 
encountered during investigations and surge operations that are 
frequently confused for counterfeit. These products fall into two 
primary categories:
    Fraudulent.--While there are a significant number of herbal, 
homeopathic, and other types of substances encountered that purport to 
treat the effects of or cure influenza, they in fact do not. By 
claiming to accomplish something they do not, these products are 
fraudulent in nature, but not counterfeit. As they are unapproved 
supplements, the assessment, review, and regulation of these products 
fall under the purview of FDA.
    Non-U.S. Licensed (``Gray Market'').--Undercover and interdiction 
activity have resulted in the identification of a significant number of 
Tamiflu products entering the United States. These products are 
licensed by Roche, the maker of Tamiflu, for manufacture and 
consumption outside of the United States. These products are not 
approved by FDA for consumption in the United States. They are not 
counterfeit, but are subject to seizure by Customs and Border Patrol 
based on not being approved by the FDA for consumption in the United 
States.
    Question 7. What else can and should be done to counter the threat 
of H1N1-related counterfeit pharmaceuticals right now?
    Answer. ICE recognizes that increased knowledge via the appropriate 
and timely dissemination of clear, concise, and accurate information is 
the strongest most reliable tool in the U.S. Government's arsenal 
against the threat of H1N1-related counterfeit pharmaceuticals. ICE 
supports any improvements to processes for National, State, regional, 
and local dissemination of information about the harm of counterfeit 
H1N1-related anti-virals and the risks of obtaining pharmaceuticals via 
unproven or unregulated sources. Public information and increased 
awareness campaigns have the ability to reach wide audiences quickly, 
and can have almost immediate impact on consumer decisions.
    Question 8. How does ICE identify vulnerabilities in the 
pharmaceutical supply chain? Is this something that the Intellectual 
Property Rights Coordination Center should do itself?
    Answer. ICE does not monitor or investigate breaches/
vulnerabilities of the legitimate pharmaceutical supply chain. The U.S. 
Food & Drug Administration and the U.S. Drug Enforcement Administration 
have the authority and the subject matter expertise concerning breaches 
of legitimate pharmaceutical supply chains. The IPR Center regularly 
consults with the pharmaceutical industry and other law enforcement 
agencies in order to identify recent trends in the manufacturing, 
smuggling, and distribution of counterfeit pharmaceuticals. ICE and the 
IPR Center, through investigative and interdiction efforts, attempt to 
identify, disrupt, and dismantle subjects, organizations, and networks 
that are involved in the smuggling and distribution of counterfeit 
pharmaceuticals which threaten the health and safety of unsuspecting 
consumers.
    Question 9. Once information has been obtained by ICE that 
counterfeit, tainted, and/or diverted pharmaceuticals have been found 
in the system, how is that information communicated to the public 
health community? How is this information communicated to other Federal 
agencies that may be investigating or could come across counterfeit, 
tainted, and/or diverted pharmaceuticals in the course of their own 
investigations or activities?
    Answer. In all ICE investigations of counterfeit, tainted, and/or 
diverted pharmaceuticals found in the system, including those that 
result from interdictions at ports of entry, international mail 
branches, and during or as a result of other law enforcement 
operations, information is released to the public health community 
through proper channels with approval from the ICE Office of the 
Assistant Secretary. Any information that is deemed releasable to the 
general public is coordinated through the ICE Office of Public Affairs.
    Where it becomes necessary for ICE to share information with 
Federal, State, and local entities, the IPR Center can disseminate 
information via several established working groups including regularly-
scheduled multi-agency operational deconfliction meetings, the ICE-led 
Operation Guardian Working Group, and established channels of 
communication through the IPR Center's Outreach and Training Unit. In 
all instances, information is disseminated in an efficient manner, with 
recurring dialogue between agencies. Since the IPR Center is a multi-
agency effort, many of the primary Federal law enforcement and 
prosecutorial agencies are on-site and able to immediately receive and 
share this information.

                                 
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