Influenza Pandemic: Challenges Remain in Preparedness (26-MAY-05,
GAO-05-760T).							 
                                                                 
Vaccine shortages and distribution problems during the 2004-2005 
influenza season raised concerns about the nation's ability to	 
respond to a worldwide influenza epidemic--or influenza 	 
pandemic--which many experts believe to be inevitable. Some	 
experts believe that the next pandemic could be spawned by the	 
recurring avian influenza in Asia. If avian influenza strains	 
directly infect humans and acquire the ability to be readily	 
transmitted between people, a pandemic could occur. Modeling	 
studies suggest that its effect in the United States could be	 
severe, with one estimate from the Centers for Disease Control	 
and Prevention (CDC) ranging from 89,000 to 207,000 deaths and	 
from 38 million to 89 million illnesses. GAO was asked to discuss
surveillance systems in place to identify and monitor an	 
influenza pandemic and concerns about preparedness for and	 
response to an influenza pandemic. This testimony is based on	 
GAO's 2004 report on disease surveillance; reports and testimony 
on influenza outbreaks, influenza vaccine supply, and pandemic	 
planning that GAO has issued since October 2000; and work GAO has
done in May 2005 to update key information.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-05-760T					        
    ACCNO:   A25218						        
  TITLE:     Influenza Pandemic: Challenges Remain in Preparedness    
     DATE:   05/26/2005 
  SUBJECT:   Disease detection or diagnosis			 
	     Emergency preparedness				 
	     Health care planning				 
	     Health hazards					 
	     Immunization programs				 
	     Immunization services				 
	     Infectious diseases				 
	     Respiratory diseases				 
	     Influenza						 
	     HHS Pandemic Influenza Preparedness and		 
	     Response Plan					 
                                                                 

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GAO-05-760T

     

     * Background
          * Influenza
          * Disease Surveillance and Response
     * Existing Influenza Surveillance System and Enhancements Woul
          * Systems Are in Place to Routinely Monitor for Influenza
          * Federal Agencies Have Undertaken Initiatives to Enhance Infl
     * Despite Efforts by Federal Officials, Challenges Remain rega
          * HHS's Pandemic Influenza Plan Remains in Draft and Leaves Ma
          * Challenges Persist in Ensuring an Adequate and Timely Influe
          * Challenges Persist in Ensuring an Adequate Supply of Antivir
          * Implementation of Control Measures to Prevent Spread of Pand
          * Most Hospitals Lack the Capacity to Respond to Large-Scale I
     * Concluding Observations
     * Contact and Staff Acknowledgments
          * Order by Mail or Phone

Testimony

Before the Subcommittee on Health, Committee on Energy and Commerce, House
of Representatives

United States Government Accountability Office

GAO

For Release on Delivery Expected at 10:00 a.m. EDT

Thursday, May 26, 2005

INFLUENZA PANDEMIC

Challenges Remain in Preparedness

Statement of Marcia Crosse

Director, Health Care

GAO-05-760T

Mr. Chairman and Members of the Subcommittee:

I am pleased to be here today as you discuss issues regarding the nation's
preparedness to respond to a worldwide influenza epidemic, or influenza
pandemic.1 The emergence of new diseases such as severe acute respiratory
syndrome (SARS) has raised concerns about our ability to respond to other
infectious disease outbreaks such as an influenza pandemic,2 which many
experts believe to be inevitable. Vaccine shortages and distribution
problems during the 2004-2005 influenza season add to these concerns.

Influenza pandemics arise periodically but unpredictably from a major
genetic change in the virus that results in a new strain.3 Some experts
believe that the next pandemic could be spawned by the recurring avian
influenza in Asia. As of May 19, 2005, 97 people, mostly young and
otherwise healthy, have been confirmed by the World Health Organization
(WHO) to have been infected with avian influenza since 2003, and 53 of
them have died. Recent studies suggest that avian influenza strains are
increasingly capable of causing severe disease in humans and suggest that
these strains have become endemic in some wild birds. If these avian
influenza strains directly infect humans and acquire the ability to be
readily transmitted between people, a pandemic could occur.

While the severity of the next pandemic cannot be predicted, modeling
studies suggest that its effect in the United States could be severe. The
Centers for Disease Control and Prevention (CDC) estimates that if a
"medium-level" influenza pandemic were to occur in the United States, in
the absence of any control measures (e.g., vaccination and drugs), it
could cause 89,000 to 207,000 deaths, 314,000 to 734,000 hospitalizations,
18 million to 42 million outpatient visits, and another 20 million to 47
million cases of the illness.4 From 15 percent to 35 percent of the U.S.
population could be affected by an influenza pandemic, with associated
costs ranging from $71 billion to $167 billion.

1An influenza pandemic is defined by the emergence of a novel influenza
virus, to which much or all of the population is susceptible, that is
readily transmitted person-to-person and causes outbreaks in multiple
countries.

2See GAO, SARS Oubreak: Improvements to Publc Healh Capaciy Are Needed for
Responding to Bioterrorsm and Emerging Infectious Diseases, GAO-03-769T
(Washington, D.C.: May 7, 2003).

3Influenza pandemics can have successive "waves" of disease and last for
up to 3 years. Three pandemics occurred in the 20th century: the "Spanish
flu" of 1918, which killed 500,000 people in the United States; the "Asian
flu" of 1957, which caused 70,000 deaths in the United States; and the
"Hong Kong flu" of 1968, which caused 34,000 deaths in the United States.

You asked us to provide our perspective on the nation's ability to conduct
disease surveillance5 for an influenza pandemic, as well as the public
health system's preparedness for an influenza pandemic. In this testimony,
I will discuss (1) surveillance systems in place to identify and monitor
an influenza pandemic and (2) challenges in preparedness and response to
an influenza pandemic.

My testimony today is based largely on our 2004 report on disease
surveillance6 as well as reports and testimony on influenza outbreaks,
influenza vaccine supply, pandemic planning, and the SARS outbreak that we
have issued since October 20007 and work we have conducted to update key
information. Our prior work on disease surveillance and influenza
pandemics included analysis of information provided by multiple federal
departments and agencies, including the Department of Health and Human
Services (HHS)-specifically from CDC and the Food and Drug Administration
(FDA)-and the Departments of Agriculture, Defense, and Homeland Security,
as well as interviews with officials of those departments and agencies. We
also interviewed public health department officials from 11 states,8
vaccine manufacturers, and vaccine distributors and surveyed physician
group practices. To learn about pandemic planning efforts, we interviewed
HHS officials in the National Vaccine Program Office and reviewed HHS's
August 2004 draft "Pandemic Influenza Preparedness and Response Plan." Our
prior work on the SARS outbreak included analysis of information provided
by U.S. agencies, WHO, and Asian governments, as well as interviews with
officials from those entities. We also conducted fieldwork on SARS in
Beijing; Hong Kong; Guangdong Province, China; and Taipei, Taiwan. In May
2005, we updated our information to include issues that arose during the
2004-2005 influenza season and to verify the current status of HHS efforts
on surveillance, planning, and preparedness activities. We conducted all
of our work in accordance with generally accepted government auditing
standards.

4See CDC, Fact Sheet, Information about Influenza Pandemics, 3,
www.cdc.gov/flu , downloaded May 12, 2005.

5Disease surveillance is the process of reporting, collecting, analyzing,
and exchanging information related to cases of infectious diseases.

6See GAO, Emerging Infectous Dseases: Review of State and Federa Dsease
SurvelanceEfforts, GAO-04-877 (Washington, D.C.: Sept. 30, 2004).

7See "Related GAO Products" at the end of this testimony for a list of our
earlier work related to emerging infectious diseases and influenza
pandemic planning.

8These states-California, Colorado, Indiana, Louisiana, Minnesota, New
York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin-were
selected based on their participation in CDC's Emerging Infections
Program, each state's most recent infectious disease outbreak, and their
geographic location.

In summary, federal public health officials plan to rely on the nation's
existing influenza surveillance system and enhancements to identify an
influenza pandemic. CDC currently collaborates with multiple public health
partners, including WHO, to obtain data that provide national and
international pictures of influenza activity. Federal public health
officials and health care organizations have undertaken several
initiatives that are intended to enhance influenza surveillance
capabilities. While some of these initiatives are focused more generally
on increasing preparedness for bioterrorism and other emerging infectious
disease health threats, others were undertaken in preparation for an
influenza pandemic. For example, in response to concerns over the past few
years about the potential for avian influenza to become the next influenza
pandemic, CDC implemented an initiative in cooperation with WHO to improve
influenza surveillance in Asia. CDC has also implemented initiatives to
improve the communications systems it uses to collect and disseminate
surveillance information. In addition, CDC, USDA, and FDA have made
efforts to enhance their coordination of surveillance efforts for diseases
that arise in animals and can be transferred to humans, such as SARS and
certain strains of influenza with the potential to become pandemic.

While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with regard
to other aspects of preparedness for and response to an influenza
pandemic. In particular, HHS has not finalized planning for an influenza
pandemic. In 2000, we recommended that HHS complete the national plan for
responding to an influenza pandemic, but the plan has been in draft format
since August 2004. Absent a completed federal plan, key questions about
the federal role in the purchase, distribution, and administration of
vaccines and antiviral drugs during a pandemic remain unanswered. Other
challenges with regard to preparedness for and response to an influenza
pandemic exist across the public and private sectors, including challenges
in ensuring an adequate and timely influenza vaccine and antiviral supply;
addressing regulatory, privacy, and procedural issues surrounding measures
to control the spread of disease, for example, across national borders;
and resolving issues related to an insufficient hospital and health
workforce capacity for responding to a large-scale outbreak such as an
influenza pandemic.

                                   Background

To be prepared for major public health threats such as an influenza
pandemic, public health agencies need several basic capabilities,
including disease surveillance systems. Specifically, to detect cases of
pandemic influenza, especially before they develop into widespread
outbreaks, local, state, and federal public health officials as well as
international organizations collect, analyze, and share information
related to cases of the disease. When effective, surveillance can
facilitate timely action to control outbreaks and promote informed
allocation of resources to meet changing disease conditions.

Influenza

Influenza is more severe than some other viral respiratory infections,
such as the common cold. Most people who get influenza recover completely
in 1 to 2 weeks, but some develop serious and potentially life-threatening
medical complications, such as pneumonia. People aged 65 and older, people
of any age with chronic medical conditions, children younger than 2 years,
and pregnant women are more likely than other people to develop severe
complications from influenza. Influenza and pneumonia rank as the fifth
leading cause of death among persons aged 65 and older.

Influenza viruses undergo minor but continuous genetic changes from year
to year. Almost every year, an influenza virus causes acute respiratory
disease in epidemic proportions somewhere in the world. Vaccination is the
primary method for preventing influenza and its more severe complications.
Influenza vaccine is produced and administered annually to provide
protection against particular influenza strains expected to be prevalent
that year. Influenza vaccine takes several months to produce. Deciding
which viral strains to include in the annual influenza vaccine depends on
data collected from domestic and international surveillance systems that
identify prevalent strains and characterize their effect on human health.
FDA decides which strains to include in the vaccine and also licenses and
regulates the manufacturers that produce the vaccine.9 HHS has limited
authority, however, to directly control influenza vaccine production and
distribution.10

9FDA decides which strains to include in the annual influenza vaccine
based on the recommendations of its Vaccines and Related Biological
Products Advisory Committee.

FDA has approved four antiviral medications (amantadine, rimantadine,
oseltamivir, and zanamivir) for prevention and treatment of influenza.
However, influenza virus strains can become resistant to one or more of
these drugs, and so they may not always be effective.

Disease Surveillance and Response

In the United States, responsibility for disease surveillance is
shared-involving health care providers; more than 3,000 local health
departments, including county, city, and tribal health departments; 59
state and territorial health departments; more than 180,000 public and
private laboratories; and public health officials from multiple federal
departments and agencies.

States, through the use of their state and local health departments, have
principal responsibility for protecting the public's health and therefore
take the lead in conducting disease surveillance and supporting response
efforts. According to the Institute of Medicine (IOM), most states require
health care providers to report any unusual illnesses or deaths-especially
those for which a cause cannot be readily established.11 Generally, local
health departments are responsible for conducting initial investigations
into reports of infectious diseases. Laboratory personnel test clinical
and environmental samples for possible exposures and identification of
illnesses. Epidemiologists in health departments use disease surveillance
systems to detect clusters of suspicious symptoms or diseases in order to
facilitate early detection and treatment. Local and state health
departments monitor disease trends. Local health departments are also
responsible for sharing information they obtain from providers or other
sources with their state departments of health. State health departments
are responsible for collecting surveillance information-which they share
on a voluntary basis with CDC and others-from across their state and for
coordinating investigations and response efforts. Public health officials
provide needed information to the clinical community and the public.

10Under the Federal Food, Drug, and Cosmetic Act, FDA ensures compliance
with good manufacturing practices and has limited authority to regulate
the resale of prescription drugs, including influenza vaccine, that have
been purchased by health care entities, such as public or private
hospitals. The term "health care entity" does not include wholesale
distributors. This authority would not extend to resale of the vaccine for
emergency medical reasons. CDC also has a role in encouraging appropriate
public health actions.

11The requirement to report clinically anomalous symptoms is particularly
important for the detection of emerging infectious diseases, many of which
may be unfamiliar to health care providers.

At the federal level, several departments and agencies are involved in
disease surveillance and response. For example,

           o  HHS has primary responsibility for coordinating the nation's
           response to public health emergencies. As part of its mission, the
           department has a role in planning to prepare for and respond to an
           influenza pandemic. One action the department has taken is the
           development of a draft national pandemic influenza plan, titled
           "Pandemic Influenza Preparedness and Response Plan."
           o  CDC is charged with protecting the nation's public health by
           directing efforts to prevent and control diseases and responding
           to public health emergencies. It has primary responsibility for
           conducting national disease surveillance and developing
           epidemiological and laboratory tools to enhance disease
           surveillance. CDC also provides an array of technical and
           financial support for state infectious disease surveillance
           efforts. In addition, CDC participates in international disease
           and laboratory surveillance sponsored by WHO.
           o  FDA is responsible for ensuring that new vaccines and drugs are
           safe and effective and for conducting research on diagnostic tools
           and treatment of disease outbreaks. The agency also regulates and
           licenses vaccines and antiviral agents through the Center for
           Biologics Evaluation and Research and the Center for Drug
           Evaluation and Research, respectively. FDA also develops influenza
           viral reference strains and reagents and makes them available to
           manufacturers for vaccine development and evaluation.
           o  The Department of Defense (DOD) contributes to global disease
           surveillance, training, research, and response to emerging
           infectious disease threats. DOD maintains the DOD Influenza
           Surveillance Program, a laboratory-based surveillance program. DOD
           maintains multiple sites throughout the world that serve as
           sentinels for disease outbreaks, where it collects and analyzes
           viral specimens.
           o  The Department of Agriculture (USDA) is responsible for
           protecting and improving the health and marketability of animals
           and animal products by preventing, controlling, and eliminating
           animal diseases. USDA undertakes disease surveillance and response
           activities to protect U.S. livestock, ensure the safety of
           international trade, and contribute to the national zoonotic
           disease12 surveillance effort.

           The United States is a member of WHO, which is responsible for
           coordinating international disease surveillance and response
           efforts. An agency of the United Nations, WHO administers the
           International Health Regulations, which outline WHO's role and the
           responsibility of member countries and regions in preventing the
           global spread of infectious diseases. WHO also helps marshal
           resources from its members to control outbreaks within individual
           countries or regions. In addition, WHO works with national
           governments to improve their surveillance capacities through-for
           example-assessing and redesigning national surveillance
           strategies, offering training in epidemiologic and laboratory
           techniques, and emphasizing more efficient communication systems.

           Surveillance is a key component in planning for an influenza
           pandemic, and federal public health officials plan to rely on the
           nation's existing annual influenza surveillance system and
           enhancements to identify an influenza pandemic. Federal public
           health officials have undertaken several initiatives that are
           intended to enhance influenza surveillance capabilities. These
           initiatives have been undertaken both through programs specific to
           influenza as well as through programs focused more generally on
           increasing preparedness for bioterrorism and other emerging
           infectious disease health threats. Federal officials have
           implemented and expanded syndromic surveillance systems13 in order
           to detect outbreaks more quickly, but there are concerns that
           these systems are costly to run and still largely untested.
           Federal officials have also implemented initiatives designed to
           improve public health communications and have undertaken
           initiatives intended to improve the coordination of zoonotic
           surveillance efforts.

           Current U.S. surveillance for identifying annual influenza
           outbreaks as well as an influenza pandemic involves multiple
           public health partners at all levels of government and relies on
           several data sources. At the federal level, CDC's Influenza Branch
           leads the national influenza surveillance effort, monitoring
           disease and viral trends using data submitted each week from
           October through May. These surveillance data are collected at the
           local and state levels and voluntarily submitted to CDC. Data
           submitted on influenza activity in the United States include data
           from more than 120 laboratories and 2,000 health care providers
           and mortality reports from 122 cities. In addition, influenza data
           are collected from all 50 state health departments and the health
           departments in the District of Columbia and New York City. CDC
           also receives data that are specifically focused on influenza in
           pediatric patients. When the data are used collectively, they
           provide a national picture of influenza activity. Specifically,
           they allow CDC to (1) identify when and where influenza activity
           is occurring, (2) determine what strains of the influenza virus
           are in circulation, (3) detect changes in the influenza virus, (4)
           monitor influenza-related illnesses, and (5) measure the impact
           influenza is having on deaths in the United States.

           DOD also plays a role in national and international influenza
           surveillance. Specifically, DOD's Influenza Surveillance Program,
           under the direction of the Air Force, collects viral specimens
           from its active duty personnel and their dependents at military
           facilities around the world. DOD's program also sends specimens to
           CDC for further analysis and contributes to the determination of
           which viral strains FDA includes in the nation's annual influenza
           vaccine. Internationally, DOD provides viral specimens to WHO and
           assists in identifying emerging influenza strains.

           In countries throughout the world, infectious disease surveillance
           is a national responsibility, but WHO assists its members' efforts
           through its Global Influenza Surveillance Network. WHO's Network
           is composed of 112 institutions, called National Influenza
           Centres, from 83 countries. Collectively, these Centres monitor
           influenza activity and annually gather more than 175,000 viral
           specimens for analysis from patients with influenza-like illnesses
           throughout the world. Selected influenza isolates-an estimated
           2,000 viruses-may also be sent to one of four WHO Collaborating
           Centres14 for further, more specific genetic analysis. The
           additional analysis conducted by the WHO Collaborating Centers is
           used for the annual WHO recommendations on which strains to
           include in the influenza vaccine for the northern and southern
           hemispheres. In addition to making recommendations on the
           components of the influenza vaccine, this Global Influenza
           Surveillance Network also serves as a global alert mechanism for
           the emergence of influenza viruses with pandemic potential.

           CDC has undertaken several initiatives that are intended to
           enhance influenza surveillance capabilities in preparation for an
           influenza pandemic. CDC works with its international partners to
           improve global surveillance for influenza. For example, CDC
           participates in international disease and laboratory surveillance
           sponsored by WHO. Also, when concerns were raised over recent
           influenza seasons that the avian influenza A (H5N1) could become
           the next influenza pandemic, CDC led a variety of efforts with its
           international partners to plan for and address threats of
           increased influenza activity worldwide. For example, CDC worked
           collaboratively with WHO to conduct investigations of avian
           influenza A in Vietnam and to provide laboratory testing. CDC also
           provided training assistance and has implemented an initiative to
           improve influenza surveillance in Asia.

           CDC also supports several domestic initiatives to improve
           surveillance capabilities for influenza. For example, CDC supports
           enhanced influenza surveillance activities through its
           Epidemiology and Laboratory Capacity (ELC) Grants. Established in
           1997, this program provides funding to state and local influenza
           programs. Grants have steadily increased from the first awards in
           1997, when less than $100,000 was provided to five states through
           August 2004, with funding totaling more than $2 million being
           given to about 47 states or major metropolitan areas. States and
           cities receiving ELC-influenza funding are encouraged to achieve
           three highlighted influenza epidemiology and laboratory
           surveillance capacities: sentinel physician surveillance, viral
           isolation and subtyping, and year-round surveillance. Each state
           targets funding to meet one or more of these three priorities and
           uses funding for support of improvements that include the
           assignment or hiring of an influenza coordinator, recruitment of
           sentinel physicians to collect influenza specimens and report
           influenza-like illness to the state, laboratory infrastructure
           enhancements to increase influenza testing capabilities for viral
           isolation and subtyping, and expansion of influenza surveillance
           activities to year-round.

           In an effort to enhance the ability to detect infectious disease
           outbreaks, particularly in their early stages, federal funding has
           supported state efforts to implement numerous syndromic
           surveillance systems. These systems collect information on
           syndromes from a variety of sources. For example, the National
           Retail Data Monitor (NRDM) collects data from retail sources
           instead of hospitals. As of February 2004, NRDM collected sales
           data from about 19,000 stores, including pharmacies, in order to
           monitor sales patterns in such items as over-the-counter influenza
           medications for signs of a developing infectious disease outbreak.

           CDC is taking steps to enhance its two public health
           communications systems, the Health Alert Network (HAN)15 and the
           Epidemic Information Exchange (Epi-X),16 which are used in disease
           surveillance and response efforts. For example, CDC is working to
           increase the number of HAN participants who receive assistance
           with their communication capacities. In addition, following
           reports of human deaths from avian influenza A in Vietnam in
           August 2004, CDC issued a HAN message reiterating criteria for
           domestic surveillance, diagnostic evaluation, and infection
           control precautions. CDC also issued detailed laboratory testing
           procedures for avian influenza through HAN. Similarly, CDC has
           expanded Epi-X by giving officials at other federal agencies and
           departments, such as DOD, the ability to use the system. CDC is
           also adding users to Epi-X from local health departments, giving
           access to CDC staff in other countries, and making the system
           available to Field Epidemiology Training Programs (FETP) located
           in 21 countries.17 Finally, CDC is facilitating Epi-X's interface
           with other data sources by allowing users to access the Global
           Public Health Intelligence Network (GPHIN), the system that
           searches Web-based media for information on infectious disease
           outbreaks worldwide.

           In addition to the efforts to enhance communication systems,
           federal public health officials also have enhanced federal
           coordination for zoonotic disease surveillance and expanded
           training programs. According to CDC, nearly 70 percent of emerging
           infectious disease episodes during the past 10 years have been
           zoonotic diseases. Moreover, recent outbreaks of human disease
           caused by avian influenza strains in Asia and Europe highlight the
           potential for new strains to be introduced into the population.
           Surveillance for zoonotic diseases requires collaboration between
           animal and human disease specialists. CDC, USDA, and FDA have made
           efforts to enhance their coordination of zoonotic disease
           surveillance. For example, CDC and UDSA are working with two
           national laboratory associations to add veterinary diagnostic
           laboratories to the Laboratory Response Network (LRN).18 As of May
           2004, 10 veterinary laboratories had been added to LRN, and CDC
           officials told us that they had plans to add more veterinary
           laboratories in the future. In addition, CDC officials told us the
           agency has appointed a staff person whose responsibility, in part,
           is to assist in finding ways to enhance zoonotic disease
           coordination efforts among federal agencies and departments and
           with other organizations. This person is helping CDC develop a
           working group of officials from CDC, USDA, and FDA to coordinate
           zoonotic disease surveillance.19 According to CDC officials, the
           goal of this working group is to explore ways to link existing
           surveillance systems to better coordinate and integrate
           surveillance for wildlife, domestic animal, and human diseases.
           CDC officials also said that the agency is exploring the
           feasibility of a pilot project to demonstrate this proposed
           integrated zoonotic disease surveillance system. In addition, USDA
           officials told us that they hired 23 wildlife biologists in fall
           2003 to coordinate disease surveillance, monitoring, and
           management activities among USDA, CDC, states, and other federal
           agencies. While each of these initiatives is intended to enhance
           the surveillance of zoonotic diseases, each is still in the
           planning stage or the very early stages of implementation.

           USDA also conducts influenza surveillance in domestic animals.
           Coordination with USDA is important because a pandemic strain is
           likely to arise from genetic mixing of animal and human influenza
           viruses. Recent outbreaks in domestic poultry in Asia and Europe
           associated with cases of human disease highlight the importance of
           coordinating surveillance activities. Surveillance for influenza
           viruses in poultry in the United States has increased
           substantially since the outbreak of highly pathogenic avian
           influenza (HPAI) in Pennsylvania and surrounding states in 1983
           and 1984. However, individual states are generally responsible for
           the development and implementation of surveillance programs that
           are consistent with the size and complexity of the resident
           poultry industry.

           Challenges regarding the nation's preparedness for and response to
           an influenza pandemic remain. Specifically, our prior work has
           found that although CDC participated in an interagency working
           group that developed the U.S. plan for pandemic preparedness that
           was posted for public comment in August 2004, as of May 23, 2005,
           the plan had not been finalized. Further, we found that the draft
           plan does not address certain critical issues, including how
           vaccine for an influenza pandemic will be purchased, distributed,
           and administered; how population groups will be prioritized for
           vaccination; what quarantine authorities or travel restrictions
           may need to be invoked; and how federal resources should be
           deployed. At the state level, we found that most hospitals across
           the country lack the capacity to respond to large-scale infectious
           disease outbreaks.

           In August 2004, HHS released its national pandemic influenza plan
           for comment. The draft "Pandemic Influenza Preparedness and
           Response Plan" describes HHS's role in coordinating a national
           response to an influenza pandemic and provides guidance and tools
           to promote pandemic preparedness planning and coordination at the
           federal, state, and local levels, including both the public and
           the private sectors. However, as of May 23, 2005, this document
           remained in draft form. Further, although the plan is
           comprehensive in scope, it leaves many important decisions
           unresolved about the purchase, distribution, and administration of
           vaccines. For example, some decisions yet to be made include
           determining the public- versus private-sector roles in the
           purchase and distribution of pandemic influenza vaccines; the
           division of responsibility between the federal government and the
           states for vaccine distribution; and how population groups will be
           prioritized and targeted to receive limited supplies of vaccines.
           Until these key decisions are made, public health officials at all
           levels may find it difficult to plan for an influenza pandemic,
           and the timeliness and adequacy of response efforts may be
           compromised.

           The draft plan does not establish a definitive federal role in the
           purchase and distribution of vaccines during an influenza
           pandemic. Instead, HHS provides options for vaccine purchase and
           distribution that include public-sector purchase and distribution
           of all pandemic influenza vaccine; a mixed public-private system
           where public-sector supply may be targeted to specific priority
           groups; and maintenance of the current largely private system. In
           its draft plan, HHS does not recommend a specific alternative.

           Furthermore, the draft plan delegates to the states responsibility
           for distribution of vaccine. The lack of a clearly defined federal
           role in distribution complicates pandemic planning for the states.
           Furthermore, among the current state pandemic influenza plans,
           there is no consistency in terms of their procurement and
           distribution of vaccine and the relative role of the federal
           government. Approximately half of the states handle procurement
           and distribution of the annual influenza vaccine through the state
           health agency. The remainder either operate through a third-party
           contractor for distribution to providers or use a combination of
           these two approaches.

           Challenges persist in ensuring an adequate and timely influenza
           vaccine supply. The number of producers remains limited, and the
           potential for manufacturing problems such as those experienced
           during the 2004-2005 influenza season is still present. When one
           manufacturer's production is affected, providers who order vaccine
           from that manufacturer can experience shortages, while providers
           who receive supplies from another manufacturer may have all the
           vaccine they need. The allocation plan CDC developed for this past
           season's shortage was dependent upon voluntary compliance by the
           private sector and individuals to forgo vaccination. Most annual
           influenza vaccine distribution and administration are accomplished
           within the private sector, with relatively small amounts of
           vaccine purchased and distributed by CDC or by state and local
           health departments. In the United States, 85 percent of vaccine
           doses are purchased by the private sector, such as private
           physicians and pharmacies. HHS has not yet determined how
           influenza vaccine will be distributed and administered during an
           influenza pandemic.

           There are many issues surrounding the production of influenza
           vaccine, which will only become exacerbated during an influenza
           pandemic. Vaccines, which are considered the first line of defense
           to prevent or reduce influenza-related illness and death, may be
           unavailable or in short supply. Producing the vaccine is a complex
           process that involves growing viruses in millions of fertilized
           chicken eggs. Experience has shown that the vaccine production
           cycle takes at least 6 to 8 months after a virus strain has been
           identified, and vaccines for some influenza strains have been
           difficult to mass-produce, causing further delay. The lengthy
           process for developing a vaccine may mean that a vaccine would not
           be available during the initial stages of a pandemic.

           Vaccine shortages during the 2004-2005 influenza season have
           highlighted the fragility of the influenza vaccine market and the
           need for its expansion and stabilization. Currently, only two
           manufacturers are licensed to sell their vaccine in the United
           States.20 Maintaining an influenza vaccine supply is critically
           important for protecting the public's health and improving our
           preparedness for an influenza pandemic. As a result, according to
           CDC officials, the agency plans to alleviate the impact of next
           year's influenza season by taking aggressive steps to ensure an
           expanded influenza supply to protect the nation. To this end, the
           agency's fiscal year 2006 budget request includes an increase of
           $30 million for CDC to enter into guaranteed purchase contracts
           with vaccine manufacturers to ensure the production of bulk
           monovalent influenza vaccine. If supplies fall short, this bulk
           product can be turned into a finished trivalent influenza vaccine
           product for annual distribution. If supplies are sufficient, the
           bulk vaccine can be held until the following year's influenza
           season and developed into vaccines if the circulating strains
           remain the same. In addition, according to CDC, this guarantee
           will help to expand the influenza market by providing an incentive
           to manufacturers to expand capacity and possibly encourage
           additional manufacturers to enter the market. In addition, the
           fiscal year 2006 budget request includes an increase of $20
           million to support influenza vaccine purchase activities.

           Even if sufficient quantities of the vaccine are produced in time,
           vaccines against various strains differ in their ability to
           produce the immune response necessary to provide effective
           protection against the disease. Studies show that it is uncertain
           how effective a vaccine will be in preventing or controlling the
           spread of a pandemic influenza virus.

           Early in an influenza pandemic, especially before a vaccine is
           available or during a period of limited vaccine supply, use of
           antiviral drugs may have a significant effect. Specifically,
           antiviral drugs can help prevent or mitigate the number of
           influenza-related deaths until an influenza vaccine becomes
           available. They can be used against all strains of pandemic
           influenza and have immediate availability as both a prophylactic
           to prevent illness and as a treatment if administered within 48
           hours of the onset of symptoms. According to HHS, analysis is
           ongoing to define optimal antiviral use strategies, potential
           health impacts, and cost-effectiveness of antiviral drugs in the
           setting of a pandemic.

           The United States has a limited supply of influenza antiviral
           medications stored for an influenza pandemic. HHS officials expect
           the amount produced will be below demand during a pandemic. This
           assumption, supported by drug manufacturers, is based on the fact
           that current production levels of antiviral drugs are set in
           response to current demand, whereas demand in a pandemic is
           expected to increase significantly if vaccines are unavailable. In
           addition, the production of antiviral medications cannot be
           rapidly expanded and involves a long production process. Moreover,
           sometimes influenza virus strains can become resistant to one or
           more of the four approved influenza antiviral drugs, and thus the
           drugs may not always work. For example, the influenza A (H5N1)
           viruses identified in human patients in Asia in 2004 and 2005 have
           been resistant to two of the four antiviral drugs, amantadine and
           rimantadine.

           Another challenge in responding to an influenza pandemic involves
           implementing certain control measures to prevent the spread of the
           disease. These control measures-case identification and contact
           tracing, transmission control, and exposure management-are
           well-established and have proved effective in both health care and
           community settings.21 However, federal attempts to limit the
           spread of SARS into the United States by advising passengers who
           traveled to infected countries faced multiple obstacles. For
           example, due to airline concerns over authority and privacy, as
           well as procedural constraints, CDC was unable to obtain passenger
           contact information it needed to trace travelers. Although HHS has
           statutory authority to prevent the introduction, transmission, or
           spread of communicable diseases from foreign countries into the
           United States,22 HHS regulations implementing the statute do not
           specifically provide for HHS to obtain passenger manifests or
           other passenger contact information from airlines and shipping
           companies for disease outbreak control purposes.23

           A challenge identified during the SARS outbreak that may also
           affect response efforts during an influenza pandemic is lack of
           sufficient hospital and workforce capacity. This lack could be
           exacerbated during an influenza pandemic, compared to other
           natural disasters, such as a tornado or hurricane, or an
           intentional release of a bioterrorist agent, because it is likely
           that a pandemic would result in both widespread and sustained
           effects.

           Public health officials we spoke with said a large-scale outbreak,
           such as an influenza pandemic, could strain the available capacity
           of hospitals by requiring entire hospital sections (along with
           their staff) to be used as isolation facilities. As we have
           reported earlier, most states lack "surge capacity," that is, the
           capacity to respond to the large influx of patients that could
           occur during a large public health emergency.24 For example, few
           states reported that they had the capacity to evaluate, diagnose,
           and treat 500 or more patients involved in a single incident. In
           addition, few states reported having the capacity to rapidly
           establish clinics to immunize or provide treatment to large
           numbers of patients. Moreover, a shortage in workforce could
           increase during an influenza pandemic because higher disease rates
           could result in high rates of absenteeism among health care
           workers who are likely to be at increased risk of exposure and
           illness.

           There are a number of systems in place to identify influenza
           outbreaks abroad, to alert us to a pandemic, and these systems
           generally appear to be working well. HHS has taken important steps
           to enhance surveillance and to fund initiatives for preparedness
           and response, including steps to increase the vaccine supply.

           However, important challenges remain in our preparedness to
           respond, should an influenza pandemic occur in the United States.
           The steps HHS is taking to address vaccine production capacity and
           stockpiling of antiviral drugs may not be in place in time to fill
           the current gaps in preparedness should an influenza pandemic
           occur in the next several years. As we learned in the 2004-2005
           influenza season, problems affecting even a single manufacturer
           can produce major shortages. Once a pandemic influenza strain is
           identified, a vaccine will take many months to produce, and our
           current stockpile of antiviral drugs is insufficient to meet the
           likely demand. Pandemic influenza would have major impacts on the
           ability of communities to respond, businesses to function, and
           public safety to be maintained when communities across the country
           are simultaneously impacted and hospital capacity is overwhelmed.

           Since 2000, we have been urging the department to complete its
           pandemic plan. A draft plan was issued in August 2004, with a
           60-day period for public comment, but as of this week, the plan
           had not been finalized. It is important for the federal government
           and the states to work through issues such as how vaccine will be
           purchased, distributed, and administered, how population groups
           will be prioritized for vaccination, what quarantine authorities
           or travel restrictions may need to be invoked, and how federal
           resources should be deployed before we are in a time of crisis.

           Mr. Chairman, this concludes my prepared statement. I would be
           happy to respond to any questions you or other Members of the
           Subcommittee may have at this time.

           For further information about this testimony, please contact
           Marcia Crosse at (202) 512-7119. Gloria E. Taylor, Gay Hee Lee,
           Elizabeth T. Morrison, and Roseanne Price made key contributions
           to this statement.

           Emergng Infecious Diseases: Revew of Sate and Federal Disease
           Surveillance Effors. GAO-04-877 . Washington, D.C.: September 30,
           2004.

           nectous Disease Preparedness: Federal Chalenges in Responding
           toInfluenza Outbreaks. GAO-04-1100T . Washington, D.C.: September
           28, 2004.

           Emergng Infecious Diseases: Asian SARS Outbreak Challenged
           nernational and Natonal Responses. GAO-04-564 . Washington, D.C.:
           April 28, 2004.

           Publc Heath Preparedness: Response Capacymproving, bu Much Remains
           to Be Accompshed. GAO-04-458T . Washington, D.C.: February 12,
           2004.

           Infectious Diseases: Gaps Remain in Surveiance Capabilies o State
           and Local Agences. GAO-03-1176T . Washington, D.C.: September 24,
           2003.

           Severe Acute Respiraory Syndrome: Estabished Infectious Dsease
           Control Measures Helped Contain Spread, But a Large-Scale
           Resurgence May Pose Challenges. GAO-03-1058T . Washington, D.C.:
           July 30, 2003.

           SARS Outbreak: Improvemens to Pubc Health Capacity Are Needed
           forResponding o Bioerrorism and Emergng Infectous Diseases.
           GAO-03-769T . Washington, D.C.: May 7, 2003.

           Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts
           Have mproved Pubc HealhResponse Capacty, but Gaps Reman.
           GAO-03-654T . Washington, D.C.: April 9, 2003.

           Global Healh: Chalenges in Improving Infectious Disease Surveance
           Systems. GAO-01-722 . Washington, D.C.: August 31, 2001.

           Flu Vaccine: Steps Are Needed to Better Prepare for Possible
           Future Shortages. GAO-01-786T . Washington, D.C.: May 30, 2001.

           Flu Vaccne: Supply Probems Heighen Need o Ensure Access for
           HighRisk People. GAO-01-624 . Washington, D.C.: May 15, 2001.

           nluenza Pandemic: Pan Needed for Federal and State Response.
           GAO-01-4 . Washington, D.C.: October 27, 2000.

           West Nile Virus Outbreak: Lessons for Pubic Healh Preparedness.
           GAO/HEHS-00-180 . Washington, D.C.: September 11, 2000.

           Global Health: Framework for Infectious Disease Surveillance.
           GAO/NSIAD-00-205R . Washington, D.C.: July 20, 2000.

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12Zoonotic diseases are those diseases that are transmitted from animals
to humans.

    Existing Influenza Surveillance System and Enhancements Would Be Used to
                         Identify an Influenza Pandemic

Systems Are in Place to Routinely Monitor for Influenza

13Many syndromic surveillance systems currently in use in the United
States were developed in response to the September 11, 2001, attacks on
the World Trade Center and Pentagon and to the anthrax outbreaks that
occurred shortly afterwards. The fundamental objective of syndromic
surveillance is to identify illness clusters early, before diagnoses are
confirmed and reported to public health agencies.

14A WHO Collaborating Centre is a national institution designated by WHO
to form part of an international collaborative network that contributes to
implementing WHO's program priorities and to strengthening institutional
capacity in countries and regions. Collaborating Centre activities include
collection and dissemination of information, education and training, and
participation in collaborative research developed under WHO's leadership.
The four Collaborating Centres that are part of WHO's Global Influenza
Surveillance Network are located in the United States, Australia, Japan,
and the United Kingdom.

Federal Agencies Have Undertaken Initiatives to Enhance Influenza Surveillance

15The Health Alert Network (HAN) is an early-warning and response system
operated by CDC that is designed to ensure that state and local health
departments as well as other federal agencies and departments have timely
access to emerging health information.

16The Epidemic Information Exchange (Epi-X) is a secure, Web-based
communication system operating in all 50 states. CDC uses this system
primarily to share information relevant to disease outbreaks with state
and local public health officials and with other federal officials. Epi-X
also serves as a forum for routine professional discussions and
nonemergency inquiries.

17In selected foreign locations, CDC operates international training
programs, such as FETP. Through FETP, each year CDC trains approximately
50 to 60 physicians and social scientists in applied public health,
integrating disease surveillance, applied research, prevention, and
control activities. Graduates of the FETP program serve in their native
country and provide links between CDC and their respective ministries of
health. CDC officials said that trainees from its international programs
have frequently provided important information on disease outbreaks.

18To strengthen the nation's capacity to rapidly detect biological and
chemical agents that could be used as a terrorist weapon, CDC, in
partnership with the Federal Bureau of Investigation and the Association
of Public Health Laboratories, created LRN in 1999. According to CDC, LRN
leverages the resources of 126 laboratories to maintain an integrated
national and international network of laboratories that are fully equipped
to respond quickly to acts of chemical or biological terrorism, emerging
infectious diseases, and other public health threats and emergencies. The
network includes federal, state and local public health, military, and
international laboratories, as well as laboratories that specialize in
food, environmental, and veterinary testing. LRN laboratories have been
used in several public health emergencies. For example, in 2001, a Florida
LRN laboratory discovered the presence of Bacillus anthracs, the pathogen
that causes anthrax, in a clinical specimen it tested.

19This working group was created in response to a congressional mandate
that the Secretary of Health and Human Services, through FDA and CDC, and
USDA, coordinate the surveillance of zoonotic diseases. Public Health
Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L.
No. 107-188, S:313, 116 Stat. 594, 674 (2002).

 Despite Efforts by Federal Officials, Challenges Remain regarding Preparedness
                   for and Response to an Influenza Pandemic

HHS's Pandemic Influenza Plan Remains in Draft and Leaves Many Important Issues
Unresolved

Challenges Persist in Ensuring an Adequate and Timely Influenza Vaccine Supply

20During the 2004-2005 influenza season, the license for a third
manufacturer was suspended by British regulatory authorities due to safety
concerns with the vaccine.

Challenges Persist in Ensuring an Adequate Supply of Antiviral Drugs

Implementation of Control Measures to Prevent Spread of Pandemic Influenza
Presents Difficulties

Most Hospitals Lack the Capacity to Respond to Large-Scale Infectious Disease
Outbreaks

21In the United States, the Healthcare Infection Control Practices
Advisory Committee, a federal advisory committee made up of 14 infection
control experts, develops recommendations and guidelines regarding general
infectious disease control measures for CDC. Expert recommendations
include (1) case identification and contact tracing, which involves
defining what symptoms, laboratory results, and medical histories
constitute a positive case in a patient and tracing and tracking
individuals who may have been exposed to these patients; (2) transmission
control, which involves controlling the transmission of disease-producing
microorganisms through use of proper hand hygiene and personal protective
equipment, such as masks, gowns, and gloves; and (3) exposure management,
which involves separating infected and noninfected individuals.

22Section 361 of the Public Health Service Act, 42 U.S.C. S: 264.

23See 42 C.F.R. pts 70 and 71; 21 C.F.R. pts 1240 and 1250.

                            Concluding Observations

24See GAO, Public Heath Preparedness: Response Capaciy Improving, but Much
Remansto be Accomplished, GAO-04-458T (Washington, D.C.: Feb. 12, 2004).

                       Contact and Staff Acknowledgments

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Highlights of GAO-05-760T , a testimony before the Subcommittee on Health,
Committee on Energy and Commerce, House of Representatives

May 26, 2005

INFLUENZA PANDEMIC

Challenges Remain in Preparedness

Vaccine shortages and distribution problems during the 2004-2005 influenza
season raised concerns about the nation's ability to respond to a
worldwide influenza epidemic-or influenza pandemic-which many experts
believe to be inevitable. Some experts believe that the next pandemic
could be spawned by the recurring avian influenza in Asia. If avian
influenza strains directly infect humans and acquire the ability to be
readily transmitted between people, a pandemic could occur. Modeling
studies suggest that its effect in the United States could be severe, with
one estimate from the Centers for Disease Control and Prevention (CDC)
ranging from 89,000 to 207,000 deaths and from 38 million to 89 million
illnesses.

GAO was asked to discuss surveillance systems in place to identify and
monitor an influenza pandemic and concerns about preparedness for and
response to an influenza pandemic. This testimony is based on GAO's 2004
report on disease surveillance; reports and testimony on influenza
outbreaks, influenza vaccine supply, and pandemic planning that GAO has
issued since October 2000; and work GAO has done in May 2005 to update key
information.

Federal public health officials plan to rely on the nation's existing
influenza surveillance system and enhancements to identify an influenza
pandemic. CDC currently collaborates with multiple public health partners,
including the World Health Organization (WHO), to obtain data that provide
national and international pictures of influenza activity. Federal public
health officials and health care organizations have undertaken several
initiatives that are intended to enhance influenza surveillance
capabilities. While some of these initiatives are focused more generally
on increasing preparedness for bioterrorism and other emerging infectious
disease health threats, others have been undertaken in preparation for an
influenza pandemic. For example, in response to concerns over the past few
years about the potential for avian influenza to become the next influenza
pandemic, CDC implemented an initiative in cooperation with WHO to improve
influenza surveillance in Asia. CDC has also implemented initiatives to
improve the communications systems it uses to collect and disseminate
surveillance information. In addition, CDC, the Department of Agriculture,
and the Food and Drug Administration have made efforts to enhance their
coordination of surveillance efforts for diseases that arise in animals
and can be transferred to humans, such as SARS and certain strains of
influenza with the potential to become pandemic.

While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with regard
to other aspects of preparedness for and response to an influenza
pandemic. In particular, the Department of Health and Human Services (HHS)
has not finalized planning for an influenza pandemic. In 2000, GAO
recommended that HHS complete the national plan for responding to an
influenza pandemic, but the plan has been in draft format since August
2004. Absent a completed federal plan, key questions about the federal
role in the purchase, distribution, and administration of vaccines and
antiviral drugs during a pandemic remain unanswered. Other challenges with
regard to preparedness for and response to an influenza pandemic exist
across the public and private sectors, including challenges in ensuring an
adequate and timely influenza vaccine and antiviral supply; addressing
regulatory, privacy, and procedural issues surrounding measures to control
the spread of disease, for example, across national borders; and resolving
issues related to an insufficient hospital and health workforce capacity
for responding to a large-scale outbreak such as an influenza pandemic.
*** End of document. ***