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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:

GAO Highlights:

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

Why GAO Did This Study:

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. 

What GAO Found:

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.

www.gao.gov/cgi-bin/getrpt?GAO-05-760T.

To view the full product, including the scope and methodology, click on 
the link above. For more information, contact Marcia Crosse at (202) 
512-7119.

[End of section]

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.[Footnote 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,[Footnote 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.[Footnote 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.[Footnote 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.

You asked us to provide our perspective on the nation's ability to 
conduct disease surveillance[Footnote 5] 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 
surveillance[Footnote 6] as well as reports and testimony on influenza 
outbreaks, influenza vaccine supply, pandemic planning, and the SARS 
outbreak that we have issued since October 2000[Footnote 7] 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,[Footnote 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.

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.[Footnote 9] HHS has limited 
authority, however, to directly control influenza vaccine production 
and distribution.[Footnote 10]

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.[Footnote 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.

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

* 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.":

* 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.

* 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.

* 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.

* 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 disease[Footnote 12] 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.

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

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 systems[Footnote 
13] 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.

Systems Are in Place to Routinely Monitor for Influenza:

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 Centres[Footnote 14] 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.

Federal Agencies Have Undertaken Initiatives to Enhance Influenza 
Surveillance:

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)[Footnote 15] and the Epidemic 
Information Exchange (Epi-X),[Footnote 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.[Footnote 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).[Footnote 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.[Footnote 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.

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

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.

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

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:

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.[Footnote 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.

Challenges Persist in Ensuring an Adequate Supply of Antiviral Drugs:

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.

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

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.[Footnote 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,[Footnote 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.[Footnote 23]

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

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.[Footnote 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.

Concluding Observations:

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.

Contact and Staff Acknowledgments:

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.

[End of section]

Related GAO Products:

Emerging Infectious Diseases: Review of State and Federal Disease 
Surveillance Efforts. GAO-04-877. Washington, D.C.: September 30, 2004.

Infectious Disease Preparedness: Federal Challenges in Responding to 
Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28, 
2004. 

Emerging Infectious Diseases: Asian SARS Outbreak Challenged 
International and National Responses. GAO-04-564. Washington, D.C.: 
April 28, 2004.

Public Health Preparedness: Response Capacity Improving, but Much 
Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: February 12, 
2004.

Infectious Diseases: Gaps Remain in Surveillance Capabilities of State 
and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003.

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

SARS Outbreak: Improvements to Public Health Capacity Are Needed for 
Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03- 
769T. Washington, D.C.: May 7, 2003.

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have 
Improved Public Health Response Capacity, but Gaps Remain. GAO-03-654T. 
Washington, D.C.: April 9, 2003.

Global Health: Challenges in Improving Infectious Disease Surveillance 
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 Vaccine: Supply Problems Heighten Need to Ensure Access for High- 
Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.

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

West Nile Virus Outbreak: Lessons for Public Health 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.

FOOTNOTES

[1] An 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. 

[2] See GAO, SARS Outbreak: Improvements to Public Health Capacity Are 
Needed for Responding to Bioterrorism and Emerging Infectious Diseases, 
GAO-03-769T (Washington, D.C.: May 7, 2003). 

[3] Influenza 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.

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

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

[6] See GAO, Emerging Infectious Diseases: Review of State and Federal 
Disease Surveillance Efforts, GAO-04-877 (Washington, D.C.: Sept. 30, 
2004).

[7] See "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.

[8] These 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.

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

[10] Under 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.

[11] The 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.

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

[13] Many 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.

[14] A 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.

[15] The 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.

[16] The 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.

[17] In 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.

[18] To 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 anthracis, the 
pathogen that causes anthrax, in a clinical specimen it tested.

[19] This 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, §313, 116 Stat. 594, 674 (2002).

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

[21] In 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.

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

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

[24] See GAO, Public Health Preparedness: Response Capacity Improving, 
but Much Remains to be Accomplished, GAO-04-458T (Washington, D.C.: 
Feb. 12, 2004).