United States Government Accountability Office

GAO Testimony 

Before the Subcommittee on Health,

Committee on Energy and Commerce,

House of Representatives 

INFLUENZA PANDEMIC

Challenges Remain in 

Preparedness 

Statement of Marcia Crosse 

Director, Health Care

For Release on Delivery 

Expected at 10:00 a.m. EDT 

Thursday, May 26, 2005 

 

GAO-05-760T
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

May 26, 2005

INFLUENZA PANDEMIC

Challenges Remain in Preparedness 

Highlights of GAO-05-760T, a testimony

before the Subcommittee on Health,

Committee on Energy and Commerce,

House of Representatives

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 largescale 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.
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 

 

t i t t

i

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 Ou break: Improvements to Publ c Heal h Capaci y Are Needed for

Responding to Bioterror sm 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. 

Page 1 GAO-05-760T 
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. 

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, 

 

i i l i il

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 Infect ous D seases: Review of State and Federa D sease Surve lance

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. 

Page 2 GAO-05-760T 
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 

Page 3 GAO-05-760T 
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. 

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. 

Background 

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

 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. 

Page 4 GAO-05-760T 
HHS has limited authority, however, to directly control influenza vaccine 

production and distribution.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.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 

 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.

Page 5 GAO-05-760T 
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 disease12 surveillance effort. 

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

Page 6 GAO-05-760T 
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 

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. 

Page 7 GAO-05-760T 
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 

 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. 

Page 8 GAO-05-760T 
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 yearround 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 influenzalike 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 

Federal Agencies Have 

Undertaken Initiatives to 

Enhance Influenza 

Surveillance 

Page 9 GAO-05-760T 
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.

 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.

Page 10 GAO-05-760T 
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 

 

i

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 anthrac s, 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, §313, 116 Stat. 594, 674 (2002). 

Page 11 GAO-05-760T 
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 

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 

Page 12 GAO-05-760T 
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 publicsector 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

Challenges Persist in

Ensuring an Adequate and 

Timely Influenza Vaccine 

Supply 

Page 13 GAO-05-760T 
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. 

 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.

Page 14 GAO-05-760T 
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. 

Challenges Persist in

Ensuring an Adequate 

Supply of Antiviral Drugs 

Page 15 GAO-05-760T 
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 

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. § 264. 

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

Page 16 GAO-05-760T 
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,

Concluding

Observations 

 l t i 24See GAO, Public Hea th Preparedness: Response Capaci y Improving, but Much Rema ns

to be Accomplished, GAO-04-458T (Washington, D.C.: Feb. 12, 2004).

Page 17 GAO-05-760T 
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.

Contact and Staff 

Acknowledgments 

Page 18 GAO-05-760T 
Page 19 GAO-05-760T 

Related GAO Products 

Emerg ng Infec ious Diseases: Rev ew of S ate and Federal Disease 

Surveillance Effor s. 

i t i t

t

I f i l

i t

I t i

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li

ll it f

i

t l i

t li

t t i i

I li t i i

t l ill

i l t t -

I f l

GAO-04-877. Washington, D.C.: September 30, 2004. 

n ect ous Disease Preparedness: Federal Chal enges in Responding to

Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28, 

2004. 

Emerg ng Infec ious Diseases: Asian SARS Outbreak Challenged 

n ernational and Nat onal Responses. GAO-04-564. Washington, D.C.: 

April 28, 2004. 

Publ c Hea th Preparedness: Response Capac y mproving, bu Much 

Remains to Be Accomp shed. GAO-04-458T. Washington, D.C.: 

February 12, 2004. 

Infectious Diseases: Gaps Remain in Survei ance Capabil ies o State and 

Local Agenc es. GAO-03-1176T. Washington, D.C.: September 24, 2003. 

Severe Acute Respira ory Syndrome: Estab ished Infectious D sease 

Control Measures Helped Contain Spread, But a Large-Scale Resurgence 

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SARS Outbreak: Improvemen s to Pub c Health Capacity Are Needed for

Responding o Bio errorism and Emerg ng Infect ous Diseases. GAO-03-

769T. Washington, D.C.: May 7, 2003. 

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have 

mproved Pub c Heal h Response Capac ty, but Gaps Rema n. GAO-03-

654T. Washington, D.C.: April 9, 2003. 

Global Heal h: Chal enges in Improving Infectious Disease Surve ance 

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 Vacc ne: Supply Prob ems Heigh en Need o Ensure Access for High

Risk People. GAO-01-624. Washington, D.C.: May 15, 2001. 

n luenza Pandemic: P an Needed for Federal and State Response. GAO01-4. Washington, D.C.: October 27, 2000. 
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GAO/NSIAD-00-205R. Washington, D.C.: July 20, 2000. 

(290466) Page 20 GAO-05-760T 
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