Scott R. Lillibridge, M.D.

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Testimony
Before the Committee on Budget
United States House of Representatives

Restructuring Government for Homeland Security: Nuclear/Biological/Chemical Threats

Statement of
Scott R. Lillibridge, M.D.
Special Assistant to the Secretary for National Security and Emergency Management
Department of Health and Human Services

For Release on Delivery
Expected at 10:00 am
on Wednesday, December 5, 2001

Mr. Chairman and Members of the Committee, I am Scott Lillibridge, the Special Assistant to the Secretary for National Security and Emergency Management. Thank you for inviting me here today to discuss the HHS role in preparing our nation for nuclear, biological and chemical threats. Our Department's work has primarily been in the area of bioterrorism response. This had already been a major focus of HHS activities, and the horrific events of September 11^th. The subsequent events related to anthrax have only sharpened that focus.

HHS is the primary agency responsible for the health and medical response under the Federal Emergency Management Agency's (FEMA's) Federal Response Plan (FRP). This plan provides HHS with a framework to respond with FEMA and 26 other Federal departments and agencies, along with the American Red Cross.

Prior to the September 11^th attack on the United States, HHS, through the Centers for Disease Control and Prevention (CDC), had made substantial gains in addressing HHS' role in preparing for response to terrorism. Since September 11^th, this progress have been dramatically accelerated, and HHS has been in constant communication with its component agencies, as well as other federal, state, and local government components, in order to ensure our preparedness to protect the Nation's health in the event of future attacks. To support this process, President Bush has requested an additional $1.5 billion as a supplement to the Fiscal Year 2002 request to strengthen our ability to respond to bioterrorism. Within HHS, the component agencies are each moving ahead with programs to further support our efforts. Allow me to describe some of these programs:

State and Local Preparedness

Over the last three years, CDC has awarded grants to 50 states, one territory and four major metropolitan health departments to support goals of building infrastructure and increasing response capacity.

The funded programs have included the Health Alert Network (HAN), the Laboratory Response Network (LRN), and the Epidemic Information Exchange System (Epi-X).

The Health Alert Network (HAN) is a nationwide, integrated, electronic communications system for public health professionals to share health advisories, distance learning, laboratory findings and other information relevant to disease outbreaks. HAN provides high-speed Internet connections and tailored content to local health officials and other essential personnel.

The Laboratory Response Network (LRN) is a partnership among the Association of Public Health Laboratories (APHL), CDC, the Federal Bureau of Investigations (FBI), state public health laboratories, the Department of Defense (DOD), and the Nation's clinical laboratories. The LRN is designed to ensure that the highest level of containment and expertise in the identification of rare and lethal biological agents is available in an emergency event. The LRN also includes the Rapid Response and Advanced Technology Laboratory at CDC, which has the sole responsibility of providing rapid and accurate triage and subsequent analysis of biological agents suspected of being terrorist weapons.

A final example is the Epidemic Information Exchange System (Epi-X): a secure, Web-based communications network that will strengthen bioterrorism preparedness efforts by facilitating the sharing of preliminary information about disease outbreaks and other health events among officials across jurisdictions and provide experience in the use of a secure communications system.

The HHS Office of Emergency Preparedness (OEP) has also been providing assistance at the state and local level, by developing local Metropolitan Medical Response Systems (MMRS). Through contractual relationships, the MMRS uses existing emergency response systems emergency management, medical and mental health providers, public health departments, law enforcement, fire departments, EMS and the National Guard to provide an integrated, unified response to a mass casualty event. As of September 30, 2001, OEP has contracted with 97 municipalities to develop MMRSs. During FY 2002, we intend to invest in 25 additional cities (for a total of 122) for bioterrorism-related planning through the MMRS and to help them improve their medical response capabilities.

OEP also coordinates the National Disaster Medical System (NDMS), a group of more than 7,000 volunteer health and support professionals who can be deployed anywhere in the country to assist communities in which local response systems are overwhelmed or incapacitated. Organized into 44 Disaster Medical Assistance Teams (DMATs), these volunteers would provide on-site medical triage, patient care and transportation to medical facilities. Four National Medical Response Teams (NMRTs), which travel with their own caches of pharmaceuticals, have capabilities to detect illness-causing agents, decontaminate victims, provide medical care and remove victims from the scene. Three of the four NMRTs can be mobilized and deployed anywhere in the nation; the fourth is permanently stationed in the Washington, D.C. area.

The Administration has requested $300 million in Emergency Response Funds (ERF) for state and local preparedness activities, including $40 million for communications systems such as the Health Alert Network and Epi-X, $35 million to improve state and local laboratory capacity and CDC's internal laboratory capacity, $50 million to upgrade MMRS' capabilities, and $20 million for the National Disaster Medical System and the Disaster Medical Assistance Teams.

National Pharmaceutical Stockpile

CDC has also established and manages the National Pharmaceutical Stockpile (NPS), which provides us with the ability to rapidly respond to a domestic biological or chemical terrorist event with antibiotics, antidotes, vaccines and medical materiel to help save lives and prevent further spread of disease resulting from the terrorist threat agent. The NPS Program provides an initial, broad-based response within 12 hours of the federal authorization to deploy, followed by a prompt and more targeted response as dictated by the specific nature of the biological or chemical agent that is used. The first emergency deployment of the NPS occurred in response to the tragedy at the World Trade Center, and was soon followed up by deployments related to the anthrax attacks.

As you may have heard, HHS has recently awarded a $428 million contract to Acambis, Inc., to produce 155 million doses of smallpox vaccine by the end of 2002. These doses, added to the current quantity in the National Pharmaceutical Stockpile, are enough to treat every American in the event of a smallpox bio-attack.

The additional smallpox vaccine doses will also, we hope, serve the function of acting as a deterrent to those who might launch such an attack against our Nation. We are not only increasing our stockpile for smallpox, however. As you may know, the current stockpile consists of 8 Push Packs, each containing antibiotics and other essential medical supplies, and each transportable within 12 hours to any area of the country requiring assistance. These Push Packs are complemented by large quantities of additional pharmaceuticals stored at manufacturers' warehouses, a system called Vendor Managed Inventory (VMI).

Between them, the Push Packs and the VMI have enough drugs currently to treat 2 million persons to prevent inhalation anthrax following exposure to the anthrax spores. The Secretary has now directed that this quantity be increased during fiscal year 2002, so that 12 million persons can be treated for anthrax. With those and other additional resources, we will also add four more Push Packs to the current eight already located across the country, making more emergency supplies available and augmenting our existing supplies of 400 tons by another 200 tons. The Administration request includes $644 million to expand the pharmaceutical stockpile.

Food Safety and Drug Therapies

Over the last few years, FDA has worked with food safety agencies at federal, state and local levels to strengthen the Nation's food safety system across the entire distribution chain -- from the farm to the table. The main results of this cooperation -- more effective prevention programs, new surveillance systems, and faster foodborne illness outbreak response capabilities -- enable the agency to protect the safety of our food supply against natural and accidental threats.

Part of FDA's ability to protect the food supply is enhanced by its strong partnership with the U.S. Department of Agriculture (USDA) and the surveillance infrastructure that has been built between the two Departments. USDA conducts surveillance of the food supply, and HHS's Centers for Disease Control and Prevention, in partnership with State and local health departments, conducts surveillance for foodborne illnesses. Cooperative efforts between HHS and USDA form the foundation for protecting our nation's food supply and will ensure the American public can continue to have complete confidence in their food supply now and well into the future.

An example of coming FDA funding initiatives is a request for $61 million to enhance the frequency and quality of imported food inspections and modernize the import data system to enable us to detect tainted food. This funding will also provide for 410 new FDA inspectors to help ensure that our food is better protected.

FDA is also requesting additional resources to assist with the development and licensure of vaccines, therapeutics and blood products to counter bioterrorism. In addition, the agency is developing regulations to identify the information needed to evaluate bioterrorism-related therapies when the traditional efficacy studies in humans are not feasible and cannot be ethically conducted under FDA's regulations for adequate and well-controlled studies in humans.

Research

Our National Institutes of Health (NIH) research program includes the development of:

New treatments for complications of the smallpox vaccination;
Improved vaccines and treatments for anthrax;
Trials to determine the extent that the current Dryvax smallpox vaccine can be diluted to "stretch" the current supply until a new vaccine is produced;

Conclusion

In conclusion, the Department of Health and Human Services has been, and continues to be, committed at every level to ensuring the health and medical care of our citizens. We have made substantial progress to date in enhancing the nation's capability to respond to a bioterrorist event, and these preparations ensured a strong response during recent events.

Mr. Chairman, that concludes my prepared remarks. I would be pleased to answer any questions you or members of the committee may have.