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FY 2007 Table of Contents

PANDEMIC PREPAREDNESS

$30,490,000

Why is this initiative necessary?

FDA plays a unique and vital role in the Nation's preparedness for an influenza pandemic. We facilitate the development and availability of safe and effective vaccines and we safeguard America's animal health and food safety systems in the event of an outbreak of avian and pandemic influenza.

The Pandemic Preparedness Initiative responds to the impending threat of pandemic influenza. It builds on the $20,000,000 emergency supplemental appropriation provided to FDA by Congress in Public Law 109-148 and base funds that support preparedness for pandemic and annual influenza.

The FDA request supports the comprehensive DHHS plan to expand the Nation's capacity to increase the availability of vaccine, antivirals, and other countermeasures to protect against an influenza pandemic. The programs and activities in this initiative will support increased vaccine manufacturing capacity to ensure the ability to produce pandemic influenza vaccine for the entire Nation within a six-month period. The request also supports research on promising new vaccine technologies and antivirals, methods to deliver vaccine more effectively and efficiently, improved surveillance to rapidly identify outbreaks of disease in the United States and abroad, and the robust information technology capability to support these requirements.

The Agency also has significant responsibilities in preparing for pandemic-related impacts on the animal and food sectors that FDA regulates. The reported use of antiviral products in poultry, for example, raises concerns about possible drug resistance and the unknown human health effects. FDA must develop or asses test methods used to determine the safety of the food supply. We must also evaluate data on the technologies and cooking methods industry and the public can rely upon to kill the avian virus. FDA must also have surveillance capability to detect and intervene if such a virus is found in the food supply and to integrate its surveillance into the coordinated effort outlined in the President's National Strategy for Pandemic Influenza. To ensure comprehensive pandemic preparedness, the Agency will expand coordination with the U.S. Department of Agriculture (USDA) in preparing and exercising animal health and food related pandemic response and quarantine contingency plans.

FDA is also using base resources to protect consumers from fraudulent products that claim to prevent or treat seasonal or avian influenza in people, as these products represent a potentially significant threat to the public health.

How does this initiative support Executive Branch public health priorities?

FDA's Pandemic Preparedness Initiative achieves the three pillars of the President's National Strategy for Pandemic Influenza. Through this initiative, the Agency will:

• Enhance preparedness to safeguard human and animal health.
• Conduct effective surveillance and detection of highly pathogenic pandemic viruses and antiviral resistant strains.
• Improve response and containment measures to limit the spread of an outbreak.

FDA's initiative also responds to the key actions for an effective pandemic response, as outlined in the HHS Pandemic Influenza Plan. The pandemic preparedness initiative also directly supports the HHS Secretary's priority of Securing the Homeland by preparing for a potential H5N1 (strain) flu pandemic. Moreover, FDA's animal health activitiesalign with a recent joint World Health Organization (WHO)/Food and Agriculture Organization/World Organization for Animal Health recommendations for control of avian influenza (H5N1) and the use of antivirals in poultry.

FDA will conduct activities in this initiative in collaboration with the Centers for Disease Control and Prevention (CDC), USDA, the Department of Homeland Security, the Department of State, and other Federal agencies responsible for preparing our Nation's fight against pandemic influenza.

What are the risks of not proceeding with the initiative?

Scientists believe it is only a matter of time until the next influenza pandemic strikes. Failure to adequately prepare for the human and animal health and the food issues associated with a pandemic could have profound public health and economic impacts for the nation. Modeling studies suggest that, in the absence of effective control measures, a medium-level pandemic in the U.S. could cause up to 200,000 deaths and nearly 50 million illnesses, and could have an economic impact of up to $160 billion.

Without funding for FDA's Pandemic Preparedness Initiative, the Agency will be unable to develop and maintain an adequate infrastructure to rapidly review or act on applications for promising pandemic influenza vaccines. We also will not be able to provide extensive technical assistance to facilitate development of new technologies to increase manufacturing flexibility and capacity. Resource gaps also would limit FDA's efforts to prepare the specific pandemic influenza reagents (substance used in a chemical reaction to help determine potency) necessary for manufacturing vaccines or developing the tools necessary to generate vaccine strains.

Failure to address pandemic-related food and animal health issues also could have significant impacts. FDA's ability to develop a methodology for screening residues is linked to the availability of resources to conduct this work. Without funding to develop, integrate and exercise FDA pandemic response plans for animal health and food issues and for contingency planning for quarantine, FDA's pandemic preparedness - and, thus, the Nation's public health and animal health preparedness - will be severely compromised.

What activities will these funds support?

FDA requests funding to conduct the following Pandemic Influenza Preparedness Initiative activities:

Vaccine-related activities ($15,145,000)

• Assess vaccine manufacturing and advise manufacturers and HHS on manufacturing issues.
• Provide extensive outreach and training in manufacturing quality. This includes conducting timely and efficient inspections of manufacturing facilities to assure product quality and preventing problems that threaten safety or availability of products essential to respond to the pandemic threat.
• Develop and assess new technologies and novel adjuvants (a nonspecific simulator of immune response) and delivery systems for antigen sparing (techniques that may allow use ofless vaccine protein to get an effective immune response).
• Monitor the safety and effectiveness of pandemic vaccines administered to patients using improved information technology systems, electronic reporting mechanisms, and analytic tools to identify vaccine safety signals.
• Through reverse genetics and other emerging technologies, prepare a library of pandemic influenza virus high growth reassortants (seed strains) for rapid manufacturing when a pandemic strikes.
• Assure that all strains and reagents used for manufacturing are high quality, safe, and suitable for high-yield, large-scale manufacturing.
• Develop and implement improved, rapid tests for vaccine safety and potency, including a new generation of tests for emerging technologies such as recombinant and cell culture based vaccines.
• Continue to work closely with CDC, WHO, and others to develop materials that facilitate vaccine production like high growth reassortant viruses and reagents for standardization and evaluation of influenza vaccine.
• To speed and increase the efficiency of the development of safe and effective new pandemic vaccines FDA is working with WHO and regulatory agencies around the world in efforts, including 2 global regulators meetings planned in 2006, to develop consensus approaches and increased global harmonization in requirements for flu vaccine development and evaluation FDA is also providing technical assistance to WHO to assist other countries.

Human and animal health-related activities ($15,345,000)

• Develop and validate methods to detect antiviral products in poultry, including the antiviral products reportedly used in Asia. Transfer methods to test imported poultry and support the export of U.S. poultry products to countries that demand assurance that U.S. poultry is free of antiviral agents.
• Coordinate with USDA on sampling and testing poultry products at import inspection stations and poultry processing plants for traces of antiviral residues.
• Ensure that drugs are not used in veterinary medicine that increase drug resistance and thus compromise the treatment the American public during an influenza pandemic.
• Issue Custom Alerts to prevent the illegal importation ofantivirals into the U.S.
• Provide technical assistance to industry on pandemic-related biosecurity activities by identifying high-risk conditions and measures for reducing the risk of avian influenza contamination.
• Develop and implement plans for containment and disposal of animal feed that has or may have been contaminated with avian flu agents.
• Develop, integrate and execute FDA animal and food response plans and quarantine activities, in coordination with USDA and CDC.
• Conduct research on possible foodborne transmission of the pandemic influenza virus to assure that the virus is not present or, if present, to assure that the food can be properly treated to ensure safety.
• Equip field labs and support technology transfer and training of field scientists to ensure adequate capacity to respond to outbreaks of avian influenza.
• Improve FDA's capacity to conduct domestic and import surveillance, and respond to reports of food or foodborne illness associated with viruses.
• Support national pandemic influenza surveillance integration efforts with a comprehensive system to detect highly pathogenic strains of avian influenza.
• Provide technical assistance to industry and conduct public education on the potential risks of foodborne avian influenza and measures to prevent illness.

What results will FDA achieve?

Vaccine-related activities

• Facilitate increased domestic manufacturing capacity to provide needed pandemic influenza vaccine to meet the 20/20 Preparedness Plan for critical workers.
• Conduct timely and efficient inspection of manufacturing facilities while performing effective post-market safety and efficacy monitoring.
• Develop a library of pandemic influenza seed strains, test and approve manufacturers' seed viruses for new strains and prepare strain-specific reagents.
• Provide expertise to conduct and review highly technical and complex inspections of influenza vaccine and drug manufacturers and to conduct associated bioresearch monitoring activities.

Human and animal health-related activities

• Achieve pandemic surge production capacity to provide vaccine for the U.S. population using a combination of current egg-based and new high-volume, rapid response cell-based production.
• Develop analytical methods to detect, identify, and quantify antiviral residues in poultry.
• Take steps to ensure that drugs are not used in veterinary medicine that increase drug resistance and thereby the treatment of people for avian influenza.
• Consult with industry, other government agencies, and external stakeholders on biosecurity strategy and create best practice systems.
• Educate producers, veterinarians, feed industry, and others about the public health threat posed by avian influenza and the proper techniques for disposal of contaminated animal feed.
• Disseminate biosecurity best practices to regulated industry, through various outreach tools. Provide technical assistance to industry as they implement biosecurity measures.
• Develop FDA response plan for animal and food pandemic issues. Develop contingency plans for quarantine of animals and articles under the Public Health Service Act, in collaboration with USDA and CDC.
• Integrate quarantine and response planning into FDA's pandemic preparedness strategies.
• Integrate and exercise FDA response plan and work with USDA and CDC to coordinate quarantine plans.
• Develop and validate detection methods for avian influenza (H5N1 strain) in foods.
• Develop and deliver effective outreach/education messages for consumption, safe handling, and cooking foods of concern. Implement new and modified detection methods. Conduct training through field laboratories.
• Integrate analytical reporting from surveillance, as appropriate, into larger biosurveillance efforts.

FY 2007 Table of Contents

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