• To increase the nation´s preparedness for an influenza pandemic the (then Acting) FDA Commissioner, Andrew von Eschenbach, M.D., established an FDA Task Force for Pandemic Influenza Preparedness in November, 2005.
  
  
• One of the FDA Task Force´s key charges was to develop an FDA strategic plan and to coordinate FDA pandemic preparedness policy, planning, priority setting, and communications.
  
  
• This FDA Pandemic Influenza Preparedness Strategic Plan is the result of the diligent work of the Task Force. The Plan provides a solid foundation for a cross-cutting initiative involving many of FDA´s centers and offices, and will serve as the basis for an implementation strategy.
  
• The FDA Pandemic Influenza Preparedness Strategic Plan coordinates with and complements the President´s National Strategy for Pandemic Influenza, the Implementation Plan for the National Strategy for Pandemic Influenza, the Department of Health and Human Service´s (HHS´s) Pandemic Influenza Plan and the HHS Pandemic Influenza Implementation Plan – Part 1.
  
  
• The FDA Pandemic Influenza Preparedness Strategic Plan has several recurring themes:
  
  
  • Proactively working and communicating with industry, academia, and others within the government to determine which approaches will be the most efficient and the most effective.
  • Teamwork and cooperation between FDA´s centers and offices; among HHS agencies; between Federal, State, local, and tribal governments; and among the United States and other countries or international organizations. This coordination is essential for a better understanding of potential pandemic influenza issues and solutions.
  • Active involvement by all stakeholders is critical for an effective national response.
    
    
• The plan focuses on initiatives such as:
  
  
  • Proactively facilitating or accelerating development, production and regulatory review of:
    
    
    • Vaccines
    • Antivirals
    • Diagnostics and other devices, including personal protective equipment (PPE)
      
      
  • Food and animal feed issues in coordination with USDA.
  • Enhancing emergency preparedness, response and communication.
  • Enforcement actions to curtail marketing and distribution of counterfeit or mislabeled products.
  • Collaboration with foreign counterpart regulatory agencies and international organizations.
    
    
• The principal FDA centers and offices that contributed to the Plan and have important roles in preparing for, and responding to, an influenza pandemic, and their roles, are as follows:
  
  
  • The Center for Biologics Evaluation and Research developed the Vaccine and Other Biologics Development, Production, and Regulatory Review section;
  • The Center for Drug Evaluation and Research developed the Anti-viral Drug Development, Production, and Regulatory Review Section;
  • The Center for Devices and Radiological Health developed the Device Development, Production, and Regulatory Review section;
  • The Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine developed the Food and Feed Safety section;
  • The Office of Crisis Management and the Office of External Relations developed the Emergency Preparedness, Response, and Communication section;
  • The Office of Regulatory Affairs developed the Enforcement section.
    
    
• The plan also details FDA accomplishments and describes recent actions the agency has taken to prepare for a possible influenza pandemic. Examples of accomplishments include:
  
  
  • Product Approvals and Prohibitions
  • Guidance
  • Facilitating Innovation
  • Global Harmonization
  • Emergency Preparedness
  • Public Communication
  • Enforcement.
    
    
• The plan describes the agency´s objectives, the actions to be taken to further those objectives, and deliverables. These activities are or will be critical to the development, review, and approval of vaccines, anti-viral drug products, and devices or to safeguarding food and animal feed. It also lists activities for protecting Americans against fraudulent or counterfeit pandemic influenza products and enhancing emergency preparedness and communication.

A copy of the plan can be found at http://www.fda.gov/oc/op/pandemic/strategicplan03_07.html

For more information on Pandemic Flu, please visit FDA´s Pandemic website at http://www.fda.gov/oc/op/pandemic/