Thursday, March 30, 2006
Working to Meet the Existing threat
As you know, the President requested $7.1 billion in emergency funding for the National Strategy for Pandemic Influenza, of which $6.7 billion was requested for HHS. Congress appropriated $3.8 billion as the first installment of the President's request to begin these priority activities, and of this amount, $3.3 billion was provided to HHS. We appreciate the action of Congress on this appropriation as it takes us an essential step forward to becoming the first generation in history to be prepared for a possible pandemic.
As you are also aware, the potential for a human influenza pandemic is a current public health concern with an immense potential impact. Pandemics are not new. There were three in the 20th century, the worst of which was the Spanish flu epidemic in 1918-1919 that is estimated to have killed over one half million people in the U.S. and 50 million worldwide. While we are focusing today on the impact of a possible pandemic of avian flu, many of the policy issues and preparedness measures that arise for avian flu apply as well to pandemics of other types of influenza, other emerging infectious disease outbreaks and public health emergencies. To put the impact of a pandemic in context, the seasonal influenza that we have today causes an average of 36,000 deaths each year in the United States, mostly among the elderly, and adds more than 200,000 hospitalizations.
Scientists cannot accurately predict the severity and impact of an influenza pandemic, whether from the H5N1 virus currently circulating in birds in Asia and Europe, or the emergence of another influenza virus of pandemic potential. However, it is still useful to model possible scenarios based on analysis of past pandemics. In a report released in December 2005, the Congressional Budget Office presents the results of modeling a severe pandemic scenario similar to the 1918 Spanish flu outbreak and a more moderate outbreak resembling the flu pandemics of 1957 and 1968. In the severe scenario, roughly 90 million people become ill and 2 million die in the United States and the impact on the real Gross Domestic Product [GDP] is about a 5 percent reduction in the year following the outbreak. While there is substantial uncertainty associated with these estimates, they illustrate the enormous public health threat of an influenza pandemic and the need for effective access to vaccines, treatments, and a robust public health infrastructure to meet the challenge.
There are several important points to note about an influenza pandemic:
HHS Preparations for Pandemic Influenza
While not tied to the $7.1 billon request, a collateral goal was to stockpile enough pre-pandemic influenza vaccine for 20 million persons.
In December 2005, Congress appropriated $3.8 billion to help the Nation prepare for pandemic influenza preparedness activities. Of that total, Congress allocated $3.3 billion to HHS for the first year of funding of the HHS Pandemic Influenza Plan, including $20 million for the FDA. HHS will use these emergency funds to help achieve five primary objectives:
HHS is working both domestically and internationally to monitor the spread of H5N1 and other possible pandemic viruses. Through collaborations with the World Health Organization (WHO), the United Nations Food and Agriculture Organization, the World Organization for Animal Health, the Institute Pasteur, and numerous national governments, HHS is working to build capacity in other countries to detect outbreaks early and to contain the spread of the virus. On the domestic front, CDC is strengthening local laboratory capacity and capability, and accelerating implementation of the national BioSense program to enhance our ability to detect an outbreak early.
In the event of a pandemic, movement restriction, social distancing measures, and antiviral drugs will be the first line of defense before a vaccine is available and could delay the spread of the pandemic. On March 22, Secretary Leavitt announced the purchase of additional antiviral drugs that could be used in the event of a potential influenza pandemic. With the FY 2006 emergency funding, HHS has ordered a total of 3.95 million treatment courses of antiviral drug Relenza and 16.2 million treatment courses of Tamiflu. With these purchases, the Strategic National Stockpile will have 26 million treatment courses of antiviral drugs that will be available to the States when an influenza pandemic is imminent.
The cornerstone of the HHS Pandemic Influenza Plan is to create domestic manufacturing capacity sufficient to produce 300 million vaccine courses within 6 months of the onset of a pandemic outbreak, and to maintain a stockpile of pre-pandemic vaccine. The FY 2006 funding will increase vaccine production capacity by accelerating cell-based manufacturing technology, increasing egg-based vaccine production capacity, and supporting the advanced development for antigen sparing technologies that could extend the vaccine supply by decreasing the amount of antigen needed to protect each individual.
Pandemic influenza preparedness requires the active planning and participation of States and local communities. If a pandemic was to occur in the U.S., it would likely affect thousands of communities at the same time over the course of many weeks. The Federal Government is working to provide guidance regarding how state, local, and tribal governments can develop pandemic preparedness plans and respond in the event of a pandemic. As part of the Administration's effort to enhance State and local pandemic preparedness, HHS has held pandemic influenza summits in 26 States and the District of Columbia. As part of the Administration's goal to enhance State and local pandemic preparedness, HHS has held pandemic influenza summits in 26 States and the District of Columbia. These summits have brought together State and local officials, public health, schools, businesses, and other stakeholders to discuss pandemic preparedness. With the FY 2006 emergency funding, HHS has awarded $100 million of the $350 million allocated for State preparedness for pandemic influenza preparedness planning activities. The remaining portion of these funds will be awarded based on benchmarks that will measure States' progress.
Effective communications and outreach are essential to pandemic preparedness. President Bush called for the development of a single, comprehensive web site to be the official Federal source of pandemic and avian influenza information. This web site, www.PandemicFlu.gov, includes a wide range of information on pandemic influenza and preparedness activities. In addition, HHS has developed checklists for State and local planning, businesses, health care providers, community organizations, and individuals and families.
FDA Activities under the Emergency Supplemental
Through these activities, FDA's goal is to support the efforts of manufacturers and others to produce pandemic influenza vaccine in the shortest possible time, and to protect the greatest number of people, using a vaccine that is safe, effective, and easy to deliver.
FDA is already hard at work to meet these goals. In the early part of this month, CBER released two draft guidance documents for pandemic and seasonal influenza vaccines, which provide manufacturers with recommendations on obtaining and submitting clinical data to show safety and effectiveness for new vaccines, as well as outlining the approach of accelerated approval for both seasonal and influenza vaccine.
The President's FY 2007 Budget Request for FDA
This increase will allow FDA to conduct additional vaccine-related work that is critical to preparedness and to enhance food and animal health programs to address the challenge of an influenza pandemic. With the additional FY 2007 resources, FDA's vaccine program will:
In FY 2007, FDA's Foods program will focus new resources on those foods that may require surveillance to ensure that the virus is not present in food. In addition, FDA's Animal Drugs and Feeds program will focus new resources on developing a method to detect antiviral drug residues in poultry and on educating the feed industry and others about the proper techniques for disposal of contaminated animal feed. Both the Foods program and the Animal Drugs and Feed program will develop best practices and provide technical assistance on biosecurity measures for the rendering, animal feed, and human food industries. FDA's Office of Crisis Management will develop and exercise an FDA response plan for animal and food issues and quarantine contingency plans and will integrate such plans into Agency preparedness planning.
These resources comprise nearly half of the requested $30 million pandemic influenza increase in FY 2007 and include activities such as developing tests for antiviral residues in poultry and coordinating with USDA and the Bureau of Customs and Border Protection on sampling and testing of imported poultry products for antiviral residues. The FDA will also develop and implement plans to contain and dispose of animal feed that has been or may be contaminated with avian flu agents and provide technical support to USDA and the States on quarantine, culling, disposal, decontamination, and species-to-species transmission. Other activities include developing and integrating avian influenza response plans, in coordination with USDA and sister HHS agencies, and conducting research on possible transmission of pandemic influenza through food.
The resources requested in FY 2007 are essential to allow FDA to maintain public confidence and perform its vital public health responsibility for medical products, food, and animal health in the face of the threat of avian influenza.
Thank you for the opportunity to share this information with you. I am happy to answer any questions.
FDA Roles and Timetable for Production of Licensed Egg-Based Pandemic Vaccine from Newly Emerging Strain [PPT - 53KB]
Last Revised: March 31, 2006