News Release

HHS Fact Sheet: Biodefense Preparedness: Record of Accomplishment

Overview:
President Bush has made strengthening the nation's defenses against biological weapons a critical national priority. While significant progress has been made, the President instructed federal departments and agencies to review their efforts and find new and better ways to secure America from bioattacks. The result of this review was "Biodefense for the 21st Century," a Presidential directive that provides a comprehensive framework for our nation's biodefense. Released in an unclassified version on April 28, "Biodefense for the 21st Century" builds on past accomplishments, specifies roles and responsibilities, and integrates the programs and efforts of various communities -- national security, medical, public health, intelligence, diplomatic, agricultural and law enforcement -- into a sustained and focused national effort against biological weapons threats."Biodefense for the 21st Century" outlines the essential pillars of our biodefense program and provides specific directives to further strengthen the significant gains put in place during the past three years. At HHS, in cooperation with the Department of Homeland Security, preparations have included the following highlights:

Federal investment in Biodefense is up 17 times, and the President has proposed another significant increase for next year.

• Combined HHS and DHS Biodefense preparedness spending:

FY 2001 -- $294 million [HHS budget]
FY 2002 -- $3 billion [HHS budget]
FY 2003 -- $4.4 billion [combined HHS and DHS budgets for Biodefense]
FY 2004 -- $5.2 billion [combined HHS/DHS – incl. BioShield proposal]

An unprecedented partnership effort with states and hospitals was launched quickly.

• A total of $2.7 billion has been made available for state, local and hospital preparedness since 2001. Another $1.5 billion is being provided this year, with a further $1.3 billion proposed for FY 2005.
• These awards comprise two programs: CDC’s program to upgrade state and local capacity ($2 billion to date); and HRSA’s program for hospital preparedness ($650 million to date).
• Funds go through state public health agencies, but 75 percent will ultimately go for direct or indirect support of local public health departments and hospitals.
• States are drawing these funds as quickly as they are able to ramp up their preparedness efforts and invest the money productively.

Public health systems are already much stronger and better prepared for bioterrorism and other mass casualty incidents.

• All 50 states have bioterrorism response plans in place, including mass vaccination plans (few states had such planning in 2001.)
• All states have established systems to rapidly detect a terrorist event through mandatory reportable disease detection systems.

• 90 percent of CDC awardees so far report they could initiate a field investigation within six hours of receiving an urgent disease report.
• All states have plans in place for receiving and distributing Push Packages from the Strategic National Stockpile.
• States are updating their laws for dealing with public health emergencies, using the draft model legislation on emergency health powers that was prepared by CDC. As of 2003, 32 states and the District of Columbia had passed bills or resolutions related to the draft model legislation.

More workers and expertise have been directed at public health emergency preparedness.

• Within the past 18 months, at least 3,850 new state and local public health staff have been funded (in whole or part) by the CDC awards.
• HHS staff dedicated to public health emergency preparedness in now 1,700, up from 212 in FY 2001. Next year, the number will rise again, to over 2,000.
• CDC has trained 500 staff for immediate emergency support. CDC is also providing expert staff to state and local public health agencies, with 500 to be assigned out by 2008.
• CDC continues to provide expert assistance, especially through its “disease detectives,” the Epidemic Intelligence Service. This two-year program has grown from 148 EIS officers in 2001 to 168 in 2004.

America’s public health laboratory capacity, a crucial element in detecting and understanding any disease outbreak, is greatly expanding.

• The Laboratory Response Network, connecting labs of many kinds that can help in an emergency, has been expanded to 120 member labs in all 50 states, up from 80 labs in 2001. By the end of FY 2004, the network will include 145 member labs. This includes 47 state and local public health labs at the BSL-3 biosecurity level, four times the number in 1999.
• Last year, CDC provided specialized bioterrorism-related training to 8,800 key laboratorians.
• Eleven new high-level biocontainment research laboratories are being funded by NIH primarily for research purposes, but they would also be available to assist in public health response to bioterrorism or infectious disease emergencies.

Communications capacity within the public health structure has been expanded and improved.

• CDC’s Public Health Information Network can reach 1 million recipients quickly, including 90 percent of all county public health agencies so far, up from 68 percent in 2001.
• CDC’s EPI-X system also connects more than 1,800 public health officials for immediate sharing of emergent public health data, compared with 200 in 2001.
• These improvements will help make public communications clearer and faster in an emergency.

Hospital preparedness efforts have resulted in new state- and region-wide coordination, with coherent plans for investment and response.

• For the first time, a nationwide initiative bought about joint planning for public health emergencies by public systems and hospitals working together toward federally-identified goals.
• All states have developed plans with their hospitals for dealing with mass casualty incidents, including terrorism, accidents or naturally-occurring disease.

Nationwide training for health care professionals is being implemented, and scientific expertise is growing.

• Almost 174,000 health professionals are being trained in FY 2003 and 2004 through HRSA’s Bioterrorism Training and Curriculum Development program, with 19 grants for continuing education aimed at the diverse health care workforce, and 13 grants to health professions schools to develop curricula.
• NIH’s new “Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases” will build a strong infrastructure for research and development while also developing our base of scientific expertise by training a new generation of science professionals to perform Biodefense research.
• CDC’s Centers for Public Health Preparedness (CPHP) help prepare frontline health workers at the local level. There are now 34 CPHPs in 46 states, comprised of schools of public health, schools of medicine and other local institutions.

Federal emergency resources have been expanded to back-up local resources when they become overwhelmed.

• The Strategic National Stockpile has increased 50 percent since 2001, now including twelve 50-ton “Push Packages,” up from eight. The amount and variety of stockpile contents has also grown.
• The National Disaster Medical System has 33 percent more personnel for its emergency response teams – 8,000 personnel today, up from 6,000 in 2001.
• HHS had quadrupled the Readiness Force in the U.S. Public Health Service Commissioned Corps, from 600 in 2001 to almost 2,300 today.

FDA is implementing the most fundamental enhancements of its food safety activities in many years.

• FDA has more than doubled its presence at ports of entry, from 40 ports in 2001 to 90 ports today.
• This year, FDA is performing 60,000 inspections of imported foods, five times more than in 2001. In FY 2005, FDA proposes to conduct 97,000 inspections, eight times higher than 2001.
• FDA is implementing its new authority for registration of food facilities (some 425,000 are expected to register); for prior notification of food import shipment (some 20,000 notices per day expected); and for record-keeping and administrative detention of suspected foods.
• FDA has created a Food Emergency Response Network, with 63 labs representing 34 states – no such network existed in 2001.
• FDA is expanding its eLEXNET communications network for immediate exchange of critical food testing data. At present, there are 108 laboratories representing 49 states and the District of Columbia. They are capable of dealing with more than 3,700 analytes. In 2000, there were eight labs, capable of tracking a sole analyte.

The Biodefense research initiative is the largest single increase in resources for any initiative in the history of NIH.

• Biodefense research funding at NIH has increased from $53 million in FY 2001 to $1.6 billion in FY 2004.
• The increased effort is guided by strategic plans developed with the guidance of panels of scientific experts.
• More than 50 biodefense initiatives have been developed to address research and development priorities in therapeutics, vaccines, diagnostics, and basic research including genomics, proteomics and bioinformatics.
• NIH has invested more than $800 million for 11 extramural labs and three intramural labs, and physical security. These are critical to developing countermeasures against agents of bioterror.
• NIH will emphasize product development and cooperative enterprises with private industry and academia, in addition to its traditional role of supporting basic scientific research.

Progress in Biodefense research has been swift and substantial.

New and improved vaccines against smallpox, anthrax, and other potential bioterror agents are being developed and evaluated and will soon enter the national stockpile through Project BioShield.

• NIH rapidly developed a fast-acting Ebola virus vaccine and showed its efficacy in monkeys; it is now being tested in human volunteers.
• NIH-supported scientists have identified antivirals that may play a role in treating smallpox or the complications of smallpox vaccination, as well as new antibiotics and antitoxins against other major bioterror threats.
• NIH has established eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE). This nationwide group of multidisciplinary centers is a key element in the HHS strategic plan for biodefense research.
• NIH has supported the genomic sequencing of all bacteria (including the anthrax bacterium) considered to be bioterror threats, as well as the sequencing of genomes for at least one strain of every potential viral and protozoan bioterror pathogen.

Capacity is being expanded to produce medical countermeasures to protect Americans from bioterrorism attacks.

• The supply of smallpox vaccine has increased from 15.4 million doses available in 2001, to more than 300 million full doses today, enough to vaccinate every American, if necessary.
• The Strategic National Stockpile includes enough antibiotic to treat 20 million people for anthrax exposure, significantly higher than in 2001. Research is also underway toward an improved anthrax vaccine.
• The President has launched the BioShield initiative, to create a more stable and assured source of funding to purchase new vaccines or treatments. BioShield will provide $5.6 billion over the next 10 years for new products.

• FDA has approved new medical countermeasures, including therapies for anthrax, radiation exposure and antidotes to nerve agent poisoning. FDA has also implemented programs to facilitate development of new products.
• In the past two years, FDA finalized the “animal rule,” which provides for using animals to test the safety and efficacy of products where human tests would be unfeasible. This rule can important in development of many Biodefense countermeasures.

Federal coordination and capacity has been expanded.

• The Department of Homeland Security creates a focal point for federal leadership.
• HHS has created a top-level Office of Public Health Emergency Preparedness to coordinate Department-wide efforts.
• HHS operating divisions work closely with states, providing specific performance measures and benchmarks, with semi-annual review of progress. HHS’ Office of Inspector General is also increasing its activities to ensure proper accounting and expenditure of federal support.
• In collaboration with the Department of Justice, CDC launched the “Forensic Epidemiology” course in 2002 to train frontline public health, public safety and law enforcement professionals to conduct effective joint investigations. So far, 42 states have elected to take part, and 5,000 professionals have been trained.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last Revised: May 17, 2004

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