Good morning, Mr. Chairman, and Members of the Subcommittee. I am Dr. Stephen M. Ostroff, Associate Director for Epidemiologic Science, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC). I am accompanied by Steven D. Bice, Chief of the National Pharmaceutical Stockpile Branch, in CDC's National Center for Environmental Health. I appreciate the opportunity to testify before the Subcommittee about the plans for and management of the National Pharmaceutical Stockpile Program (NPSP), one component of CDC's overall public health response to the threat of bioterrorism. An appropriate response to a potential bioterrorism threat requires unprecedented partnerships among security agencies, first responders, and the public health community at all levels of government.
As the Nation's disease prevention and control agency, it is CDC's responsibility on behalf of the Department of Health and Human Services (DHHS) to provide national leadership in the public health and medical communities in a concerted effort to detect, diagnose, respond to, and prevent illnesses, including those that occur as a result of bioterrorism or any other deliberate attempt to harm our citizens. This task is an integral part of CDC's overall mission to monitor the health of the U.S. population. This mission unfolds every day in various forms, such as disease outbreak response, concern for worker safety, and critical work in global health. CDC, working with other partners inside and outside of DHHS, also has significant experience in responding to explosion and chemical related events and emergencies.
In 1998, CDC issued Preventing Emerging Infectious Diseases: A Strategy for the 21st Century, which describes CDC's plan for combating today's emerging diseases and preventing those of tomorrow. It focuses on four goals, each of which has direct relevance to preparedness for bioterrorism: disease surveillance and outbreak response; applied research to develop diagnostic tests, drugs, vaccines, and surveillance tools; infrastructure and training; and disease prevention and control. This plan emphasizes the need to be prepared for the unexpected -- whether it be a naturally occurring influenza pandemic or the deliberate release of anthrax by a terrorist. Copies of this CDC plan have been provided previously to the Subcommittee.
CDC is continuing to build on these efforts. An example of this is the strategic plan that CDC is developing with its partners to define the specific activities that will need to be conducted over the next several years to continue to ensure that the country is prepared to respond to any threat or actual act of bioterrorism.
Unlike an explosion or a tornado, in a biological event, it is unlikely that a single localized place or cluster of people will be identified for traditional first responder activity. The initial responders to such a biological attack will most likely include county and city health officers, hospital staff, members of the outpatient medical community, and a wide range of response personnel in the public health system. Thus, protection against terrorism requires investment in the public health system. This point is underscored in a report, commissioned by the Department of Health and Human Services Office of Emergency Preparedness (OEP) and recently released by the Institute of Medicine and the National Research Council, Chemical and Biological Terrorism: Research and Development to Improve Civilian Medical Response, which stresses the need for long-term public health improvements in surveillance and epidemiology infrastructure.
Increased vigilance and preparedness for unexplained illnesses are an essential part of the public health effort to protect the American people against bioterrorism. Toward this end, CDC, working in collaboration with State and local health departments, many other public health partners, and other Federal agencies, has begun the effort to upgrade public health capabilities locally and nationally to respond to biological and chemical terrorism. With these partners, CDC has moved aggressively in five areas, including model preparedness planning, developing of national biological and chemical agent laboratory diagnostic capacity, strengthening surveillance and epidemiologic investigation capacity, and enhancing communications systems, particularly at the local level. The fifth integral component of public health preparedness has been the development of a National Pharmaceutical Stockpile (NPS), which can be called upon in response to an episode caused by a biological or chemical agent. Today I will be discussing CDC's approach to development and implementation of the pharmaceutical stockpile, but it should be emphasized that this must be developed in concert with the other segments of the public health infrastructure.
The mission of CDC's NPSP is to ensure the availability of life-saving pharmaceuticals, vaccines, antidotes, other medical supplies, and equipment for prompt delivery to the site of a biological or chemical terrorist event anywhere in the United States. The NPSP is not the first response to an incident of biological or chemical terrorism. That response will come from local and state emergency, medical and public health personnel. However, few local governments have the resources to create sufficient stockpiles on their own. Therefore, a primary purpose of the NPSP is to provide critical drugs and medical material that would otherwise be unavailable. Key elements of the stockpile program include: procurement and logistics management; monitoring, quality assurance, system testing and evaluation; contract management; training and education; operational research and evaluation; and coordination of emergency response efforts. CDC will manage the NPSP in collaboration with a number of important partners, as I will describe in detail later. In particular, CDC has chosen the Department of Veterans Affairs (VA) as our primary acquisition partner. This decision was reached after a systematic assessment of all available information and exploration of alternatives.
This morning, I am going to discuss the stockpile's relationships to other national pharmaceutical stockpiles, its contents, its deployment, and its overall management.
Relationship to and Coordination with Other National Pharmaceutical Stockpiles
CDC's NPSP is a unique resource available to all United States public health departments. However, there are other national pharmaceutical stockpiles; and it is essential that the NPSP coordinate with these resources for the most cost-effective protection of the American people.
OEP has established four National Medical Response Teams (NMRTs), which have stockpiled enough antidotes and equipment to treat an affected population of up to 5,000 people each when responding, particularly to the release of chemical agents. CDC has been collaborating closely with OEP to make sure CDC's stockpiles complement the NMRT stockpiles. CDC will continue to collaborate with OEP in FY 2000 through co-inspections of stockpiled items, and OEP will continue to be involved in CDC's program planning and expert working groups.
The Marine Corps' Chemical and Biological Incident Response Force (CBIRF) may be deployed to assist civilian communities; therefore interagency coordination is critical. CDC has met with CBIRF staff to begin coordination of our efforts.
Contents of Stockpile
CDC has implemented an on-going deliberative process to guide the purchasing decisions for the NPSP. The process involves enhancing preparedness for biologic and chemical agents that would be catastrophic if released into the population. The process involved extensive input from experts including representatives from the intelligence community, DHHS, academic experts, and state and local health authorities. The experts met in two working groups in June 1999. CDC's FY1999 purchasing decisions were based on the recommendations of these groups and the FY1999 DHHS operating plan. A sub-committee of the Advisory Committee to the Director, CDC, will be convened to continue this process, and because priorities will change over time, will continue to meet at least once annually. In addition, CDC has established relationships with various national security agencies so as to facilitate continuous updates and analyses of threat agents and ensure that the stockpile reflects current needs.
The expert working groups convened by CDC prioritized the following biological agents: smallpox, anthrax, pneumonic plague, tularemia, botulinum toxin and viral hemorrhagic fevers. Because anthrax, plague and tularemia can be effectively treated with antibiotics that are immediately available, purchasing these products for the NPSP formulary was given first priority in the stockpile section of the DHHS FY 1999 operational plan. Smallpox and botulism require materials that are not immediately available and will require a series of additional research, FDA regulatory, and production steps before these can be procured. These efforts are a high priority for DHHS and the Department of Defense (DOD).
The working groups also identified chemical agents that could be used in a terrorist incident, including nerve agents such as sarin, and respiratory irritants and vesicants such as sulfur mustard and cyanide. In addition to medications and supplies for intravenous administration, CDC proposes to include medical equipment that would be essential for treatment, including airway supplies, bandages and dressings, other emergency medications, and a back-up supply of chemical antidotes. These are items that local clinicians may find in short supply in the event of a biological or chemical terrorism incident.
Components of the National Pharmaceutical Stockpile
The National Pharmaceutical Stockpile (NPS) has two basic components. The first component consists of four 12-hour push packages for immediate response. A 12-hour push package is a pre-assembled set of supplies, pharmaceuticals, and medical equipment ready for quick delivery to and use in the field. These packages will permit emergency medical staff to treat a variety of different agents, since the actual threat may not have been identified at the time of the stockpile deployment. The packages will be color-coded on aircraft pallets, positioned in environmentally-controlled and secured warehouses, and ready for immediate deployment by the contract carrier to reach the affected area within 12 hours of the federal decision to deploy.
The second component, Vendor Managed Inventory (VMI) packages, will be activated if the incident requires a larger or continued response. The VMI packages will be shipped to arrive at 24 and 36 hours after activation. The VMI packages will comprise material that will be delivered from one or more pharmaceutical manufacturers or prime vendors, who, per a contractual arrangement with VA and CDC, will hold inventory that can be released at the time of an emergency, and will be tailored to provide medications, supplies, and/or products specific for the suspected or confirmed agent(s).
Deployment of the Stockpile
The decision to deploy the stockpile will be based on the best epidemiologic, laboratory and public health information regarding the nature of the threat. This is one of the major reasons that development of the public health infrastructure for bioterrorism response is so important. One scenario for deployment of the NPS begins with an overt bioterrorist act, resulting in a state governor requesting assistance from the President. The Federal Response Plan would be put into effect, under which CDC is responsible for the management of public health issues surrounding biological and chemical terrorist events. A more likely scenario would be that CDC, at the request of a state health department, would begin investigating an unusual pattern of illness and conclude that the outbreak might be the result of a bioterrorist event. When a biological or chemical terrorist incident is suspected, CDC will begin or enhance surveillance activities, laboratory confirmation procedures, notification of appropriate Federal agencies and provision of pertinent technical support. With regard to the stockpile, the Director of CDC, in consultation with the Assistant Secretary for Health (ASH), will direct the mobilization of NPS assets. If CDC stockpile components are needed, 12-hour push packages will be rapidly deployed to best address the needs of the stricken population. CDC will then begin the process of tailoring subsequent deliveries of stockpile components from the VMI as indicated by the specific biological or chemical agent.
Mobility of the Stockpile
CDC is taking steps to assure the mobility of the stockpile by negotiating a contract with a commercial cargo carrier to transport the stockpile on a moment's notice. Any operational airport in the country could be used as a potential offload and distribution site for the NPS. If a terrorist incident occurs, the NPS will be delivered to a secure site proximate to but outside of the affected area. CDC will be working with the carrier to ensure that the stockpile can be moved by either land or air for delivery to any US location.
1. Direct coordination and management by CDC staff
The GAO report on the management of existing stockpiles identified weaknesses in internal controls and management structures. Over the past year, CDC has worked closely with GAO to address these coordination, oversight, and partnership concerns as they relate to the NPSP. Three aspects of the NPSP management plans are critical in this regard: (1) direct coordination and management by CDC staff; (2) on-going monitoring, quality assurance, and evaluation; and (3) partnerships, collaboration and communication.
The stockpile's pharmaceuticals, vaccines, antidotes, other medical supplies, and equipment will by managed by highly-trained professionals, who will complement state and local public health teams' efforts. This team of professionals is vital to the stockpile's effectiveness. Each member of the program has a clearly defined role that results in increased accountability.
The Role of CDC
CDC will provide guidance, oversight, operational control, and evaluation elements as the designated executive manager for the NPSP. CDC staff members are hired for their technical expertise and professional backgrounds and will be retained on the basis of demonstrated competence in the performance of their duties. The NPSP staff is functionally organized so that a single staff member has the lead for ensuring that all monitoring, quality assurance, and evaluation responsibilities are carried out with diligence and efficiency, and every NPSP staff member has some level of supportive responsibility for each of these areas as part of his performance work plan.
CDC chose the VA as the acquisition partner to work with the NPSP. At the time the decision was made, CDC was aware that GAO had identified problems in a similar collaboration. Therefore CDC considered other options, including DOD and CDC self-management. However, after an intensive deliberative process, using the best information available, CDC feels that the VA is the best partner and that following carefully planned management steps can prevent the problems identified by GAO.
First, CDC will continually monitor the status of NPS inventory at both VA and VMI locations. One of the strengths of the CDC-VA partnership will be the development of a real-time look-down inventory monitoring system. This system will track inventory levels, the ordering and receipt of all products, the status of all NPS transactions, and the scheduled rotation of stock to maintain current expiration dates on medications and devices. This monitoring will be done through direct access to the inventory systems of all partners to the NPSP.
Second, each year CDC will conduct no fewer than 3 periodic "no notice" or unannounced inspections of facilities that store NPS pharmaceuticals and other response material. CDC staff will carry out these visits using a standardized protocol covering all aspects of NPSP responsibility, including storage, security, and deployment procedures. These facilities will need to register under the Food, Drug, and Cosmetics Act and will also be subject to FDA inspection. CDC staff will also conduct operational capability inspections at the contract carrier's shipping locations. CDC staff will cite any deficiencies identified during inspections and hold partners accountable for prompt corrections.
Third, CDC staff will carry out no fewer than 2 periodic exercises each year to test various aspects of the NPSP. CDC and external monitors will be used to observe and record how CDC staff and its partners perform in a simulated deployment. These monitors will rate performance using a combination of objective and subjective rating criteria. A follow-up report of such exercises, citing strengths and weaknesses, will be accompanied by specific actions that partners and CDC must take to correct any system defects.
The Role of the VA
The VA was selected to serve as the primary acquisition partner for the stockpile while CDC will manage and provide oversight of all aspects of the stockpile program. The VA was selected as this logistics and purchasing partner due to its experience with large pharmaceutical purchases on behalf of the U.S. government and its strong willingness to partner with CDC to ensure successful implementation of the NPS. The NPS has a logistical team that will be working closely with the VA and medical suppliers and vendors throughout the country. The VA has a staff member who will serve as a single point of contact on stockpile issues and is fully dedicated to the NPSP. This person is directly responsible for VA's stockpile duties and will provide continuous management. In addition, each push package will have a dedicated VA pharmacist on staff.
The 12-hour push packages will be stored separately from normal operating stock in a secured section of either a commercial or VA-owned warehouse approved by CDC. The 12-hour push packages will be managed with CDC oversight in the form of scheduled and unannounced inspections that are part of the NPSP quality assurance activities.
The VA, with CDC concurrence, will award the VMI portion of the stockpile's supplies to a medical products distribution or manufacturing company or a combination of both. The VMI material may be co-mingled with the contractor's normal operating stock and continuously rotated to insure potency of government-owned and reserved material. The VA will ensure compliance with the VMI contract and will provide quarterly reports to CDC on compliance and internal control issues. In addition, CDC staff will conduct periodic unannounced inspections of sites where stockpile VMI is being stored.
2. Monitoring, quality assurance, and evaluation.
CDC has taken steps to ensure that the Memorandum of Agreement (MOA) between CDC and VA is explicit, comprehensive and precise. In addition, CDC's tradition of strong oversight, technical assistance, and on-site presence will be an integral part of the NPSP. A thorough monitoring and evaluation loop will include any remediation needed to quickly fix identified gaps. CDC will utilize the ongoing partnership between FDA and VA to assure the quality of the NPS contents.
Inventory and Record-Keeping
The VA will procure medical material contained on the NPSP requirements list. It is anticipated that there will be several CDC procurement cycles during each year. The VA will update procurement records to ensure timely status of orders and expected delivery dates. Each product shipped to the VA distribution center must have a minimum of 95% of its shelf life remaining at the time of receipt. Products received with insufficient shelf life remaining will be returned to the manufacturer. Any exceptions to this 95% requirement dictated by limited market availability must be approved by CDC.
All NPSP material will be stored in a secure, well-lighted, temperature-controlled warehouse or distribution center. The 12-hour push packages will be stored separately from operational stock and kept in a limited access area. Inventory management records will reflect a CDC ownership code for both the 12-hour and VMI packages and will facilitate the rotation of medical material prior to its expiration.
Through its real-time access to the VA's electronic inventory record system, CDC will routinely monitor the purchase of stockpile pharmaceuticals and medical equipment, rotation of stock, and disposal (or shelf-life extension) of items for which there is no comparable civilian use. CDC will physically verify the records of stock maintenance and transactions as part of its site visits. CDC's MOA with the VA specifies the prompt and proper recording of transactions because it is the intention of CDC to monitor this information through the VA system of electronic inventory control. From this documentation, CDC logistics staff will provide periodic reports and analyses on the status of stockpile products.
Security measures are or will be in place in FY 2000 to safeguard NPSP pharmaceuticals, supplies and equipment. The NPSP demands that storage areas for general medical supplies be appropriately secured; that access to warehouses be confined to a limited number of personnel; that internal documents be updated frequently to reflect personnel turn-over; and that keys or combinations are changed when personnel leave the agency. All medical controlled substances shall be ordered, received, stored, and issued in accordance with all applicable Drug Enforcement Administration (DEA) regulations; and all controlled substances shall be stored in a safe or vault with a combination lock with a combination that is known by only the primary and alternate responsible staff. The review and tightening of these physical security measures will be a prominent part of CDC's unannounced inspections. Since CDC staff are not security experts, we are seeking technical assistance from the U.S. Marshals Service to provide a security assessment of our 12-hour Push Package sites.
Stockpile Deployment Exercises
CDC must ensure that the stockpile can be deployed quickly and effectively before it needs to be used in a biological or chemical terrorist incident. As noted earlier, CDC will conduct periodic exercises to test all aspects of stockpile deployment. These exercises will begin in FY2000.
CDC, in conjunction with its partners, will develop scenarios for situational field exercises to evaluate the capabilities of the stockpile deployment and distribution mechanisms. These exercises will range from tabletop scenarios to full-scale, real-time simulated operations that will incorporate multiple jurisdictional partners and federal agencies. A full system exercise will take CDC to the point of hand-off to state officials and will review their distribution plan and their performance as part of the overall system.
3. Partnerships, collaboration and communication.
The responsibility for overseeing and managing the NPS requires that CDC partner with state and local governments and coordinate with OEP and other federal agencies. This is necessary to provide US citizens with the maximum protection available. In addition, CDC is learning from and utilizing the expertise of many partners, including drug and equipment manufacturers, transportation companies, the FDA, and the VA to ensure production, maintenance, security, and delivery of NPS items.
Partnering with federal agencies
The responsibility for oversight and management of the NPSP requires CDC to partner and coordinate with other federal agencies as well as state and local health departments in order to provide a comprehensive protection program. In addition to the VA, other key federal partners involved in issues related to the management and deployment of the NPS include OEP, FDA, DOD, FBI, and FEMA.
Partnering with state and local agencies
CDC will work with state and local health agencies to provide, distribute, and administer the products in the stockpile. In order for the stockpile to be deployed quickly and effectively, CDC must provide technical assistance to aid in the development of state and local capacity to receive and distribute the NPS.
Local organizations at the city, county, and regional level will be essential in the effort to reach all citizens who need medical help after a terrorist incident. However, these partners need to become fully aware of the NPS to ensure that they are able to most effectively plan for and use this valuable resource. To meet this need, CDC is now planning extensive training, including use of the Internet and a continuing education effort, to fully prepare our state and local partners. Other private or industry organizations will also have important roles to play in the local or state deployment of the stockpile. For example, organizations such as nursing home associations, private ambulance services, and trucking companies all provide services that could be critical to the timely deployment of the stockpile.
CDC is also prepared to provide technical and scientific assistance to state and local governments who wish to purchase pharmaceuticals, chemical antidotes, other medical supplies, and medical equipment to augment their current emergency response capacities. In summary, we believe that these components of the National Pharmaceutical Stockpile Program will prevent the stockpile management concerns identified in the GAO Report and will provide medical supplies, pharmaceuticals, and other stockpile equipment in a timely fashion.
Thank you, Mr. Chairman and members of the Subcommittee, for the opportunity to testify before you today about CDC's National Pharmaceutical Stockpile Program. I am happy to answer any questions you may have.
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