What GAO Found
The SNS contains supportive care items for thermal burns, such as bandages, pain medications, intravenous fluids, and topical antimicrobial cream needed for the immediate treatment of burn injuries to reduce the risk of infection and stabilize injured individuals. HHS officials told us that the goal of the SNS is to supplement state and local supplies used for immediate care in the initial responseidentified as within 72 hours of sustaining injury. CDC compiled supplies needed for the immediate treatment of burn injuries into kits in 2002 and 2003, based on information provided at that time by burn experts about needed items. Because most medical countermeasures for thermal burns can be found in local hospitals, countermeasures in the SNS would be used to supplement local supplies and inventories, with kits deployed within 24 to 48 hours of notification. The SNS does not contain other countermeasures that may be available for both the immediate care and the longer-term treatment of burn injuries. However, HHS is currently considering whether to acquire some additional countermeasures, including those for longer-term treatment of burn injuries.
HHS has taken several steps since 2010 to obtain information about thermal burn countermeasures, such as conducting interviews and site visits with burn experts, clinicians, and industry officials, which also signaled to industry HHSs interest in these products. HHS has issued two formal notices to solicit information from industry about the types of countermeasures that may be available specifically to treat thermal burns in a mass casualty incident. For example, these notices solicit information about products for immediate care of thermal burns, such as bandages with antimicrobial barriers that could be used for several days without needing to be changed, and products for longer-term burn care, such as temporary skin substitutes. HHS officials stated that in response to these notices and consistent with the Federal Acquisition Regulation (FAR), HHS has also had e-mail, telephone, and in-person discussions with interested companies. In addition, HHS has discussed with industry the departments interest in these additional countermeasures at regional meetings held in 2011.
NIH has some medical countermeasures that are currently in the development and acquisition pipeline that could serve to address thermal burns. The National Institute of Allergy and Infectious Diseases (NIAID), the NIH institute tasked with developing a research program to identify and develop new medical countermeasures for use in radiological and nuclear incidents, is funding research on candidate countermeasures, such as topical creams and antibiotics. NIAID is also funding basic research on the effects of burns and radiation injuries to skin and other tissue. NIHs National Institute of General Medical Sciences is currently funding research on potential or improved burn care treatment. According to HHS officials, NIHs National Institute of Arthritis and Musculoskeletal and Skin Diseases is also funding research on such treatment.
Why GAO Did This Study
A failed car bomb attempt in New York City in spring 2010 underscored the nations vulnerability to intentional terrorist threats from explosive devices, such as conventional explosives, radiological dirty bombs, and nuclear weapons. The blast and subsequent fires from such weapons could inflict serious thermal burns; in the case of a nuclear detonation, these injuries could affect hundreds to thousands of people. In such an attack, stabilizing individuals with burns and other injuries would be an immediate priority. Medical care for thermal burns in a mass casualty incident would require the ready availability of large quantities of medical countermeasures, such as pain medications, wound dressings, and intravenous fluids, both on-site and in emergency treatment facilities.
The Department of Health and Human Services (HHS) is the federal agency primarily responsible for identifying and supporting the development and acquisition of the medical countermeasures needed to prevent or mitigate potential health effects from exposure to chemical, biological, radiological, and nuclear (CBRN) agents and other terrorist threats. In addition to identifying these countermeasures, including those for thermal burns, HHS also has responsibility for engaging with industry to research and develop them and, ultimately, for acquiring them for the U.S. Strategic National Stockpile (SNS), if appropriate. The Project BioShield Act of 2004 authorized the establishment of a procurement fund for these countermeasures. Specifically, the act authorized the appropriation of about $5.6 billion over the 10-year period from fiscal year 2004 through fiscal year 2013 for the Project BioShield Special Reserve Fund to acquire certain medical countermeasures for the SNS.
Multiple organizations have raised concerns about HHSs ability to work with industry to successfully develop and acquire medical countermeasures to respond to CBRN incidents and other terrorist threats, and since 2004 congressional committees have held several hearings to assess HHSs medical countermeasure development and acquisition efforts. Congress requested that we examine whether HHS has developed and acquired medical countermeasures that address thermal burn injuries that would result from conventional explosives or radiological or nuclear devices. Our review addresses (1) the medical countermeasures in the SNS that would address thermal burns, (2) the steps HHS has taken to obtain information about and inform industry of its interest in additional countermeasures for thermal burns, and (3) the medical countermeasures in the pipeline for development and acquisition into the SNS that could serve to address thermal burns.
GAO is not making any recommendations in this report.
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