oversight

National Preparedness: Countermeasures for Thermal Burns

Published by the Government Accountability Office on 2012-02-22.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

United States Government Accountability Office
Washington, DC 20548



           February 22, 2012

           The Honorable Joseph I. Lieberman
           Chairman
           The Honorable Susan M. Collins
           Ranking Member
           Committee on Homeland Security and Governmental Affairs
           United States Senate

           Subject: National Preparedness: Countermeasures for Thermal Burns

           A failed car bomb attempt in New York City in spring 2010 underscored the nation’s
           vulnerability to intentional terrorist threats from explosive devices, such as
           conventional explosives, radiological “dirty bombs,” and nuclear weapons. 1 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. 2 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) 3 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. 4 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




           1
            A dirty bomb, or radiological dispersal device, is a mix of explosives, such as dynamite, with
           radioactive material. When the dynamite or other explosives are set off, the blast carries radioactive
           material into the surrounding area.
           2
            Thermal burns, as distinguished from chemical and electrical burns or injury to the skin from
           radioactive isotopes, are caused by intense light and heat.
           3
            For a full list of abbreviations, see enc. I.
           4
            For a list of previous GAO products relevant to this topic, see Related GAO Products at the end of
           this report.



                                                               GAO-12-304R Thermal Burn Countermeasures
U.S. Strategic National Stockpile (SNS), if appropriate. 5 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. 6

Multiple organizations have raised concerns about HHS’s 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 HHS’s medical countermeasure
development and acquisition efforts. 7 You 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.

To identify the medical countermeasures in the SNS that would address thermal
burns, we reviewed relevant HHS documents, such as risk assessments,
requirements papers, documentation of the contents of the SNS and related gap
analyses, and other HHS information about the types of medical countermeasures
needed and the department’s prioritization of countermeasures for thermal burns.
We interviewed HHS officials from the Office of the Assistant Secretary for
Preparedness and Response (ASPR), the Biomedical Advanced Research and
Development Authority (BARDA), the Centers for Disease Control and Prevention
(CDC), the Food and Drug Administration (FDA), and the National Institutes of
Health (NIH) to obtain information on the types and status of medical
countermeasures in the SNS that are available to treat thermal burns. We also
interviewed burn experts, such as officials from the American Burn Association and
the Department of Defense, to gain a better understanding of thermal burns and the
care and treatment of these injuries. Finally, we interviewed state and local

5
 The SNS is a national repository of medications, medical supplies, and equipment for use in a public
health emergency. SNS items may be stored in dedicated warehouses, preplaced in local or state
jurisdictions, or managed by pharmaceutical and medical device manufacturers if needed for use in a
public health emergency. In addition, HHS may have agreements in place with hospitals or other
facilities to make use of certain products in the event of a public health emergency.
6
 The Project BioShield Act of 2004 authorized the appropriation of funds for the Special Reserve
Fund for the acquisition of certain medical countermeasures using the authorities granted under that
law. 6 U.S.C. § 321j. Prior to enactment of this law, the Department of Homeland Security
appropriations act for fiscal year 2004 appropriated the amount of the Special Reserve Fund. Pub. L.
No. 108-90, 117 Stat. 1137, 1148 (2003).
7
 For example, see Senate Committee on Appropriations, Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies, Defending Against Public Health Threats, 111th Cong.,
2nd sess., 2010; Senate Committee on Homeland Security and Governmental Affairs, Six Years after
Anthrax: Are We Better Prepared to Respond to Bioterrorism? 110th Cong., 1st sess., 2007; and
House Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and
Science and Technology, Can BioShield Effectively Procure Medical Countermeasures That
Safeguard the Nation? 110th Cong., 1st sess., 2007.



2                                                  GAO-12-304R Thermal Burn Countermeasures
government disaster management officials to obtain a better understanding of the
issues related to deployment of thermal burn countermeasures.

To identify the steps HHS has taken to obtain information about and inform industry
of its interest in additional countermeasures for thermal burns, we reviewed HHS’s
medical and public health consequence assessments and countermeasure
requirements, and documentation and reviews of the contents of the SNS. We also
reviewed HHS’s requests for information, notices, and any other information HHS
made publicly available from 2010 through 2011 to determine how HHS
communicated its thermal burn countermeasure needs to industry and other
partners. We chose this period because it reflects HHS’s most recent activities for
countermeasure development and acquisition. We interviewed HHS officials to
obtain information on how the department determined the need for thermal burn
countermeasures and the extent to which HHS has provided information to industry
about its thermal burn countermeasure needs. We also contacted experts
knowledgeable about HHS’s medical countermeasure activities, including officials at
the Institute of Medicine and officials from five pharmaceutical and medical device
companies varying in size and product mix that have experience working with HHS
on countermeasure development or acquisition, to obtain their perspectives on the
extent to which HHS has provided information to industry and other relevant
stakeholders about its thermal burn countermeasure needs.

To identify the medical countermeasures in the pipeline for development and
acquisition into the SNS that could serve to address thermal burns, we reviewed
BARDA and NIH data on medical countermeasure investments for CBRN and
related incidents. This review helped us to determine which investments could serve
to address needs for thermal burn countermeasures and to analyze NIH data on
countermeasures currently in the pipeline that could address thermal burns. We
interviewed HHS officials to obtain information on how they identify candidate
products in the pipeline that have the potential for use as countermeasures for
thermal burns.

We conducted this performance audit from October 2011 to January 2012 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain sufficient, appropriate
evidence to provide a reasonable basis for our findings and conclusions based on
our audit objectives. We believe that the evidence obtained provides a reasonable
basis for our findings and conclusions based on our audit objectives.

Results in Brief

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 response—identified 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


3                                          GAO-12-304R Thermal Burn Countermeasures
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 HHS’s 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 department’s 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.
NIH’s National Institute of General Medical Sciences is currently funding research on
potential or improved burn care treatment. According to HHS officials, NIH’s National
Institute of Arthritis and Musculoskeletal and Skin Diseases is also funding research
on such treatment.

Background

Care of Thermal Burns Following a Mass Casualty Incident

Thermal burns from fires, conventional explosives, or radiological and nuclear
weapons are treated similarly in the first days and weeks of injury. 8 Immediate
treatment of thermal burns may require medical countermeasures such as
intravenous pain medications and fluids, wound dressings, and intubation if an
airway is obstructed by swelling resulting from the burns. In addition, individuals with
thermal burns sustained in a mass casualty incident may require topical

8
 For burns sustained from radiological or nuclear detonations, once initial burn care has begun,
affected individuals would be monitored for radiation exposure and short- and long-term health effects
of such exposure in the weeks and months after an incident.



4                                                  GAO-12-304R Thermal Burn Countermeasures
antimicrobial cream or antimicrobial barrier bandages and dressings to prevent or
mitigate infection and stabilize patients. Antimicrobial barrier bandages and
dressings may include those that are impregnated with silver as the antimicrobial
agent and do not need frequent changing for patients who may not be able to be
cared for immediately or may need to be transferred to specialized burn centers.

Longer-term treatment for serious burns may require surgical removal of damaged
skin and grafting of temporary skin or skin substitutes until permanent skin grafting
using the patient’s own skin can be performed. Typical products used for temporary
coverage include cadaver or pig skin. For prolonged periods of time beyond the
acute or initial phase of the medical response, care for serious thermal burns also
requires additional specialized staff, resources, and equipment. These additional
needs make the overall response to a mass casualty incident complicated. For
example, the number of health care providers with significant burn care expertise
may be in short supply locally, and care for severely burned individuals beyond the
initial response requires complex, expensive, resource-intensive care, such as skin
grafts. There are approximately 1,850 burn beds in 126 burn units across the United
States. The American Burn Association estimates that 700 to 800 of these beds may
be occupied at any given time. To respond to a mass casualty incident such as a
nuclear detonation—in which HHS estimates the number of individuals requiring
specialized burn care could be over 10,000—burn patients would need to be
transferred to specialized burn centers throughout the country because there may be
relatively few dedicated burn beds available in the region. In addition, patients may
need to be treated in other care sites, such as trauma centers, if specialized burn
centers are filled to capacity.

Federal Roles and Responsibilities Related to Medical Countermeasures

In 2006, HHS established the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE), a federal interagency body responsible for providing
recommendations to the Secretary of HHS on medical countermeasure priorities,
development and acquisition activities, and strategies for distributing and using
medical countermeasures held in the SNS. 9 PHEMCE’s working groups and senior
council serve as the primary means of communication between HHS and
participating federal departments on medical countermeasure issues. As required by
the Pandemic and All-Hazards Preparedness Act of 2006, PHEMCE also conducts
annual reviews of the contents of the SNS. 10

Within HHS, several agencies and offices have specific responsibilities for medical
countermeasure development and acquisition.



9
 PHEMCE is composed of officials from several HHS offices and agencies that have specific
responsibilities for countermeasure development and acquisition. PHEMCE also includes officials
from other federal departments and offices, including officials from the Departments of Agriculture,
Defense, Homeland Security, and Veterans Affairs. See GAO, National Preparedness: Improvements
Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources,
GAO-12-121 (Washington, D.C.: Oct. 26, 2011).
10
    PHEMCE conducts these reviews on behalf of the HHS Secretary. 42 U.S.C. § 247d-6b(a)(1).



5                                                 GAO-12-304R Thermal Burn Countermeasures
•    ASPR leads PHEMCE and the medical and public health response to potential
     mass casualty incidents, including strategic planning, medical countermeasure
     prioritization, and support for developing and acquiring medical
     countermeasures.

•    Within ASPR, BARDA—established by the Pandemic and All-Hazards
     Preparedness Act—oversees advanced development and acquisition of some
     medical countermeasures into the SNS. 11

•    NIH’s NIAID leads the agency’s CBRN countermeasure programs and, as such,
     conducts and funds basic and applied research needed to develop new or
     enhanced medical countermeasures and related medical tools to protect the
     nation against threats posed by CBRN agents.

•    CDC maintains the SNS and supports state and local public health departments’
     efforts to detect and respond to public health emergencies, including providing
     guidance and recommendations for the mass distribution and use of medical
     countermeasures from the SNS.

•    FDA assesses the safety and effectiveness of medical countermeasures and
     regulates their development, approval or licensure, and postmarket surveillance
     as part of its overall role to assess the safety and effectiveness of medical
     products. 12 FDA also provides technical support for the creation of tools to
     support medical countermeasure development and may authorize the emergency
     use of medical products that have not yet been approved or licensed or were
     approved or licensed only for other uses.

Medical Countermeasure Research, Development, Acquisition, and Support

HHS’s and PHEMCE’s medical countermeasure acquisition strategy is based on a
multistep process that includes assessing the threat and public health consequences
of CBRN agents, determining the type and quantity of needed medical
countermeasures, evaluating the public health response capability, and developing
and acquiring countermeasures for the SNS. The Project BioShield Act requires
HHS to assess the public health consequences of exposure to CBRN agents that
the Department of Homeland Security (DHS) determines are material threats to the
nation 13 and to determine for which of these agents medical countermeasures are

11
 42 U.S.C. § 247d-7e(c). The act also gave BARDA the authority to make advance and milestone-
based payments to vendors prior to product delivery to the SNS. 42 U.S.C. § 247d-7e(c)(5)(C), (D).
12
  Under federal law and FDA regulations, vaccines and other biologics are “licensed,” drugs are
“approved,” and devices may either be “approved” or “cleared.” See 42 U.S.C. § 262, 21 U.S.C.
§ 355, 21 U.S.C. §§ 360e, 360(k).
13
  As part of its responsibilities under the Project BioShield Act, DHS develops material threat
assessments to assess the threat posed by given CBRN agents or classes of agents and the
potential number of human exposures in plausible, high-consequence scenarios. DHS uses the
material threat assessments to determine which CBRN agents pose a material threat sufficient to
affect national security. See GAO, National Preparedness: DHS and HHS Can Further Strengthen
Coordination for Chemical, Biological, Radiological, and Nuclear Risk Assessments, GAO-11-606
(Washington, D.C.: June 21, 2011).



6                                                  GAO-12-304R Thermal Burn Countermeasures
necessary to protect the public’s health. 14 HHS’s public health consequence
modeling reports use the exposure information from DHS’s material threat
assessments to calculate the number of individuals who may become ill, be
hospitalized, or die based on a specific scenario or set of scenarios. HHS then
evaluates the public health response capability based in part on the availability of
desired medical countermeasures. Because desired medical countermeasures may
not be developed to a point where they are available for acquisition, NIH and
BARDA oversee and support countermeasure research and development, which is
conducted in several stages: (1) basic research, (2) applied research, (3) early
development, 15 and (4) advanced development. 16 (See fig. 1.) NIH and NIAID
typically provide federal funding for basic and applied research and early
development. BARDA typically funds advanced development of medical
countermeasures. If a medical countermeasure is not FDA approved or licensed, 17
its acquisition into the SNS is typically funded by the Project BioShield Special
Reserve Fund. 18 If a countermeasure is FDA approved or licensed, CDC may
purchase the countermeasure for the SNS.




14
    42 U.S.C. § 247d-6b(c)(2)(B).
15
  This early, or basic, research seeks to better understand the effects of illness and injury sustained
from CBRN incidents and the response of the host organism to illness and injury through the study of
the cellular and molecular biology and physiologic processes. Applied, or translational, research
builds on basic research by validating and testing concepts in practical settings to identify potential
products. Successful concepts move from the applied research stage into the early development
stage, in order to demonstrate basic safety, reproducibility, and ability to be used in humans.
16
  In the advanced development stage, potential medical countermeasures are further evaluated to
demonstrate safety and effectiveness for preventing, diagnosing, or treating disease. Successful
products are then available for development and acquisition. In addition, BARDA determines whether
manufacturing, scale-up production, and licensing of countermeasures can be achieved in a timely
and reliable manner.
17
  In addition to approving or licensing medical countermeasures, FDA works with researchers
throughout the development stages to review safety and effectiveness test results and provide
technical assistance to help ensure that research meets FDA’s regulatory requirements.
18
  The Project BioShield Act provides that the Special Reserve Fund may be used to acquire
countermeasures for which the HHS Secretary determines the scientific research supports a
reasonable conclusion that the product will qualify for FDA approval or licensing within 8 years.
42 U.S.C. § 247d-6b(c)(1)(B)(i)(III)(bb).



7                                                   GAO-12-304R Thermal Burn Countermeasures
Figure 1: Processes for Medical Countermeasure Development and Acquisition




a
 In addition to approving or licensing medical countermeasures, FDA works with researchers throughout the development
stages to review safety and effectiveness test results and provide technical assistance to help ensure that research meets
FDA’s regulatory requirements.


The SNS Contains Supportive Care Items for the Immediate Treatment of
Thermal Burns, Such as Bandages and Pain Medications

The thermal burn countermeasures in the SNS include supportive care items for
thermal burns compiled in kits that include sterile bandages and dressings, 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. According to HHS officials, the goal of the SNS is to supplement
state and local supplies used for immediate care in the initial response—within
72 hours of sustaining injury. In addition to the items needed specifically for burns,
CDC officials told us that the SNS contains certain multiuse products that could be
helpful for treating patients with thermal burns. For example, the SNS contains
airway management supplies such as ventilators and intubation supplies, as well as
ancillary supplies for this equipment, which would be needed for individuals with
compromised airways. 19 Most of the thermal burn countermeasures in the SNS were
initially acquired in 2002 and 2003. HHS officials told us that CDC acquired the
supplies for the burn kits after consulting with burn clinicians about needed products.
For example, officials from burn centers as well as the American Burn Association
provided CDC with a list of recommended products for the immediate treatment of
burns, which included topical antimicrobial creams and other supplies to prevent
infection and stabilize individuals. CDC officials told us that most medical
countermeasures for immediate treatment of thermal burns can typically be found in
local hospitals and community medical care sites. Therefore, in an incident requiring
thermal burn care, countermeasures in the SNS could be used to supplement local
supplies and inventories. According to CDC officials, the thermal burn
countermeasure kits can be deployed to an affected area within 24 to 48 hours of
notification.
19
  According to CDC officials, the thermal burn countermeasures are for treating heat-related injuries
regardless of heat source and may be of some use in treating radiation or chemical injuries. Airway
management and ancillary supplies may also be used in treating the health effects of exposure to
other CBRN agents and infectious diseases, such as pandemic influenza, and in treating injuries
other than burns.


8                                                               GAO-12-304R Thermal Burn Countermeasures
The SNS does not contain other countermeasures that may be available for thermal
burns, but HHS is currently considering whether to acquire additional
countermeasures for immediate and longer-term burn care. In September 2010,
HHS established the PHEMCE Thermal Burns Product Coordination Team, which is
specifically responsible for assessing available medical countermeasures for the
treatment of thermal burns that might be sustained during a nuclear detonation.
According to HHS officials, this coordination team has discussed the possibility of
acquiring additional products and supplies for both the immediate care and the
longer-term treatment of burn injuries. As part of this process, in October 2011, HHS
completed an analysis of the number and types of thermal burns that would
potentially be sustained in a nuclear detonation and the resources and capabilities
needed to care for injured individuals. HHS officials told us that this analysis
provided HHS and PHEMCE with an estimate of the demand for thermal burn
products and helped identify what may currently be available in the market to close
any gaps in available supplies. The analysis also included HHS’s requirements for
needed types and quantities of additional thermal burn countermeasures. Although
HHS has not yet made any decisions about whether to add specific products to the
SNS, burn clinicians and burn experts told us that countermeasures that ideally
should be in the SNS for immediate care of burns within the 72-hour window after
injury include supplies such as silver-impregnated antimicrobial barrier bandages
and dressings, topical antimicrobial creams, intravenous fluids, and pain
medications. Some burn clinicians and experts indicated that silver-impregnated
antimicrobial barrier bandages and dressings, which are not currently in the SNS,
could be useful for stabilizing patients until they could be transported to a burn
center, where specialized personnel could care for them. Clinicians and experts told
us that these products, which are available from several different manufacturers,
may be beneficial since the dressings may not need to be changed for several days,
can be stored at room temperature, and require less specialized skill to apply than
topical antimicrobial creams. This could be helpful in a mass casualty incident in
which immediate access to burn clinicians may be limited. Local and state
government disaster management officials agreed that countermeasures needed in
the SNS for the immediate care of thermal burn injuries would include topical
antimicrobial creams, silver-impregnated antimicrobial barrier dressings, and other
supplies that would allow first responders to conduct burn first aid and stabilize
patients until they could be treated in a burn center.

The SNS also does not contain, and HHS is not currently stockpiling,
countermeasures for longer-term care, such as artificial skin and other skin
therapies. Burn clinicians and experts we spoke with were uncertain about the
benefit of stockpiling products for longer-term care in the SNS for several reasons.
First, burn clinicians and experts emphasized that even if there were existing
stockpiles of skin products and available burn beds, the availability of clinicians with
the appropriate expertise to administer these therapies would be the limiting factor,
because artificial skin or skin substitutes require application by skilled burn
surgeons. Second, burn clinicians and CDC officials told us that biological products
such as artificial skin have very short shelf lives. For example, some artificial skin
products have a shelf life of 18 to 24 months. CDC officials pointed out that if HHS
stockpiles more of these products than are used in the United States on a routine
basis, HHS may need to dispose of expired and unused excess quantities. Third,


9                                            GAO-12-304R Thermal Burn Countermeasures
burn clinicians and experts also told us that products for longer-term care, such as
artificial skin and skin therapy products, must be kept refrigerated at very low
temperatures. This storage need may also complicate the transport of these
products to care sites.

HHS Met with Experts and Industry Representatives and Issued Notices of
Interest to Solicit Information about Thermal Burn Countermeasures

HHS has taken several steps to obtain information about thermal burn
countermeasures, which also signaled to industry its interest in these products. To
obtain information about existing and needed countermeasures for thermal burns,
HHS and the PHEMCE thermal burns coordination team that was established in
September 2010 conducted outreach to potential end users of these products,
including physicians, burn experts, and first responders. For example, HHS officials
conducted interviews with representatives from the American Burn Association,
clinicians at local and regional burn centers, and Department of Defense burn
researchers and experts. HHS and PHEMCE participants visited burn centers and
attended meetings with burn experts. HHS also conducted interviews with industry
representatives to obtain information about potential products in development.

HHS has issued several notices to solicit information from industry about thermal
burn countermeasures, 20 which also informed industry about HHS’s interest in
additional thermal burn countermeasures.
•    In December 2010, BARDA issued a request for information (RFI) for thermal
     burn countermeasures to solicit information from manufacturers about the types
     of products that may be in development or available to treat thermal burns
     resulting from a mass casualty nuclear detonation. 21 The RFI also sought
     information on the degree to which potential products would require specialized
     expertise or specialized resources, the capability of manufacturers to “surge”
     production—or increase their usual rates of production and supply—and
     alternate strategies for stockpiling potential products.

•    In August 2011, BARDA issued a “sources sought” notice for information on
     thermal burn countermeasures for a mass casualty nuclear detonation incident. 22
     The sources sought notice expanded on the previous RFI to solicit additional
20
  In addition to the notices specifically for thermal burn countermeasures, in March 2011, HHS also
renewed its 2009 Broad Agency Announcement soliciting advanced research and development for
the range of medical countermeasures for CBRN agents that PHEMCE is interested in acquiring.
According to HHS, proposals for the development of thermal burn countermeasures are within the
scope of the Broad Agency Announcement.
21
  An RFI may be issued when an agency requires technical, scientific, or business information, or a
combination of these, and input from the marketplace for project planning purposes regarding the
availability of existing or potential solutions. The notice and the information received are not to be
used to determine how well respondents can perform a requirement, which can only be evaluated in
response to a solicitation. 48 C.F.R. § 315.201.
22
  The primary purpose of a sources sought notice is to identify all potential sources, regardless of
organizational type and size classification, and determine their capabilities to fulfill a potential
government requirement. Like an RFI, the notice and the information received are not to be used to
determine how well respondents can perform a requirement, which can only be evaluated in response
to a solicitation. 48 C.F.R. § 305.205.



10                                                  GAO-12-304R Thermal Burn Countermeasures
     detail about products that could be used by first responders in the field for
     immediate care and for products that could be used by clinicians in medical
     settings for longer-term burn care. Desired products for immediate care include
     bandages with antimicrobial barriers that could be used for several days without
     needing to be changed and other bandages or dressings that would require
     minimal changing. Desired products for longer-term care include temporary skin
     substitutes and products that use an individual’s own skin cells to form skin
     substitutes or replacements. HHS officials told us that because the department
     did not limit the notices to either immediate or long-term care products, it
     received information on a mix of products, some of which reflect advances in
     products since the burn kits in the SNS were assembled. For example, the SNS
     contains silver-based antimicrobial cream that must be applied to burns, covered
     with a bandage, and reapplied at least once every 24 hours; newer products
     include bandages impregnated with antimicrobial silver that only require applying
     the bandage and can be changed less frequently.

HHS officials told us that consistent with the FAR, HHS has also discussed its
interest in thermal burn countermeasures through e-mail, telephone, and in-person
discussions with industry representatives and at the department’s regional medical
countermeasure meetings. HHS officials told us that once the department posted the
thermal burns RFI, HHS held a number of technology meetings and had telephone
and e-mail conversations with industry representatives. In addition, in January, June,
and October 2011, BARDA held regional “industry days” for countermeasure
manufacturers during which HHS officials discussed the department’s interest in
thermal burn countermeasures. According to HHS officials, the technology meetings
and regional meetings allowed HHS to obtain additional information from industry
about potential thermal burn countermeasures in development.

Some Medical Countermeasures in Development Could Address Thermal
Burns

NIH has some medical countermeasures in the development and acquisition pipeline
that could address thermal burns. NIAID, the institute at NIH that coordinates CBRN
countermeasure research and development for injuries caused by radiation
exposure combined with other injuries such as thermal burns, informed us that the
countermeasures for thermal burns in the pipeline include topical creams and
antibiotics, such as a topical formula using amino acid peptides. In addition, NIAID is
funding basic research to determine how burns and radiation-related injuries affect
skin and other tissue on a molecular level. 23

Within NIAID, medical countermeasures that could address thermal burns are a
secondary focus of most of its research, according to officials. NIAID’s research
primarily concentrates on radiation injury combined with burns and other injuries. In
addition, NIAID officials told us that the research on these combined radiation and
thermal burn injuries and potential countermeasure candidates is still in the early

23
  According to NIH officials, as part of its CBRN countermeasure work, NIAID routinely works with
NIH’s National Cancer Institute to determine whether its countermeasure research may be applicable
to radiation-induced injuries.



11                                               GAO-12-304R Thermal Burn Countermeasures
stages. Therefore, NIAID officials did not provide us with an estimate of how long it
could take HHS to acquire any of these candidate countermeasures, if successful,
for the SNS. 24

In addition to the research being funded by NIAID, other NIH institutes are also
funding burn research. For example, NIH’s National Institute of General Medical
Sciences funds academic research centers and training programs in trauma, burn,
and wound healing. This institute is currently funding research on potential burn care
treatments, which may be helpful in developing future countermeasures for thermal
burns. For example, one research study is examining the effects of certain white
blood cells in burn healing, burn excision, and skin grafting for the purposes of
potentially developing therapeutics for burn patients. According to HHS officials,
NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases is also
funding research on such treatment.

Agency Comments

We provided a draft of this report to HHS, and its comments are reprinted in
enclosure II. In its comments, HHS stated that the report provides a fair and
balanced presentation of HHS’s efforts to prepare for a mass casualty incident that
could result in a large number of individuals with thermal burns. HHS discussed its
thermal burn countermeasure development and acquisition activities, including
stockpiling supportive care products for the immediate treatment of thermal burns
and exploring the development of new and improved products for longer-term burn
care. HHS also described other BARDA and PHEMCE activities beyond
countermeasure development and acquisition that could help the department
respond to a mass casualty incident, such as the National Disaster Medical
System’s detailed roster of available personnel who could support state and local
authorities’ medical response efforts. In addition, HHS provided technical comments,
which we incorporated as appropriate.
                                             –––––
We are sending copies of this report to the Secretary of HHS and interested
congressional committees. In addition, the report is available at no charge on the
GAO website at http://www.gao.gov.




24
  The federal government faces a variety of challenges in developing and acquiring medical
countermeasures. One scientific challenge is that as with other medical products, the failure rate for
development of certain CBRN medical countermeasures can be higher than 80 percent for those
drugs, vaccines, and diagnostic devices in the early development stage, with an increasing probability
of success as the product moves further through development. In addition, HHS estimates that the
period from scientific discovery to product licensure or approval of successful countermeasures can
be as long as 20 years. See GAO, Public Health Preparedness: Developing and Acquiring Medical
Countermeasures Against Chemical, Biological, Radiological, and Nuclear Agents, GAO-11-567T
(Washington, D.C.: Apr. 13, 2011).



12                                                 GAO-12-304R Thermal Burn Countermeasures
If you or your staff members have any questions about this report, please contact
me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last page of this
report. GAO staff who made key contributions to this report are listed in enclosure III.




Marcia Crosse
Director, Health Care
Enclosures – 3




13                                          GAO-12-304R Thermal Burn Countermeasures
Enclosure I

                                  Abbreviations

ASPR          Office of the Assistant Secretary for Preparedness and Response
BARDA         Biomedical Advanced Research and Development Authority
CBRN          chemical, biological, radiological, and nuclear
CDC           Centers for Disease Control and Prevention
DHS           Department of Homeland Security
FAR           Federal Acquisition Regulation
FDA           Food and Drug Administration
HHS           Department of Health and Human Services
NIAID         National Institute of Allergy and Infectious Diseases
NIH           National Institutes of Health
PHEMCE        Public Health Emergency Medical Countermeasures Enterprise
RFI           request for information
SNS           Strategic National Stockpile




14                                       GAO-12-304R Thermal Burn Countermeasures
Enclosure II

        Comments from the Department of Health and Human Services




15                                  GAO-12-304R Thermal Burn Countermeasures
Enclosure II




16             GAO-12-304R Thermal Burn Countermeasures
Enclosure II




17             GAO-12-304R Thermal Burn Countermeasures
Enclosure III

                   GAO Contact and Staff Acknowledgments

GAO Contact

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

Staff Acknowledgments

In addition to the contact named above, key contributors to this report were:
Sheila K. Avruch, Assistant Director; Shana R. Deitch; Tracey King; Carolina M.
Morgan; Roseanne Price; and Jessica C. Smith.




18                                        GAO-12-304R Thermal Burn Countermeasures
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19                                       GAO-12-304R Thermal Burn Countermeasures
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