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The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) was established by the Department of Health and Human Services (HHS) in 2006 as a Federal inter-Agency coordinating 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 Strategic National Stockpile (SNS) to prevent or mitigate potential health effects from exposure to chemical, biological, radiological, and nuclear agents and other terrorist threats. The PHEMCE mission is therefore to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE inter-Agency partners.
The 2012 PHEMCE Strategy has established the following 4 goals over the next 5 years: (1) Identify, create, develop, manufacture, and procure critical medical countermeasures; (2) establish and communicate clear regulatory pathways to facilitate medical countermeasures development and use; (3) develop logistics and operational plans for optimized use of medical countermeasures at all levels of response; and (4) address medical countermeasure gaps for all sectors of the American population. This is a complex mission space and many Federal Agencies, including FDA, have responsibilities that are critical to its success.
FDA is hosting this public workshop to address topics specific to national preparedness for a burn mass casualty incident of radiological, nuclear, or chemical origin. The blast and subsequent fires from such weapons could inflict serious thermal burns. With respect to a nuclear detonation, these injuries could affect hundreds to thousands of people. In such an attack, stabilizing individuals with burns and concomitant injuries becomes an immediate priority. Medical care for burns in a mass casualty incident would require the ready availability of large quantities of medical countermeasures for resuscitation, wound management, pain relief, and nutritional- and airway/breathing support in the initial post-injury period. The overall response is further complicated by the complex, expensive, and resource-intensive needs that extend over the longer-term treatment period for serious burns compounded by burn care expertise being in short supply.
There are approximately 1,850 burn beds in 126 burn units across the United States. The American Burn Association estimates that 700-800 of these beds may be occupied at any given time. To respond to a mass casualty incident such as a nuclear detonation—whereupon an estimated 10,000 or more individuals could require specialized burn care—patients may need to be transferred to specialized burn centers throughout the country because there may be relatively few dedicated burn beds available in the region. Also, patients may need to be treated in other care sites, such as local or regional trauma centers, if specialized burn centers are filled to capacity. The short supply of specialized burn experts and facilities may need to be considered one driver in regard to burn care product(s) design and development, enabling versatile use in the hands of nonspecialists as well.
The workshop sessions will focus on the following general topics: Product (drug, device, biologic, and combination products) development challenges; clinical study design considerations for new products; regulatory pathways to market; challenges related to the organization and delivery of burn care