Regulatory Focus™ > News Articles > FDA Looks to Regulatory to Plan for Potential Mass Casualty Event

FDA Looks to Regulatory to Plan for Potential Mass Casualty Event

Posted 04 September 2012 | By Alexander Gaffney, RAC 

Are US regulators prepared to deal with a mass casualty incident involving burns caused by a radiological, nuclear or chemical device?

The question is the focus of an upcoming meeting sponsored by the US Food and Drug Administration (FDA), which said it is looking to assess how to promote burn treatment products to fill "gaps in the product landscape," and determine which regulatory pathways and testing methods best fill those gaps.

The meeting is a part of a program launched by the US Department of Health and Human Services in 2006 known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The program offers recommendations on what to add to the US Strategic National Stockpile (SNS) to mitigate the effects of an attack, including a terror attack, on US citizens.

PHEMCE aims to not only identify needs for the stockpile but also help spur the development of products to meet those needs through the development of new and innovative regulatory pathways.

Burns Represent Unique Need

FDA noted in its Federal Register posting that the development of products to address a mass casualty burn event is particularly important given the seriousness of a burn, the limited hospital resources to address burns and the likelihood that they would occur in a radiological, nuclear or chemical event.

"In such an attack, stabilizing individuals with burns and concomitant injuries becomes an immediate priority," FDA wrote. "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."

Though a nuclear event, for instance, could potentially burn tens of thousands-and more-individuals, just 1,850 burn beds exist in 126 hospital burn units in the entire US, with approximately half already taken by existing burn victims.

"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 non-specialists as well," noted FDA.

The workshop will be held 27-28 September 2012 at FDA's White Oak campus in Silver Spring, MD.


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