Global & Disaster Medicine

How FDA helps make MCMs (medical countermeasures) available in emergencies

How FDA helps make MCMs available in emergencies
The first in an occasional series on the ways FDA helps prepare for and respond to public health emergencies
During public health emergencies, medical countermeasures (MCMs) may be needed to prevent or treat diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents or emerging infectious diseases, like pandemic influenza or Ebola.
Depending on the emergency and public health need, MCMs may be provided by the Strategic National Stockpile (managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR), in the U.S. Department of Health and Human Services (HHS)), or through state and local stockpiles or other supplies. When needed during a public health emergency, MCMs are usually dispensed or administered to impacted individuals by healthcare workers and public health responders under official federal, state, and local emergency response plans.
In some cases, MCMs might already be approved and will be used in approved ways during a response. In other cases, the best medical products available for a response might be unapproved or need to be used in unapproved ways. Because of our role in regulating medical products, FDA may need to use special authorities to allow the use of such MCMs in impacted populations during or in anticipation of emergencies.
Mechanisms FDA can use to allow the emergency use of MCMs include the Emergency Use Authorization (EUA) authority and several authorities related to the emergency use of approved MCMs.

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