MCM Emergency Use Authorities
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), provides key legal authorities to sustain and strengthen national preparedness for 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) or emerging infectious disease threats, like pandemic influenza. MCMs are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies, needed to respond to emergencies involving such threats.
Depending on the emergency and public health need, MCMs may be provided by the Strategic National Stockpile (SNS), which is overseen by the Centers for Disease Control and Prevention (CDC), 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 health care workers and public health responders under official federal, state, and/or 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 its 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.
More information in this section
- Emergency Use Authorization (EUA) - more information and a list of current EUAs
- Emergency Use Authorization - archived information
- Summary of process for EUA issuance - graphic illustrating the process
- Emergency use of approved MCMs, including expiration dating extensions