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  1. MCM Legal, Regulatory and Policy Framework

MCM Emergency Use Authorities

FDA can allow the emergency use of MCMs through Emergency Use Authorization (EUA) and authorities related to emergency use of approved MCMs

Emergency sign on building

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 Assistant Secretary for Preparedness and Response (ASPR), 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 use specific authorities within the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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, under section 564 of the FD&C Act, use of expanded access authorities for investigational products, and several authorities related to the emergency use of approved MCMs.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

More information in this section

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