Emergency Preparedness and Response

What are Medical Countermeasures?

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Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, a naturally occurring emerging disease, or a natural disaster.

MCMs  can be used to diagnose, prevent, protect from, or treat conditions associated with  chemical, biological, radiological, or nuclear (CBRN) threats, or emerging infectious diseases.

MCMs can include:Pharmacist with clipboard, with medical products on shelves in background

  • Biologic products, such as vaccines, blood products and antibodies
  • Drugs, such as antimicrobial or antiviral drugs
  • Devices, including diagnostic tests to identify threat agents, and personal protective equipment (PPE), such as gloves, respirators (face masks), and ventilators

What is FDA’s role in supporting the development of medical countermeasures?

Through the FDA Medical Countermeasures Initiative (MCMi), FDA works with partners at all levels of government—local, state, national and international—to support MCM-related public health preparedness and response efforts. FDA is part of the U.S. Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which coordinates MCM-related efforts across HHS and USG interagency partners.

FDA also works with non-government organizations, universities and research centers, and industry to further the development of MCMs for public health emergency preparedness.

How are MCMs accessed and used in emergencies?

Depending on the emergency and public health need, during a public health emergency, 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 pharmaceutical caches.  MCMs are usually dispensed or administered by health care workers and public health responders under official federal, state, and/or local emergency response plans.

In some cases, at the time of a public health emergency, MCMs may be approved by FDA and will be used in approved ways during a response. Some MCMs may not be approved yet, or they may be approved but not for the indication under consideration during the emergency.

Because of its role in regulating medical products, and the nature of some of these 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.

What is the Animal Rule?

Before a medical product can be approved by FDA, the sponsor must demonstrate efficacy—that the product works. In some cases, such as developing MCMs for potential bioterror threats, human challenge studies (exposing people to the threat agent) would not be ethical or feasible.

In these cases, FDA may grant approval based on well-controlled animal studies, when the results of those studies establish that the drug or biologic product is reasonably likely to produce clinical benefit in humans. The product sponsor must still demonstrate the product’s safety in humans. Visit the FDA Animal Rule information page for more.

Still have questions? Email AskMCMi@fda.hhs.gov.

Additional Information

References

Page Last Updated: 03/21/2017
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