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:
- 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.
- FY 2016 Medical Countermeasure Approvals
List of MCMs approved in fiscal year 2016
Medical Countermeasure Resources
Links from FDA, HHS and other government partners
Frequently Requested MCMi Links
MCM-related links, sorted by audience
Animal Rule Information
FDA's Animal Rule information page, including links to the latest guidance and presentations
MedicalCountermeasures.gov facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness
PHEMCE Mission Components
The PHEMCE mission is to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners
List from CDC, including high-priority agents/organisms that pose a risk to national security
FDA Strategic Priorities: 2014 - 2018 Document(PDF - 3.7MB)
FDA Strategic Priorities, September 2014 (MCM-related info on page 17)
- What are medical countermeasures?
Blog post from the Presidential Commission for the Study of Bioethical Issues, March 20, 2013 (archived)