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, or a naturally occurring emerging disease.
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 (certain face masks), and ventilators
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.
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 Administration for Strategic Preparedness and Response (ASPR), 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.
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.
Note: Infographic current as of the end of FY 2022 (September 30, 2022)
Descriptive text for the What are medical countermeasures? infographic
Medical countermeasures, or MCMs, are FDA-regulated products that may be used in a public health emergency stemming from a terrorist attack with or accidental release of a biological, chemical, or radiological/nuclear agent, or a naturally occurring emerging infectious disease.
MCMs prevent, protect against, treat, or diagnose diseases or health effects caused by CBRN threat agents (CBRN = chemical, biological, radiological, nuclear), and emerging infectious diseases.
Examples of MCMs include biologic products (vaccines, blood products, antibodies), drugs (antimicrobials, chemical threat antidotes, treatments for radiation injury), and devices (diagnostic tests and personal protective equipment, or PPE, which includes gloves, respirators/certain masks, and gowns.
Some examples of FDA’s MCM roles:
FDA is responsible for assessing safety and effectiveness of MCMs for FDA approval. Activities include: review evidence for approval, regulatory science, policy and legal support, and professional development.
FDA works with partners to advance development and availability of MCMs. Partners include: governments (state, local, territorial, tribal, national, and international), international organizations, medical and scientific community, industry, and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which is comprised of federal agencies.
To prepare for and respond to emerging threats, FDA can issue Emergency Use Authorizations (EUAs) to enable access to MCMs prior to approval, or for unapproved uses. There are more than 370 MCM approvals since 2012* and more than 600 EUAs enabling access to hundreds of MCMs since 2005.** FDA also has other legal authorities to facilitate emergency access to MCMs.
*This number includes approved MCMs listed in the MCMi annual program update in fiscal years 2012-2022. You can find these reports here. This number may not include clearances for numerous medical devices that can be used to support all-hazards preparedness (e.g., PPE).
**To support COVID-19 response, multiple devices were authorized for use under a single "umbrella" EUA in some cases, including certain tests, PPE, and ventilators/accessories.
FDA Medical Countermeasures Initiative (MCMi):
MCMi is an FDA-wide initiative across FDA product centers (including CBER, CDER, and CDRH) and offices to coordinate MCM development, preparedness, and response, led by the Office of Counterterrorism and Emerging Threats, in the Office of the Chief Scientist.