The Medical Countermeasures Initiative (MCMi) is an FDA-wide initiative to coordinate medical countermeasure development, preparedness and response, led by the Office of Counterterrorism and Emerging Threats (OCET) in the Office of the Chief Scientist (OCS).
FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.
Together with U.S. government partners through the Department of Health and Human Services Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), FDA helps define and prioritize requirements for MCMs in public health emergencies. This includes coordinating research, setting deployment and use strategies, and facilitating access to MCMs.
FDA launched MCMi in August 2010 in response to a comprehensive, year‐long review of the PHEMCE. The review was ordered by the Department of Health and Human Services (HHS) Secretary to assess our nation’s readiness for future public health emergencies, and improve our nation’s capacity to respond faster and more effectively to chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats, such as pandemic influenza.
MCMi builds on programs already under way at FDA medical product centers, and devotes additional resources to foster the development and availability of medical products that will be needed to counter public health emergencies.
Office of Counterterrorism and Emerging Threats (OCET)
Michael Mair, MPH
Acting Assistant Commissioner for Counterterrorism Policy, and Acting Director, Office of Counterterrorism and Emerging Threats