The Medical Countermeasures Initiative (MCMi) is an FDA-wide initiative to coordinate medical countermeasure development, preparedness and response. This includes funding intramural research, and working with multiple FDA centers and offices to help ensure that U.S. laws, regulations, and policies support preparedness and response for potential chemical, biological, radiological and nuclear (CBRN) and emerging infectious disease threats.
FDA centers and offices supporting MCMi activities include, but are not limited to:
Center for Biologics Evaluation and Research (CBER)
CBER oversees the safety, effectiveness, quality, and availability of biological products, including vaccines, cells, tissues, and the blood supply. CBER collaborates in facilitating product development, manufacturing, and quality for needed CBRN MCMs.
Center for Drug Evaluation and Research (CDER)
CDER ensures that safe and effective drugs are available for preventing and treating illnesses from exposure to CBRN agents. CDER facilitates new drug development and new uses for already-approved drugs that could be used as MCMs.
Center for Devices and Radiological Health (CDRH)
CDRH ensures that safe and effective diagnostics and personal protective equipment are available for diagnosing and preventing illnesses from exposure to CBRN agents, and ensures that radiation-emitting products meet radiation safety standards.
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
CVM ensures that animal drugs, food additives, devices, and medicated feeds are safe and effective, and makes certain that animal-based food is safe.
National Center for Toxicological Research (NCTR)
NCTR conducts scientific research related to CBRN threats, including identifying virulent biomarkers, technologies for intervention, and rapid, “field-rugged” tests that can help detect bioterrorism agents.
Office of Regulatory Affairs (ORA)
ORA protects consumers and enhances public health by maximizing compliance with FDA laws and regulations. Inspects regulated products and facilities, and conducts law enforcement activities to prevent tampering with or adulteration of regulated products.
Office of Global Policy and Strategy (OGPS)
OGPS serves as the primary liaison with other U.S. government components, international and foreign governments for policy formulation and execution impacting FDA and FDA-regulated products.
Office of Minority Health and Health Equity (OMHHE)
OMHHE serves to promote and protect the health of diverse populations through research and communication of science that addresses health disparities.
Office of Women’s Health (OWH)
OWH promotes the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of sex/gender analysis.
Office of the Chief Scientist (OCS)
OCS supports the research foundation, science, and innovation that underpins FDA’s regulatory mission through a broad framework that encompasses scientific collaborations, laboratory safety, the transfer of FDA inventions to the private sector, scientific integrity in FDA policy- and decision-making, professional development, and research to generate the vital data FDA requires for regulatory decision-making and development of sound regulatory policy.
Office of Counterterrorism and Emerging Threats (OCET)
OCET facilitates development and availability of safe, effective public health emergency medical countermeasures, and establishes policies to safeguard medical products from adulteration and prevent disruption of supplies as a result of terrorist activities. OCET coordinates the MCMi.