Counterterrorism

The U.S. Food and Drug Administration (FDA) plays a vital and multi-faceted role in securing the homeland through its broad regulatory oversight, monitoring infrastructure and responding to terrorist attacks and naturally occurring emerging threats with timely and appropriate countermeasures.  FDA fosters the development of safe and effective medical countermeasures to mitigate the effects of such threats by actively engaging the medical countermeasures industry, Federal, State and local partners.  All the FDA Centers and Offices have a role in the agency's counterterrorism mission.

The Center for Biologics and Evaluation and Research (CBER) oversees the safety, effectiveness, quality and availability of biologic products, including oversight of vaccines, cells, tissues and the US blood system; works collaboratively to facilitate product development, manufacturing and quality for needed CBRN medical countermeasures. 

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available for treating and preventing illness due to CBRN agents; facilitates the development of new drugs and new uses for already-approved drugs that could be used as medical countermeasures.

The Center for Devices and Radiological Health (CDRH) ensures that safe and effective diagnostics and personal protective equipment are available for diagnosing and preventing illness due to CBRN agents; assures that radiation-emitting products meet radiation safety standards.

The Center for Food Safety and Applied Nutrition (CFSAN) protects the Nation's food supply against CBRN agents, prevents the distribution of suspect food imports and minimizes the risk of CBRN contamination of food.

The Center for Veterinary Medicine (CVM) ensures that animal drugs, food additives, animal devices, and medicated feeds are safe and effective and ensures that food from treated animals is safe.

The National Center for Toxicological Research (NCTR) conducts scientific research applicable to CBRN threats including the identification of virulent biomarkers, technologies for intervention, and rapid, field-rugged tests to detect bioterrorism agents.

The Office of Regulatory Affairs (ORA) protects consumers and enhances public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products;  inspects regulated products, including food, and facilities; conducts law enforcement activities for tampered and adulterated products.

The Office of Counterterrorism and Emerging Threats (OCET) coordinates the portfolio of FDA CT policy initiatives; develops an FDA strategy for CT; promotes CT policy, goals, and needs; facilitates intra-and inter-agency CT communications; coordinates Emergency Use Authorization activities.

The Office of Crisis Management (OCM) coordinates emergency/crisis response activities involving FDA regulated products or in situations when FDA regulated products need to be utilized or deployed; works closely with US Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response in coordination with the FDA Centers and Offices to develop policies to help FDA respond quickly to emergency or crisis situations;  plans/direct activities related to FDA's physical and personnel security programs.