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FDA works with partners at all levels of government—state and local, national and international—to support medical countermeasure-related public health preparedness and response efforts.

Partners include government agencies, non-government organizations, universities and research centers, and FDA medical product centers and offices.

Federal Scientific and Policy Partnerships

• FDA is part of the U.S. Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). FDA and PHEMCE partners have a Memorandum of Understanding (MOU) in place. The MOU Establishes a framework to promote efficiency and collaboration between FDA and PHEMCE partners to meet common needs for considering issues related to safety, efficacy, and utilization of drugs, biologics, and medical devices for use in emergencies, including response preparedness and planning. View this MOU      

• FDA and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), including the Biomedical Advanced Research and Development Authority (BARDA) have an MOU in place to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between Federal partners. View this MOU

• FDA has an MOU with the Defense Advanced Research Projects Agency (DARPA) to support innovation in medical product development, including for medical countermeasures, and new technologies that can advance regulatory science. View this MOU   

• The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) establishes streamlined mechanisms to facilitate certain MCM preparedness and response activities without FDA having to issue an Emergency Use Authorization (EUA, which can be a time- and resource-intensive process).  One tool, which is applicable only to eligible FDA-approved medical products intended for use during a CBRN emergency, allows the Centers for Disease Control and Prevention (CDC) to create and issue, and government stakeholders to disseminate, special emergency use instructions (EUI) (also referred to as fact sheets for recipients of an MCM and for health care professionals) about the FDA-approved conditions of use for such MCMs before a CBRN event occurs. FDA and CDC entered into an MOU to facilitate creation of EUI. View this MOU - more about emergency use of approved MCMs  

• The National Institutes of Health (NIH), U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS), and FDA signed an MOU in 2016 to set forth a framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare. Implementation of this agreement is intended to maintain and enhance agency effectiveness while avoiding duplication of efforts to achieve required standards for the care and use of laboratory animals. View this MOU

• BARDA, CDC, NIH, and FDA signed an MOU in 2016 to provide a framework for coordination and collaborative efforts to spur innovation in the development of diagnostic devices that would be of great clinical and public health utility in combating the development and spread of bacteria that are resistant to antimicrobial drugs. View this MOU

• FDA is a member of the National Interagency Confederation for Biological Research (NICBR), a collaboration of Federal agencies involved in medical research and advanced biotechnology whose goal are to enhance public health, medical research, and biotechnology development by coordinating scientific interactions and leveraging resources.  

• FDA is collaborating with the Defense Threat Reduction Agency (DTRA) and the National Center for Biotechnology Information (NCBI) to establish a publicly available reference database that will be critical to developers seeking to validate their candidate multiplex in vitro diagnostic tests.  

• In August 2017, FDA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) signed new confidentiality commitments, allowing FDA and the European Commission/EMA to share full inspection reports as part of cooperative law enforcement or cooperative regulatory activities. View these Confidentiality Commitments: from FDA,  from EMA and DG SANTE

• On January 16, 2018, FDA and the Department of Defense (DoD) announced the launch of a joint program to prioritize the efficient development of safe and effective medical products intended for deployed American military personnel. The framework for the program was put in place through H.R.4374, which authorized DoD to request, and FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. View the initial work plan for products relevant to DoD

More: MCM-related cooperative arrangements
 

FDA Medical Countermeasures Initiative (MCMi) Partners

• Center for Biologics Evaluation and Research (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 chemical, biological, radiological and nuclear (CBRN) MCMs.

• Center for Drug Evaluation and Research (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)
  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)
  Protects the nation's food supply from CBRN agent contamination and prevents suspect food imports from being distributed.     

• Center for Veterinary Medicine (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)
  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)
  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 International Programs (OIP)
  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 Counterterrorism and Emerging Threats (OCET)
  Facilitates development and availability of safe, effective public health emergency MCMs, and establishes policies to safeguard medical products from adulteration and prevent disruption of supplies as a result of terrorist activities. Manages the MCMi.