In addition to its regulatory responsibilities, FDA works closely with U.S. government and other partners—domestic and international—to build and sustain the medical countermeasure (MCM)-related programs necessary to effectively respond to public health emergencies. Federal partnerships include, but are not limited to, the following.
FDA is part of the HHS Public Health Emergency Medical Countermeasures Enterprise, or PHEMCE. FDA and PHEMCE partners have a Memorandum of Understanding (MOU) in place since 2014, establishing 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.
FDA supports the PHEMCE by providing subject-matter expertise in MCM development and by providing scientific and regulatory input to inform MCM development, procurement, and stockpiling decisions, and helps facilitate access to available MCMs to respond to public health emergencies. FDA provides technical assistance to dozens of standing interagency working groups that develop MCM requirements, plans, priorities, and policies and conduct program oversight and integration.
ASPR / BARDA
FDA and the HHS Administration for Strategic Preparedness and Response (ASPR), including the Biomedical Advanced Research and Development Authority (BARDA) have an MOU in place since 2012 and renewed in 2019, to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between Federal partners.
BARDA, the U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health (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.
The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) established 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. In 2018, FDA and CDC entered into an MOU to facilitate creation of EUI. More about emergency use of approved MCMs
Laboratory testing surge capacity
In May 2022, FDA, CDC, and several stakeholders signed an MOU to collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic.
FDA and the CDC National Institute for Occupational Safety and Health (NIOSH) have an MOU in place, since 2017, to provide a framework for coordination and collaboration between the agencies relating to regulation of surgical N95 respirators and N95 filtering facepiece respirators (FFRs) used in healthcare settings.
Tri-Agency Task Force for Emergency Diagnostics
FDA meets regularly with CDC and the Centers for Medicare and Medicaid Services (CMS) to address implementation issues associated with in vitro diagnostic (IVD) tests made available under EUAs. The Tri-Agency Task Force for Emergency Diagnostics (TTFED), established in 2019, has met routinely since January 2020.
National Institutes of Health (NIH)
Innovative diagnostic testing
FDA is also working with the National Cancer Institute (NCI) at NIH to independently assess the performance of certain antibody tests, and has leveraged this data for EUA authorizations. FDA meets regularly with NIH’s Rapid Acceleration of Diagnostics (RADx) program and participants to provide advice to participants to assist with the program’s goal to speed the development, validation, and commercialization of innovative diagnostics.
Laboratory animal care and welfare
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 and renewed in 2021, 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.
National Institutes for Allergy and Infectious Diseases (NIAID)
FDA’s Office of Counterterrorism and Emerging Threats (OCET) and NIAID are collaborating to develop in vitro organ-on-a-chip technology for modeling of SARS-CoV-2 infection, including identification of biomarkers and testing of medical countermeasures. This collaboration will help researchers gain better understanding of the utility of in vitro human and animal microphysiological systems to predict clinical responses and support testing of medical countermeasures.
OCET and NIAID are also collaborating to develop a nonhuman primate (NHP) lung microphysiological system (tissue-on-a-chip) with a focus on modeling SARS-CoV-2 infection and testing of medical countermeasures with NHP cell systems. The goal of this project is to generate NHP lung tissue chips and use them to gain in-depth understanding of SARS-CoV-2 infection across multiple species to help determine the relative efficacy of candidate medical countermeasures.
DoD Enhanced Engagement Action Team
In 2018, FDA and DoD signed an MOU setting forth the framework for the ongoing partnership and the creation of a joint program under Public Law 115-92 that can better serve the health care needs of American military personnel. This MOU, builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service member, including:
- Working closely with DoD’s Office of Health Affairs to better understand the military’s medical needs for deployed personnel;
- Expediting the review of priority DoD medical products in a manner similar to products under the breakthrough therapy designation program; and
- Providing ongoing technical advice to DoD to aid in the rapid development and manufacturing of medical products for use by the military.
FDA has also worked with DoD partners to support COVID-19 response efforts, including the Joint Rapid Acquisition Cell-Screening and Diagnostics Capability (JRAC-SDC) to assist shortage analysis supporting diagnostics industrial base expansion efforts for HHS and the DoD Clinical Laboratory Supply Working Group to understand critical clinical lab supplies, reagents, and consumables currently in short supply as a result of SARS-CoV-2.
In addition, FDA is working with the U.S. Army Medical Research and Development Command’s (USAMRDC) Telemedicine and Advanced Technology Research Center (TATRC), supporting the rapid development, deployment and testing of the National Emergency Telecritical Care Network (NETCCN). Read more: FDA/DoD Collaborations
FDA has an MOU with the Defense Advanced Research Projects Agency (DARPA), since 2012 and renewed in 2017, to support innovation in medical product development, including for medical countermeasures, and new technologies that can advance regulatory science.
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.
Additionally, as part of its regulatory science mission, FDA’s OCET and DTRA have an interagency agreement to coordinate resources—including existing research contracts, funding, and subject matter expertise—to establish better understanding of filoviruses. Filoviruses can cause severe hemorrhagic fever in humans and nonhuman primates. This agreement focuses on Marburg viruses known to circulate in Africa.
U.S. Army Medical Research and Materiel Command (USAMRMC)
In 2020, FDA and DoD’s USAMRMC signed an MOU to establish a training program in the form of an inter-agency detail to support their shared interests in the training of scientific and medical personnel in medical product development and FDA’s regulatory processes.
In addition to extensive work with HHS and DoD and their agencies, FDA works with a variety of other federal partners to support development of and access to medical countermeasures. These efforts include, but are not limited to, the following U.S. government examples.
National Institute of Standards and Technology (NIST)
In 2021, FDA and NIST created a new collaboration through an MOU, intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes. The MOU signals alignment between senior leadership at both institutions in recognition of the importance of modernizing regulatory frameworks as well as industry practices to meet public health needs in the U.S. Read more: Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure
Under this MOU, in September 2022, FDA and NIST launched a new project to develop new methods to standardize description of the temperature sensitivity and stability of monoclonal antibodies (mAbs) and other large molecules used for vaccines and therapeutics. This work could help reduce the burden on cold storage supply chains and help facilitate the distribution of mAbs and other biomolecules during public health emergencies.
3D printing for public health emergency preparedness and response
FDA is teaming with NIH 3D Print Exchange (3DPX) and Department of Veterans Affairs (VA) Innovation Ecosystem to enhance access to critical medical products through non-traditional manufacturing approaches. The NIH 3DPX COVID 3D TRUST collection included 625 designs, with more than 2 million views from nearly every country around the globe. The most popular downloads were face masks, face shields, and ear savers—favorites of small groups with desktop 3D printers responding to the urgent needs of frontline workers. This work was supported by an MOU signed in 2020, enabling FDA and other stakeholders to share data, and coordinate on open-source medical products for the COVID-19 response. Read more: FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership
National Aeronautics and Space Administration (NASA)
In 2018, FDA and NASA signed an MOU to provide mutual support to biomedical research on drugs, biologics, and medical devices and for MCM development. In 2021, NASA solicited science investigations for Extended Longevity of 3D Tissues and Microphysiological Systems for Modeling of Acute and Chronic Exposures to Stressors (3DTANDMPS). This multi-agency solicitation for research in support of common cross-organizational goals was sponsored by:
- NASA’s Human Exploration and Operations Mission Directorate (HEOMD)’s Human Research Program (HRP);
- NIH: National Center for Advancing Translational Sciences (NCATS), NIAID, National Cancer Institute (NCI);
- HHS/BARDA; and
This solicitation is focused on adapting existing 3D tissues and microphysiological systems (MPS), also known as “tissue chips” or “organs-on-chips,” to extend the current longevity of the 3D tissues and MPS to at least 6 months. In October 2022, NASA announced the teams of researchers working to extend the tissue chip longevity to study a wide variety of biological changes including neurotoxic stressors, radiation exposure, and acute and chronic exposures to drugs.
In addition to the numerous multi-agency collaborations noted above, FDA is partnering with DoD and the Department of Homeland Security (DHS) to address questions about the safety of food that may have been exposed to coronavirus, specifically evaluating environmental stability of SARS-CoV-2 on food and food packaging, as well as whether the virus is infectious via oral exposure to contaminated food.
In addition, 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.