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  6. Focus Area: Antimicrobial Resistance​
  1. Focus Areas of Regulatory Science Report

Focus Area: Antimicrobial Resistance​

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Importance to FDA

Antimicrobial resistance (AMR) refers to a change in a microorganism that makes the microorganism resistant to antimicrobial products (e.g., antibacterial, antiviral, or antifungal drugs). Antimicrobial products used to treat and cure an infection lose effectiveness when microorganisms become resistant. AMR remains a significant global public health threat—according to the Centers for Disease Control and Prevention (CDC), each year in the United States, at least 2.8 million antibiotic-resistant (a subset of AMR) infections occur, and more than 35,000 people die as a result.

FDA participates in and contributes to Combating Antibiotic-Resistant Bacteria (CARB) Task Force, a U.S. government-wide, interagency effort tasked with tackling AMR challenges. This group implements priorities outlined in the Presidential Advisory Council on CARB National Action Plan. In addition, the FDA Antimicrobial Resistance Taskforce and related workgroups collaborate with other government agencies and external stakeholders to develop approaches to detect, prevent, and limit the impact of AMR. FDA facilitates development of enhanced diagnostic and surveillance tools and develops standards to detect AMR earlier, monitor it, and minimize resistance development. FDA also works to improve these approaches to better understand how AMR appears and spreads. In addition, FDA facilitates development of new drugs and biologics to prevent or fight infections, including new antimicrobial products (e.g., bacteriophage therapy—the use of viruses that invade and kill bacterial cells).


  • The CDC and FDA Antibiotic Resistance Isolate Bank is a resource of diverse antibiotic resistant strains of bacterial isolates that manufacturers can use to validate diagnostic assays to detect antibiotic resistance. Availability of panels supports innovation in diagnostics and drug development. FDA uses data from product developers generated with the panels to evaluate drugs and medical devices, such as those with infection-preventing technologies.
  • FDA takes a One Health approach to monitoring for AMR in bacteria—a strategy that leverages the interconnection between people, animals, plants, and their shared environment. As a NARMS partner with CDC and the US Department of Agriculture (USDA), FDA monitors bacteria sampled from retail meats and seafood for AMR and engages in research to explore expanded testing.
  • FDA’s Veterinary Laboratory Investigation and Response Network (Vet-LIRN) plays an important role in One Health monitoring for AMR in veterinary pathogens collected from companion animals.
  • FDA leads the Systemic Harmonization and Interoperability Enhancement for Lab Data (SHIELD) initiative, which aims to improve the accessibility, shareability, and quality of laboratory data supporting evaluation of in vitro diagnostics. The SHIELD initiative helps laboratories across its multi-agency and stakeholder network (e.g., National Institutes of Health, non-governmental organizations such as Pew Charitable Trusts, academia) to better understand clinical management practices and health outcomes, specially to address antimicrobial resistance due to timely discovery of patterns in interoperable data repositories.
  • Scientific approaches are applied to develop targeted patient therapies and more rapid control measures to reduce infection development. Examples include advancing the science of clinical trial design, evaluating novel strategies such as combination antimicrobials, and studies of non-traditional antimicrobial products, such as bacteriophage therapy, understanding mechanisms of resistance to minimize its evolution, and facilitating development of diagnostic devices to detect infection by AMR organisms earlier.
  • FDA researchers are developing tools to efficiently assess the role of plasmids (genetic structures outside of the bacterial chromosome that often carry genes encoding AMR and/or virulence traits) that can be spread among pathogens. These efforts are targeting understanding factors that increase the ability of resistance plasmids to be transmitted among bacteria spreading AMR.
  • FDA performs studies and develops models to facilitate the development of safe and effective vaccines against pathogens such as Mycobacterium tuberculosis, Neisseria gonorrhoeae, and Clostridioides difficile. Effective preventive vaccines indirectly
    decrease the need for antimicrobial use. Thus, availability of vaccines preventing infection of these and other pathogens with high rates of AMR may prolong the usefulness of antimicrobial agents and reduce the development of multi-drug resistant pathogens.
  • FDA explores strategies to prevent the emergence of bacterial resistance. Using a hollow fiber system, FDA has demonstrated that combinations of three antimicrobials may prevent the emergence of high-level resistance that occurs during treatment with a single antibiotic. Ongoing animal studies are determining whether combination therapy has a harmful impact on the microbiome. This work might help to inform further development of clinical approaches to reducing emergent bacterial resistance.




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