For Immediate Release: Oct. 24, 2017
"Antimicrobial resistance is a growing public health threat, and all uses of antimicrobial products can contribute to the development of antimicrobial-resistant bacteria," said FDA Commissioner Scott Gottlieb, M.D. "At FDA, we’re committed to engaging with stakeholders across all relevant sectors to ensure that these products are used judiciously so we can preserve their effectiveness when they’re needed to treat human and animal infections."
The U.S. Food and Drug Administration is employing a multi-faceted approach to fight antimicrobial resistance. In the human arena, the agency’s work focuses on encouraging the development of new antibiotics to treat serious infections like pneumonia, kidney infections and tuberculosis. The FDA and key stakeholders have worked together to improve the efficiency of the antibiotic development process, and our ability to properly characterize the benefits and risks of a new drug before it is prescribed to patients. On the animal side, the FDA completed implementation of its final Guidance for Industry (GFI) #213 earlier this year, which requested that animal drug manufacturers of medically important antimicrobials (those important in human medicine) intended for use in animal feed or drinking water of food-producing animals voluntarily revise the labeling of their products to remove production indications (e.g., growth promotion) and to require veterinary oversight of all remaining therapeutic uses of their products. It is now illegal to use these products for growth promotion and their therapeutic use requires the involvement and authorization of a licensed veterinarian.
The FDA is working in collaboration with other agencies, including the U.S. Department of Agriculture and U.S. Centers for Disease Control and Prevention, to develop approaches for enhancing ongoing data collection efforts in order to assess the impact of these changes over time. One of the ways the FDA is monitoring the effect of its policies on the development of antibiotic-resistant bacteria is through the National Antimicrobial Resistance Monitoring System (NARMS), a collaborative program of state and local public health departments and universities, the FDA, the CDC, and the USDA. This national public health surveillance system tracks changes in the antimicrobial susceptibility of intestinal bacteria found in ill people (CDC), retail meats (FDA) and food animals (USDA) in the U.S. NARMS is a key component of the U.S. National Strategy to Combat Antimicrobial Resistant Bacteria.
Today and tomorrow, the FDA together with its NARMS partner agencies, the CDC and the USDA, are holding a two-day public meeting on NARMS. The 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System will feature the current status of the NARMS and discuss directions for the future. Items that will be discussed during this meeting include an update on the development of new analytical and reporting tools, the latest advances in the use of DNA sequencing technologies, and new surveillance data tracking the nature and magnitude of antimicrobial resistance in bacteria studied by NARMS. The agencies are also inviting public comment on four key questions related to: (1) the format of the NARMS Integrated Reports; (2) how to improve the program’s stakeholder engagement; (3) recommendations for focus areas over the next 5-10 years; and (4) how to prioritize recommendations from the FDA Science Board relating to NARMS.
The NARMS program helps promote and protect public health by providing information about emerging bacterial resistance, how resistant infections differ from susceptible infections, and the impact of interventions designed to limit the spread of resistance. NARMS data are used by the FDA to make regulatory decisions designed to preserve the effectiveness of antibiotics for humans and animals.
An agenda is available on the FDA’s website.
For More Information:
- Federal Register Notice
- 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System
- The National Antimicrobial Resistance Monitoring System
- NARMS 2015 Integrated Report
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.