How the Office of New Animal Drug Evaluation Uses NARMS Data
FDA’s Center for Veterinary Medicine (CVM) approves and regulates antimicrobials for use in animals to treat, control, or prevent diseases. Some of these same antimicrobials can be used to fight diseases in humans. With any antimicrobial use, antimicrobial resistance can occur.
In order to protect and promote human health, CVM requires drug companies, as part of the approval process, to provide information about the antimicrobial drug. This information includes details on what risks there are to the consumer through food animal products, such as meat or milk. CVM microbiologists then evaluate the risk of whether the drug’s use could result in the development of antimicrobial resistant bacteria in the food supply.
NARMS provides antimicrobial resistance data from bacteria taken from retail meat samples, human infections, and farm animals.
CVM’s Microbial Food Safety Team uses data from NARMS to:
- Help describe the risk of the development of antimicrobial resistance
- Estimate the level of bacterial contamination in or on a particular meat product
- Estimate the percent of bacteria that are resistant to the antimicrobial in question
NARMS data can help provide answers for CVM’s Microbial Food Safety Team in the following ways:
- How many E. coli, Salmonella, and Campylobacter species bacteria were detected on retail meats (chicken breasts, ground beef, pork chops, or ground turkey) in the last 5 years by the NARMS program?
- How many of these bacteria were similar to those found in food animals on the farm and those at slaughter?
- Were any of these bacteria resistant to the antimicrobial currently under review?
- How many people became ill with E. coli, Salmonella, or Campylobacter that were resistant to the antimicrobial under review?
Finally, CVM’s Microbial Food Safety Team takes into consideration the importance of the antimicrobial drug in human medicine for treating human diseases.
- Is this antimicrobial used to treat human foodborne illness?
- Is this antimicrobial a drug of last resort to treat other human illnesses?
- What is the risk of a person getting sick from a foodborne pathogen that is resistant to the antimicrobial in question? What is the risk that this sick person’s treatment will fail?
CVM uses NARMS data and other studies to reach an overall risk estimation for the proposed use of an antimicrobial drug in food animals. This risk estimation is used to guide CVM’s decision to approve or deny approval of the use of an antimicrobial drug in food animals. CVM may also limit the drug’s conditions of use based on this risk estimation.
Want to learn more? Visit CVM’s website! From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process