The Food and Drug Administration on Wednesday finalized updates to its framework for evaluating potential risks antimicrobial resistance could pose to humans when considering whether to approve livestock antibiotics.
FDA initially proposed updated antimicrobial guidelines four years ago. Since 2003, when FDA first issued guidance on the subject, "new antimicrobial drugs have been developed, disease patterns have shifted, and prescribing practices have evolved,” the agency said
in a press release.
Under
the new guidance, FDA will use three factors to score antibiotic and antimicrobial drugs: the likelihood the drug will breed resistant bacteria in an animal, the likelihood a person would eat the bacteria on meat, and how important that class of drug is in human medicine.
If the agency determines a drug is at higher risk for antimicrobial resistance, it could lead to that drug receiving prescription-only status, monitoring requirements, and limits on how many animals can be treated and for how long.
Article by: Izzy Hill
Director of Regulatory Affairs
Project
APIS m.