Antibiotic Advisory

Oct. 31, 2003 -- The Food and Drug Administration (FDA) issued a new guidance document that outlines a comprehensive evidence-based approach to preventing antimicrobial resistance in humans that may result from the use of antimicrobial drugs in animals.

Antimicrobial drugs, such as antibiotics, are medicines often used to treat bacterial infections in both humans and animals. When bacteria develop resistance to antimicrobials, both human and animal health is at risk because the medicines that we depend on to treat infections become ineffective.

The purpose of this new FDA draft document is to ensure the safety of animal drugs used in food-producing animals and to evaluate the human health impact of their intended use. It discusses a recommended three-part approach for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern.

If the assessments show that the risks are significant, FDA could approve the drug with conditional usage or deny the application for marketing authorization. Comments on the draft guidance will be accepted through the end of 2003 and should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 or e-mailed to: fdadockets@oc.fda.gov. The full text of the document can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc.

Staff contact: Paul Rodgers, 304-647-9981

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