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FDA charts new direction on drug use in livestock

The U.S. Food and Drug Administration (FDA) Monday released a “draft guidance” document setting new policy goals for using antibiotics in livestock production. The document outlines FDA’s current thinking on how to assure that antibiotics important for treating humans “are used judiciously” in animal agriculture, FDA said.

FDA Deputy Commissioner Dr. Joshua Sharfstein said the document sets out three principles FDA will use to develop strategies to prevent antibiotic resistance. The principles could include potential regulations as well as voluntary industry actions. The three principles:

…The agency goal is to protect antibiotics important to human health. Non-therapeutic use of drugs, or using them to promote growth, “is an injudicious use.”



…”Medically important” drugs given to livestock should be limited to uses necessary for assuring animal health, and should include veterinary “oversight and consultation.”

…The growing resistance of humans to antibiotics “is a major public health issue.”



Sharfstein said, “We don’t expect anyone to change their practices today,” however, he did not rule out a regulatory process. Dr. Bernadette Dunham, director of FDA’s Center for Veterinary Medicine, said there would be collaboration with the livestock industry, veterinarians and pharmaceutical companies. To read the draft guidance document, visit http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.

The U.S. Food and Drug Administration (FDA) Monday released a “draft guidance” document setting new policy goals for using antibiotics in livestock production. The document outlines FDA’s current thinking on how to assure that antibiotics important for treating humans “are used judiciously” in animal agriculture, FDA said.

FDA Deputy Commissioner Dr. Joshua Sharfstein said the document sets out three principles FDA will use to develop strategies to prevent antibiotic resistance. The principles could include potential regulations as well as voluntary industry actions. The three principles:

…The agency goal is to protect antibiotics important to human health. Non-therapeutic use of drugs, or using them to promote growth, “is an injudicious use.”

…”Medically important” drugs given to livestock should be limited to uses necessary for assuring animal health, and should include veterinary “oversight and consultation.”

…The growing resistance of humans to antibiotics “is a major public health issue.”

Sharfstein said, “We don’t expect anyone to change their practices today,” however, he did not rule out a regulatory process. Dr. Bernadette Dunham, director of FDA’s Center for Veterinary Medicine, said there would be collaboration with the livestock industry, veterinarians and pharmaceutical companies. To read the draft guidance document, visit http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.