FDA Proposes Voluntary Limits on Antibiotics Use

The U.S. Food and Drug Administration (FDA) is proposing a voluntary initiative to reduce the use of antibiotics in livestock in order to curb antimicrobial resistance in humans.

"It is critical that we take action to protect public health," FDA Commissioner Margaret A. Hamburg said. "The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available."

FDA issued three guidance documents to help veterinarians, farmers and animal producers "use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems."

The voluntary initiative discourages use of certain antibiotics for so-called production purposes such as growth and feed-efficiency enhancements in an animal. Such antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.

The FDA on Friday published three documents in the Federal Register:

• Final guidance for industry that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
• A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
• A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

The links to the Federal Register postings can be found in the FDA section at www.gpo.gov/fdsys/search/getfrtoc.action.

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