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FDA Introduces Voluntary Initiative on Antimicrobials

12 April 2012

US - The US Food and Drug Administration (FDA) announced yesterday that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals. A voluntary initiative for labelling and use of antimicrobial drugs in livestock is proposed.

Antimicrobial resistance occurs when bacteria or other microbes develop the ability to resist the effects of a drug. Once this occurs, a drug may no longer be as effective in treating various illnesses or infections. Because it is well established that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary, says the FDA.

Based on a consideration of relevant reports and scientific data, FDA is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labelled and used in food-producing animals. FDA is taking this action to help preserve the effectiveness of medically important antimicrobials for treating disease in humans.

Yesterday, the FDA issued three documents that will 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. Under this new voluntary initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.

“It is critical that we take action to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “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.”

The FDA published three documents in the Federal Register.

  1. A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
  2. 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.
  3. 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.

“USDA worked with the FDA to ensure that the voices of livestock producers across the country were taken into account,” said Dr John Clifford, USDA Chief Veterinary Medical Officer, “and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”

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