The U.S. Food and Drug Administration today published three documents outlining a voluntary initiative for members of the livestock industry to phase out production uses of antibiotics in food-producing animals. The documents will help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address disease and health problems, the FDA said. Under the initiative, certain antibiotics would not be used for production purposes, such as to enhance growth or improve feed efficiency in an animal. However, the antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian. The documents, published today in the Federal Register, include: = A final guidance for industry titled 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. = A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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 FDA is also reaching out to animal producers who operate on a smaller scale or in remote locations to ensure the drugs they need to protect the health of their animals are still available, said FDA commissioner Margaret Hamburg, M.D. The U.S. Department of Agriculture worked with the FDA in producing the documents to ensure that livestock producers were taken into account, and the USDA will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to assist with the transitions laid out in the new initiative, according to John Clifford, DVM, veterinary medical officer for the USDA. Earlier this month, an FDA order prohibited production use of most cephalosporin class antimicrobial drugs in food-producing animals. The FDA also recently lost a federal court case that, if not appealed, would force the agency to start the process of withdrawing approval for production uses of penicillins and tetracyclines in food-producing animals. <HOME>
