The U.S. Food and Drug Administration (FDA) announced April 11 that it is taking three steps to promote the judicious use of medically important antibiotics in food-producing animals. 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 labeled 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.
Under this new voluntary initiative, certain antibiotics would not be used 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.
- 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.
- A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.
“USDA [U.S. Department of Agriculture] 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.
“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.” PD
—From U.S. Food and Drug Administration news release
