FDA Issues Guidance on Antibiotic Use in Livestock
The U.S. Food & Drug Administration (FDA) today announced it is taking three steps to protect public health and 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" it states. "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 for so-called "production" purposes, such as to enhance growth or improve feed efficiency in an animal, says the FDA. 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 is publishing three documents today 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- A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.
Reacting to the announcement, the Animal Heath Institute (AHI) said it supports the process. "AHI and its member companies have supported the stakeholder approach used by FDA to reach this point and we will continue to work collaboratively to implement the policy goals articulated in these documents," it states.
"The veterinarian is critically important in animal care decisions and, ultimately, in protecting food safety and human health. We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals," AHI said in a prepared statement.
