Three documents issued outlining industry guidance
The Food and Drug Administration has finalized a plan for asking drug companies to voluntarily limit the use of certain antibiotics in animal feed, in the wake of a U.S. federal judge’s decision that their overuse is endangering human health by promoting the development of antibiotic-resistant superbugs.
The FDA is asking drugmakers to stop using 200 products for growth promotion and instead use them just to treat and prevent diseases. Companies that opt to do so will be required to revise their product labels to reflect the change, and once the antibiotics are relabeled they will no longer be available to farmers over the counter. “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 has issued three documents to help veterinarians, farmers and animals producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems:
- 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- A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.
The industry is now turning its attention to the details of how the plan will be put in place, particularly to the role veterinarians will play.