The Food and Drug Administration (FDA) is taking the first steps toward phasing out non-treatment-based uses of antibiotics in agriculture.
The agency issued two major industry guidance rules to eventually eliminate so-called production use of the drugs; some farmers have been exploiting antibiotics by adding them to feed to boost growth and reduce the amount that animals eat to gain weight. The FDA’s actions will limit the medications to their original purpose — to treat infections — and require veterinarians to dispense the drugs.
The guidance is in response to concerns that over use of antibiotics on farms that can encourage antibiotic resistant super bugs to emerge; many of these drugs are the same ones used to treat infections in people, and the resistant strains can mean more challenges for controlling disease in human patients.
“Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary,” FDA officials said in their announcement.
The agency is asking animal pharmaceutical companies to voluntarily revise their labels to display only the FDA-approved, treatment-based uses. The FDA wants these companies to remove any growth-promotion claims for antibiotics that are also used to treat human illness.
The plan also requires changing the over-the-counter status of these drugs so that they now require a prescription from a veterinarian. Vets will then have authority to dispense antibiotics for specific animals in order to prevent or treat particular infections. The companies have three months to notify the FDA that they plan to participate in the new plan, and then will have three years to implement the guidance.
“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor in a statement. “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”