The Food & Drug Administration released a draft guidance document this morning laying out new policy goals for the use of antimicrobials in livestock production. This new document could mean greater health risks and higher costs for meat animal producers.
According to the National Pork Producers Council, the guidance could cause costly review or elimination of previously approved animal-health products. Disturbingly, the NPPC also reports that their appears to be no science by which the FDA based the guidance.
Today’s draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture. The FDA acknowledges current veterinary and animal producer organizations’ efforts to implement guidance on the use of antimicrobial drugs; however, the agency believes more needs to be done.
FDA’s guidance calls for antibiotics that are “medically important” to humans to be used in animals only when necessary to assure their health. It also says those antibiotics should be administered with veterinary oversight or “consultation.”
“This guidance could eliminate certain antibiotics that are extremely important to the health of animals,” said NPPC President Sam Carney, a pork producer from Adair, Iowa. “FDA didn’t present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food. We know that healthy animals produce safe food, and we need every available tool to protect animal health.”
The guidance outlines three principles the FDA believes to be crucial in assuring that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture.
FDA deputy commissioner Dr. Joshua Sharfstein explained the three principles in the draft guidance are:
- Non-therapeutic use of antimicrobials, or sub-therapeutic use for feed efficiency, “is an injudicious use.” The agency goal is to protect antibiotics that important to human health.
- “Medically important antimicrobial drugs” should be limited “to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation.”
- Hazards of antimicrobial resistance, including the growing emergence of multiple-drug resistance is “a major public health issue”
Director of the FDA’s Center for Veterinary Medicine commented on the new guidance: “Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals.”
The NPPC, however, is concerned with the possible direction of the guidance. NPPC supports veterinary supervision of antimicrobial administration, but also recognizes the extreme shortage of large animal veterinarians; and the requiring of all antibiotics to be accompanied by feed directives could be problematic under the given circumstances. Additional issues arise with the guidance as well. The measure seems to create more trouble and hassle than benefits considering the lack of scientific evidence in the measures.
While the guidance does not have the force of law, FDA may treat it as such. This move is an attempt to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on antibiotic use in livestock and poultry production, NPPC notes. But top scientists with the Centers for Disease Control and Prevention and the National Institutes of Health recently told a U.S. House committee that there is no scientific study linking antibiotic use in food-animal production with antibiotic resistance.