Nearly a week has passed since a federal judge in New York ruled that the U.S. Food and Drug Administration (FDA) must start taking action on certain antibiotic usage in animal agriculture. As the dust clears, and more evaluations have taken place, veterinarians associated with food-animal production are speaking up.
Liz Wagstrom, DVM, the National Pork Producers Council’s (NPPC) chief veterinarian, points out that the judge’s ruling addresses only the growth promotion and nutritional efficiency uses of penicillin and tetracycline. She emphasizes that the drugs would still be available for use in disease prevention, control, and treatment.
On Wednesday, the American Veterinary Medical Association (AVMA) stepped forward to reaffirm its support of the responsible antibiotic use in food-animals production.
“AVMA acknowledges the growing concern regarding antimicrobial use and resistance in animals and people, and supports the judicious use of antimicrobials to maximize public and animal health benefits while minimizing risks,” says Ron DeHaven, DVM, AVMA’s chief executive officer. “The judicious use of antimicrobials plays a key role in preserving the health of our nation’s food animals and the safety of our nation’s food supply.”
While many agree that more recordkeeping and veterinary oversight regarding antimicrobial use in food-producing animals would be beneficial, the question is whether the ruling is the right action.
For the past two years, FDA had been working with industry stakeholders to address antimicrobial use in food-animal production. Following a December announcement, FDA had begun work on guidance documents (Guidance #209) for drugs used for growth promotion versus disease prevention and control. Those documents were expected to be released any day.
The judge’s ruling now requires FDA to start shift gears and start proceedings to withdraw approval of “production uses” of penicillins and tetracyclines in food-producing animals, points out AVMA. As part of the withdrawal process, drug manufacturers can request hearings to allow them to provide scientific evidence that the production use of antimicrobial products does not pose a threat to public health.
However, that’s a bit like proving a negative, Christine Hoang, DVM, assistant director of scientific activities division for AVMA, told Mike Adams, host of AgriTalk. “We don’t really know how any drug manufacturer would be able to prove that definitively; FDA has said they don’t know how they’d go about that.” She says it’s akin to proving a person’s innocence versus guilt.
This ruling, beyond tying FDA’s hands, could actually delay actions and cost more money and resources, which FDA does not have.
The way the ruling has come about, Hoang says subtherapeutic use of antimicrobials could “likely be withdrawn within the next two years.”
AVMA did support FDA’s proposed voluntary process to move away from growth-promotion applications for antimicrobials to disease prevention and control usage.
While Hoang points out there is room on both the human side and the animal side to use antimicrobials more effectively and judiciously, the question always comes back to is the use in food-animals creating “super bugs”. “We would have to say that the science just isn’t there to support such a broad-based ban,” she points out. “The risk-analysis over the years, including some by FDA and AVMA, suggests the risk to human health (through this application) is very very small.” (You can hear more of her interview in the audio at the top of the article.)
DeHaven cautions that any decision to withdraw approval or ban any antimicrobial uses should be based on solid science and risk-based assessment, and not on anecdotal reports and speculation. “It is crucial that safe and effective antimicrobials remain available for use in veterinary medicine to ensure the health and welfare of animals and, consequently, the health of humans,” he says.
The American Association of Swine Veterinarians (AASV) is keeping a close watch on developments. “Swine veterinarians continue to promote the judicious use of FDA-approved antimicrobials for the purposes prescribed on the product label,” says Harry Snelson, DVM, AASV’s communications director. “It is our intent to continue to work with FDA and product manufacturers to enhance veterinary oversight while maintaining access to the antimicrobials approved to control, prevent and treat disease in swine.”
The legal process from here is unclear. The question is whether the ruling would be open to an appeal. “My understanding is that FDA is evaluating its next steps,” Hoang says.
AVMA, AASV, NPPC and others say they will continue to work closely with FDA on the issue and to formulate a science-based strategy to deal with it.