Court stands with FDA on its approach to antibiotics use in farm animals

Scientific evidence from the FDA proves a correlation between nonmedical use of antibiotics to fatten farm animals and spikes in antibiotic-resistant infections. And dangerous ones, too--spreading infections like MRSA led the agency to revise its animal health rules earlier this year, warning food producers against dispensing livestock antimicrobials unless the animals are sick. So why was a federal appeals court panel divided over whether these drugs can be added to animal feed even if the drugs aren't medically necessary? The short, simple answer is that the FDA has just been giving advice on the practice.

In a 2-1 ruling July 24, a divided federal appeals court upheld the regulator's policy to allow the use of penicillin and some tetracyclines in feed for cows, chickens and pigs even if the livestock aren't sick. The basic argument was that even though the FDA is making strides to warn the public of potential risks associated with the indiscriminate use of antimicrobials by food producers--and certainly discourages it--the agency never made an explicit move to ban the practice.

The ruling by the 2nd U.S. Circuit Court of Appeals in New York reversed a 2012 decision in a case brought by the Natural Resources Defense Council (NRDC) and a coalition of its partners that directed the FDA to stop the routine use of penicillin and some tetracyclines in healthy animals unless proven safe. Circuit Judge Gerard Lynch, writing for the majority, said the FDA "does not necessarily believe that the administration of antibiotics to animals in their feed is inherently dangerous to human health" despite regarding "the indiscriminate and extensive use of such drugs in animal feed as threatening."

Chief Judge Robert Katzmann dissented, saying, "Today's decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug. It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results."

The plaintiff NRDC and its coalition of partners--which now widely comprise health advocacy group Keep Antibiotics Working--have slammed the decision and released a statement that dispensing non-medically necessary antimicrobials paves the way for exposing humans to "superbugs." David Wallinga, a physician on the committee, wrote, "We can no longer afford to rely on voluntary policies or half-measures to address the crisis of antibiotic resistance. The court has done consumers a serious disservice by failing to order the FDA to ban the overuse of antibiotics on the farm."

The court decision comes after the President's Council of Advisors on Science and Technology met on July 11 to discuss the negative impact of feeding livestock non-medically necessary antimicrobials and antibiotic-resistance in humans. The advisory committee's report, to be issued in a few weeks, will likely beleaguer the practice after council co-Chairman Eric Lander said during the meeting that there was "clear documentation" that antibiotic-resistant microbes transfer from animals to humans, according to the transcript.

The FDA announced with a progress report on June 30 that 31 antimicrobials have been completely withdrawn from the market. Twenty-six drug companies, including animal health heavyweights Zoetis ($ZTS), Bayer and Boehringer Ingelheim, are cooperating with the agency in phasing out their products. The agency is now 7 months into a three-year transition period for its actions with full industry cooperation. 

- here's the NRDC v. US FDA decision (PDF)
- read the PCAST transcript (PDF)