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Ruling on FDA’s Oversight of Animal Antibiotic Use Called a ‘Big Blow to Public Health’

In a 2-1 decision, the U.S. Second Circuit Court of Appeals in New York ruled Thursday that the U.S. Food and Drug Administration is not required to hold hearings concerning the safety of feeding antibiotics at subtherapeutic levels.

The ruling overturns two district court rulings from 2012 in a case initially filed in 2011 by the Natural Resources Defense Council (NRDC), the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists.

The groups argue that FDA is required by statute to hold hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed after the agency declared that the subtherapeutic use of the drugs in animal feed “ha[s] not been shown to be safe” in the late 1970s.

Such hearings would be a requirement for industry to prove that the use of these drugs as approved is safe.

“If they were not able to do that, then FDA would have to proceed with withdrawing the approvals for those drugs, which would effectively ban those drugs in animals for food production,” said Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future.

NRDC says that not requiring hearings means FDA “does not have to consider banning” the practice of feeding antibiotics to healthy animals.

“The science was there in 1977 and 40 years later, it’s only gotten stronger that these low-dose, routine use of antibiotics on livestock is causing development of antibiotic-resistant bacteria and that bacteria is coming off the farm in many different ways and affecting humans,” said Mae Wu, an attorney with NRDC’s health program.

“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,” wrote Judge Robert Katzmann in his dissent. “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.”

Part of FDA’s argument in the case has been Guidance #213, which will ban the use of antibiotics for growth promotion in food animals, as an alternative strategy for dealing with resistance. But NRDC and other groups have argued that it won’t be effective at curbing antibiotic use on farms because “disease prevention” labels could simply replace those for growth promotion.

The Centers for Disease Control and Prevention estimates that at least 23,000 people die each year from antibiotic-resistant infections.

“Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases, not to promote growth,” reads CDC’s report on antibiotic resistance threats, released last September.

Today’s decision was a “big blow to public health,” Nachman said. “It’s tough to know where it’s going to go from here. I would expect that NRDC would appeal this decision in some manner; I would hope they would.”

When asked if NRDC plans to appeal Thursday’s ruling, Wu told Food Safety News, “I can’t say today what we’re going to do because it takes a lot more discussion, but we’re not discounting any options at this point.”

© Food Safety News
  • Dr.. Rima

    I propose a name change for this agency from Food and Drug Administration to the far more accurate Fraud and Death Administration.

    The WHO says that we are “approaching an antibiotic resistance apocalypse”. And the FDA is cheering it on! Pompoms courtesy of its industrial friends.

    Their totally corrupt position: “We establish that the drugs are dangerous but we excuse ourselves from having to even consider banning them. Why? Because we say, so, that’s why! And somehow, the Court has upheld this abdication and contortion or responsibility and reason.
    So this is the regulatory logic of the agency we have mistakenly entrusted our safety to: “Even more people are going to die from this decision? Not our problem.

    Leave that to an agency entrusted with overseeing public safety through foods and drugs.

    Oh, that’s us.

    Well, never mind. I’m retiring in 2 years and going back to an even cushier corporate job than the one I left.

    And I don’t eat that crap, anyway! I can afford clean food!”

    This is yet another in a long and deadly line of unconscionable action (and equally unconscionable inaction) by decision-makers in an agency totally corrupt and conflict-riddled in every sphere of its regulatory responsibilities.
    We have seen time and again that although there are good men and women advising the decision making level, the decision makers are free to ignore public health, and the counsel of their own scientists in favor of both their own self interest and that of their corporate buddies. One merely has to think of Vioxx, Avandia, the war on raw milk, Rotateq vaccine, mercury and aluminum in vaccines, forbidding mad cow screening by organic cattle farmers, and the picture could not be clearer or more despicable.

    As the Medical Director of the Natural Solutions Foundation, a public interest, not for profit organization focused on health and health freedom, I propose that we disband the FDA, redefine conflict of interest through new legislation which imposes stiff civil and criminal penalties for a regulator or other public employee to have any financial dealings with any corporation or other entity regulated by that agency. I would also have that legislation include a 5 year moratorium for employment in any segment of the regulated industry before or after employment in the regulatory agency.

    Hmmm. Not a bad idea for all of the regulatory agencies. We might regulation instead of corporate prostitution.

    Yours in health and freedom,
    Dr. Rima
    Rima E. Laibow, MD
    Natural Solutions Foundation

  • serulin

    What can I do as a concerned American citizen to show my support for the campaign against antibiotics in animals?

    • pawpaw

      Support your local farmer who chooses antibiotic-free feeds. Farmers markets a good place to start, then ask questions and even visit the farm during open house.
      Please do note: Several times per year, we treat wounds or infections with botanicals, and occasionally topical or injectable antibiotics. Hope we don’t lose the ability to buy and use these injectables. If so, we’d likely put more animals down. As wouldn’t make economic sense to take most hurt animals to the vet, or pay for a farm visit.
      For pasture-based animals, most producers deworm their stock one to few times a year. Depending on species and location, can be tough to raise some animals without anti-helminthics.

    • crookedstick

      BOYCOTT BEEF, Serulin. I will never eat it again or Buy it.

  • Shane

    This disastrous ruling makes it very clear that American public health and safety are secondary to factory farming’s drive for profit at the expense of our health and humane treatment of animals. Corporations are indeed sowing the seeds of the next biological catastrophe and the public will be the ones reaping the whirlwind.

    • Oginikwe

      So, who owns the two judges?

      • Foodsick

        Monsanto