Wednesday, June 6, 2012

Antibiotics challenged

New York judge Theodor Katz is forcing the United States Food and Drug Administration to take another look at petitions from those who want a ban on antibiotics in livestock and poultry farming.

The judge is tangling with a powerful Washington bureaucracy, not to mention the makers and marketers of antibiotics and livestock and poultry farmers.

But Katz may just win in a controversy that's at least 45 years old, dating back to before the Swann report in the United Kingdom said it's foolish to keep adding antibiotics to livestock and poultry feeds because it gives free range for antibiotic-resistant bacteria to multiply and then become a threat to human health.

Katz rejected an FDA appeal of the order Katz issued in March. He refused then to allow the FDA to be excused from considering petitions filed by several organizations. The FDA argued it didn't need to listen to the objections because it has put voluntary guidlines in place urging judicious use of antibiotics in food animal production.

Two months ago another court compelled the FDA to withdraw approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses are safe.

The petitions were filed by the Natural Resources Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists and urge FDA to revoke approvals for all nontherapeutic uses of antibiotics in livestock production.

At issue is whether the widespread use of antibiotics in animal agriculture (often via feed) diminishes the effectiveness of these medicines in treating infections in humans.

The citizen petitions were filed seven and 13 years ago and Katz said the FDA failed to address the scientific evidence presented by the petitions that the use of penicillin, tetracycline, and five additional drug classes in livestock production poses risks to human health.

The court decision noted, “for over 30 years, the FDA has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.”

Katz said the concern that proceedings would be too time consuming is “both ironic and arbitrary” and said that “had the Agency addressed the petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now.” 

The Animal Health Institute, speaking for companies making and marketing antibiotics for use in livestock and poultry farming, said “the decision by the U.S. District Court in New York adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.  

“The court has now ordered FDA to initiate two different, competing and resource intensive processes,” said Ron Phillipa, vice president for legislative and public affairs for the Animal Health Institute.

The court called for risk assessments, but Phillips said

“in fact, several risk assessments have been published in peer-reviewed journals, and FDA has performed its own risk assessment on one compound.  

“All these scientific assessments come to the same conclusion:  The actual human health risk of the use of antibiotic use in animals resulting in the inability of the drug to treat human disease is extremely small – in one instance, less than the risk of dying from a bee sting,” Phillips said.