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Judge Orders FDA to Restrict Antibiotic Use in Animals

WASHINGTON—A federal judge has ordered the U.S. Food and Drug Administration (FDA) to begin withdrawing approval for some antibiotics used on livestock until drugmakers can prove the drugs are not contributing to drug-resistant bacteria and whether they are safe for human consumption. The ruling comes days before the FDA was scheduled to issue voluntary industry guidelines for antibiotic use in animals.

The decision stems from a lawsuit filed last year by the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS).

In 1977, FDA concluded that feeding animals low doses of certain antibiotics used in human medicine, namely penicillin and tetracyclines, for purposes of growth promotion and feed efficiency could promote antibiotic-resistant bacteria capable of infecting people. Despite this conclusion and laws requiring that the agency move on its findings, FDA failed to take action on penicillin and tetracyclines to protect human health for the last 35 years.

The court decision noted, “In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown."

The ruling compels FDA to take action on its own safety findings by withdrawing 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 ruling also makes clear that future nonbinding guidance from FDA will not excuse the agency from its obligation to hold hearings on whether to withdraw approval for antibiotics covered by the decision.

The ruling stated: “Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be--and has been--transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."

Click here to view the entire 55-page ruling.

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