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Appeals court uphold FDA action on judicious use of antibiotics

The Second Circuit Court of Appeals issued a decision supporting FDA's decision to pursue a stakeholder process to antibiotic use in livestock.

The Second Circuit Court of Appeals issued a decision July 24 supporting the Food & Drug Administration’s decision to pursue a collaborative stakeholder process to implement significant changes to antibiotic use rather than a regulatory action is a welcome development, according to the Animal Health Institute (AHI).

The court, in which one of the three panel judges dissented, joins the Centers for Disease Control and the President’s Council of Advisors on Science & Technology in expressing support for FDA’s judicious use effort.

FDA’s policy is also supported by AHI. As FDA recently reported, all 26 companies affected by the policy have pledged to align their products with the effort and changes have begun. As a result of this policy being implemented, all medically important antibiotics used in food animals will be used to fight disease at the direction of a veterinarian.

The legal challenges and citizen’s petitions that are set aside by this decision have diverted agency resources from focusing on moving ahead with implementing the judicious use policy. AHI said it believes this decision will clear the way and allow FDA to focus on working with stakeholders to successfully implement this policy in a timely manner.

The Natural Resources Defense Council (NRDC) brought the lawsuit with its partners, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists in May of 2011. The district court rulings were issued in New York in March and June 2012 (Feedstuffs, April 2 and June 11, 2012).

In the March 2012 ruling a federal judge in New York ruled that FDA must address the use of non-therapeutic antibiotics in livestock in response to a lawsuit fi led last May by the plaintiffs.

The decision by U.S. magistrate Judge Theodore Katz in the U.S. District Court for the Southern District of New York required FDA to move forward with procedures to withdraw existing approvals for the growth-promoting use of two antibiotics — penicillin and tetracyclines (specifically, chlortetracycline and oxytetracyline) — in animal agriculture.

The case centered on FDA's withdrawal in January 2012 of two 1977 notices of opportunity for a hearing (NOOHs) that proposed to eliminate certain approved uses of penicillin and tetracyclines in feeds for food-producing animals (Feedstuffs, Jan. 2).

In the June 2012 ruling a federal judge ruled that FDA must reconsider previously denied petitions to ban certain medically important antibiotics used in animal agriculture. The order came shortly after FDA issued a notice that it will appeal the March 2012 ruling.

Katz was the dissenting member of the panel in the current ruling.

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