Mark Hamblett, New York Law Journal

The U.S. Food and Drug Administration was not required to conduct hearings on whether to withdraw approval for the use of penicillin and tetracyclines in animal feed, a divided federal appellate panel ruled Thursday.

The U.S. Court of Appeals for the Second Circuit dealt a blow to public interest groups that oppose antibiotics in animal feed, used to make animals grow faster on less food, because they have been linked to human resistance to the drugs. The groups claimed the FDA failed to follow its own rules and procedures and broke a promise to review the science and hold hearings on the issue.

Instead, the groups, led by the Natural Resources Defense Council, claimed the FDA provided flimsy justifications for adopting a program of voluntary reduction in the use of penicillin, tetracyclines and other drugs.

The circuit’s decision reversed a lower court’s 2012 ruling that the FDA violated the Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. §360(e) and the Administrative Procedure Act, 5 U.S.C.§706(2).

Plaintiffs led by NRDC, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists had claimed that the FDA failed to follow through on the Bureau of Veterinary Medicine’s 1977 Notices of Opportunity for Hearing (NOOH) that could have led to the withdrawal of approval for using the drugs.

The bureau said drug manufacturers had “failed to resolve the basic safety questions that underlie the subtherapeutic use of [antibiotics] in animal feed.”

The plaintiffs alleged that Congress slowed the move toward hearings by calling for, and funding, additional research into the drugs. The FDA ultimately withdrew the notices and never held hearings.

The plaintiffs filed citizen petitions in 1999 and 2005 asking the FDA to withdraw regulatory approval for the drugs.

But with the FDA taking no action on the citizen petitions, the plaintiffs finally filed suit in 2011, claiming the FDA should be compelled to hold the hearings and had unreasonably delayed responding to the petitions.

It was only after the suit was filed that the agency issued final responses denying the petitions.

Before Magistrate Judge Theodore Katz, the FDA took the position that withdrawing approval for drugs was a costly and lengthy procedure, and that pursuing a course of voluntary measures was better.

But in March 2012, Katz granted summary judgment on the plaintiffs claims based on the withdrawal of 1977 notices.

Then, in 2012, Katz said the denial of the citizen petitions was arbitrary and capricious within the meaning of the Administrative Procedure Act (NYLJ June 6, 2012).

The government appealed to the Second Circuit, where oral argument was heard on Feb. 8, 2013 by Judges Gerard Lynch and Robert Katzmann and Southern District Judge Katherine Forrest, sitting by designation.

IMAGE: Some groups went to court in an unsuccessful bid to halt the use of antibiotics in animal feed. They are concerned the practice might increase the resistance of humans who consume the meat to the drugs. Bob Nichols/ USDA

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