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)
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 (See Profile) and Robert Katzmann (See Profile) and Southern District Judge Katherine Forrest (See Profile), sitting by designation.
Lynch and Forrest were in the majority reversing Katz in Natural Resources Defense Council,Inc. v. U.S. Food and Drug Administration, 12-2106-cv. Katzmann dissented.
Writing for the majority, Lynch noted antibiotics have provided “dramatic medical advances” in the treatment of bacterial infections, but repeated exposure to the drugs has created antibiotic resistance and “infections in humans caused by antibiotic-resistant bacteria result, on average, in longer hospital stays, worse side effects of treatment, and a greater likelihood of death.”
For “each dose of antibiotics given to humans for medical purposes,” he said, “four doses are given to livestock for non-medical reasons to encourage faster, healthier growth.” In 2009 some 28.8 millions pounds were administered to animals raised for food.
“Unfortunately, research has shown that bacteria that develop resistance to antibiotics used in animal feed can transfer to human beings and pose a risk to public health,” he said.
But Lynch said the FDCA, 21 U.S.C. §360b(e)(1), while clearly requiring the FDA to withdraw approval once finding that a drug is unsafe, never made such a finding, and “the mandate to order withdrawal only applies after the agency has held a hearing.”
“[I]f the NOOH’s contain or embody the findings on which plaintiffs rely, plaintiffs are confronted with the problem that those NOOHs have been withdrawn,” he said. “Nothing in the statute or regulations explicitly restricts the FDA’s ability to withdraw an NOOH after it has been issued.”
“Thus, at this moment, there is no operative document that contains any formal finding, final or preliminary, that any use of animal antibiotics pose health threats to humans,” Lynch said.
He also said the majority was “firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage, and the FDA retains the discretion to initiate or terminate proceedings to withdraw approval of animal drugs by issuing or withdrawing NOOHs.”
The court went on to rule that the denial of the citizen petitions was not arbitrary or capricious, as the court accepted the FDA determination that a voluntary reduction program offers greater prospects for “immediate and significant reductions” in the use of the drugs “than the pursuit of a potentially contentious withdrawal hearing.”
In dissent, Katzmann said, “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.”
“It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug,” he added. “I do not believe the statutory scheme can be read to permit those results.”
Jennifer Sorenson of the Natural Resources Defense Council argued for the council, with Mitchell Bernard and Avinash Kar on the brief. Sorenson said in a statement the plaintiffs are reviewing avenues for relief, saying the court “gives a free pass to ignore science when it is politically inconvenient.”
Kar, in a statement, said, “This decision allows dangerous practices known to threaten human health to continue. Adding antibiotics to farm animals’ feed, day after day, is not what the doctor ordered and should not be allowed.”
The government is represented by Southern District Assistant U.S. Attorneys Ellen London, Amy Barcelo and Benjamin Torrance; and, from the Department of Health and Human Services, David Horowitz, deputy general counsel; Elizabeth Dickinson, chief counsel of the Food and Drug Division; Eric Blumberg, deputy chief council, litigation; and Thomas Cosgrove, associate chief counsel.