The 2nd U.S. Circuit Court of Appeals in New York yesterday ruled 2-1 to overturn lower court rulings that compelled the Food and Drug Administration (FDA) to begin hearings on the withdrawal of various antibiotics used in animal feed. The litigation stems from a lawsuit filed by the Natural Resources Defense Council (NRDC) and several other groups, which argued that the FDA is required to proceed with hearings to withdraw the drugs after having issued notices of opportunity for hearings (NOOHs) in 1977 and then withdrawing them in 2011.
The FDA has long since promoted voluntary limits on animal feed containing the antibiotics. In December, it began implementing a plan to phase out the feed’s use, with an exception for when such use is “medically necessary.” On June 30, the FDA said all 26 drugmakers affected by its December plan had agreed to “fully engage in” phasing out the use of the antibiotics in animal feed for food production and phasing in veterinarians to oversee the remaining medical uses.
Reversing a lower court ruling, the U.S. Circuit Court of Appeals said the FDA was empowered to reject two citizen challenges to its policy, which discourages but does not ban the use of penicillin and some tetracyclines in feed for chickens, cows, and pigs. The court 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] that the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs … ”
Writing for a 2-1 appeals court majority, Circuit Judge Gerard Lynch said the FDA deserved deference, even if agency officials had scientific concern about the feed’s safety. “While the agency regards the indiscriminate and extensive use of such drugs in animal feed as threatening, it does not necessarily believe that the administration of antibiotics to animals in their feed is inherently dangerous to human health,” Lynch wrote.
As a result, he said the FDA was not arbitrary or capricious in denying the petitions, or in encouraging what the agency has called “judicious” use of the feed, rather than seeking to withdraw approval through a “protracted administrative process and likely litigation.”
FDA spokeswoman Jennifer Dooren said, “The FDA is currently reviewing the decision but is pleased with the outcome.” Jennifer Sorenson, a lawyer for the NRDC, said the group will explore its legal options.
