In a 2-1 decision handed down last week, a panel of judges from the US Court of Appeals for the Second Circuit reversed two 2012 district court rulings, in a case initially filed in 2011 by the NRDC and others, which had directed the FDA to stop the routine use of antibiotics in healthy animals unless drug makers proved the safety of such use.
Kurt Karst, a principle in the Washington D.C. firm, Hyman, Phelps & McNamara, told this publication: "Given Chief Judge Katzmann’s strong dissent, I think it is likely they [NRDC et al] will file an appeal, but it seems unlikely that it will be granted based on the Second Circuit court's track record."
FDA not “arbitrary or capricious"
In the Second Circuit court ruling, the judge, Gerard Lynch, disagreed with the earlier district court decrees.
He said the FDA was not “arbitrary or capricious” in denying the petitions from the NRDC and other non-profit organizations, or in encouraging the "judicious" use of antibiotics in feed, as opposed to withdrawing approval for their use through a "protracted administrative process and likely litigation."
However, Judge Robert Katzmann, in a dissenting opinion, said the appeal court’s decision allows the US agency to openly declare that a particular animal drug is risky, but then refuse to withdraw approval of that drug.
Plaintiffs likely to seek rehearing
Karst said if the non-profit groups appeal, they would most likely seek an en banc rehearing.
En banc is a legal term used to refer to a case heard or to be heard before all judges of a court - the entire bench – rather than by a panel selected from them.
However, Karst, who advises drug companies on FDA regulation, said the Second Circuit has proceeded to a full hearing en banc only in rare and exceptional circumstances.
So, he said the odds seem stacked against the advocacy organizations and last Thursday’s motion looks likely to stand.
When we asked the NRDC last week if it was going to appeal the ruling, the Council's health attorney, Mae Wu, told feednavigator.com: “Everything is on the table. We are considering all legal options."
Drug makers on board, says FDA
The FDA supports a collaborative stakeholder process to implement significant changes to antibiotic use in livestock feed rather than a regulatory action.
In December 2013, it began implementing a plan to phase out the use of medically important antimicrobials in farmed animals by 2017, whereby then, it says, antibiotics will only be given to farm animals for therapeutic treatment, and, at the direction of a veterinarian.
Last month, the FDA said all 26 drug companies behind the manufacture of livestock antibiotics were fully engaging with this strategy.