In a 2-1 decision, the U.S. Second Circuit Court of Appeals on Thursday overturned earlier district court rulings resulting from a lawsuit filed by activist groups seeking to end the use of antibiotics in livestock feed.
The lawsuit, intending to force the FDA to hold hearings on the safety of using antibiotics in feed and ultimately eliminate the practice, was filed by the National Resources Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists in May of 2011. Two district courts ruled in favor of the activist groups in 2012, and FDA appealed the rulings, leading to this week’s decision in the Court of Appeals.
“Our survey of the text, the context, the regulations, and the background legal principles leave us firmly persuaded that Congress has not required the FDA to hold hearings when FDA officials have scientific concerns about the safety of animal drug usage,” wrote the two judges in their majority opinion.
In his dissenting opinion, Judge Robert Katzmann wrote: “Today’s decision allowed 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 for an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”
Last year, the FDA issued its Guidance for Industry (GFI) #213 calling on drug companies to voluntarily remove performance claims from the labels of their feed-grade antibiotic products. In June, FDA announced that all 26 drug manufacturers affected by GFI 213 have agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs. While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.
Activist groups do not think GFI 213 goes far enough, claiming companies will re-label the affected products for disease prevention, allowing producers to continue using them.