A judge told the U.S. Food and Drug Administration to begin pulling approval for some antibiotics used on livestock until drugmakers prove the products are safe.
Regulators must hold hearings on the risks posed to humans by antibiotics mixed into feed or water for pigs, cows, chickens and turkeys, according to a ruling yesterday on a case against the FDA at the U.S. District Court in the Southern District of New York. The mandate comes less than a week before the FDA was scheduled to issue voluntary industry guidelines for the drugs.
Advocacy groups led by the National Resources Defense Council sued last year to force the FDA to act on a 1977 determination the agency made that feeding animals low doses of certain antibiotics may promote drug-resistant bacteria capable of infecting people. The FDA never acted on the opinion, and the evidence of the risk of widespread use of antibiotics to human health has grown since, according to the ruling.
“This health threat has been hiding in the margins,” Jen Sorenson, a lawyer for the defense council, said in a statement today. “Drug manufacturers will finally have to do what FDA should have made them do 35 years ago: prove that their drugs are safe for human health, or take them off the market.”
While the FDA is being forced to complete withdrawal proceedings on the penicillin and tetracycline treatments, “the court is not ordering a particular outcome,” U.S. Magistrate Judge Theodore Katz said in the ruling.
The Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists also participated in the lawsuit against the FDA.
“We are studying the opinion and considering appropriate next steps,” Siobhan DeLancey, a spokeswoman for the FDA, said in an e-mail.
The FDA was scheduled to release guidelines next week for antibiotic use only when medically necessary in livestock. The recommendations encourage the industry to voluntarily curtail use of some antibiotics, which are given to livestock to encourage growth or cure or prevent illnesses.
Regulators restricted in January antibiotics known as cephalosporins beginning April 5. The drugs can’t be used for disease prevention.