A federal judge in New York City has ordered the FDA to start proceedings to revoke approvals for the use of antibiotics in livestock, a practice blamed for the spread of antibiotic-resistant "superbug" bacteria.
In a case brought by five environmental and consumer advocacy groups, Judge Theodore Katz of the Southern District of New York ruled that the FDA had violated its own regulations when, in 1977, it identified risks to human health from widespread antibiotic treatment of livestock but then failed for nearly 35 years to take action.
The lead plaintiff, the Natural Resources Defense Council (NRDC), applauded the ruling. "Today, we take a long overdue step toward ensuring that we preserve these life-saving medicines for those who need them most – people," said the group's health attorney, Avinash Kar, in a statement.
In 1977, the FDA officially concluded that low doses of penicillin and tetracycline antibiotics -- commonly used to promote weight gain in chickens, hogs, and other livestock, rather than to treat infections -- may foster emergence of antibiotic-resistant bacterial strains.
The agency issued notices at that time that it intended to withdraw approvals of the agents for this purpose. But, said Judge Katz in an opinion released late Thursday, "[a]lthough the notices were properly promulgated and over twenty drug sponsors requested hearings on the matter, the FDA never held hearings or took any further action on the proposed withdrawals."
He also noted the evidence that widespread antibiotic dosing in farm animals was creating a threat to human health that had only increased in the intervening years, "and there is no evidence that the FDA has changed its position that such uses are not shown to be safe."
Environmental groups filed so-called citizen petitions with the FDA seeking to spur action, but the agency did not respond.
Last May, the NRDC and four other groups (Public Citizen, the Union of Concerned Scientists, the Center for Science in the Public Interest, and Food Animal Concerns Trust) filed the suit in federal court in another attempt to force the FDA's hand.
In response, the FDA formally withdrew the 1977 notices and argued to the court that the suit was now moot.
Katz rejected that argument and directed the agency to begin the proceedings specified in the notices.
"Specifically, the Commissioner of the FDA or the Director of the CVM [the FDA's Center for Veterinary Medicine] must reissue a notice of the proposed withdrawals (which may be updated) and provide an opportunity for a hearing to the relevant drug sponsors; if drug sponsors timely request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing. If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order," according to Katz's ruling.
The judge stressed that he was not ordering the FDA to actually withdraw the approvals at this time.
"If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval," he wrote.
The FDA was planning to issue nonbinding guidance next week calling on the livestock industry to use antibiotics in livestock only to treat infections.
Prophylactic use of cephalosporins in animals was already formally barred in an order scheduled to take effect in April.
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