MANHATTAN (CN) – The U.S. Food and Drug Administration must re-evaluate whether cattle farmers can continue using antibiotic-laced feed to address cramped and unsanitary livestock conditions, a federal judge ruled.
Watchdog groups say the FDA gave its approval to fortify feed for healthy livestock with “preventative” antibiotics in the 1950s.
But the FDA found in 1977 that “subtherapeutic” doses of penicillin and tetracyclines – at levels too low to treat disease – contributed to development of antibiotic-resistant bacteria that could be transferred to humans.
The National Resources Defense Council estimates that these infections, known as “superbugs,” kill 70,000 people in U.S. hospitals annually.
In the wake of the 1977 study, the FDA issued Notices of Opportunity for Hearing (NOOHs), to begin the process to withdraw the previous approval, but the regulators never followed through.
When a group of nonprofits led by the NRDC filed suit to compel completion of the withdrawal proceedings in May 2011, the FDA tried to rescind the NOOHs.
U.S. Magistrate Judge Theodore Katz said Thursday that the maneuver did not do the trick.
“The FDA has not issued a single statement since the issuance of the 1977 NOOHs that undermines the original findings that the drugs have not been shown to be safe,” the 55-page order states.
Katz ordered the FDA to move forward with those hearings.
“Specifically, the commissioner of the FDA or the director of the [Center for Veterinary Medicine] must re-issue 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,” Katz wrote. “If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order.”
A spokeswoman for the FDA’s Center for Veterinary Medicine said the agency is “studying the opinion and considering appropriate next steps.”
In addition to the FDA and Center for Veterinary Medicine, the NRDC named as defendants the Department of Health and Human Services and the director of each organization.