“In the mid-1960s, the FDA became concerned that the long-term use of antibiotics, including penicillin and tetracyclines, in food-producing animals might pose threats to human and animal health. As a result in 1970, the agency convened a task force to study the risks associated with the use of antibiotics in animal feed.”

“In 1972, the task force published its findings, concluding that: (1) the use of antibiotics in animal feed, especially at doses lower than those necessary to prevent or treat disease, favors the development of antibiotic-resistant bacteria; (2) animals receiving antibiotics in their feed may serve as a reservoir of antibiotic pathogens, which can produce human infections; (3) the prevalence of bacteria carrying transferrable resistant genes for multiple antibiotics had increased in animals, and the increase was related to the use of antibiotics; (4) antibiotic-resistant bacteria had been found on meat and meat products; and (5) the prevalence of antibiotic resistant bacteria in humans had increased…. The task force made several recommendations, including that (1) antibiotics used in human medicine be prohibited from use in animal feed unless they met safety criteria established by the FDA, and (2) several specific drugs, including penicillin and tetracyclines, be reserved for therapeutic use unless they met safety criteria for non-therapeutic use….

“In response to the findings of the task force, the FDA (in this article we use “FDA” to designate the Food and Drug Administration or any of its units), in 1973, issued a regulation providing that the agency would propose to withdraw approval of all subtherapeutic uses of antibiotics in animal feed unless drug sponsors and other interested parties submitted data within the next two years “which resolve[d] conclusively the issues concerning [the drugs’] safety to man and animals…under specific criteria” established by the FDA.”

The data the drug sponsors submitted to the FDA at that time did not, in the opinion of the FDA, establish that the use of these two antibiotics in feed is safe. As a result, the FDA “issued notices of an opportunity for hearing…on proposals to withdraw approval of all subtherapeutic uses of penicillin in animal feed…and, with limited exceptions, all subtherapeutic uses of oxytetracycline and chlortetracycline [the two forms of tetracycline under consideration] in animal feed.”

In response to these notices, “approximately twenty drug firms, agricultural organizations, and individuals requested hearings.” After granting the request for the hearings, the FDA “Commissioner never set a date for the hearings on the [FDA’s] proposal to withdraw approval of the use of penicillin and tetracyclines in animal feed.” Though the FDA has continued research on antibiotic resistance as the result of the subtherapeutic use in animal feeds, it did not rescind the notices for the opportunity for hearing and has not concluded that their use is safe.

The NRDC case was filed to force the FDA, after 35 years, to proceed with the process of holding the hearings and unless the drug sponsors submitted data documenting the safety of the antibiotics in question withdrawing approval of the use of these antibiotics in animal feed.

It was this request to proceed with the process that Katz agreed to. “Specifically, the Commissioner of the FDA…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. If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order.

“The Court notes the limits of this decision. Although the Court is ordering the FDA to complete mandatory withdrawal proceedings for the relevant penicillin and tetracycline [use authorizations], the Court is not ordering a particular outcome as to the final issuance of a withdrawal order. If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval.”