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 20 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.”

Daryll E. Ray holds the Blasingame Chair of Excellence in Agricultural Policy, Institute of Agriculture, University of Tennessee, and is the Director of UT’s Agricultural Policy Analysis Center (APAC). Harwood D. Schaffer is a Research Assistant Professor at APAC. (865) 974-7407; Fax: (865) 974-7298; dray@utk.edu and hdschaffer@utk.edu; http://www.agpolicy.org.