The Food And Drug Administration (FDA) released a new Guidance for Industry: Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals. This guidance supersedes the Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry published in April 1992. One significant change to the guidance is the elimination of sections detailing protocols for testing the efficacy of prophylactic uses of anticoccidial drugs.
The FDA has been under pressure to take action to combat the growth of antibiotic resistant bacteria, particularly in facilities where food-producing animals are raised and processed. This revised guidance may signal that the FDA is focusing its efforts on policy changes that do not require resource-intensive notice-and-comment rulemaking procedures. But note that although the guidance no longer addresses prophylactic use directly, the FDA considers the indication “for the control of coccidiosis caused by (specific Eimeria sppl)” appropriate for anticoccidial drugs. This indication description may still leave room for prophylactic uses of anticoccidial drugs.