But according to Michael Jacobson, CSPI executive director, draft guidance or “draft discouragement” doesn’t really go far enough in putting a stop to antibiotic misuse. CSPI’s intent was to have FDA create a rule banning the practice of the prophylactic use of antibiotics in food animals. “FDA thinks its approach of cooperating with industry would be more efficient than going through a rulemaking process.” Jacobson says Congress is considering legislation, and FDA could adopt a regulation, but probably neither will happen.
According to FDA, the CSPI petition requests the FDA Commissioner to “rescind already approved, sub-therapeutic uses of medically important antibiotics in livestock feed.” The petition alleges the drugs are unsafe under the Federal Food, Drug and Cosmetic Act when used for sub-therapeutic purposes in animal agriculture because such use can drive the selection and transfer of antibiotic resistance in human pathogens, thereby compromising the effectiveness of antibiotics for treating infections in humans.