reviewing existing approvals, although Guidance #152 notes the importance of doing so. Specifically, Guidance #152 sets forth the responsibility of the FDA Center for Veterinary Medicine (CVM), which is charged with regulating antimicrobials approved for use in animals: to approving an antimicrobial new animal drug application, FDA must determine that the “prior drug is safe and effective for its intended use in the animal. The Agency must also determine that the antimicrobial new animal drug intended for use in food-producing animals is safe with regard to human health (FDA-CVM, The Guidance also says that FDA believes that 2003).” “the human exposure through the ingestion of antimicrobial-resistant bacteria from animal-derived foods represents the most significant pathway for human exposure to bacteria that have emerged or been selected as a consequence of antimicrobial drug use in it goes on to animals.” However, warn that the including this guidance, do not establish legally “FDA’s guidance documents, enforceable responsibilities. Instead, the guidance describes the current thinking on the Agency’s topic and should be viewed only as guidance, unless specific regulatory or statutory requirements are cited. The use of the in Agency guidance means that something is suggested or word ‘should’ recommended, but not (FDA-CVM, 2003). required” The Commission believes that the in Guidance #152 should be made legally “recommendations” enforceable and applied retroactively to previously approved antimicrobials. Additional funding for FDA is required to achieve this recommendation. If any reviews of antibiotic use under Guidance #152 have been conducted by the Center for Veterinary Medicine, the results of the review should be released immediately. Clarify antimicrobial definitions to provide clear estimates of use and Recommendation #2. facilitate clear policies on antimicrobial use.
reviewing existing approvals, although Guidance #152 notes the importance of doing so. Specifically, Guidance #152 sets forth the responsibility of the FDA Center for Veterinary Medicine (CVM), which is charged with regulating antimicrobials approved for use in animals: “prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective for its intended use in the animal. The Agency must also determine that the antimicrobial new animal drug intended for use in food-producing animals is safe with regard to human health (FDA-CVM, 2003).” The Guidance also says that “the FDA believes that human exposure through the ingestion of antimicrobial-resistant bacteria from animal-derived foods represents the most significant pathway for human exposure to bacteria that have emerged or been selected as a consequence of antimicrobial drug use in animals.” However, it goes on to warn that the “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, the guidance describes the Agency’s current thinking on the topic and should be viewed only as guidance, unless specific regulatory or statutory requirements are cited. The use of the word ‘should’ in Agency guidance means that something is suggested or recommended, but not required” (FDA-CVM, 2003). The Commission believes that the “recommendations” in Guidance #152 should be made legally enforceable and applied retroactively to previously approved antimicrobials. Additional funding for FDA is required to achieve this recommendation. If any reviews of antibiotic use under Guidance #152 have been conducted by the Center for Veterinary Medicine, the results of the review should be released immediately. Recommendation #2. Clarify antimicrobial definitions to provide clear estimates of use and facilitate clear policies on antimicrobial use.