Preventing Antibiotic Resistance Act of 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial (used to treat humans) and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4) there is reasonable certainty of no harm to human health from microbial resistance to the drug.
Sponsors of certain medically important antimicrobials already approved for use in food-producing animals must submit evidence to the FDA that demonstrates that their drug meets the criteria described above for approved indications. The FDA must withdraw approval for any indication for which the FDA determines there is insufficient evidence that the drug meets the criteria.
This bill expresses the sense of the Senate that a veterinarian-client-patient relationship should ensure that medically important antimicrobials are used in food-producing animals in a manner consistent with best practices.
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