Description
1. What is FDA doing?2. What are antimicrobial drugs and antimicrobial resistance, and what is the difference between an antibiotic and an antimicrobial?3. What do you mean by “production purposes”?4. What types of drugs are the focus of FDA’s strategy?5. Why are you taking this collaborative (voluntary) approach?6. How can FDA ensure that animal producers won’t use these products the same way they always have, under the guise of “preventing” disease?7. Why is the involvement of a veterinarian important?8. How will FDA determine whether its strategy has had a positive impact on slowing antimicrobial resistance to these drugs?9. How will FDA ensure that animal producers and veterinarians are no longer using the affected medically important antimicrobial drugs for production purposes like growth enhancement or feed efficiency?
Scope & Applicability
Product Classes
4Target population for the anticoccidial drugs; Target population for the evaluation of drug effectiveness.
Subject to approval under section 512 of the FD&C Act.
Drugs used in food-producing animals that impact human health
The category of products covered by this guidance.
Stakeholders
4A recommended principle for the use of medically important antimicrobial drugs
implementation of changes by animal drug sponsors to voluntarily align use conditions.
Professional providing oversight for antimicrobial drug use; Veterinarian is to determine the actual duration that the drug will be used; Professional ordering the duration of use for antimicrobial drugs
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3Dosage levels often used for growth promotion rather than disease treatment
Antimicrobial drugs that meet criterion 1.; Ranking (C): Antimicrobial drugs that meet Criterion 1.
Level of antimicrobial use in animal feed often associated with resistance development.
Identified Hazards
Hazards
3Public health threat resulting from loss of effectiveness of antimicrobial therapies; Efforts to mitigate the development of antimicrobial resistance.; Public health concern that labeling changes aim to mitigate.; development and spread of antimicrobial resistance encouraged by certain practices
Major pathway for resistant bacteria from food animals to humans.
Environmental factors affecting biological products