Regulatory Brief

 Final Comments to FDA Guidance 209 - Judicious Use of Medically Important Antimicrobial Drugs


Formal Title: [Docket Number FDA-2010-D-0094] Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability 

Brief Description:

The Food and Drug Administration (FDA) is announcing the availability of guidance (#209) entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals.” This draft guidance is intended to inform the public of FDA’s current thinking on the use of medically important antimicrobial drugs in food producing animals.

AVMA Response: 

The AVMA has carefully reviewed and evaluated the FDA Guidance for Industry (GFI) #209: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals and the key scientific reports summarized within it.

We concur with the FDA that to effectively respond to public health concerns associated with antimicrobial resistance, it is important to broadly consider how medically important antimicrobials are being used.

The AVMA has long been a proponent of judicious drug use by veterinarians, having historically worked with the FDA and other stakeholders to help develop principles and processes that foster the appropriate and judicious use of medically important antimicrobials.

The AVMA agrees that the wide availability of antimicrobial drugs in human and veterinary medicine has provided tremendous benefits to human and animal health for more than 50 years. We also recognize that any use of these drugs can result in selection pressure on microbes toward decreased antimicrobial susceptibility and loss of effectiveness, potentially posing a threat to human and animal health. Yet, the AVMA believes production uses should not be categorically presumed to be injudicious, particularly if a veterinarian is involved in the decision-making process and FDA’s own risk assessments have shown infinitesimally small risks.1,2

FDA-Recommended Principles Regarding Judicious Use in Animals

Principle: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

The AVMA agrees that medically important antimicrobial drugs should be used judiciously in both humans and animals, avoiding unnecessary or inappropriate use. However, the AVMA does not concur with the FDA’s assertion that all production uses of medically important antimicrobials are necessarily injudicious (inappropriate or unnecessary). The AVMA believes veterinarians, with their unique training, knowledge, and expertise, are the only animal caretakers who have the ability to decide when antimicrobial use is appropriate and judicious. If a product currently labeled for production uses have demonstrated therapeutic effects, the AVMA strongly encourages drug manufacturers to seek the appropriate approvals for these products and that the products be relabeled accordingly.

Therefore, we urge the FDA to recognize that the decision to use antimicrobials is made on the basis of many factors, which a licensed veterinarian is uniquely qualified to consider at his or her professional discretion.

Principle: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.

The AVMA agrees that veterinarians should be involved in the decision-making process for the use of antimicrobials in animals, regardless of the distribution channel through which the antimicrobial was obtained.

 

Background Documents:

Federal Register Notice

July 9, 2012 AVMA Comments

Relevant AVMA Policies

Link to Previous Comments

 
 
1.             Claycamp HG, Hooberman BH. Risk assessment of streptogramin resistance in Enterococcus faecium attributable to the use of streptogramins in animals. Virginiamycin risk assessment. Silver Spring, Md: FDA Center for Veterinary Medicine, 2004. Available at: www.fda.gov/downloads/AnimalVeterinary/NewsEvents/CVMUpdates/UCM054722.pdf. Accessed Jul 7, 2012.
2.             Institute of Medicine Committee on Human Health Risk Assessment of Using Subtherapeutic Antibiotics in Animal Feeds. Report of a study. Human health risks with the subtherapeutic use of penicillin or tetracyclines in animal feed. Washington, DC: National Academy Press, 1988.