Regulatory Brief

 FDA Draft Guidance #209 – Judicious Use of Medically Important Antimicrobial Drugs


Formal title: Docket Number [FDA-2010-D-0094] Draft Guidance #209: the Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals


Brief Description:

This draft guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals and is being distributed for comment purposes only. Antimicrobial drugs have been widely used in human and veterinary medicine for more than fifty years, with tremendous benefits to both human and animal health. The development of resistance to this important class of drugs, and the resulting loss of their effectiveness as antimicrobial therapies, poses a serious public health threat.

Antimicrobial drug use contributes to the emergence of drug resistant organisms. Therefore, these important drugs must be used judiciously in both animal and human medicine to slow the development of resistance. The FDA is providing a framework for policy regarding the appropriate or judicious use of medically important antimicrobial drugs in food producing animals. This framework includes the principles of phasing in such measures as:

  1. limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health
  2. limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation

Developing strategies for reducing antimicrobial resistance is critically important for protecting both public and animal health.

AVMA Response:

The AVMA greatly appreciates the FDA's initiative in clearly conveying its current thinking to relevant stakeholders through the issuance of a draft guidance and allowing opportunity for public comment. 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 fifty years. We recognize that any use of these drugs can result in increasing selective pressures and loss of effectiveness, potentially posing a threat to human and animal health. The AVMA also agrees that in order to effectively respond to public health concerns associated with antimicrobial resistance, it is important to broadly consider how medically important antimicrobials are being used. These drugs must be used judiciously in both humans and animals.

We assert that reducing the overall quantity of antimicrobials used is only one of the means by which to evaluate successes or improvements in judiciousness, since microbes respond differently to reductions in selection pressure. Because reduction in overall antimicrobial use may not necessarily provide a human health benefit, we must remain cognizant of potential detrimental consequences to animal health and welfare that might accompany a reduction in use. Therefore, we caution against overly broad limitations and recommend targeted interventions based on scientific quantitative risk assessments.

Furthermore, the documented ability of production use of an antimicrobial to improve human food safety should be a key consideration when assessing the judiciousness of a use. Additionally, 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.

FDA Recommended Principles Regarding Judicious Use in Animals

Principle 1 – 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 agency's assertion that all production uses of medically important antimicrobials are necessarily injudicious. The AVMA believes that 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. Furthermore, it is imperative that veterinarians use antimicrobials in a preventative fashion in order to minimize animal suffering and disease and maximize strategic use of antimicrobials.

Principle 2 – Under the existing framework, there is no mechanism to limit uses to those that have veterinary oversight or consultation. The AVMA agrees that veterinarians should be involved in the decision-making process for the use of antimicrobials regardless of the distribution channel through which the antimicrobial was obtained.

As a result, barriers to providing greater veterinary stewardship over medically important antimicrobials warrant further dialogue. We must recognize areas of the country that are underserved by veterinarians and minimize any disruptions in drug availability that do not improve judiciousness, yet negatively impact animal health and welfare. We should remain cognizant that delays in timely medication could allow animal disease and suffering to progress, which in turn may impact food availability and safety.

Background Documents:

Federal Register - Docket No. FDA-2010-D-0094 (PDF)

FDA Draft Guidance #209 (PDF)

The AVMA responded on August 30, 2010. (PDF)