FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobials in Food-Producing Animals

June 30, 2010 — 

The U.S. Food and Drug Administration has issued a draft guidance outlining the FDA's current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture.

While the FDA acknowledges the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, the agency believes additional steps are needed.

In a recent teleconference, FDA deputy commissioner Dr. Joshua Sharfstein indicated that the agency's future direction with regards to antimicrobial use in animal agriculture is based on three key principles:

• Non-therapeutic use of antimicrobials, or sub-therapeutic use for feed efficiency, "is an injudicious use." The agency goal is to protect antibiotics that important to human health.
• "Medically important antimicrobial drugs" should be limited "to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation."
• Hazards of antimicrobial resistance, including the growing emergence of multiple-drug resistance is "a major public health issue."

According to the guidance document, FDA has concluded that the use of feed grade antimicrobials for growth promotion and feed efficiency "is not in the interest of protecting and promoting the public health."

While a guidance document is not a legally binding interpretation, it serves to outline the current direction of the agency and will likely form the basis for future regulatory action. The agency has indicated that it intends to use a variety of methods including regulation and voluntary industry actions to reduce the overall use of medically important antimicrobial drugs with the objective of reducing antimicrobial resistance in the human population. FDA has stated its intent to "actively work with drug companies; the veterinary, public health, and animal agriculture communities; and other stakeholders to implement its recommendations in a way that protects human and animal health without negatively impacting animal health or disrupting the animal agriculture industry."

The agency invites comments on the draft guidance, entitled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. There is no deadline for comment on guidance documents, but timely comments should be submitted prior to August 30.