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FDA Issues Draft Guidance on Antibiotics in Ag

The federal government may be a step closer toward banning–or severely limiting–the subtherapeutic use of antibiotics in animal agriculture in the interest of public health.

The U.S. Food and Drug Administration (FDA) released draft guidance Monday “intended to help reduce the development of resistance to medically important antimicrobial drugs” that are widely used in food animal production to ward off disease and promote growth.

In the draft guidance, which does not establish regulation, but seeks comment from stakeholders, FDA acknowledges the efforts by veterinary and animal industry organizations to create guidelines for the judicious use of antimicrobial drugs, but says additional steps are needed.

The document states that the overall weight of evidence supports “the conclusion that using medically important antimicrobial drugs for production or growth enhancing purposes (i.e., non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting the public health.”

The guidance recommends two principles: (1) 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, and (2) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.

“Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” said Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine. “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.”

The draft guidance was not well received by some industry groups.

The National Pork Producers Council responded to the release of the document by saying “there appears to be no science on which FDA based the guidance.”

“This guidance could eliminate certain antibiotics that are extremely important to the health of animals,” said Council president Sam Carney, a pork producer from Adair, Iowa. “FDA didn’t present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food. As we know, healthy animals produce safe food, and we need every available tool to protect animal health.”

The National Cattlemen’s Beef Association also questioned the basis of the report.

“Antimicrobial resistance is a multi-faceted and extremely complex issue that cannot be adequately addressed by solely focusing on the use of these medications in animal agriculture,” said Association Chief Veterinarian Elizabeth Parker in a statement. “[The National Cattlemen’s Beef Association] supports actions based only on sound, peer-reviewed science and risk assessment relative to the use of antibiotics.

The Pew Charitable Trusts’ Campaign on Human Health and Industrial Farming called the announcement a small yet “overdue” step towards curbing antibiotic use in food animal production. 

“This announcement is a small step toward controlling the overuse of antibiotics in food animal production,” said Laura Rogers, director of the project, in a statement yesterday.  She added that Pew welcomed the agency’s acknowledgment that antibiotics used for growth promotion is not judicious.

Rogers also called on the agency to be more specific and define “what constitutes judicious use.”
“The authorization for the therapeutic use of antibiotics should be limited to treatment of sick animals, in cases that have been diagnosed and documented by a veterinarian,” said Rogers.  “As it currently stands, the agency’s attempt to define appropriate therapeutic uses of antibiotics in food animal production may actually create a loophole, jeopardizing effectiveness of the drugs in humans and animals.”

The FDA is inviting comments on the draft guidance, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (pdf). See the Federal Register notice (pdf) for more information.

The agency is accepting comments on a rolling basis, but recommends submitting before August 30 for comments to be considered in the next draft. 

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