Regulatory Focus™ > News Articles > FDA Releases New Guidance To Voluntarily Limit Many Uses of Antibiotics in Animals

FDA Releases New Guidance To Voluntarily Limit Many Uses of Antibiotics in Animals

Posted 11 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) released three new guidance documents that seek to phase out the "injudicious use" of antibiotics in food-producing animals through voluntary actions through voluntary actions by industry.

The guidances follow an order in late March 2012 by US Magistrate Judge Theodore Katz for FDA to remove antibiotics from animal feed or withdraw the non-therapeutic uses of those drugs entirely.

The newly-released guidance calls for "judicious use of medically important antimicrobial drugs," which would prima fascie seem to fulfill Katz's order.

"It is critical that we take action to protect public health," said FDA Commissioner Margaret A. Hamburg, M.D. "The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available."

The move also follows an earlier order in January 2012 to prohibit most uses of cephalosporin-based antibiotics in food-producing animals. That order banned the use of cephalosporin for disease prevention purposes and at unapproved doses, frequencies, durations and routes of administration.

FDA's Guidance for Industry: Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (GFI #209), released 11 April 2012, largely leaves an earlier draft guidance by the same name intact.

GFI #209 "discusses FDA's concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner."

The guidance also "recommends that the use of medically important antimicrobial drugs be limited to uses in animals that are considered necessary for assuring animal health and include veterinary oversight or consultation"

FDA noted it was addressing comments, which were critical of the agency's lack of implementation specificity, in a separate guidance.

That guidance, Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209, addresses the needs of sponsors that wish to develop "revised conditions of use" for antibiotics for food-producing animals.

Consistent with its other two guidance documents, FDA also released a veterinary feed directive, which calls for "(1) providing for alignment between the criteria for appropriate veterinary supervision or oversight and those established as part of veterinary licensing and practice requirements, (2) providing veterinarians greater flexibility to exercise their professional discretion to authorize producer access to appropriate VFD drugs, and (3) streamlining administrative procedures."


Read more:

FDA - FDA takes steps to protect public health

FDA - Veterinary Feed Directive

FDA - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209

FDA - Guidance for Industry: Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals

Regulatory Focus - Judge Orders FDA To Remove Antibiotics from Animal Feed

Regulatory Focus - FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

The New York TImes - U.S. Tightens Rules on Antibiotics Use for Livestock

NPR - FDA Launches Voluntary Plan to Reduce Use of Antibiotics In Animals


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