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Animal Health Institute Statement on FDA Final Guidance 213

WASHINGTON, D.C. – The Animal Health Institute (AHI) issued the following statement in response to the Food and Drug Administration’s publication of the final Guidance 213 and proposed VFD rule implementing the policy of extending veterinary oversight and eliminating  the subtherapeutic use of medical important antibiotics in animal agriculture.

“Today’s publication of the Food and Drug Administration’s final Guidance 213 and proposed Veterinary Feed Directive (VFD) rule establishes a three year timeframe for phasing out growth promotion uses of antibiotics important in human medicine and phasing in veterinary oversight of these products.  Animal health companies have supported this policy since it was announced in 2012 and will continue to work with FDA on its implementation.

“It is important for consumers to know that within three years, all uses of medically important antibiotics in animal agriculture will be only for therapeutic, or targeted, purposes under the supervision of a licensed veterinarian.   We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals.  This policy fulfills the request by a number of public health advocacy groups in a July, 2009 letter to the White House.

“Label changes involving new therapeutic indications envisioned by this Guidance document will require submission of data to FDA, similar to submitting a new animal drug application.   Data will be reviewed by FDA to determine if a new label claim has been scientifically supported by the data.  Label directions for antibiotics used in feed must be followed by veterinarians.   Extra-label use of antibiotics in feed will remain prohibited even under a VFD.

“The responsible use of antibiotics to keep food animals healthy carries a public health benefit.  Healthy animals are the first link in the food safety chain.  Other links in this chain include the reduction of pathogenic bacteria at critical steps in processing and good food hygiene through the safe handling and cooking of meat and poultry.  Responsible use of antibiotics by farmers and veterinarians to keep food animals healthy at the beginning of the food safety chain helps the entire chain produce a safer food product.”

MEDIA CONTACT:  Ron Phillips, RPhillips@AHI.org

The Animal Health Institute represents companies with an interest in veterinary health. Its member companies develop and produce the medicines that help our pets live longer, healthier lives and contribute to safe food by keeping food animals healthy.

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