Veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process.
By Dr. Horrys Friaça, Agricultural Health and Food Safety Specialist, IICA, horrys.friaca@iica.int
Over the past several years, the US Government has taken important steps towards fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. The Food and Drug Administration (FDA) is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians. The Veterinary Feed Directive (VFD) is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals. It’s the legal instrument to enforce the implementation of FDA’s Guidances # 209 and # 213 at the end of 2016.
The VFD outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes. Medically important drugs are those listed in the FDA’s Guidance 152, and include such compounds as penicillins, tetracyclines, macrolides and streptogramins. Compounds like ionophores, which are not used in human medicine, or bacitracin, which is used for minor human uses, are not covered by this new policy. This policy covers only in-feed and water uses of these medically important compounds.
Veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. Currently, none of these medically important antimicrobial drugs that fall under the FDA’s judicious use strategy are VFD drugs and do not require veterinary oversight or involvement. After the changes outlined in the judicious use strategy are made, medically important antimicrobials approved for use in animal feed will fall under the VFD regulation.
Aligned to the VFD, the full implementation of FDA’s Guidance #213 in December 2016 will significantly change the way medically important antibiotics have been used in animal agriculture for decades. Once the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease. All the affected drug sponsors have committed to implementing the changes described in Guidance #213 by the December 2016 target date.
The FDA’s Guidance #213 outlines the process whereby a sponsor, or company, can withdraw growth claims from the label of products containing medically-important antibiotics. It also describes how a sponsor can apply for a prevention claim, or therapeutic claim, on those same compounds. Application for a prevention claim in this case generally follows the process of a supplemental new animal drug application, and requires the sponsor to submit data demonstrating the drug is safe and effective at a specified dose against a targeted pathogen or a targeted disease. In the case of disease prevention, the FDA believes it is important such use is appropriately targeted to animals at risk for a specific disease and the use duration is limited and risk-based.
In summary:
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All changes are being phased in by December 2016, with additional action by FDA detailed in the VFD rule.
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For all medically important antibiotics used in feed, these products will be moved to VFD status.For all medically important antibiotics used in water veterinary prescription status would apply.
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For all medically important antibiotics used in feed, growth promotion claims will be eliminated.FDA intends this to be done by December 2016.
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On compounds where growth claims exist without prevention claims, sponsors could seek new prevention claims but this would require new data to be submitted to FDA.
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Once this policy is fully implemented, all medically important antibiotics used in animal feed or water will be used only for the therapeutic purposes of disease treatment, disease control or disease prevention under the supervision of a licensed veterinarian.
*The opinion expressed in this newsletter are those of the author and they do not reflect the position of the Institute on the topics presented.
This post appears in the IICA Delegation in the USA Newsletter – March – April 2016
