CATTLE RAISERS COMMUNITY
INDUSTRY NEWS
What to Expect From the Veterinary Feed Directive Rules in 2016
T
HE ANIMAL DRUG AVAILABILITY ACT, ENACTED BY CONGRESS in 1996 to facilitate the approval and marketing of new animal drugs and medicated feeds, was amended this year to create a new category of products called veterinary feed directive drugs, or VFD drugs. Adminis- tration of these drugs can only be under a veterinarian’s order and professional supervision.
A veterinary client-patient relationship is key Veterinarians will play an integral role in the VFD rules by ensuring the proper use of medically important antimicrobial drugs according to label directions and only when appropriate to meet specifi c needs. By add- ing this level of oversight, the veterinarian can ensure proper use of the drug, including the appropriate length of time and the correct dosage.
A key element of the VFD rules will be the VCPR, or veterinary client-patient relationship, which will require the veterinarian to have a level of engagement with the client or producer to assume responsibility for making clinical judgments about health, have suffi cient knowl- edge of the patient by virtue of examination or facility visit and provide necessary follow-up evaluation or care.
FDA position on judicious use of medically important antimicrobials
The FDA’s position is that medically important anti-
biotics labeled for continuous or undefi ned durations of use are not consistent with the principles of judicious use. In the case of disease prevention, the FDA believes
it is important such use appropriately targets animals at risk for a specifi c disease and that the use duration is limited and risk-based.
Once the changes are fully implemented in Decem- ber 2016, it will be illegal to use feed- and water-based antibiotics for production purposes. Producers will need to obtain authorization from a licensed veterinarian to use VFD drugs for prevention, control or treatment of a specifi cally identifi ed disease.
Control is critical to reducing unnecessary use of such drugs in animals and to slowing or preventing any potential for the development of bacterial resistance to antimicrobial drugs. Safety concerns relating to diffi culty
34 The Cattleman December 2015
of diagnosis of disease conditions, high toxicity, or other reasons may also dictate that the use of a medicated feed be limited to use by order and under the supervision of a licensed veterinarian.
The FDA is working to address the concerns that producers, veterinarians and other industry stakehold- ers have about these new rules. The FDA is actively engaged with the U.S. Department of Agriculture, the Centers for Disease Control and other stakeholders, to collect more data on the issue of antimicrobial drug use in food-producing animals.
December 2016
According to Dr. William Flynn, deputy director for science policy, FDA Center for Veterinary Medicine, although the deadline agreed to by the animal drug sponsors affected by FDA’s judicious use strategy is not until December 2016, companies are already working to transition their medically important antimicrobial drug products to a marketing status that requires veterinar- ian oversight. By releasing the rule now, drug manufacturers, pro- ducers and veterinarians are afforded the time to become familiar with the new regulations and gives companies the time they need to make these changes without caus- ing signifi cantly more disruption to the animal health and agriculture industries.
“As over-the-counter (OTC) antimicrobial drugs used in feed transition to VFD status as part of the agency’s judicious use strategy, the agency will provide education and training to veterinarians, distributors (including feed mills) and animal producers, in order to foster better understanding of the regulations,” Flynn said. The FDA intends to use a phased enforcement strategy for implementation of this fi nal rule, which went into effect on Oct. 1, 2015.
For more information on the VFD drug rules, and the effects they may have on your operation, visit
fda.gov and search “VFD.” The Cattleman magazine will also feature a column
in 2016 that will focus exclusively on the VFD rules and how they will affect producers, veterinarians and other industry stakeholders.
thecattlemanmagazine.com
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