Veterinarians, food animal producers, and feed manufacturers will have to comply with FDA’s new restrictions on the use of certain antibiotics in food animals, as published in Guidance for Industry #213. These new restrictions, which are currently voluntary, require enhanced oversight by veterinarians when antibiotics are added to feed or water to treat animals; they prohibit the long-time FDA approved labeled use of antibiotics as growth promotants; and require drug companies to “voluntarily” remove those claims from labels of previously approved drugs.
While the science behind the cause and effect of antibiotic resistance remains mired in controversy, opponents on both sides of this issue disagree as to whether these changes are necessary, on the one hand, or do not go far enough, on the other hand. Skeptics are also concerned that producers, using loopholes in FDA’s guidelines, will continue to use low, non-therapeutic doses of antibiotics. Veterinarians and drug manufacturers, through the American Veterinary Medical Association and the Animal Health Institute, have expressed support for the FDA guidelines, reaffirming their committment to the judicious use of antibiotics in animals.
What the FDA guidelines require:
The FDA guidelines prohibit the future of use of antibiotics as growth promotants. To achieve this goal, FDA has asked pharmaceutical manufacturers to voluntarily remove the labeled use of these drugs for all uses other than preventive or therapeutic treatment. Once removed, producers will be unable to use antibiotics unless prescribed by a veterinarian to treat or prevent disease. The required oversight by veterinarians for the use of antibiotics for disease prevention or treatement, appears, in theory to provide the type of oversight that will ensure that antibiotic use is judicious.
Veterinarians enhanced oversight:
What remains unclear is how the declining number of food animal veterinarians will be able to abide by the new FDA guidelines along with existing requirements that require a valid veterinary-client-patient relationship (“VCPR”) before writing a prescription for any medication, and state veterinary licensing laws that limit veterinary practice to those veterinarians with valid state licenses.
While there are some decisions that can be made from afar, herd and flock veterinary care have typically required the use of 4 of our 5 senses, something not yet available through video conferencing. If a veterinary prescription will be required for antibiotic treatment of herds and flocks, what will that veterinarian have to do before that prescription is provided? If a herd/flock visit is required before each prescription is written, that will certainly tax the limited number of food animal veterinarians available to service the nations livestock and poultry. These veterinarians should recognize that their practices will be under greater scrutiny by FDA officials and skeptics. Also, as in other countries facing restrictions similar to those proposed by FDA , the use of antibiotics for therapeutic use is expected to increase signficiantly, requiring even more veterinary interaction. In areas that are already underserviced by food animal veterinarians, these increased requirements and expected increased use of therapeutic antibiotics, may stretch the veterinary community very thin.
This is what veterinarians and producers should keep in mind:
A veterinarian must have a valid VCPR before writing a prescription for any medication;
Historically, a valid VCPR requires site visits and visual inspections of the herds and flocks under a veterinarians care, on a regular enough basis to ensure that the veterinarian has knowledge of the health status of those animals;
A visual inspection of the animals may or may not be required before each prescription is provided-for example, results of diagnostic testing may provide a diagnosis which serves as the basis for prescribing antibiotics to at-risk animals, without an additional veterinary visit;
A valid VCPR generally also requires the veterinarian to have a state veterinary license for each state in which their herds or flocks are located, although, occasionally, the state may permit veterinarians to practice as a consultant without a license-veterinarians should review each state’s laws for the specific requirements;
If veterinary services are increasingly in demand, and span multiple states, the state laws governing veterinary practice may have to evolve to permit non-licensed veterinarians access to herds and flocks for adequate oversight and treatment, at least until those veterinarians can be properly licensed.
Fortunately, the FDA guidelines permit continued access to antibiotics for the treatment of sick food animals to ensure that these animals receive proper care. Veterinarians should be extra-vigilant to ensure that they are complying with all relevant federal and state guidelines, so they do not run afoul of the law, while they are helping maintain the health of animals and the wholesomeness of our food supply.