Historically, veterinarians have played an integral role in the health of food animals on the farm. The relationship between veterinarians and farmers is based on a shared interest in preserving and improving the health of the animals in our care. This relationship has evolved over the years, but has never lost focus on what is important: the health of the animals. Those of us in the profession of food-animal medicine understand this responsibility and have accepted the accountability that goes with veterinary oversight.
As is the case with many terms, “veterinary oversight” may mean different things to different people. Recently there has been increased interest in veterinary oversight. One area of attention is the use of antimicrobials. This has been a “hot button” issue for the media, anti-agriculture activists, regulatory agencies, and even the US Congress. With this amount of attention, it is imperative that the veterinarians who are out on the farms are aware of impending changes and have a say in the issue.
In Guidance Document #209, the Food and Drug Administration (FDA) published its current thinking on the judicious use of antimicrobials in food animals. The FDA wrote “The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.” This is a draft guidance that was published for comment, but it will soon be finalized and published as a regulatory document. The AASV supports a thoughtful approach to this issue that results in policy that does not compromise the ability of veterinarians and farmers to provide proper care for animals.
For many years now, the AASV has taken this position: “Veterinarians should work with those responsible for the care of animals to use antimicrobials judiciously regardless of distribution system through which the antimicrobial was obtained.” We also have the position that “Judicious use requires the oversight of a veterinarian at some point in the decision-making process.” Neither of these positions dictates that oversight should be regulatory in nature, but rather reflect what is practical and effective for veterinarians and farmers. Veterinary oversight can be an effective part of decision making when focused on ensuring animal health while protecting public health.
The AASV has provided written comment to the FDA on Guidance #209. In addition, the AASV leadership and staff have met with the director and staff of the FDA Center for Veterinary Medicine (CVM) on a regular basis. This ongoing effort has resulted in open and frank communication between AASV and the FDA CVM. I am encouraged by the level of communication and outreach from the FDA to veterinary organizations like the AASV.
Other veterinary organizations have ongoing efforts in the area of veterinary oversight. The American Veterinary Medical Association (AVMA) established the AVMA Steering Committee for FDA Policy on Veterinary Oversight of Antimicrobials to address this issue. Dr Paul Ruen, AASV past president, is serving on this five-member committee. It has met several times and is also in communication with the FDA.
The AASV has also been in close communication and collaboration with the American Association of Bovine Practitioners. Within the pork industry, our close working relationship with the National Pork Producers Council and National Pork Board has continued on this issue. There is tremendous benefit from working together with like-minded stakeholders with shared concerns and beliefs.
One area of shared concern is that the definition of veterinary oversight could be overly restrictive or too narrowly defined. If that were to happen, access to antimicrobials could be limited, resulting in threats to animal health and welfare. It could also result in a burdensome process for veterinarians in issuing drug orders and record-keeping. In light of this, the requirement of a veterinary-client-patient relationship (VCPR) as currently defined in other FDA regulations (Animal Medicinal Drug Use Clarification Act and Veterinary Feed Directive) is not needed for effective veterinary oversight of antimicrobials when used according to the label. A VCPR was originally required by regulation for extra-label drug use, which does require a more restrictive oversight. However, there is no evidence that a VCPR is needed for labeled uses of antimicrobials.
Another area of concern has to do with the perceived goals of judicious use. There are those who endorse “judicious use” merely as a means to decrease the use of antimicrobials in food animals. I suspect that those who hold this view have no connection with animals or farms and are more politically motivated than science based. Their belief ignores the importance of antimicrobials to animal health. Judicious use is meant to optimize efficacy, minimize resistance development, and protect animal and public health.
As veterinary oversight is phased in over the coming years, it is going to be up to veterinarians to implement any changes that are made. Therefore it is up to veterinarians to be involved now, as those changes are being planned. We must be involved as a profession, as an industry, and as an association. This involvement must be driven by practicing veterinarians. They have the practical knowledge and the responsibility to implement oversight on the farm. Ultimately they are the professionals who will be held accountable. It is crucial that practitioners have a voice as decisions are made to increase veterinary oversight of antimicrobials used in food animals.
-- Tom Burkgren, DVM