My daughter Anna graduated from high school in May – the class of 2015. For her, the preparation leading up to graduation day seemed like a few short weeks. For Joan and me, it seemed like preparation for this day had been going on for years. Well, of course it had! We had been following and helping to facilitate Anna and her classmates through sports, music, academics, and social activities since grade school. Now, for Anna, Joan and me, it seems like it is all finished – or is it? We’ve had a summer break, it’s time to look ahead.
Summer in Nebraska has been filled with activities, including trips to the Missouri River, family reunions, and small-town celebrations. Anna is now at a “pivotal point” for the next stage of life. By the time you read this, she will be a college freshman participating in the Honors Academy within the University of Nebraska-Lincoln College of Business Administration. She will experience the many changes that college life offers. Along with those changes come responsibilities and some fresh new opportunities. As for all of us, her challenge will be to realize and capture opportunity when it presents itself.
This year also represents a pivotal point of change and a fresh new opportunity for veterinarians in private practice. In June 2015, the Federal Drug Administration (FDA) published their final rule for the updated version of the Veterinary Feed Directive (VFD),1 which will go into effect October 1, 2015. The VFD rule change is the third of three core documents that FDA is using to announce and implement its policy framework for the judicious use of medically important antimicrobial drugs in food-producing animals. The first two rule documents are FDA Guidance 2092 and FDA Guidance 213.3 Together, the three documents eliminate over-the-counter use of most antibiotics in feed, provide rules for new labeling requirements, and direct the responsibility of legal oversight to veterinarians.
The VFD is not a new instrument. It is similar to a veterinary prescription, but is defined differently to account for usage of antimicrobials in livestock feed. It was implemented in the year 2000 within the Animal Drug Availability Act.4 The usage of VFDs has been limited because there have been only two new antibiotics approved for swine since then. Up until now, the frequency of VFDs issued by veterinarians has been relatively low. The new FDA antibiotic rules will necessitate a large increase in the number of VFDs.
What is particularly interesting in the new VFD rule is the reference to a veterinary-client-patient-relationship (VCPR). Until the new ruling was published, it was unclear what role the VCPR would have. The FDA has affirmed the VCPR is a requirement for all VFDs and defers to individual states regarding VCPR definitions. For most states, two portions of a VCPR present a challenge.
The first challenging portion of the VCPR is “The veterinarian assumes responsibility for making clinical judgments regarding the health and medical treatment of the animals, and the client has agreed to follow the instructions of the veterinarian.” Historically, an agreement between veterinarians and their clients has not been required when blending over-the-counter antimicrobials into livestock feed. This represents a paradigm shift and will require a period of adjustment for both producers and veterinarians. I anticipate that veterinarians will ask producers to sign a written agreement to follow veterinary instructions before new VFDs are issued. This could potentially release veterinarians from liability of noncompliance.
The second challenging portion of the VCPR, to paraphrase, is that the veterinarian must be personally familiar with the care of the animals and the veterinarian has made medically appropriate and timely visits to the premises where the animals are kept. The phrase “timely visits to the premises” will lend itself to interpretation. This time period will be debated, but I speculate that no less than one visit per year will become standard. Yes, there will be added expense. And yes, more veterinarians will be employed.
I see the new FDA rules as an opportunity to get veterinarians on the farm to see things that may be overlooked. Health programs should be reviewed during farm visits. Animals and facilities should be observed. Site assessments can be included for Pork Quality Assurance (National Pork Board) site status. Biosecurity protocols can be reviewed. Preparations can be made for the next Common Industry Audit. All of these services allow veterinarians to enhance their relationship with producers of all herd sizes.
The new FDA rules place us veterinarians at our own pivotal point, providing a chance to capture an opportunity – an opportunity to strengthen client relationships and enhance the public image of veterinarians. As with my daughter Anna, we too are entering a time with fresh new opportunity. We as veterinarians are being entrusted with the stewardship of antibiotics. Let’s make good with it.
1. Federal Register. Veterinary Feed Directive. A Rule by the Food and Drug Administration on 06/03/2015. Available at https://www.federalregister.gov/articles/2015/06/03/2015-13393/veterinary-feed-directive. Accessed 7 July 2015.
2. Federal Register. Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Availability. A Notice by the Food and Drug Administration on 04/13/2012. Available at https://www.federalregister.gov/articles/2012/04/13/2012-8846/guidance-for-industry-on-the-judicious-use-of-medically-important-antimicrobial-drugs-in. Accessed 7 July 2015.
3.Federal Register. Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability. A Notice by the Food and Drug Administration on 12/12/2013. Available at: https://www.federalregister.gov/articles/2013/12/12/2013-29697/guidance-for-industry-on-new-animal-drugs-and-new-animal-drug-combination-products-administered-in. Accessed 7 July 2015.
4. Federal Register. Animal Drug Availability Act; Veterinary Feed Directive. A Rule by the Food and Drug Administration on 12/08/2000. Available at: https://www.federalregister.gov/articles/2000/12/08/00-31151/animal-drug-availability-act-veterinary-feed-directive. Accessed 7 July 2015.