Relationships between veterinarians, clients and feed suppliers are about to change, as the FDA's new veterinary feed directive (VFD) rule mandates veterinary oversight for medically important antimicrobials used in feed or water.
The highly anticipated VFD rule, which FDA announced on June 2, places considerable emphasis on the veterinarian-client-patient relationship (VCPR).
The FDA previously issued the proposed VFD rule in 2013, and at the same time published Guidance for Industry 213, which calls on drug manufacturers to voluntarily stop labeling medically important antimicrobials for performance use such as growth promotion. The VFD rule and Guidance 213 serve as the cornerstones of FDA's strategy to promote the judicious use of antimicrobials in food-producing animals.
Simply put, Guidance 213 puts an end to performance-enhancement uses of most feed-grade antimicrobials. Some of the same products, however, are labeled for prevention or control of disease, and the VFD rule places those applications under the control of a licensed veterinarian.
For this purpose, the VCPR does not mean the veterinarian simply is acquainted with the client and the client's animals. The rule specifies that a veterinarian issuing a VFD "operate in compliance with appropriate state-defined VCPR requirements or federally defined VCPR requirements where no applicable and appropriate state VCPR requirements exist." At the basic level, a valid VCPR means the veterinarian must:
1. Engage with the client to assume responsibility for making clinical judgments about patient health.
2. Have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed.
3. Provide for any necessary follow-up evaluation or care.
The final rule specifies that copies of the VFD and records of the receipt and distribution of VFD feed must be kept for a period of two years. This was a change from the proposed rule, which would have required records to be kept for one year. Veterinarians will issue three copies of the VFD: one for their own records, one for their client, and one to the client's VFD feed distributor. The VFD includes information about the number and species of animals to receive feed containing one or more of the VFD drugs. FDA anticipates that about half of the food-animal industry will use electronic VFD generation and recordkeeping over the next three years.
The rule becomes effective on Oct. 1, 2015, 120 days after it was published in the Federal Register. FDA intends to use a phased enforcement strategy for implementation of the final rule as over-the-counter (OTC) drugs become VFD drugs. First, the agency plans to provide education and training for stakeholders such as veterinarians, producers, feed mills and other distributors. Over time, the FDA plans to engage in risk-based general surveillance, inspections and enforcement, and the rule spells out specific regulations for drug companies, veterinarians, distributors such as feed mills, and producers.
Labels for VFD drugs will include a cautionary statement saying "Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian." The veterinarian cannot provide clients with VFD drugs without filing the VFD documents. Producers can feed the VFD drugs to animals only after receiving a lawful VFD issued by a licensed veterinarian. The client is obligated to use the VFD feed as indicated on the VFD and as specified on the product's label. Also, the VFD feed cannot be fed to the animals after the expiration date of the VFD.
Positive response from stakeholders
Since the FDA issued Guidance 213 and the proposed VFD rule in 2013 the industry, overall, has been supportive of the administration's strategy to promote the judicious use of antimicrobials in food-producing animals.
While Guidance 213 specified a three-year timeframe, until December 2016, for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them. And FDA reported in June 2014 that all 26 drug sponsors affected by the guidance had "agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs."
As for the VFD rule, several stakeholder organizations issued statements supporting the policy.
The American Veterinary Medical Association (AVMA), which has collaborated with the FDA in developing antimicrobial policy, applauded the VFD rule.
"The VFD is integral to the implementation of the guidance documents, and we are pleased to have had the opportunity to provide valuable input into the regulation," says AVMA's CEO Dr. Ron DeHaven. "This is a great example of how collaboration by the FDA with stakeholders has brought about meaningful improvements and a successful outcome."
DeHaven adds that antibiotic resistance is a threat that the veterinary profession takes very seriously, "and that's why the nation's veterinarians have been, and remain, engaged with the FDA and food producers to ensure that livestock are healthy and that our food supply stays safe by overseeing the use of antibiotics to ensure appropriate use."
AVMA also expressed support for the rule's emphasis on linking the use of VFD drugs to a valid VCPR. "This is really a milestone in the antimicrobial-resistance strategy," DeHaven says. "Veterinary oversight is critical to ensuring appropriate judicious use, and this provision provides clarity to those who will be responsible for it."
Evaluating the impact
FDA has acknowledged it will need to collect more information on antibiotic use in agriculture to measure the impact of the judicious use strategy. The agency is collaborating with the USDA and the Centers for Disease Control and Prevention to develop a plan for collecting additional data on antibiotic use to supplement existing sales data. The agency also continues to collect data on antibiotic resistance though the National Antimicrobial Resistance Monitoring System.
According to the FDA, the evaluation process will assess the rate of adoption of changes outlined in Guidance 213, gauge the success of stewardship efforts, guide their continued evolution and assess associations between antibiotic-use practices and resistance trends over time. The agency also plans to hold a public meeting this summer to obtain input from the public on the evaluation plan.
For more information and access to the full VFD rule, visit the FDA/CVM website at fda.gov/AnimalVeterinary.