This week the FDA’s Center for Veterinary Medicine (CVM) announced the final Veterinary Feed Directive (VFD) rule, which will end over-the-counter (OTC) sales of medically important antimicrobial drugs intended for use in feed or water. Instead, the rule places those drugs under the supervision of a veterinarian within the context of a valid veterinarian-client-patient relationship (VCPR).
Since the FDA issued 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. Along with the VFD rule, that strategy includes Guidance for Industry 213, which calls for companies to voluntarily remove animal-performance claims from medically important antimicrobials.
While many are still analyzing the details, several stakeholder organizations this week issued statements supporting the VFD rule.
The American Veterinary Medical Association (AVMA), which has collaborated with the FDA in developing antimicrobial policy, applauded the VFD rule.
“The veterinary feed directive (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 veterinarian-client-patient relationship. “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.”
The American Feed Industry Association (AFIA), while generally supportive of the rule, expressed some concerns.
"The final rule shows many improvements for the industry that will make the process more effective and timely," says Richard Sellers, AFIA’s senior vice president of legislative and regulatory affairs.
AFIA expressed surprise though, that the rule includes a requirement for producers, veterinarians and distributers of VFD drugs such as feed mills to maintain VFD records for two years, instead of one year as originally specified in the proposed rule. "That's a concern, as we believed we had convinced FDA the two-year requirement should be reduced to one year to agree with the one-year recordkeeping requirement that appears in the Current Good Manufacturing Practices regulations,” Sellers says.
Read more in “New Veterinary Feed Directive rule emphasizes the VCPR.”