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  1. Development & Approval Process

FACT SHEET: Veterinary Feed Directive Final Rule and Next Steps

Background

Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. The agency has moved to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals.

VFD Final Rule

The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.

The Veterinary Feed Directive (VFD) final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient-relationship (VCPR) and specifies the key elements that define a VCPR. These key elements include that the veterinarian engage with the client (i.e., the animal producer) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where the patient is managed, and provide for any necessary follow-up evaluation or care. The final rule requires veterinarians to follow state-defined VCPR requirements; in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians need to adhere to a VCPR that includes the key elements in the final rule.

The rule facilitates veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while at the same time ensuring that veterinarians in all states are conducting such oversight in accordance with nationally consistent principles. FDA defers to individual states for the specific criteria for acceptable veterinary professional conduct when those standards require a VCPR for the issuance of a VFD and include the key elements of the federal VCPR standard. The FDA requires adherence to the federally-defined VCPR for those states with VCPR requirements that do not include the key elements of the federally-defined VCPR, or that do not require a VCPR for issuing a VFD. The agency  has worked with each state to review their VCPR requirements and determine if they are consistent with the federal standards, and has provided the following webpage for reference, Does the State or Federal VCPR Definition Apply to a Lawful VFD in my State?.

Veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, help ensure that medically important antimicrobial drugs are  used in feed according to label directions and only when appropriate to meet specific animal health needs.

Next Steps: Continuing to ensure the Judicious Use of Medically Important Antimicrobials

In January 2017, FDA reported that all affected drug applications have either aligned with the recommendations outlined in Guidance for Industry (GFI) #213, or their approvals have been voluntarily withdrawn. As a result of these changes, these products cannot be used for production (e.g., growth promotion) purposes and may only be used under the authorization of a licensed veterinarian.

Of the 292 new animal drug applications initially affected by Guidance for Industry #213:

  • 84 were completely withdrawn
  • Of the remaining 208 applications, 
    • 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status,
    • 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status
  • Production (e.g., growth promotion) indications were withdrawn from all (31) applications that included such indications for use

Implementation of FDA’s Guidance #213 significantly changed the way medically important antimicrobials can be used in food-producing animals. When the changes were fully implemented, it became illegal to use these medically important antimicrobials for production purposes, and animal producers now need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.

Building on that progress, in September 2018, CVM unveiled its five-year action plan for supporting antimicrobial stewardship in veterinary settings. This plan includes applying a risk-based approach to evaluate new and currently approved antimicrobial products for animals, collaborating with key stakeholders to support stewardship of these products by end users, and collecting data on resistance and antimicrobial use to monitor the effectiveness of these actions to slow the development of resistance.

CVM plans to initiate the actions outlined in this document in phases over the next five fiscal years. This phased approach will allow for adjustments based on critical, science-based analysis, public health impact, and feedback from stakeholders.