The FDA has announced the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of 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.
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. Now, the agency is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency). Antimicrobial drugs, which include bacteria-fighting antibiotics, have been added to the feed of cattle, hogs, poultry and other animals for production (as opposed to animal health) purposes, such as to help them gain weight faster. The problem is that all use of antimicrobials, in humans and animals alike, generally contributes to the development of antimicrobial-resistant bacteria, considered a global threat to public health. Drug-resistant strains of bacteria could be fatal if they enter the human body through uncooked or improperly cooked food and the medicines created to combat them are rendered ineffective.
The 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 animal producer or caretaker to assume responsibility for making clinical judgments about the animal’s health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care. The final rule will require veterinarians to follow state-defined VCPR requirements. In states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians will need to adhere to a VCPR that includes the key elements in the final rule.
“The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals,” said Michael R. Taylor, FDA deputy commissioner for foods. “The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles.”
In December 2013, the agency published a guidance document, which calls on animal drug manufacturers of approved medically important antimicrobials that are put into water or feed of food-producing animals to voluntarily stop labeling them as drugs that can be used to promote animal growth and change the labeling of their products for the remaining uses to require veterinary oversight of these drugs when they are used for therapeutic purposes. All of the affected makers of these drugs have committed in writing to participate in the strategy.
See the FDA Announcement
See also the FDA’s Placing Animal Drugs under Veterinarian Oversight: Questions and Answers with Michael Taylor and William Flynn
See also the FDA Fact Sheet: Veterinary Feed Directive Final Rule and Next Steps
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, July 2012 Report: Foodborne Illness: When Grabbing a Bite Can Be Deadly