FDA Makes Move Toward Regulating Antibiotic Use in Livestock

The U.S. Food and Drug Administration announced yesterday 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 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 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., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The announcement comes on the heals on the White House’s unveiling of a plan to address the widespread use of antibiotics in livestock and the issues that it creates. President Obama has referred to the issue of antibiotic resistance as “one of the most pressing public health issues facing the world today,” deeming it a matter of national security.

Officially called “The National Action Plan For Combating Antibotic-Resistant Bacteria,” the document increases funding to the United States Department of Agriculture for the improvement of practices that involve administering antibiotics in livestock. The National Action Plan includes broad provisions that seek to monitor antibiotic use in both humans and animals. Some of its provisions include new procedures for hospitals that require them to track and report the administration of antibiotics and the establishment of DNA databanks that catalogue superbugs for research purposes. The provision requiring hospitals to track their antibiotic is particularly important considering the there currently is no comparable requirement, leaving researches and scientists with no base level of information regarding the use of antibiotics across the States.

Roughly 80% of all the antibiotics sold in the United States are for the purposes of treating animals in agricultural settings. A new study from the National Academy of Sciences suggests that the global meat industry used roughly 63 tons of antibiotics in 2010 alone, and estimates that this figure will jump 67% by the year 2030.

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