USDA looking to simplify animal vaccine labels with new proposed rule


The USDA is attempting to simplify unnecessarily complicated animal vaccine labels that the AVMA says have caused confusion for veterinarians and monopolized the time of USDA and industry resources.

According to Dr. Lynne White-Shim, assistant director of the AVMA Scientific Activities Division, the USDA published a proposed rule on April 21 that can potentially provide greater clarity for veterinarians and save time for USDA employees and other industry resources. 

Doing away with the tiered system

The current animal vaccine labeling system utilizes four tiers for distinguishing between vaccines based on safety and efficacy.

These tiers have often led to confusion because it is not always clear which tier is applicable to certain vaccines, and veterinarians in the field sometimes have trouble deciding which label is appropriate for their purposes, the AVMA said.

The four tiers currently used are:

  • "For the prevention of infection with..."
  • "For the prevention of disease due to..."
  • "As an aid in the prevention of..."
  • "As an aid in the control of..."

In the new proposed labeling system, there would be a single statement: "This product has been shown to be effective for the vaccination of healthy animals ___ weeks and older." 

Changes to safety and efficacy data dissemination

The USDA's proposed rule also seeks to change how safety and efficacy information is provided to the end user.

Currently, the USDA is responsible for approving vaccine labels and packaged information that feature safety and efficacy study data, the AVMA said.

In the proposed process, labels would refer the end user to the APHIS Center for Veterinary Biologics (CVB) website, where they could view all of the study data utilized in the product's licensure by the USDA.

According to the USDA, placing comprehensive study data on the CVB website instead of including selected study data on printed labels will allow the end user to better assess product performance. 

"The CVB website would also provide educational information to address the complex nature of efficacy studies as well as explanatory statistical information, where appropriate, related to individual data summaries," the USDA wrote in its proposed rule. "In addition, the website would include a statement advising users to consult with a licensed veterinarian for further information regarding the use of a veterinary biological product. We believe an educational component is an integral part of disseminating such complex information as efficacy and safety data."

The AVMA reported that it anticipates submitting its comments on the proposed rule before the June 20 deadline, and the organization welcomes comments from members.


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