Regulatory Brief

 Single Label Claim for Veterinary Vaccines

Formal Title: Docket No. APHIS-2011-0049/RIN 0579-AD64-Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products

Excerpts from the AVMA Response:

The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) proposes to amend the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format with a goal of better communicating product performance expectations to the end-user. The USDA intends to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. In addition, it proposes to require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the USDA in support of the issuance of a full product license or conditional license.

The AVMA has long advocated for simple vaccine labels that are accompanied by USDA-vetted safety and efficacy information, so that veterinarians and other end-users have the relevant facts they need to make sound decisions about vaccines. However, we encourage USDA to implement its label proposals simultaneously for the benefit of end-users who will be encountering these new labels, and for industry, who will need substantial time undergoing the painstaking process of the various new label changes for the approximately 5,500 products currently licensed. To this end, we also strongly encourage USDA to coordinate with industry and AVMA regarding a suitable implementation timeline that is prioritized by species, to diminish impacts on product availability and innovation for the two proposed rules.

Being a longtime advocate for more transparent, simpler biologic labels with relevant supporting data, the AVMA commends the USDA, APHIS, Veterinary Services (VS) Center for Veterinary Biologics (CVB) for seeing this important initiative to fruition.

The AVMA stands ready to assist the APHIS CVB in its implementation of substantial changes to vaccine labels to make them more informative and understandable for end-users. We support the CVB's willingness to develop guidance documents explaining changes to vaccine labels and expectations for industry implementation (e.g., a "User's Guide"), and we offer our assistance as the CVB develops such guidance.

Background Documents:

Related AVMA Policies: