Today the AVMA submitted our support for the new vaccine label changes the United States Department of Agriculture (USDA) is currently proposing. In April, the USDA proposed to remove the tiered structure of vaccine label statements and replace those with one universal, simple label statement about effectiveness that is accompanied by all the applicable safety and efficacy data, vetted by USDA when a vaccine is licensed. See our April 2014 blog post about USDA’s announcement. If the proposal is finalized by USDA, the new labels are expected to provide the relevant scientific data that veterinarians want when selecting vaccines for use in their patients.
Alongside our support for the new proposed rule is our strong encouragement that it be implemented simultaneously with a second vaccine label initiative that USDA proposed three years ago. The rule, published in 2011, proposed other concepts we think are just as critical, including proposed requirements for labels to provide only scientifically based recommendations about risks of use in pregnant animals, and about the level of immunity demonstrated in vaccinated animals over time. We think the new proposal and the 2011 proposal should be implemented in one process to limit the chance of having disruptions in product availability, while companies work with the USDA to incorporate new label language. There are approximately 5,500 currently licensed vaccines in the U.S., so the process should be as straightforward as possible on all parties involved.
The topic arose originally from the members of AVMA’s Council on Biologic and Therapeutic Agents and its Clinical Practitioners Advisory Committee many years ago, stemming from questions about what the statements really mean, and whether the information on the label was truly based on scientific data (including historical revaccination intervals, and recommendations for use in pregnant animals).
It’s been a substantial effort for our volunteer leaders who worked closely with USDA and industry representatives in this collaborative process across organizations. Their perseverance through the years, on behalf of AVMA members, could be coming to fruition. Certainly we will keep members posted as we await further steps from the USDA on this important initiative.