July 15, 2011

 

 USDA considers changing efficacy claims on biologics

posted June 29, 2011
 

Efficacy claims on veterinary biologics should be simpler, according to a concept paper from the Center for Veterinary Biologics within the Department of Agriculture's Animal and Plant Health Inspection Service.

Statements on veterinary biologics currently carry one of four efficacy claims, ranging from "minimal efficacy" to "full protection."

For many years, the AVMA Council on Biologic and Therapeutic Agents and Clinical Practitioners Advisory Committee have advocated for changes in biologics labels. In July 2009, representatives of the AVMA as well as biologics manufacturers met with APHIS to discuss indications statements. The AVMA noted that many veterinarians consider current indications statements to be confusing and expressed a desire for labels that provide insight into the performance of biologics, including summaries of safety and efficacy data.

In May 2011, the CVB released a concept paper that proposes changing indications statements to state simply that a biologic is "effective" for an indication and to refer users to the product insert for additional information and to a website for a summary of efficacy data.

Representatives of the AVMA presented oral comments at a June 16 meeting on the concept paper. The Association supports pairing the single efficacy claim with relevant efficacy data. In addition, the AVMA continues to advocate for safety summaries on labels.

The CVB also is accepting written comments on the concept paper.