June 01, 2014


 USDA proposes simpler biologics labels, more data access

​Posted May 14, 2014

Proposed regulatory changes would give veterinary biologics simpler labels intended to more clearly describe product performance expectations.

The changes also would give veterinarians access to standardized summaries of efficacy and safety data.

Officials with the Department of Agriculture announced in an April 21 Federal Register notice that the department’s Animal and Plant Health Inspection Service would accept comments through June 20 on the proposed changes, which are described here.

If APHIS implements the proposed changes to the Virus-Serum-Toxin Act regulations, labels on veterinary biologics will have a uniform format rather than one of four current formats that reflect different levels of effectiveness. Efficacy and safety information for each product also would become available to the public through the APHIS Center for Veterinary Biologics website, which is accessible through the APHIS website.

The APHIS notice states that, in a 2009 meeting, representatives from the AVMA had indicated veterinarians considered existing labeling indication statements to be confusing, and they wanted statements that gave insight into actual performance, with safety and efficacy data. Rep­resentatives from associations of veterinary biologics manufacturers expressed concern at that time that such changes would reduce emphasis on product differences or diminish their position in the market by requiring disclosure of company information.

APHIS responded with a draft guide that described potential changes similar to those requested by the AVMA. And, at a 2011 public meeting on that guide, comments generally showed support for changing the label format to one that describes expectations for product efficacy, the notice states.

If the regulatory changes are approved, APHIS will require new labels for existing biologics within four years, although agency officials would consider extension requests. Prod­ucts licensed within six months of the proposal would have one year for compliance, and any biologics licensed more than six months after the effective date would need to have labels in the new format.

Dr. Elizabeth Curry-Galvin, AVMA assistant executive vice president, said, “Guided by our teams of volunteer veterinarian leaders, AVMA has worked to support veterinarians by helping to ensure that biologic product labels provide clinically relevant information that veterinarians can use to guide their clinical recommendations to clients.” 

The proposed changes to veterinary biologics labels are available here.