April 22, 2014

US inspection service to amend rules on veterinary products' labelling


In order to provide for the use of a simpler labelling format that would better communicate product performance to the user, the US Animal and Plant Health Inspection Service (APHIS) is proposing to amend the Virus-Serum-Toxin Act regulations.


We intend to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. We are also proposing to require biologics licensees to provide a standardised summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.


APHIS administers and enforces the Virus-Serum-Toxin Act, as amended. The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instruction. The regulations on "Packaging and Labelling," (referred to as the regulations) prescribe requirements for the packaging and labelling of veterinary biologics. The regulations ensure that labelling provides adequate information concerning the proper use and safety of the product, including vaccination schedules, warnings, and cautions.

Current APHIS guidelines provide examples of label claims that may be used to reflect the expected performance of the product provided that appropriate efficacy data has been submitted and approved by APHIS. The guidelines describe performance requirements and allowable indications statements for four different levels (tiers) of effectiveness.


In July 2009, representatives of veterinary biologics manufacturers and the American Veterinary Medical Association (AVMA) met with APHIS to discuss the Agency's current labelling guidance and to explore the possibility of developing a single indications statement that would convey clinically useful information to veterinary practitioners and other consumers of veterinary biologics. At that meeting, the AVMA, which represents the largest group of consumers of veterinary biologics, informed APHIS that its members consider labelling indications statements based on the current guidance to be confusing, and expressed a desire for indications statements to provide insight into the actual performance of the product, including summaries of safety and efficacy data.


On the other hand, representatives of the trade associations representing veterinary biologics manufacturers have remarked that their members expend significant resources on studies to provide data to support labelling that includes indications statements emphasising the unique properties of their product versus that of a competitor. They expressed concern about any change to the labelling regulations that would de-emphasise product differences or require public disclosure of proprietary information that could compromise a manufacturer's competitive position in the marketplace.


In response to the concerns expressed by these stakeholders, APHIS developed a draft guideline (concept paper) concerning the effectiveness indications statements used in veterinary biologics labelling. The draft guideline would replace current indications statements that may reflect any of four different levels of effectiveness with a single indications statement.


In addition to a standardised indications statement, the draft guideline would also require biologics licensees to provide a summary of their data, with confidential business information removed, of the efficacy and safety data submitted to APHIS in support of the issuance of the product license. These proposed changes would not alter the current efficacy requirements for veterinary biological products and are not intended to constitute re-licensure of currently licensed products. These changes would not apply to diagnostic products.


On May 24, 2011, it was published in the Federal Register a notice of a public meeting to discuss the draft guideline (concept paper) concerning effectiveness indications statements in veterinary biologics labelling. At the meeting, we received comments from national trade associations representing veterinary biologics manufacturers, the AVMA, a veterinary consulting group, private and academic veterinarians, pet owners, and manufacturers. There was general support to change the format in which expectations of product efficacy are communicated on labels. APHIS has carefully considered the comments received on the draft guideline and has taken these comments into account in the drafting of this proposed rule.


Currently licensed products would not need to be re-licensed based on these proposed changes. This proposal is not intended to change the efficacy requirements for currently licensed veterinary biological products. Disease syndromes and primary parameters used in the case definitions would continue to be included in the indications statement where appropriate.

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