Regulatory Brief

 Instituting a Post-Marketing Surveillance Program for Animal Vaccine Adverse Events


Formal title: Docket Number [00-071-2] Viruses, Serums, Toxins, and Analogous Products; Records and Reports


Brief Description:

The USDA reproposal would require animal vaccine makers (licensees and permitees) to keep adverse event report records and file reports to the USDA Center for Veterinary Biologics (CVB). Specifically, vaccine makers would keep a detailed record for every adverse event report received and compile and submit a summary report of all adverse event reports to the CVB annually, and six months following original licensing of a product.

The AVMA congratulates the USDA CVB on proposing to improve post-licensing surveillance of veterinary biologics.

AVMA Response:

The AVMA has great interest in CVB's plans for capture of adverse event report information, analysis of the information, processes for determining regulatory action, and mechanisms for feedback of clinically relevant information to the profession to enhance patient care. The AVMA identified areas for improvement and further development. The AVMA strongly supports the USDA's general effort to institute an adverse event reporting system and believes constructive dialogue can further improve the proposal.

Background Documents:

View AVMA response to USDA (PDF)

View Federal Register document (PDF)

Status:

AVMA responded on October 15, 2005 and is awaiting publication of USDA response.