Reports required after veterinary biologics problems

Makers of vaccines and other veterinary biologics now need to send health authorities reports on adverse events.

Before this June, the Department of Agriculture's Animal and Plant Health Inspection Service required those manufacturers to collect reports on adverse events but let them decide whether those incidents were signs of broader problems and worthy of reports to the agency. The change aligns U.S. regulations with standards from the World Organisation for Animal Health (OIE), and it should improve safety, efficacy, and access to export markets, according to Federal Register notices.

Reportable adverse events include failures of products to protect animals, harmful side effects, and, with products that help identify disease, incorrect results.

A May 2018 notice states that the previous reporting system worked well but would be improved by letting APHIS track product performance. Without reporting requirements, APHIS officials may not know about problems in biologics or may not know about them soon after they occur.

The agency now requires reports within three business days when biologics products are linked to serious and unexpected adverse events or anytime a biologics maker sees signs of quality problems in their products. Other adverse event reports need to be filed within 90 days.

"We are taking this action in order to limit the harm to animals due to adverse events related to a product's purity, safety, potency, efficacy, preparation, testing, or distribution," the notice states. "Current regulations may hinder APHIS from taking expeditious action in cases where veterinary biologics are unsatisfactory."

APHIS officials had not given the public access to previous reports of adverse events. But, with required reporting, they plan to post summaries on the agency's website.

"APHIS is working to determine the specifics on how often those reports are published and what explanatory information is included," the notice states.