Data previously only available via a Freedom of Information Act request now electronically accessible to the public.

April 3, 2019

2 Min Read
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In its continuing commitment to increase transparency, the U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) announced April 3 the availability of data from more than 30 years of adverse event reports related to animal drugs and devices used in animals.

Previously, CVM said this detailed level of data was only available via a Freedom of Information Act request, but now this information is electronically accessible to the public and available for automated searching.

The posting will include reports associated with approved animal drugs, unapproved/compounded drugs used in animals and devices used in animals and will be accessible via openFDA.gov, a platform used by researchers, statisticians and other academics to access large, valuable public health datasets collected by the agency, CVM said.

CVM’s Adverse Event Reporting (AER) system is one of the post-market surveillance tools that FDA uses to monitor the animal and human user safety of animal drugs and devices used in animals, as well as the efficacy of these products. Manufacturers of FDA-approved animal drugs are required to report adverse events to the agency. The dataset also includes voluntary reports from a variety of sources, including pet owners, animal producers, veterinarians and other health care providers.

FDA said it anticipates that this increased transparency will help to spur veterinarians, pet owners and other animal care providers and members of the public to enhance reporting to FDA or product manufacturers when animals experience adverse events after receiving an animal drug or using a device.

The agency said complete and detailed reports are immensely helpful when it is identifying safety signals and determining which products may require additional investigation.

The CVM AER system captures adverse events or product defect reports related to animal drugs or devices used in animals. These can include minor to major health-related events, but also complaints about an off-color of a product, defective packaging and other non-health-related issues.

However, CVM said it’s also important to understand the information in the database is as reported to the agency, and the agency has not necessarily determined if the products in question were the actual cause of the events reported.

The animal drug and device AER data that CVM posted on openFDA.gov covers the period from Jan. 1, 1987, to Sept. 30, 2018. FDA will update the information quarterly to ensure that the public has the most current information available about adverse events reported to CVM in relation to animal drugs and devices. The next dataset will become available later this month and will cover the time period from Sept. 30 to Dec. 31, 2018.

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