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U.S. Department of Health and Human Services

Animal & Veterinary

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OSC Ends 2010 with an Expansion

by Melanie McLean, DVM, Center for Veterinary Medicine, FDA

An adverse event is an undesired side effect associated with a product, or a lack of effect (the product does not do what it is supposed to do).
In November 2010, CVM’s Office of Surveillance & Compliance (OS&C) created the Division of Veterinary Product Safety, or DVPS. Analysts in this new division monitor CVM’s database of adverse events reported for approved and unapproved animal drugs, pet food, and animal devices.  Using the information in the database, the analysts identify safety and effectiveness concerns about products marketed for animals.

The responsibilities of the new division include:

  • making sure the label for an approved animal drug has accurate safety information so veterinarians, animal producers, and pet owners are aware of any risks associated with the drug;
  • working with FDA district offices on reports about defective animal products to identify safety issues;
  • monitoring medication errors with animal drugs;
  • participating in outreach programs to encourage veterinarians to report adverse events associated with animal products; and
  • participating in outreach programs to inform the public about the medical risks and benefits of animal products.

Three teams make up the new division:

  • Adverse Drug Event Review Team
  • Adverse Event Review Team
  • Data Management and Analysis Team

The work done by the three teams in OS&C’s new Division of Veterinary Product Safety supports CVM’s mission to protect human and animal health.