Animal & Veterinary

FDA’s Concerns about Unapproved Animal Drugs

The information on this page pertains to illegally marketed unapproved animal drugs, not to legally marketed indexed drugs.

FDA has serious concerns about unapproved animal drugs. These drugs are not reviewed by FDA and may not meet FDA’s strict standards for safety and effectiveness. Unapproved animal drugs also may not be labeled or advertised appropriately or truthfully.

Many unapproved animal drugs are marketed in the United States. Drug companies that make and sell these unapproved animal drugs unfairly compete against drug companies that spend the time and financial resources to get drugs approved by FDA. If the market is full of unapproved drugs, drug companies may be less willing to go through FDA’s drug approval process. This means that even fewer animal drugs that are reviewed for safety and effectiveness will be available.

Benefit of FDA Review and Approval

Knowing a drug is safe, effective, and high-quality is the benefit of FDA’s drug approval process. To get an animal drug approved, a drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species. If the drug is for use in food-producing animals, the drug company must also prove that food made from animals treated with the drug is safe for people to eat;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug company must show that the drug can be consistently produced from batch to batch; and
  • The labeling is truthful and complete. The drug company must make sure that the labeling contains all necessary information to use the drug safely and effectively, including the risks associated with the drug.

Continued FDA Monitoring

FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor the drug's:

  • Safety and effectiveness to determine if concerns arise that were not known at the time of approval;
  • Manufacturing process to ensure quality and consistency are maintained from batch to batch; and
  • Labeling to make sure the information remains truthful and complete.

For a prescription animal drug, FDA also monitors how the drug is marketed to make sure the advertisements are truthful and not misleading.

Adverse Drug Event Reporting

As part of FDA’s continued monitoring of safety and effectiveness, a drug company is required to report to FDA all adverse drug events that occur after the drug is approved. An adverse drug event, also called an adverse drug experience or ADE, is an undesired side effect associated with the drug, or a lack of effect (the drug does not do what it is supposed to do). The required reporting of adverse drug events allows FDA to more easily identify and correct problems with approved animal drugs.

For more information about reporting adverse drug events, please visit the following website:

Veterinary Adverse Event Voluntary Reporting

Risk of No FDA Review and Monitoring

With no FDA review of an animal drug, there is no way for veterinarians, pet owners, and animal producers to know if a drug is safe and effective or if its manufacturing process is adequate to maintain the drug’s quality and consistency from batch to batch. Also, because there are no reporting requirements of adverse drug events for unapproved animal drugs, problems with these drugs may be slow to be identified.

By bypassing FDA’s drug approval process, drug companies that make and sell unapproved animal drugs potentially put the health of animals and people at risk.

Page Last Updated: 07/09/2014
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