Animal & Veterinary
Animal Drugs Illegally Marketed as Animal Devices
The information on this page pertains to illegally marketed unapproved animal drugs, not to legally marketed indexed drugs.
The information on this page pertains to animal medical devices, not human medical devices. For more information about human medical devices, please visit the website of FDA’s Center for Devices and Radiological Health (CDRH).
FDA is aware that some drug companies illegally market animal drugs as animal devices. Unknown risks may be associated with the use of these products because animal devices do not go through the same rigorous pre-market review and post-market monitoring that approved animal drugs go through.
Animal Drug or Animal Device?
The key difference between an animal drug and an animal device is how the product works. If it relies on a chemical action occurring in or on the animal’s body to work, the product is a drug, not a device. If it needs to be metabolized by the animal’s body to work, the product is a drug, not a device.
Antibiotics, anesthetics, and insulin are examples of drugs. Needles, syringes, surgical instruments, X-ray equipment, certain diagnostic test kits, and dental appliances are examples of devices.
Pre-Market Review of Approved Animal Drugs
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.
Post-Market Monitoring of Approved Animal Drugs
As long as the drug company markets the animal drug, FDA 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 that makes and sells an approved animal drug is required to report to FDA all adverse drug events that occur after the drug is on the market. 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:
Risks of Animal Drugs Marketed as Animal Devices
An animal device does not go through a rigorous scientific review before it is marketed. With no pre-market review of a product by FDA, there is no way for veterinarians, pet owners, and animal producers to know if a product is safe and effective or if its manufacturing process is adequate to maintain the product’s quality and consistency from batch to batch.
Also, an animal device is not closely monitored by FDA after it is on the market. There are no requirements to report problems with an animal device, which may lead to a delay between when the product causes harm and when FDA becomes aware of problems with the product.
Companies that market animal drugs under the guise of animal devices are really selling unapproved animal drugs that have not been reviewed by FDA for safety and effectiveness. Companies that engage in this practice unfairly compete against companies that sell approved animal drugs.
There is often a financial advantage for companies to illegally market unapproved animal drugs as animal devices because the companies do not always:
- Conduct all appropriate tests on the product before marketing it; or
- Manufacture the product under strict manufacturing standards.
Also, companies must pay FDA user fees to review animal drugs but not animal devices. Companies that market unapproved animal drugs as animal devices illegally avoid paying user fees to FDA.
By ignoring their legal obligations and bypassing FDA’s drug approval process, companies that market unapproved animal drugs as animal devices potentially put the health of animals and people at risk. If this illegal practice continues, fewer products that have been reviewed by FDA for safety and effectiveness will be available to veterinarians, pet owners, and animal producers.