As used on this page, the term “unapproved animal drug” refers to a drug intended for use in animals that meets the definition of “new animal drug” in the Federal Food, Drug, and Cosmetic Act and does not have legal marketing status.
FDA has serious concerns about unapproved animal drugs. These drugs have not been reviewed by FDA and may not meet the agency’s strict standards for safety and effectiveness. Unapproved animal drugs also may not be properly manufactured or properly labeled.
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 obtain what’s called “legal marketing status” for their products. To legally market an animal drug, a drug company must get the drug approved, conditionally approved, or indexed by FDA. Each pathway has different requirements, but they all lead to legal marketing status and provide the benefit of an FDA pre-market review. If the market is full of unapproved animal drugs, drug companies may be less willing to take one of these pathways. This means that even fewer animal drugs that are reviewed by FDA for safety and effectiveness will be available.
Benefit of FDA Pre-Market Review of Approved Animal Drugs
Knowing a drug is safe, effective, and high-quality is the benefit of FDA’s drug approval process. The agency rigorously evaluates an animal drug before approving it. As part of the approval process, the 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 of Approved Animal Drugs
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. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
- The manufacturing process to ensure quality and consistency are maintained from batch to batch;
- The drug's labeling to make sure the information remains truthful and complete; and
- The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.
Required Reporting of Problems with Approved Animal Drugs
As part of FDA’s continued monitoring of safety and effectiveness, a drug company is required to report to FDA all problems that occur with a drug after it's approved. Problems include adverse drug events and product defects. 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 doesn't do what it's expected to do. Adverse drug events also include unfavorable reactions in people who handle the drug. Product defects are problems such as defective packaging or an abnormal appearance of the drug. The required reporting of adverse drug events and product defects 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:
Risk of No FDA Review and Monitoring
With no FDA pre-market 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 and product defects 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.