Animal Medicines, Like Human Medicines, Are Strictly Regulated by the Food and Drug Administration.
Before they can be manufactured or marketed, animal medicines are subject to the same rigorous approval processes as human medicines. Once approved, animal medicines remain heavily regulated and are subject to strict laws that protect animals, humans, and the environment.
The federal agencies involved in the approval of animal medicines are the USDA (biologics such as vaccines), the FDA (pharmaceuticals), and the EPA (pesticides such as flea and tick medicine). While undergoing approval, animal medicines are vigorously researched and tested for safety, purity, and efficacy, a process that can take five to seven years and cost tens of millions of dollars.
A 2015 study of the U.S. domestic market by HealthforAnimals found that on average, when developing a drug with a new active ingredient, it takes 6.5 years and $22.5 million to bring a new companion animal pharmaceutical to market and 8.5 years and $30.5 million for a new pharmaceutical product for livestock. These are averages and costs were found to be as high as $62 million. The cost of developing new animal drugs are increasing; it is estimated that overall development costs have increased by more than 50% since 2011.
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
USDA Approval of Animal Biologics
Animal biologics (including vaccines) are reviewed and approved by the USDA Center for Veterinary Biologics (CVB) in the Animal and Plant Health Inspection Service. To manufacture and sell veterinary biologics, animal health companies must have an establishment license granted by the CVB. These licenses are given to manufacturers that have appropriate, inspected facilities with people qualified to run them. Manufacturers must also have a product license from CVB, which ensures compliance with the four characteristics outlined in the Virus-Serum-Toxin Act of 1913: purity, potency, safety, and efficacy.
FDA Approval of Animal Pharmaceuticals
Animal pharmaceuticals are reviewed and approved by the FDA’s Center for Veterinary Medicine (CVM) as governed by the Federal Food, Drug and Cosmetic Act (FFDCA). The standards and processes for reviewing animal pharmaceuticals are very similar to those used for pharmaceuticals intended for humans. Both require safety and efficacy assessments consisting of laboratory and clinical studies. The clinical studies must show that animal pharmaceuticals will work as intended and that they provide a consistent, clinical improvement or cure.
The studies designed to evaluate a new drug’s safety and efficacy must meet strict standards known as Good Laboratory Practices and Good Clinical Practices. The FDA inspects the facilities that run the studies to ensure they are performing at the highest standards. Additionally, studies must be geographically diverse and statistically designed. This helps to ensure a veterinarian, farmer, and pet parent can have confidence a medicine is safe and effective regardless of differences in climate, patient characteristics or disease variations across the country.
EPA Approval of Flea and Tick Medicines
Medicines that treat pests such as fleas, ticks and mites are considered pesticides, which is why their approval is managed by the Environmental Protection Agency (EPA). The EPA evaluates proposed pesticides to ensure that they are safe, effective, and meet federal safety standards for human health and environmental protection. These standards are found in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Regulation of Animal Medicines
Government oversight of animal medicines extends throughout the entire lifecycle of the product. After withstanding rigorous research and strict approval processes, animal medicines continue to be subject to strict laws that protect animals, humans, and the environment.
Efforts to continue monitoring an animal medicine after approval requires close cooperation between animal health companies and regulatory agencies such as the FDA, USDA, and EPA.
Both animal health companies and regulatory agencies collect information on adverse events that occur when an animal takes medicine. This information is submitted by veterinarians, pet parents, and farmers and is used to continue evaluating the safety and effectiveness of a product. At times, the regulatory authority will ask for new information to be added to a label of an already approved product. Such information is aimed at providing additional information to those prescribing and administering the medicine to an animal.
Additional inspections and reviews continue after product approval. For instance, the government inspects the manufacturing facilities to ensure that they continue meeting that agency’s rigorous standards. The FDA/CVM also regulates product labels and promotional materials to ensure they are accurate and not misleading.