The Center for Veterinary Medicine (CVM), a branch of the Food and Drug Administration (FDA), is responsible for ensuring that animal drugs are safe and effective, and manufactured to the highest quality standards. The standards and processes for reviewing pharmaceuticals intended for animals are the same in most respects as those used for reviewing pharmaceuticals intended for humans.
Both the animal and human approval processes require safety and efficacy assessments consisting of laboratory and clinical studies. The clinical studies are required to show that animal pharmaceuticals will work in the way they are intended to, and that they provide a clinical improvement or cure. The study must be geographically diverse and statistically designed.
FDA inspections of manufacturing facilities examine the way pharmaceuticals are produced, and consist of product stability assessments, reviews of manufacturing practices, and other procedures. Animal pharmaceutical companies must assure the CVM that they can consistently manufacture their products to approved specifications.
Pharmaceutical Regulatory Process in Focus: Animal Antibiotics
Each animal antibiotic regulation process includes a safety assessment, requiring the animal health company to submit data showing that use of the antibiotic is safe for the animals in which it is to be used, and that it will not jeopardize the health of humans who consume food derived from treated animals. The safety assessment for food animals is more stringent than that for human antibiotics in three respects:
- No Animal Benefits Considered: While the FDA conducts a risk-benefit assessment for human antibiotics, there is no consideration of benefits in the review of antibiotics used in food animals. This means that the risk to human health for products under review must be extremely low since the FDA does not consider any benefits to offset the risks.
- Food Safety: The safety assessment for food animal antibiotics requires sponsors to submit human food safety studies to ensure that meat from animals treated with certain antibiotic will be safe for human consumption. Data from these studies are used to establish withdrawal periods, or periods prior to harvest during which antibiotics cannot be used in order to ensure that the final food product is free of residues above tolerance levels.
- Preventing the Spread of Antibiotic Resistance: In 2003 the FDA implemented an additional safety measure that “outlines a comprehensive, evidence-based approach to preventing antimicrobial resistance that may result from the use of antimicrobial drugs in animals.” ¹ This process was a priority action item in the U.S. Public Health Action Plan. In addition to making antimicrobial resistance screening a requirement for all new antibiotics, CVM is in the process of working with animal health companies to examine all existing, approved products using this new methodology.
The FDA continues to update its regulatory framework, and in 2010 introduced its guidelines for Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. The draft guidance is intended to inform the public of the FDA’s current thinking on the use of medically important antimicrobial drugs in food-producing animals.
1FDA News, October 23, 2003
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process (also available as a PDF)