FDA’S Approval Process for Food Animal Antibiotics: Tougher Than for Human Antibiotics
It takes more than a decade and tens of millions of dollars in research for an animal health company to obtain approval of an antibiotic for use in food-producing animals. The approval process is a stringent, science-based regulatory review by U.S. government authorities.
The Center for Veterinary Medicine (CVM), a branch of the Food and Drug Administration (FDA), is responsible for ensuring that animal drugs are safe, effective and manufactured to the highest standards of quality. In most respects, the process for reviewing an antibiotic used in animals is the same as that for an antibiotic used in humans.
Each process includes a safety assessment, requiring sponsors to submit data that shows the antibiotic is safe to use in humans or animals. The safety assessment for food animals is more stringent than that for human antibiotics in three ways:
1
While the FDA conducts a risk-benefit assessment for human antibiotics in which it weighs benefits against risks, there is no consideration of benefits in the review of antibiotics used in food animals. This means 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.
2
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 the 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. This is to ensure that there are no residues above tolerance levels in the final product.
3
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 all proposed antibiotics submitting to this process, CVM is in the process of working with animal health companies to use this new methodology to examine all existing approved products.
The animal and human antibiotic approval processes both require an efficacy assessment, which refers to the submission of data from geographically diverse, statistically-designed studies that show the product will work in the way it is intended to provide clinical improvement or cure.
Finally, both processes require a quality or manufacturing assessment that consists of facility inspections, assurance of product stability and adherence to Good Manufacturing Practices, among other procedures. This assessment assures the agency that the sponsor can manufacture the product in the approved form.
This entry was posted
on Monday, April 20th, 2009 at 11:35 pm and is filed under Antibiotic Papers.
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