FDA releases industry guidance on antibiotics
Dec 01, 2003
Dr. Linda Tollefson, deputy director for FDA's Center for Veterinary Medicine (CVM), explains, "What this document represents is a risk-based approach to help prevent antimicrobial resistance that may result from the use of antimicrobial drugs in food producing animals."
This new approach will apply to therapeutic and non-therapeutic antimicrobial drugs intended for food-producing animals. FDA adds that it will lead to a review of all existing approvals.
Industry is not disagreeing either.
According to the Animal Health Institute (AHI), a national organization representing animal health manufacturers, it's a better approach to regulating antibiotics.
"The new guidance is a superior approach to regulating antibiotics, compared to the European phase-out of antibiotics for growth promotion or to legislation proposed in the U.S. Congress. The new guidance bases decisions on science and risk assessment, rather than politics, and requires drugs to be looked at individually rather than lumping them all together, AHI says.
This new risk-assessment guidance will apply to all antibiotics approved for use in food-producing animals. FDA explains, the guidance provides a scientific process for assessing the likelihood that an antimicrobial drug used to treat an animal may cause an antimicrobial resistance problem in humans consuming meat or other byproducts from that animal.
"This process can help prevent antimicrobial drugs with a high risk of causing such problems from being improperly used in food-producing animals, and thereby potentially leading to antimicrobial resistance in humans," FDA says.
The new guidance encourages drug sponsors to use a risk assessment process to demonstrate that an antimicrobial drug used to treat food-producing animals will not create a risk of antimicrobial resistant bacteria likely to lead to human health problems.
Details, details The agency has devised a three-part system for determining an antimicrobial drug's potential risk to humans if used to treat food-producing animals. The three parts include:
Once the risk estimation has been completed, it leads to a ranking of drugs: high, medium, low. These risk-based rankings are associated with certain risk management categories.
CVM says it also has risk management strategies for drugs that rank high. For example, an application for approval could be flat-out denied, or approved under specific-use conditions. FDA could place limits on marketing, including prescriptions or Veterinary Feed Directive, prohibition on extra-label use or even limits on duration/method of administration.
Tollefson adds that FDA consciously decided to release this risk assessment as a guidance document rather than regulation because it is much easier to amend due to changing science.