Antibiotics important in human medicine should only be used in food animals to assure animal health and should be limited to uses under the oversight of a licensed veterinarian.
Antibiotics important in human medicine should only be used in food animals to assure animal health and should be limited to uses under the oversight of a licensed veterinarian.
This fact sheet was updated in June 2016 to reflect finalization the previous month of an FDA proposed rule requiring animal drug companies to provide species-level sales estimates on medically important antibiotics.
Antibiotic resistance is a growing and urgent public health threat fueled by the frequent and widespread use of antibiotics. The more antibiotics are used, the more likely it is that bacteria will develop resistance, making it essential to minimize inappropriate or avoidable use of the drugs in both humans and animals. As part of the effort to combat antibiotic-resistant bacteria, the U.S. Food and Drug Administration is taking steps to help ensure that antibiotics are used responsibly in food animals, meaning only as medically necessary and appropriate.
Although publicly available data regarding the use of antibiotics in animal agriculture are limited, FDA reports suggest large-scale use of antibiotics important to human medicine in food animals. In 2014, more than 20 million pounds of medically important antibiotics were sold for use in food-producing animals in the United States—a 23 percent increase since 2009.1 Further, 97 percent of these drugs were purchased over the counter, meaning without any veterinary involvement or oversight, and administered to animals primarily through feed or water.
The landmark policies detailed below should help address some of the problems highlighted by these 2014 statistics, but more work is needed. Next steps include strengthening the policies already in place, as well as providing technical assistance for compliance and collecting more robust data to monitor and assess their impact.
The landmark policies detailed below should help address some of the problems highlighted by these 2014 statistics, but more work is needed.
Guidance #213 acts as a blueprint for implementing the principles set forth in Guidance for Industry #209: Antibiotics important in human medicine should be used in food animals only to assure animal health and should be limited to uses under the oversight of a licensed veterinarian.
Tailor drug labels to ensure the appropriate use of antibiotics for disease prevention. While Guidance #213 defines appropriate uses for disease prevention, some antibiotics still have labels with approved disease prevention indications that are inconsistent with those principles. For example, some antibiotics currently on the market have approved disease prevention uses that are not targeted toward a specific disease or do not include defined durations of use. Legitimate prevention should not include instances where medically important antibiotics are routinely needed or used over multiple consecutive production cycles for the same diseases, especially on entire herds or flocks. The agency should go further and work with drug companies and other stakeholders to remove prevention indications that are inconsistent with judicious use.
Develop a clear plan for evaluating success. FDA provides periodic public updates regarding antibiotic label changes occurring in compliance with Guidance #213. However, more data will be needed in order to effectively evaluate the impact of this policy. Under the Animal Drug User Fee Act, FDA has already expanded its reporting of sales and distribution data, and two additional initiatives will also be important to collecting more robust information.
Food producers and veterinarians will need technical assistance and training to comply with these policy changes.
FDA’s Veterinary Feed Directive (VFD) rule and associated industry guidance aim to foster the responsible use of antibiotics in food animals by outlining the process and framework for veterinary authorization of drugs used in animal feed.
Consider a plan to systematically collect VFD data. These data would provide useful monitoring information regarding compliance with Guidance #213 and insight into why antibiotics are being used (e.g., the indication). At a minimum, FDA could initiate a pilot program in various regional and production settings to better understand the potential usefulness of this information.
Food producers and veterinarians will need technical assistance and training to comply with these policy changes. While Guidance #213 directly applies to drug companies and businesses that make medicated feed, it indirectly forces changes in farming practices. Food producers will need to understand the full implications of Guidance #213 and alternate production methods that do not rely on medically important antibiotics for growth promotion, or over-the-counter sales of antibiotics to be administered through feed or water. Veterinarians will need further education on the proper use of the VFD and associated compliance requirements. Additionally, food producers and veterinarians may encounter practical roadblocks that USDA extension services and other third-party veterinary and agricultural organizations can help address through educational outreach and stakeholder engagement.
For further information, please visit saveantibiotics.org.