By: Michael R. Taylor
For the past several years, the FDA has been taking steps to fundamentally change how antimicrobials are legally used in food-producing animals. The agency is moving to eliminate the use of these drugs for production purposes – such as speeding weight gain – and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians. These changes are critical to ensuring these drugs are used judiciously and only when necessary for legitimate animal health purposes.
Today, we added another element to our overall strategy, one that recognizes the important role that veterinarians fulfill as guardians of animal health and preservers of judicious use of medically important antimicrobials. The Veterinary Feed Directive (VFD) final rule lays out what veterinarians must do when they need to authorize the use of these products in feed to protect the animals they serve.
This rule is a key piece of FDA’s initiative to combat the overuse of antimicrobial medications — including antibiotics — in both people and animals, which has created a global health crisis. Disease-causing bacteria commonly develop resistance to the medications created to kill them, but misuse of these important treatments ups the ante. FDA is particularly concerned about the use of “medically important” antibiotics in animal agriculture because they are also used to treat human disease and could become useless if bacteria become resistant to their effects.
Of course, change takes time. Since December 2013, we have been implementing a plan with animal drug companies to phase out the use of medically important antibiotics for enhanced food production. We have been working since then with drug companies, animal producers and veterinarians to change how these antibiotics are used in animals that enter the food supply, such as cattle, hogs and poultry.
Partnership and collaboration is delivering results. All 25 affected animal drug companies agreed to work with FDA to remove production uses for growth promotion and feed efficiency from the approved uses of their drug products, and move the therapeutic uses of these products from over-the-counter availability to a marketing status requiring veterinary oversight. By December 2016, we expect to see significant changes in the way medically important antibiotics are used in animal agriculture as compared to how they have been used for decades.
What will this mean in practice? Once these changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, period. Instead of having unrestricted over-the-counter access, animal producers will need to obtain authorization from a licensed veterinarian to use these medications for therapeutic uses — for prevention, control or treatment of a specifically identified disease.
The VFD rule respects the diversity of circumstances that veterinarians encounter on the farm, but also ensures that their oversight is in line with nationally consistent principles. They will be required to have sufficient knowledge of the animals being treated by examining them or visiting the facility at which their care is managed.
Specifically, veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. That means using a product for a specifically-identified disease, at the right dose, and for the period of time stipulated on the product label.
We aren’t done yet. The next step is getting the data we need on how medically important antibiotics are now being used on farms, information that will be essential to measuring the impact of our judicious use strategy. Right now we collect antibiotic sales and distribution data but do not have explicit regulatory authority to require data to be submitted on how antibiotics are actually being used in farm animals. We are evaluating how to obtain additional detailed information on such things as the species, indication, dose, and duration of use in order to better understand links between usage patterns and trends in antibiotic resistance. This will help provide a more comprehensive and science-based picture of antibiotic use and resistance in animal agriculture. FDA is actively engaged with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need. We plan to hold a public meeting this summer to discuss how to collect and present this data.
Finally, FDA has been actively engaging veterinary organizations, animal producer organizations, and other stakeholders to express concern about some currently-approved preventive, therapeutic uses of medically important antibiotics that have no limit on how long they can be given to the animal. This is not what we consider a judicious use. We believe that veterinarians should work with their clients to explore alternative approaches for managing certain animal health conditions, and we will be working with animal producers and drug companies to make any needed changes in approved conditions of use.
Antimicrobial resistance is everyone’s problem. It requires determination and cooperation to make the changes needed to protect the utility of these life-saving drugs. We are grateful for the way our partners and stakeholders across the food system are responding to this challenge.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine