January 20, 2016
This CVM Update is the U.S. Food and Drug Administration’s fourth progress report highlighting its recent actions to promote the judicious use of antimicrobials in food-producing animals.
In December 2013, the agency took a significant step forward in addressing antimicrobial resistance by publishing Guidance #213, which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to remove from their product labels indications for use related to growth promotion, and to bring the remaining therapeutic uses of these products under the oversight of a veterinarian by the end of December 2016.
All of the affected drug sponsors have committed in writing to making the changes described in the guidance by the end of 2016. The FDA fully expects this process to be completed by this deadline.
There were 293 applications initially affected by Guidance for Industry #213. Some of these sponsors have already started implementing the recommended changes to their affected antimicrobial products: three applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 35 affected applications have been completely withdrawn.
Once these label changes have been made, these products will only be obtainable upon the valid order of a licensed veterinarian.
Additional FDA Action
The FDA sent letters in September 2015 to all affected sponsors outlining the process of transitioning their products to remove approval for production use and to phase in veterinary oversight by the end of December 2016. The letter explains the approval process for each label change and outlines the materials sponsors need to submit to the agency in order to complete the transition.
In December 2015, FDA issued draft Guidance for Industry #233 to help drug sponsors meet certain requirements for VFD drug approval. The agency anticipates this guidance, once finalized, will assist the manufacturers of medically important antimicrobials as they transition their products to veterinarian oversight in the coming months.
The FDA also issued two regulations in 2015 to further promote the judicious use of antimicrobials in food-producing animals. In May, the agency proposed revisions to its annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals in order to obtain estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys).
The FDA also announced the Veterinary Feed Directive (VFD) final rule in early June. The VFD final rule outlines the revised process for authorizing use of VFD drugs in feed and requires, among other things, that veterinarians who want to authorize the use of VFD drugs to do so within the context of a valid veterinarian-client-patient relationship. Once the changes recommended by Guidance for Industry #213 are fully implemented, medically important antimicrobials intended for use in animal feed will be limited to use under a VFD order issued by a licensed veterinarian.
Important Upcoming Milestones
Gathering information on the way medically important antibiotics are used is essential to measuring the impact of the FDA’s judicious use strategy. The FDA, U.S. Department of Agriculture, and the Centers for Disease Control and Prevention are working together to develop and implement a plan to collect additional data on estimated antibiotic use in food-producing animals. In September 2015, these agencies held a jointly sponsored public meeting to obtain input on approaches for collecting on-farm antimicrobial drug use and resistance data, and invited public comment on this topic through November 30, 2015. FDA, USDA, and CDC plan to finalize this data collection plan in 2016.
By the end of 2016, FDA expects all label changes to be completed by drug sponsors; and by January 2017, changes in drug use practices will begin. FDA has a goal of publishing the first assessment of changes in drug use practices in 2018. FDA is committed to continued assessment over time to ensure that these measures are having the desired effect on antibiotic stewardship and resistance.