June 30, 2016
This CVM Update is the U.S. Food and Drug Administration’s fifth 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 to food-producing animals 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 (GFI) #213. Many of these sponsors have already started implementing the recommended changes to their affected antimicrobial products: four applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 41 affected applications have been completely withdrawn. On May 11, 2016, the FDA sent a letter to remind affected drug sponsors about the agreed-upon timeframe (the end of 2016) for aligning their product with GFI #213.
Once the changes recommended in GFI #213 have been made, these products will only be obtainable upon the valid order of a licensed veterinarian and can legally only be used for therapeutic indications.
Additional FDA Action since January 2016
The FDA issued a letter on June 20, 2016, reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016. Once the changes are in place, distributors of those medically important antimicrobials will need to comply with appropriate requirements for Rx and VFD drugs when dispensing these products. The letter also provides retail establishments with recommendations for addressing current and future inventory of medically important antimicrobials for use in feed or water for food animals.
The FDA recognizes the need for continued education and outreach during the implementation of GFI #213 and has made presentations to dozens of stakeholders groups and responded to hundreds of individual questions over the past six months. The agency intends to continue these efforts in the future as resources permit.
To request a presentation on the judicious use of antimicrobials in food-producing animals or for more information, please contact the FDA Center for Veterinary Medicine at AskCVM@fda.hhs.gov.
Gathering information on the way medically important antibiotics are used is essential to measuring the impact of the FDA’s judicious use strategy. In March 2016, the FDA announced a funding opportunity for antimicrobial use and resistance data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (cattle, swine, chickens, and turkeys), a critical element in measuring overall impact of the agency’s judicious use strategy. The data collection efforts are also expected to provide important information on methodologies to help optimize long-term strategies for collecting and reporting such data.
To further promote the judicious use of antimicrobials in food-producing animals, the FDA issued a final rule on May 10, 2016, revising the annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals. The additional data the FDA will gather as a result of that rulemaking will improve our understanding of how antimicrobials are sold or distributed for use in major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.
The FDA is committed to continued assessment of surveillance activities that support stewardship of judicious use of medically important antimicrobials. The FDA is collaborating with the U.S. Department of Agriculture and the Centers for Disease Control and Prevention to develop a plan for collecting on-farm antibiotic use and resistance data. The agencies held a public meeting in September 2015, and provided an opportunity for the public to submit comments through November 30, 2015. The FDA is in the process of reviewing all public comments (both oral and written) to determine next steps.
Important Upcoming Milestones
The FDA’s Center for Veterinary Medicine is working diligently to ensure that the changes outlined in GFI #213, which all of the affected animal drug sponsors agreed to make, are fully and effectively implemented by January 1, 2017. By that time, the agency expects that drug sponsors will have completed all of the recommended changes. The agency also expects by this date that those using medically important antibiotics in animal feed or drinking water will begin to follow the veterinary oversight procedures required for new animal drugs that currently have VFD or Rx marketing status.