The FDA’s Center for Veterinary Medicine (CVM) this week issued its fourth progress report outlining its actions promoting judicious use of antimicrobials in livestock. The FDA’s efforts in this area have focused on reducing the use of medically important antimicrobials administered through feed, particularly those used to improve animal performance, and to bring other uses of those products under the oversight of veterinarians.
To address those goals, the FDA issued its Guidance for Industry 213 in December of 2013. That guidance calls on drug sponsors, by December 2016, to voluntarily remove indications for use related to growth promotion from product labels of medically important feed-grade antimicrobials. According to the FDA/CVM, there were 293 applications initially affected by Guidance 213. All of the affected drug sponsors have indicated they intend to comply with the voluntary guidance by the December deadline, and some already have begun implementing the recommended changes. 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have been converted from over-the-counter to prescription dispensing status, production indications have been withdrawn from one application and 35 affected applications have been completely withdrawn.
Also, in June 2015, the agency issued its final veterinary feed directive (VFD) rule, which places the use of medically important antimicrobials, used in feed for prevention, control or treatment of disease, under the oversight of veterinarians. Many of those products have been available for over-the-counter purchase. Once the changes recommended by Guidance 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. The rule also specifies that veterinarians can issue VFD orders only in the context of a valid veterinarian-client-patient relationship (VCPR).
In December 2015, FDA another document, draft Guidance for Industry #233, which is titled “Veterinary Feed Directive Common Format Questions and Answers.” The draft guidance is intended to help drug sponsors meet certain requirements for VFD drug approval. FDA began accepting public comments on draft Guidance 233 on December 1, 2015, and the comment period will continue until January 30. To electronically submit comments to the docket, visit regulations.gov and type FDA-2010-N-0155 in the search box.
For these efforts to provide much value to the public, the FDA and other agencies will need to quantify their effects on antimicrobial use and, ultimately, on antimicrobial-resistance trends. Toward that goal, in May 2015 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.
Also the FDA, USDA 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. The agencies held a public meeting in September 2015, and intend to finalize this data collection plan in 2016.