August 21, 2015
The U.S. Food and Drug Administration announced today its third progress report highlighting its recent actions to promote the judicious use of antimicrobials in food-producing animals. The agency is also announcing open registration for its public meeting to obtain stakeholder input on approaches for collecting on-farm antimicrobial drug use and resistance data.
There were 293 applications initially affected by Guidance For Industry #213, which calls on animal drug sponsors of approved medically important antimicrobials administered through medicated feed or water to voluntarily remove from their product labels indications for use related to growth promotion, and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016. All of the affected drug sponsors have committed in writing to making the changes described in the guidance. 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have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 32 affected applications have been completely withdrawn.
The FDA has also issued two regulations to further promote the judicious use of antimicrobials in food-producing animals. 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 (cattle, swine, chickens, and turkeys). The FDA also announced the Veterinary Feed Directive (VFD) final rule in early June 2015. The VFD final rule outlines the revised process for authorizing use of VFD drugs in feed. 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.
The VFD final rule updates recordkeeping requirements and takes advantage of electronic tools to make the process of issuing VFD drugs more efficient and flexible. It also requires veterinarians who want to authorize the use of these drugs to do so within the context of a veterinarian-client-patient relationship (VCPR). The final rule specifies the key elements that define a VCPR, which include that the veterinarian must engage with his or her clients and assume responsibility for making clinical judgments about animal health, have sufficient knowledge of the animal by virtue of examination and/or visits to the facility where animals are managed, and provide for any necessary follow-up evaluation or care.
Public Meeting - Data Collection
Gathering information on the way medically important antibiotics are used is essential to measuring the impact of the FDA’s judicious use strategy as outlined in Guidance for Industry #213. The FDA currently collects sales data on antimicrobial drugs sold for use in food-producing animals (reported under section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105)) and data on antimicrobial resistance (collected under the National Antimicrobial Resistance Monitoring System (NARMS)). However, the agency recognizes that additional information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance.
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 antibiotic use in food-producing animals and will conduct a jointly sponsored public meeting to obtain input on approaches for collecting on-farm antimicrobial drug use and resistance data. The public meeting will be held on September 30, 2015, from 8:00 a.m. to 4:30 p.m. at the Jefferson Auditorium, 14th and Independence Avenue SW, Washington, DC 20201.
On-farm use data collection is consistent with objectives outlined in the National Action Plan for Combating Antibiotic-resistant Bacteria to enhance monitoring of antimicrobial-resistance patterns, as well as antimicrobial sales, usage, and management practices, at multiple points in the production chain for food-producing animals and retail meat.
This data collection plan is intended to provide the data needed to 1) assess the rate of adoption of changes outlined in the FDA’s Guidance #213, 2) help gauge the success of stewardship efforts and guide their continued evolution and optimization, and 3) assess associations between antimicrobial use practices and resistance trends over time.
On-farm data will supplement existing ADUFA 105 sales data and data on antimicrobial resistance, including data currently collected under NARMS. When combined, this information will provide a more comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture.
Early registration for the public meeting is recommended because seating is limited. Due to limited resources, the meeting will not be Webcast. A recording of the meeting will be available approximately 60 days after the meeting takes place. Attendees may register, ask general questions about the meeting, request an opportunity to make an oral presentation, or request special accommodations due to a disability by contacting Kelly Covington, Food and Drug Administration, Center for Veterinary Medicine (HFV-6), 7519 Standish Pl., Rockville, MD 20855, 240-402-5661, email: Kelly.Covington@fda.hhs.gov.