Details of the US Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) new five-year plan to promote stewardship of antimicrobial use in production animals was released Friday [September 14].
The plan builds upon the work to reduce antimicrobial use that has already been completed – including ending the use medically important antimicrobials for growth promotion purposes and to give veterinarians additional oversight on the therapeutic use of products.
Scott Gottlieb, FDA commissioner, highlighted some areas of progress and for future efforts regarding antimicrobial stewardship during a presentation with the Pew Charitable Trusts on Friday. The issue is an important one to address to maintain medical advancements both for current and future generations, he added.
“We can’t count on outracing drug resistance, but we can use stewardship and science to slow its pace and reduce its impact on human and animal health,” he said. “To do so we need an all hands on deck approach – both in human and veterinary settings.”
The FDA is adopting an approach with four major components, which includes work to promote stewardship and improve regulation, he said. The Center for Veterinary Medicine’s new plan play a role in the larger effort.
“First we’re facilitating product development to ensure a robust pipeline of safe and effective treatments that can help combat resistant organisms, second we’re promoting antimicrobial stewardship, careful stewardship across human and animal health to help preserve the effectiveness of available treatments and may help slow the development of AMR,” he said. “Third, we’re supporting the development of tools for surveillance of antimicrobial use for determining when pathogens develop resistance, and finally we’re advancing scientific initiatives to help all stakeholders answer critical questions related to antimicrobial resistance – this includes research that can help support the development of alternative treatment solutions.”
Future work and plan highlights
Continued work on antimicrobial stewardship builds off what was already started with previous guidance for the animal production industry regarding the labeling and use of antimicrobial products in feed and water and in relation to the updates to the Veterinary Feed Directive, said Gottlieb.
“The aim was to eliminate production uses of antibiotics such as growth promotion and the goal was to bring all remaining therapeutic uses under oversight of licensed veterinarians – the successful implementation of these changes depended on the commitment of key partners and stakeholders to work with FDA,” he added.
“We were able to reach our goal of updating 100% of the nearly 300 affected products and because of this work now 95% of the total quantity of medically important antimicrobials sold or distributed for use in food-producing animals are now under veterinary oversight – this is significant public health progress,” he said. However, more work remains.
The FDA is planning a set of guidance documents to be released in 2019 to further work on antimicrobial stewardship, he said. These efforts are set to include work to bring the remaining medically important antimicrobials under veterinary oversight and ensuring that antibiotics carry labels with “appropriately defined durations of use.”
“The FDA has determined that about 40% of approved medically important antimicrobials drugs used in feed and water of food-producing animals include at least one indication that doesn’t have a defined duration of use,” said Gottlieb. “That’s why FDA is announcing today our plans to develop and implement a strategy to address this issue.”
There also are set to be ongoing efforts to share information on stewardship for both animal and human medical use, he said.
Additionally, it is “essential” to continue to gather data on antimicrobial use and resistance, he said. Part of that effort is set to include work done by the National Antimicrobial Resistance Monitoring System (NARMS) and on efforts to refine industry reporting on antimicrobial sales data.
“We’re seeking to gain a better understanding of how these products are actually used on farms,” he said.
The five-year plan also includes efforts to address the use of antimicrobial products with companion animals, said the FDA. Along with efforts to support the development of alternatives to the use of antimicrobials.
Later steps include identifying and addressing the “Inappropriate marketing of antimicrobial drugs,” and reporting on information gathered regarding the use of antimicrobials in four major production species, the agency said. And providing technical assistance for developing countries in the process of starting programs to address responsible antimicrobial use.