FDA Plan Previews the Future of Antimicrobial Stewardship

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Veterinarians will, over the next five years, become more involved in overseeing the use of all forms of medically important antimicrobials used in livestock.

A new five-year plan from FDA’s Center for Veterinary Medicine (CVM), title “Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023,” also specifies that labels for medically important antimicrobials will eventually need to specify duration of use for all food-animal applications.

The plan sets goals, but does not unveil any new regulations, and FDA will seek public comments on several proposals included in the plan. Many of the proposed actions build on the existing FDA Guidance for Industry 213, which removed production or performance uses from product labels, and the updated VFD rule, which places the use of medically important antimicrobials in in feed and water under the oversight of veterinarians.

Significantly, the plan states that CVM supports the judicious use of antimicrobials in food-producing animals and “is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases.”

For the fiscal years 2019 through 2023, CVM plans activities organized under three goals:

Align antimicrobial drug product use with the principles of antimicrobial stewardship.

Foster stewardship of antimicrobials in veterinary settings.

Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

In the plan, CVM notes that about 40% of approved medically important antimicrobial drug applications include at least one indication of use that does not have a defined duration of use. The authors also note that, according to sales data, about 95% of antimicrobials used in food animals are administered through feed or water, and thus fall under the VFD rule. That leaves though, another 5% administered through other routes, such as injectable products. Many of those products remain available for over-the-counter (OTC) sales.

Under their first goal, CVM plans several actions to address those issues by 2021:

• Publish a list of medically important antimicrobial drugs administered in the feed or drinking water of food-producing animals that are approved for indications that lack a defined duration of use.
• Issue a draft strategy to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use. Issue a draft strategy, followed by a final strategy, to bring all dosage forms (including, injectable, intramammary, etc.) of medically important antimicrobial drugs approved for use in food-producing animals under the oversight of a licensed veterinarian.
• Engage with stakeholders on how antimicrobial product label information could better support antimicrobial stewardship.

During Phase 2 of the plan, in 2022 through 2023, CVM intends to issue a final strategy for specifying duration of use.

In the plan, also under Goal 1, CVM acknowledges that potential development of antimicrobial-resistant bacteria in companion animals, which could lead to transfer of antimicrobial resistant bacteria from companion animals to humans through direct or indirect contact.

CVM intends to seek public input regarding antimicrobial use in companion animals and their impact on the development of resistance and ultimately implement a strategy for promoting antimicrobial stewardship in companion animals. This will include steps to ensure that all dosage forms of medically important antimicrobials for use in companion animals are under the oversight of a licensed veterinarian.

Since the new VFD rules took effect in 2016, FDA has focused on education, but the plan indicates a shift toward more compliance enforcement. Planned actions include:

• In conjunction with ongoing inspection activities, publish a summary assessment of the VFD pilot inspections conducted in fiscal years 2016 through 2018.
• Expand the comprehensive VFD compliance strategy to integrate a VFD component into inspections associated with the Drug Residue Inspection Program.
• Initiate steps to identify and address the inappropriate marketing of antimicrobial drugs.

Read the full plan from FDA/CVM.