The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) on October 1 launched the latest phases of its ongoing plan to promote stewardship of medically important antimicrobials used to treat animals, including pets.
Published in late September, “Supporting antimicrobial stewardship in veterinary settings, goals for fiscal years 2024-2028” is meant to build on the progress of the previous plan covering fiscal years (FY) 2019-23. The FDA explained that both five-year strategies are a “transparent roadmap” for stakeholders that describe actions that correspond to the agency’s three main stewardship goals for veterinary medicine:
- 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.
The FDA’s latest plan has an objective to develop and publish a strategy for promoting antimicrobial stewardship in companion animals by 2026. Other targets include revising, as necessary, the conditions of use for approved medically important antimicrobials in food-producing animals, strengthening FDA CVM compliance program activities to support antimicrobial stewardship, and enhancing the collection and analysis of antimicrobial resistance data.
“The nature of the antimicrobial resistance threat requires that public health officials, medical professionals, pharmaceutical companies, and agriculture industries collaborate to ensure that effective antimicrobials are available in the future for human and animal use,” the plan states. “While real progress has been made, continued vigilance and technological advancements are still needed.”
In 2017, the FDA CVM worked with manufacturers of animal drugs to transition all medically important antimicrobials used in the feed or drinking water of food-producing animals from over the counter to veterinary feed directive or prescription status, respectively, and to eliminate use of these products for production purposes, such as growth promotion. Between 2016 and 2017, this policy resulted in a 33% drop in sales of antimicrobial drugs approved for use in animals. Since that time, the antimicrobial sales volume has remained at reduced levels.
In 2018, FDA CVM published its first five-year action plan, “Supporting antimicrobial stewardship in veterinary settings: Goals for fiscal years 2019-2023.”
Earlier this year, FDA CVM and drug manufacturers agreed to change the marketing status for the remaining medically important antimicrobials from over the counter to prescription, requiring under veterinary oversight for their use. Examples of affected products include injectable penicillin and oxytetracycline. The AVMA has more information and a complete list of affected products.
The agency also published proposed new ranking criteria for determining the degree of importance in human medicine of antimicrobial drug classes and applied those criteria to revise the ranking of antimicrobial drug classes. Once FDA CVM finalizes this revised document, it expects to reassess the rankings periodically to align with current science and clinical practices in human medicine.