FDA previews veterinary stewardship plan

The head of the US Food and Drug Administration (FDA) announced today that the agency will soon be implementing a 5-year blueprint to advance antimicrobial stewardship in veterinary settings.

While few details of the forthcoming plan were provided, FDA commissioner Scott Gottlieb, MD, said the blueprint will include goals, objectives, and actions the agency will focus on during fiscal years 2019-2023. The three main goals are aligning antimicrobial use in animals with stewardship principles, fostering better stewardship in veterinary settings, and enhancing the monitoring of antimicrobial use and resistance in animals.

Gottlieb said in a statement that the agency wants to further its efforts to reduce the overuse of antimicrobial drugs and combat the rising threat of antimicrobial resistance by expanding on current programs to advance antimicrobial stewardship in veterinary settings, and launching some new programs.

"While important progress has been made, we know that additional work is needed to address the complex challenge of antimicrobial resistance," Gottlieb said.

Concerns about disease prevention, lack of duration limits

Antibiotic use in food-producing and companion animals is currently overseen by the by the FDA's Center for Veterinary Medicine (CVM). In 2017, CVM implemented Guidance for Industry #213, which ended the use of medically important antibiotics for growth promotion in food-producing animals and required veterinary supervision for all antibiotics administered via water and feed. The hope is that GFI #213 will help reduce the use of medically important antibiotics by US farmers. Approximately 70% of all medically important antibiotics in the US are sold for use in food-producing animals.

While many have welcomed these stricter guidelines, critics have complained that the agency still allows the use of medically important antibiotics for disease prevention in healthy livestock and poultry, a practice that the World Health Organization (WHO) is pushing to end as part of its campaign to combat antimicrobial resistance. Guidelines issued by the WHO in November 2017 argued that widespread use of medically important antibiotics for growth promotion and disease prevention in healthy animals is contributing to the spread of antimicrobial resistance.

Another issue of contention is that some medically important antibiotics used in food-producing animals lack defined duration limits on their labels, which means farmers can continuously use them at sub-therapeutic doses. Critics are concerned that this also contributes to rising resistance to drugs that are critical for human health.

Gottlieb said establishing appropriate duration limits is one of the issues that will be addressed in the new plan, and noted that the FDA will soon be publishing a list of all medically important antibiotics used in animals that lack duration limits on their labels. The plan will also include new strategies to improve the collection and sharing of data on antimicrobial use and resistance in food animals, and strategies to promote stewardship in companion animals.

"We’ll advance these goals in new guidance that the FDA will develop with broad stakeholder input," Gottlieb said. "And we’ll enhance transparency and keep the public apprised of progress being made."

Gottlieb also highlighted CVM's 2017 proposal for the use of a biomass denominator to provide estimates of annual antibiotic drug sales adjusted for the size of the animal population, a method he said would give the agency a more nuanced view of how antibiotics are used in US animal production.

Experts weigh in on FDA announcement

Gail Hansen, DVM, a public health and veterinary medicine consultant, said in an email that the statement indicates that the agency is "looking hard at antibiotics with no listed duration limits, and they are trying to get a more precise handle on antibiotics used per animal, rather than just sales."

But Lena Brook, interim director of food and agriculture at the Natural Resources Defense Council, said the statement indicated no substantive changes in current policy.

"To keep these miracle drugs working when sick people and animals need them, FDA must end the widespread practice of using these drugs for so-called 'disease prevention' and set clear targets for antibiotics reduction in the industry," Brook said in a press release. "If the Commissioner wants to get serious about tackling this problem, he must address these core pieces."

See also:

Jul 31 FDA statement

Jul 31 NRDC press release

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