August 01, 2018
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FDA pushes for better antimicrobial stewardship in veterinary medicine

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Photo of Scott Gottlieb
Scott Gottlieb

To combat the risk of antimicrobial resistance in animals, the FDA announced that it is pushing for better antimicrobial stewardship in veterinary settings.

“Antimicrobial resistance is a global public health challenge,” FDA Commissioner Scott Gottlieb, MD, said in the statement. “Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.”

For those reasons, the FDA is asking that good practices be implemented in both human and veterinary settings to slow the development of resistance and extend the usefulness of the drugs.

Currently, the FDA uses its Center for Veterinary Medicine (CVM) to ensure the safety and effectiveness of animal drugs, including antimicrobials. In January 2017, CVM implemented new guidelines — Guidance for Industry #231 — with the goal of transitioning medically important antimicrobials that are used in the feed and drinking water of food-producing animals to veterinary oversight and eliminate the use of these products in animals for productions purposes.

More than 80 of the 292 new animal drug applications were completely withdrawn following the guidelines’ implementation, and 93 others were converted from over-the-counter to prescription status. An additional 115 were converted from over-the-counter to veterinary feed directive.

CVM has already taken additional steps to update approved conditions of use to support judicious use, according to the FDA.

Gottlieb said that to further these efforts, the FDA will implement a new, 5-year blueprint for how they will build on pre-existing programs, expand existing actions and launch new programs.

These new activities will be aimed at aligning antimicrobial drug product use with the principles of antimicrobial stewardship, supporting efforts to foster better stewardship of antimicrobials in veterinary settings and enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals, Gottlieb explained.

Some other important issues that will be addressed in the new plan include establishing appropriate duration of use, bringing all dosage forms of medically important antimicrobials under veterinary oversight and developing new strategies for promoting antimicrobial stewardship in companion animals.

“I look forward to releasing this plan shortly and continuing to work collaboratively to promote stewardship and preserve the effectiveness of antimicrobials for human and animal health,” Gottlieb said in the statement. – by Caitlyn Stulpin

Disclosure: Gottlieb reports no relevant financial disclosures.