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August 01, 2021

FDA wants to bring more antimicrobials under veterinarian control

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Federal regulators plan to give veterinarians oversight of all animal uses of antimicrobials considered important for human medicine.

Over the next two years, Food and Drug Administration officials expect pharmaceutical companies will voluntarily agree to changes in the remaining drug approvals that allow over-the-counter access to such drugs for administration to animals. Guidance published in June indicates the request comes with the threat of regulatory proceedings against companies that fail to comply.

“If we determine that adequate progress has not been made by the end of the 2-year timeframe, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for addressing matters related to the safety of approved new animal drugs may be appropriate,” the document states.

FDA officials previously convinced drug companies to voluntarily make similar changes to approvals that had allowed over-the-counter access to medically important antimicrobials administered in the feed or water of animals raised for food. The affected companies agreed, and all of those changes took effect by January 2017.

FDA officials consider an antimicrobial medically important if it is in the same drug class as antimicrobials used in human medicine. About 96% of such animal-use drugs are administered under veterinarian oversight, an FDA announcement states.

The guidance published in June applies to that remaining 4% of antimicrobials considered important for human medicine and still available over the counter, such as those delivered through injections or oral boluses.

“Veterinarians have specialized scientific and clinical training and practical experience that can help guide the judicious use of antimicrobials,” the announcement states. “FDA believes good antimicrobial stewardship practices in animals helps slow the development of antimicrobial resistance and preserve the effectiveness of these drugs in both humans and animals.”

The action affects 94 drug approvals, with applications in companion animal and food animal medicine, according to a list published by the FDA. The agency also published an FAQ document that addresses concerns from farmers and ranchers.