Federal judge orders FDA to start proceedings over subtherapeutic antibiotic uses - DVM
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Federal judge orders FDA to start proceedings over subtherapeutic antibiotic uses
Animal Health Institute says order diverts resources from current stakeholder activity.


DVM360 MAGAZINE


Katz's order now requires the FDA to initiate withdrawal proceedings for relevant NADAs (new animal drug applications) and ANADAs (abbreviated new animal drug applications). More specifically, Katz says the FDA must reissue a notice of the proposed withdrawals, which may be updated, and provide opportunities for hearings to drug sponsors. A withdrawal order must follow the hearing if the drug sponsor is unable to prove the safety of the drug. If sponsors demonstrate that subtherapeutic uses of penicillin and tetracyclines in livestock are safe, then the FDA cannot withdraw approval, Katz says.

Both the FDA and the plaintiffs have requested additional clarification on a timeline for conducting the hearings and the issuance of final decisions, according to court records.

The American Veterinary Medical Association (AVMA) announced a partnership with the FDA last summer and pledged to create a steering committee to provide veterinary input to federal regulators charged with crafting new antimicrobial use guidelines.

"The AVMA acknowledges the growing concern regarding antimicrobial use and resistance in animals and people, and supports the judicious use of antimicrobials to maximize public and animal health benefits while minimizing risks," says AVMA Chief Executive Officer Dr. Ron DeHaven. "The judicious use of antimicrobials plays a key role in preserving the health of our nation's food animals and the safety of our nation's food supply. Many agree that there is a need for greater veterinary oversight of antimicrobial use in food-producing animals, and the AVMA is currently working with the FDA to develop practical means to increase this veterinary oversight."

But DeHaven cautions the withdrawal of approval or a ban on any antimicrobial uses should be based on solid science and risk-based assessment, not on anecdotal reports and speculation.

"It is crucial that safe and effective antimicrobials remain available for use in veterinary medicine to ensure the health and welfare of animals and, consequently, the health of humans," DeHaven adds. "The AVMA will continue to work closely with the FDA to formulate a sound, science-based strategy to deal with this complex issue."


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Source: DVM360 MAGAZINE,
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