Dr. Bernadette Dunham, director, US Food and Drug Administration, Center for Veterinary Medicine, addressed the National Turkey Federation’s annual convention electronically and said that all uses of antibiotics can be a driver of resistance.
Antibiotic use in human and veterinary medicine as well as use in horticulture and other industries. She explained that in 2013 finalizing both a revision to the Veterinary Feed Directive and the Draft Guidance for Industry 213, regarding use of antimicrobials with importance to human medicine in food producing animals, are both priorities for FDA. “We hope to move forward on both documents concurrently,” she said.
“FDA believes a proactive and collaborative strategy is the best approach as this provides a path forward for addressing public health concern in a manner that takes into account animal health needs and impacts on animal agriculture,” Dunham said. “While there are gaps in our understanding, the science continues to evolve.”
Dunham said that the National Antimicrobial Resistance Monitoring System (NARMS), which was initiated in 1996, has provided data that has been used in FDA’s decision making regarding drug approvals. FDA CVM has prohibited extra label use in food producing animals for flouroquinolones and glycopeptides. In 2003, FDA released Guidance for Industry 152, which established a framework for assessing antimicrobial resistance risks as part of the new drug approval.
Judicious use of antimicrobials focuses is on initiating steps to assure that medically important antimicrobial drugs are used as judiciously as possible, according to Dunham. The idea is to move towards only therapeutic drug use in food producing animals and to move away from sub-therapeutic use for “growth promotion.”
The proposals would limit the use of medically important antimicrobial drugs to those uses that include veterinary oversight or consultation. Use of these drugs would require a prescription; they would no longer be sold over the counter. FDA would use the Veterinary Feed Directive as the framework for regulating medicated feeds. FDA has drafted a proposed rule to update the Veterinary Feed Directive.
Dunham said poultry producers can expect to see a gradual phase-out of use of medically important drugs for production or “growth promotion” purposes. There will be a gradual phase-in of greater involvement of veterinarians. She said that non-medically important drugs will still available over-the-counter and for production use.
Antibiotic use in human and veterinary medicine as well as use in horticulture and other industries. She explained that in 2013 finalizing both a revision to the Veterinary Feed Directive and the Draft Guidance for Industry 213, regarding use of antimicrobials with importance to human medicine in food producing animals, are both priorities for FDA. “We hope to move forward on both documents concurrently,” she said.
“FDA believes a proactive and collaborative strategy is the best approach as this provides a path forward for addressing public health concern in a manner that takes into account animal health needs and impacts on animal agriculture,” Dunham said. “While there are gaps in our understanding, the science continues to evolve.”
Dunham said that the National Antimicrobial Resistance Monitoring System (NARMS), which was initiated in 1996, has provided data that has been used in FDA’s decision making regarding drug approvals. FDA CVM has prohibited extra label use in food producing animals for flouroquinolones and glycopeptides. In 2003, FDA released Guidance for Industry 152, which established a framework for assessing antimicrobial resistance risks as part of the new drug approval.
Judicious use of antimicrobials focuses is on initiating steps to assure that medically important antimicrobial drugs are used as judiciously as possible, according to Dunham. The idea is to move towards only therapeutic drug use in food producing animals and to move away from sub-therapeutic use for “growth promotion.”
The proposals would limit the use of medically important antimicrobial drugs to those uses that include veterinary oversight or consultation. Use of these drugs would require a prescription; they would no longer be sold over the counter. FDA would use the Veterinary Feed Directive as the framework for regulating medicated feeds. FDA has drafted a proposed rule to update the Veterinary Feed Directive.
Dunham said poultry producers can expect to see a gradual phase-out of use of medically important drugs for production or “growth promotion” purposes. There will be a gradual phase-in of greater involvement of veterinarians. She said that non-medically important drugs will still available over-the-counter and for production use.
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