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美國食品及藥品管理局(FDA)要求取消使用促生長用抗生素


美國DVM新聞雜志   2010年6月29日



FDA建議逐步取消抗生素在可食用動物上的應用，除非有必要用于治療。



FDA于6月28日公布擬議的指導文件，要求逐步取消在食用動物上使用促生長抗生素。這份文件也重申了抗生素作為治療用途在食用動物上的好處，它是作為保護動物健康和保障人類健康的手段。



“美國獸藥協會（AVMA）很高興FDA和獸醫專業人士一起共同關注抗生素的抗藥性問題”AVMA的首席執行官德黑文.羅恩博士在擬議的規章中發表聯合聲明。“獸醫關于對疾病的控制及預防的重要性的任何討論都是必須的，我們期望對草案進行評估和討論。”



FDA的指導文件將在接下來的60天進行公開的討論。



今年三月，美國獸藥協會AVMA的代表游說國會議員，希望不要通過“目前正在聯邦政府層面討論的全面禁止使用抗生素促生長劑法案，例如只能使用抗生素作為藥物治療用途的法案。



FDA新的指導文件認知獸藥行業要求采用合理的方法使用抗菌藥物以減少抗生素抗藥性的努力，但同時也聲明“額外的法規是需要的”。



FDA稱，這份草案提議限制抗生素在食用動物上的使用，除非這類藥物用于治療，并且必須由一名獸醫監管或咨詢。



“盡可能合理地使用抗生素是減少病菌抗藥性的關鍵，也是維持抗生素藥物對人類和動物的治療效果的關鍵”，FDA獸藥中心主任伯納黛特.鄧納姆博士說。“FDA將與動物抗生素制造商、獸醫和公衆健康團體、畜牧養殖界，和所有其他有興趣的利益集團，一起致力于制定切實可行的戰略來減少病菌對抗生素的抗藥性問題，以便保護人類和動物的健康.


FDA calls for 'phase out' of antimicrobial use for growth promotion
AVMA applauds agency's acknowledgment of veterinarian's role

Jun 29, 2010
DVM NEWSMAGAZINE

  

Rockville, Md. -- The Food and Drug Administration (FDA) proposes to phase out antibiotic use in food animals unless there is medical necessity.
The proposed guidance was issued June 28 by FDA, and calls for a phase out of antimicrobial use for growth promotion in food animals. The document reiterates the benefits of therapeutic uses of antibiotics in food animals as means of protecting animal health and safeguarding human health.

“The American Veterinary Medical Association (AVMA) is pleased that the FDA is committed to working with the veterinary profession to address antimicrobial resistance concerns,” Dr. Ron DeHaven, AVMA’s chief executive officer states in the association’s statement on the proposed rules. “Veterinarians are essential to any discussion regarding the importance of disease control and prevention. We look forward to reviewing and commenting on the draft guidance.”

The FDA guidance document is open to public comment for the next 60 days.

In March, AVMA representatives lobbied lawmakers against passage of broad antibiotic bans currently under review at the federal level, like the Preservation of Antibiotics for Medical Treatment Act (PAMTA).

FDA’s new guidance document acknowledges the veterinary profession's efforts in calling for judicious use of antimicrobial drugs as a method to stave off antimicrobial resistance, but states that “additional steps are needed.”

The draft document proposes to limit antimicrobial use in food animals unless such drugs are medically necessary and administered by oversight or in consultation with a veterinarian, FDA reports.

“Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” says Bernadette Dunham, DVM, PhD, director of FDA’s Center for Veterinary Medicine. “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.”