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美国食品及药品管理局(FDA)要求取消使用促生长用抗生素


美国DVM新闻杂志   2010年6月29日



FDA建议逐步取消抗生素在可食用动物上的应用，除非有必要用于治疗。



FDA于6月28日公布拟议的指导文件，要求逐步取消在食用动物上使用促生长抗生素。这份文件也重申了抗生素作为治疗用途在食用动物上的好处，它是作为保护动物健康和保障人类健康的手段。



“美国兽药协会（AVMA）很高兴FDA和兽医专业人士一起共同关注抗生素的抗药性问题”AVMA的首席执行官德黑文.罗恩博士在拟议的规章中发表联合声明。“兽医关于对疾病的控制及预防的重要性的任何讨论都是必须的，我们期望对草案进行评估和讨论。”



FDA的指导文件将在接下来的60天进行公开的讨论。



今年三月，美国兽药协会AVMA的代表游说国会议员，希望不要通过“目前正在联邦政府层面讨论的全面禁止使用抗生素促生长剂法案，例如只能使用抗生素作为药物治疗用途的法案。



FDA新的指导文件认知兽药行业要求采用合理的方法使用抗菌药物以减少抗生素抗药性的努力，但同时也声明“额外的法规是需要的”。



FDA称，这份草案提议限制抗生素在食用动物上的使用，除非这类药物用于治疗，并且必须由一名兽医监管或咨询。



“尽可能合理地使用抗生素是减少病菌抗药性的关键，也是维持抗生素药物对人类和动物的治疗效果的关键”，FDA兽药中心主任伯纳黛特.邓纳姆博士说。“FDA将与动物抗生素制造商、兽医和公衆健康团体、畜牧养殖界，和所有其他有兴趣的利益集团，一起致力于制定切实可行的战略来减少病菌对抗生素的抗药性问题，以便保护人类和动物的健康.


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 We look forward to reviewing and commenting on the draft guidance.”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.”