美國抗生素動物用藥之管制──政策與法律觀點

The U.S. Approach on Phasing out Certain Antibiotic Use in Food Animals: Policy and Legal Perspective

抗生素對抑制細菌功效顯著，且可促進食用動物的生長，但過度使用易衍生抗藥性的問題。為處理畜牧業抗生素的濫用，早年美國食品與藥物管理署(FDA)曾進行撤銷該藥物上市許可的程序，但因國會的關切而中止。近年由於此問題已演變為公衛危機，FDA決定採取新的管理政策。FDA不使用法律授權之強制的撤銷許可程序，而採取業者自願性撤回的政策；此舉受到民間團體的法律挑戰。本文除分析對此管制裁量的司法審查外，亦探討該自願性政策之利弊。

"Anti-biotics have proved effective in treating illness caused by bacteria. Further, they may promote the growth of food animals. Nevertheless, the overuse has led to the problem of drug resistance in human. The US Food and Drug Administration (FDA) had managed to solve the rampant use of anti-biotics by food animal industry by initialing the withdrawal of New Animal Drug Application (NADA) for certain antibiotic drugs. But, the move was suspended because of the disagreement of Congress.
Given the antimicrobial resistance has increasingly constituted a public health crisis, FDA finally decided to tackle the problem more seriously. FDA announced the plan to phase out certain antibiotic use in animal feeding on December 2013. Instead of reinstating the original withdrawal process, FDA tends to end the use for growth promoting purpose on a voluntary basis. The approach has recently been challenged by a civil society for its failure to comply with the mandate of the law. This paper aims to analyze the judicial review on this administrative discretion. Further, the advantage and problems of the voluntary policy will be revealed."