The posture of American regulation of medicine is negative—we assume that a new drug is unsafe and ineffective until it is proven safe and effective.1 This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law.2 It is defensible, if debatable, in many ordinary circumstances.3 But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply.

中文翻译：

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对官僚来说太重要了：重新思考危机时期的风险和监管假设

美国对药物的监管态度是消极的——我们假设一种新药在被证明是安全和有效的之前是不安全和无效的。1这种监管姿态是一种启发式规范原则，是公共卫生法中所谓预防原则的一个具体实例。2在许多普通情况下，它是可以辩护的，如果有争议的话。3但与许多规范启发式方法一样，这种消极态度可能会迫使在紧急情况下做出次优决策，在这种情况下，必须做出针对具体情况的决策，并且可能会应用一系列独特的价值观。