In May 2017, the US Food and Drug Administration (FDA) denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), a drug manufactured by Amgen to manage hypercalcemia, common among patients with end-stage renal disease who are undergoing dialysis. The FDA determined that Amgen’s pediatric studies had been conducted inadequately and had provided inconclusive safety data. Amgen brought a lawsuit, Amgen v HHS (US Department of Health and Human Services), to challenge the denial.1 If Amgen prevails, it can delay generic competition for 6 months for a drug that generated $1.24 billion of revenue in 2016.2 More broadly, a decision favoring Amgen could diminish the FDA’s ability to encourage clinically meaningful pediatric studies and thus undermine the purpose of Congress in offering patent extensions to reward pediatric research.

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儿科排他性和监管机构

2017 年 5 月，美国食品和药物管理局 (FDA) 拒绝将 Sensipar（西那卡塞）的市场独占权延长 6 个月，这是一种由 Amgen 生产的药物，用于管理高钙血症，在接受透析的终末期肾病患者中很常见. FDA 确定安进的儿科研究进行得不充分，并提供了不确定的安全数据。Amgen 提起诉讼，Amgen v HHS（美国卫生与公共服务部），以挑战否认。1 如果 Amgen 获胜，它可以将一种在 2016 年产生 12.4 亿美元收入的药物的仿制药竞争推迟 6 个月。2 更广泛地说，有利于安进的决定可能会削弱 FDA 鼓励具有临床意义的儿科研究的能力，从而破坏国会提供专利延期以奖励儿科研究的目的。