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.
Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA. 2018;319(1):21–22. doi:10.1001/jama.2017.16477
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