8 November 2017 - In May 2017, the US FDA denied a 6-month extension of market exclusivity for Sensipar (cinacalcet), a drug manufactured by Amgen to manage hypercalcaemia, common among patients with end-stage renal disease who are undergoing dialysis. 

The FDA determined that Amgen’s paediatric 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. If Amgen prevails, it can delay generic competition for 6 months for a drug that generated $1.24 billion of revenue in 2016. 

More broadly, a decision favouring Amgen could diminish the FDA’s ability to encourage clinically meaningful paediatric studies and thus undermine the purpose of Congress in offering patent extensions to reward paediatric research.

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