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January 2, 2018

Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS

Author Affiliations
  • 1Collaboration for Research Integrity and Transparency (CRIT), Yale Law School, New Haven, Connecticut
  • 2Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
JAMA. 2018;319(1):21-22. doi:10.1001/jama.2017.16477

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.