EpiPen, Patents, and Life and Death

Drug pricing disputes, while significant public health concerns, are not typically immediate life or death matters. But they may be for certain emergency medicines, medicines used for potentially lethal and rapidly onset illnesses or injuries. This is especially true for emergency drug-device combination products, like Mylan’s EpiPen, for which patients can bear a significant brunt of the products’ cost. Scholarly commentary on the controversy surrounding the pricing of Mylan’s EpiPen, however, has largely elided over this relationship among combination products, emergency medicine, and patient payment, often focusing instead on classic issues of antitrust and competition. This brief Essay explores how EpiPen’s pricing capacity is a function of a peculiar intersection of emergency medicine, FDA law and policy, and patents, and suggests areas of further analysis for other drug-device emergency combination products.Ope