Both Carroll and the Wall Street Journal have described how government has allowed EpiPen’’s manufacturer to hike prices so much. EpiPen is complicated, being both a drug and a device. The drug is very inexpensive, and not patented. The device is protected by patents issued in 2005, which expire in 2025.
First, the government made a couple of interventions in the market that allowed the manufacturer to raise prices above the free-market level. The federal government changed its guidelines such that the EpiPens have to be sold in packages of two (while customers might prefer just one, or at least an odd number). Also, the federal government gave public-emergency grants to states on condition they stockpile EpiPens.
Further, the Food and Drug Administration has hindered other manufacturers’ ability to compete. Those with differentiated products (which do not infringe the patents) have struggled for market access. A competing device which entered the market in 2013 had to withdraw in 2015 after 26 potential malfunctions in the U.S. and Canada, in which it delivered the wrong dose. However, according to the FDA’s own report of the recall:
None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.In hindsight, we might conclude a caution might have been a better response than a recall. By creating an environment in which EpiPen prices are higher than otherwise, the federal government may have made them unaffordable to many families. That will cause more harm than 26 unconfirmed cases of bad dosing by its now unavailable competitor.
(Sources which require subscription: Aaron E. Carroll, “The EpiPen, A Case Study in Health System Dysfunction,” , The Upshot blog, New York Times, August 25, 2016); “Anaphylactic Political Shock,” Review & Outlook editorial, Wall Street Journal, August 24, 2016.)