Ill-conceived regulations and bureaucratic red tape emanating from the U.S. Food and Drug Administration (FDA) have inhibited competition and hiked EpiPen prices, according to a new report by National Center for Policy Analysis Senior Fellow Devon Herrick, as noted in a press release.
“Epinephrine has long since lost patent protection. The epinephrine injected by the EpiPen is available in ampules costing less than $1. So why is a 40-year-old product used to administer a generic drug so expensive?” asks Herrick. “Like many costly drugs, much of the blame is due to the way drugs are regulated in the United States by the FDA.”
The EpiPen is a relatively simple auto-injector that administers epinephrine, a form of adrenaline that was synthesized over 100 years ago. About a decade ago one EpiPen sold for less than $60. Today the cost is more than $304, and EpiPens must be purchased in twin-packs costing more than $600.
Consumers have numerous options other than the expensive and better-known EpiPen, including having their doctor prescribe a generic epinephrine auto-injector or asking if they may be a candidate for a generic epinephrine ampule and a syringe or preloaded auto-injector. Research also shows that EpiPens are potent several years after expiration.
The FDA should allow drug makers to use the 510(k) premarket notification process to market generic auto-injectors pre-filled with epinephrine. For that matter, there is little reason to limit epinephrine auto-injectors — used for potentially fatal emergencies — to the prescription-only market.
According to Herrick, “Twenty dollars is probably about how much a generic EpiPen would cost if the FDA approved an over-the-counter version or a version pharmacists could dispense to patients without a doctor’s prescription.” An over-the-counter version would also save Americans nearly $1 billion a year.