Anaphylactic Political Shock Sorry, Hillary. The feds are to blame for Mylan’s EpiPen monopoly.
http://www.wsj.com/articles/anaphylactic-political-shock-1472078239
The latest political pile-on over alleged pharmaceutical price gouging is officially underway now that Hillary Clinton joined the scrum on Wednesday. Usually these exercises are inspired by cures or important clinical innovations that happen to be expensive. The irony this time is that the target is a monopolist created by the same government that Mrs. Clinton wants to hand far more power over drugs.
In a statement, the Democrat assailed the “outrageous” cost of EpiPen, an emergency treatment for allergic reactions known as anaphylaxis, and she demanded that drug maker Mylan “immediately reduce the price.” Federal and Senate investigations are pending into these spring-loaded syringes filled with epinephrine (adrenaline) used primarily by children with life-threatening sensitivities to food or insect stings.
Mylan has raised the price of EpiPen in semiannual 10% to 15% tranches so that a two-pack that cost about $100 in 2008 now runs $500 or more after insurance discounts and coupons. Outrage seems to be peaking now because more families are exposed to drug prices directly though insurance deductibles and co-pays, plus the political class has discovered another easy corporate villain.
Still, the steady Mylan rise is hard to read as anything other than inevitable when a billion-dollar market is cornered by one supplier. Epinephrine is a basic and super-cheap medicine, and the EpiPen auto-injector device has been around since the 1970s.
Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.
Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.
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