Thursday, August 25, 2016

EpiPen Costs $500 Because The FDA Will Not Allow Generic Competitors

From The Wall Street Journal, Opinion, "Anaphylactic Political Shock: Sorry, Hillary. The feds are to blame for Mylan’s EpiPen monopoly:"
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.

But no company has been able to do so to the FDA’s satisfaction.

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