One doesn’t have to look far from today’s headlines to see this pattern. The latest controversy: the price of the EpiPen – Mylan’s famous medical auto-injector that delivers an immediate and measured dose of epinephrine – recently skyrocketed 400%, causing an uproar amongst 3.6 million people who depend upon the prescribed product. For those who live in fear of anaphylactic shock, the cost of living quite literally went up.
Unfortunately – and as no surprise to libertarians and free market advocates – federal regulators continue to buffer the padding that surrounds Mylan’s monopoly. Shortly after the Auvi-Q recall, Teva Pharmaceutical Industries pitched a generic version of the EpiPen. However, the Food and Drug Administration (FDA) squashed their efforts, citing “major deficiencies” in their application. Teva plans to appeal the decision, but won’t be able to effectively move forward until 2017 at the earliest.
Teva isn’t alone in this struggle. Windgap Medical, a Boston startup, and Adamis, a small biotech firm based in San Diego, have both struggled to bypass FDA’s barriers of entry in the marketplace as well.
If you need further convincing that the FDA impedes the market, consider the following:
The average time it takes for a drug to go from the lab to the medicine cabinet is 12 years
Only 1 in 5,000 new drugs will make it through the FDA approval
Based on the regulatory burden of creating new medicine, the average price tag for research and development for a new compound is $2.6 billion
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