The reason that there are “rights” to this drug that this guy was able to purchase and exploit -
and the reason that there’s no generic competitor -
and the reason that you can’t order a cheap version of it from a foreign pharmacy -
are all the same…United States law, and the FDA’s regulations.
He’s a bad man. But he’s not taking advantage of “unbridled capitalism.”
He’s exploiting the existing bridle. He’s using the government to enrich himself.
Could somebody fill me in as to why, exactly, there’s no generic competitor available for this drug?
Presumably because it wasn’t worth getting the hardware to produce it at the price it was being produced at. Raise the price to $750 and a generic competitor would make sense except that after you’ve spend millions of dollars getting set up they can realize the error in their ways, reduce the price to $1.50 a pill until you go out of business, and then suddenly decide $750 is a good price again.
At least that’s what I’d be thinking if I were contemplating getting into this. It’s possible that kind of behaviour is illegal, but good luck with that.
The approval for a generic drug under EU legislation can cost up to 1 million Euros for the needed bioequivalency trials and is a lenghty process (6 months to 2 years). I learnt here on BB that the FDA requirements are similar - so don’t hold your breath that we’ll see an alternative soon. [The numbers are out of my head, I read them a few days ago in a progenerika publication, a lobbyist of the generic drug industry. the ballpark seems about right, but I don’t find the link anymore]
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