martin #shkreli # FDA #daraprim #pyrimethamine solution

The drug industry wants us to think Martin Shkreli is a rogue CEO but is isn’t.

 

#Shkreli #FDA #FDA Approval Some Notes Toward a Comprehensive Plan For Screwing Martin Shkreli

Why not trust European drug regulators?  Actually, it turns out to be even weirder than that. Take the case of Fansidar. It’s a combination of pyrimethamine and sulphadoxine made by Roche. It was approved by the FDA in 1981 and went on the market in 1982, primarily as an anti-malarial drug.1 Roche has sold bazillions of tablets since then, and the cost seems to vary from a dollar or two in small quantities to a few cents in large quantities. It’s even been tested for toxoplasmosis and found to be pretty effective.  So: Roche already manufactures pyrimethamine.

They already have FDA approval for a drug that contains it. They already have a well-respected manufacturing capability. And they already have distribution in the US. All they’d have to do is make the same tablet but without the sulphadoxine and put it on the market. If the FDA were willing to streamline the approval, the startup costs would be very low.  Now, for a company the size of Roche, it might still not be worth it. But there are plenty of other companies that make pyrimethamine/sulphadoxine combinations. If the FDA offered quick approval for a pyrimethamine-only tablet, I wonder if someone would take them up on it? Legally, the FDA is not supposed to consider cost in its approval process, but surely it would be worth making an exception just to see Shkreli take a bath on his cute little scheme.

 

 

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