There's good reason to blame FDA regulations for problems with the Daraprim debacle. Even for approved, out-of-patent drugs, it's still expensive to get a new g

There's good reason to blame FDA regulations for problems with the Daraprim debacle. Even for approved, out-of-patent drugs, it's still expensive to get a new generic instance approved, and for drugs that have few users like this, it's just not worth it for a new supplier to get it. Generic drugs don’t need the excruciatingly drawn-out safety and efficacy studies required of new brand-name medications, but they do need to pass a bioequivalency study proving that their drug is absorbed the same way as the original. ... it’s just too hard to start making a generic medication. If all you want to do is synthesize an active ingredient in powder form, and you’re not too concerned about staying on the right side of the law, it costs pennies and takes however long you need to FedEx something from China. If you also want FDA approval, it costs $2 million and takes two years. Remember, Daraprim is used by about 10,000 people per year, and before the recent Turing price markup, it cost $13.50 per pill x eighty pills per treatment. 10,000 x 80 x $13.50 = about $10 million per year, of which maybe $5 million was profit. That means you have to capture a big chunk of the Daraprim market before it’s worth trying to get yourself approved to make Daraprim; the FDA is essentially telling pharma companies to “go big or go home”. Nobody wanted to go big, so they all went home. In the absence of this barrier, it would be easy for small boutique companies with a couple of chemical engineers on hand to spend a few weeks manufacturing a few thousand doses of the drug whenever it was necessary to meet demand. This is how the supplement and nootropic industries work right now, and nootropics are dirt cheap - http://slatestarcodex.com/2015/09/24/the-problems-with-generic-medications-go-deeper-than-one-company/ http://slatestarcodex.com/2015/09/24/the-problems-with-gener... (and if you don't read SlateStarCodex regularly, this is a good time to start)