Legally, it was above board, and financially, it was sensible regulatory arbitrage. Morally, though, it was reprehensible.
IIRC this program grants advertising exclusivity (weaker than patent exclusivity) as a carrot to give companies "IP protection-lite" in exchange for re-testing old drugs under the FDA phase flow.
Which is subsidized by the customers of insurance companies that do pay the 56x markup, which are funded by the employers and individuals who pay for private insurance or tax dollars that pay for medicare. There's no free lunch.
Drug design isn't free. That R&D money is coming from somewhere. Where's it come from in your world?
Sociopaths often do small goods to whitewash their ills. Saying that any action Shrkeli might take is ok because some other purported endeavor is designed to help people is a perfect example. To say that the only way to get money for medical research is to exploit society and its regulatory environment, sounds to me like a bad faith argument, since it's so easy to come up with counter examples (VC, public grants, prior profits from normal development/sales cycles).
Besides, Shrkeli is in prison for securities fraud unrelated to his pharma shenanigans, so how does that work when he's actually a terrific person?
He spent a tiny portion of his earned wealth to honor and support the Arts--in particular he supported struggling African American rap artists with a long history of strong performance and depth. Shkreli is a bona fide Rennaissance man, and I certainly do not hold this gesture against him. I am tempted even to call it charity.
> Besides, Shrkeli is in prison for securities fraud unrelated to his pharma shenanigans, so how does that work when he's actually a terrific person?
His "financial crimes" are nearly universally acknowledged even in this thread to have been contrived by his political enemies in retaliation for his more famous antics which were unambiguously legal. The case they brought against him was an absolute joke, and he would have been acquitted of all eight charges (instead of just five!) if he had been given a fair trial. Then, to further make the crooked lawfare obvious, they absolutely slammed him at sentencing with an outrageous ruling that departed dramatically from federal guidelines and rulings in similar cases, including those involving his "co-conspirators"! It was an unambiguous "f_ck you" to an American hero who deserves nothing but respect and admiration. He rose into wealth and prominence in a highly technical field despite coming from virtually nothing by the force of sheer talent and motivation, and the established powers that be were really rubbed the wrong way. This is all yet another sad case of feelings of inferiority by bug-souled racists clashing with pvre Albanian Excellence.
Also, funnily enough, in an actual capitalist environment you couldn't do this, because a competitor would immediately undercut you. However, the drugs market is heavily regulated, and Skhreli exploited the fact that it would take years and cost a lot of money for any putative competitor to get a generic version through FDA approvals.
It's more than that, the FDA grants advertising exclusivity, which is de jure weaker than patents (the patent office and the law regulates patent criteria, the FDA cannot) but is de facto just as effective, and is an IP lock on the product. (I would also call this "not really free market capitalism")
As noted, this was all legal and I agree that he was railroaded to jail for essentially completely unrelated wrongdoings, but there's no universe where he's not a scumbag.
Focus on developing products to treat rare diseases characterized by severe unmet medical needs.
I also see several preclinical programs and product candidates. You must have missed those. Odd case, very strange.