3 ms·
Of course it's possible to say it's a "pure artifact of regulation". It's also meaningless. It seems to me that anything making the broad claim that this gener
by dalke 11y ago
Of course it's possible to say it's a "pure artifact of regulation". It's also meaningless.
It seems to me that anything making the broad claim that this generic is a 'pure artifact of regulation' must also be against patents, trademarks, copyright and other similar monopolies backed by the power of the state. Are these not also all pure artifacts of regulation?
But perhaps those regulations are somehow "natural" or "fair", so I'll put that argument aside. This piece says:
> which he cleverly amplified by sharp practices described by Ronald Bailey: “First, he apparently talked Impax [a predecessor holder of the sole FDA rights to market Daraprim] into starving the wholesale market of the drug, so that when Turing completed its purchase of the rights there were no extra pills floating around. Next, he set up an exclusive distribution network as a way of preventing potential competitors from obtaining enough Daraprim to conduct [the equivalence] trials for the FDA” necessary to develop an ANDA so as eventually to challenge his regulatory monopoly.
See that part about 'exclusive distribution network', which is praised as a 'sharp practice'? How did that get to be there? If the FDA prevented closed distribution, then other companies could get the supply needed to demonstrate that their copy was sufficiently similar. While that wouldn't prevent price jacking, it would lower how high the price could be jacked.
So long as companies are required to demonstrate biosimilarity and have no way to get access to the materials needed to demonstrate biosimilarity, then there's a problem. If you think demonstrating biosimilarity is the problem then you think regulation are in the way (and you're fine letting people distribute snake oil as a replacement for a tested drug). If you think that restricted access to the drugs is the problem, then you think that the regulations we have should be tweaked.
This piece only looks at the former, and praises the latter.