5 ms·

Yes, that $750 generic pill is a pure artifact of regulation

1 points by monort 11y ago

DanBC 11y ago
The article talks about the burden of regulation, but fails to recognise that the reason all that regulation exists is because people would happily sell vitamin C as a cure for cancer or lemon juice as a cure for HIV/AIDs if the regulation didn't exist. The fact that an abusive idiot manages to find and exploit a loophole is a failure of that person's ethics and morals, not of regulation. EDIT > Underlying it all — but seldom asked — was whether the gigantic costs of regulatory approval are really a necessary evil. Libertarian-minded critics were especially inclined to question whether hugely expensive studies and paperwork should really be required in the case of grandfathered or “generally recognized as safe” drugs, many of which have been familiar to the medical profession for decades or even centuries, allowing for a collective sense to emerge of their safety and effectiveness. But the view that progressives tended to champion — which prevailed — was that older compounds and those used for rare diseases should be held to no less stringent a standard than any other, and should either be withdrawn from the market or have their safety and effectiveness proved at someone’s expense. A bunch of now generics were introduced when studies were just not very good. There are good reasons to want to see evidence of safety and efficacy.
deleted 11y ago
[deleted]
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.

1 points by monort 11y ago

DanBC 11y ago

The article talks about the burden of regulation, but fails to recognise that the reason all that regulation exists is because people would happily sell vitamin C as a cure for cancer or lemon juice as a cure for HIV/AIDs if the regulation didn't exist. The fact that an abusive idiot manages to find and exploit a loophole is a failure of that person's ethics and morals, not of regulation. EDIT > Underlying it all — but seldom asked — was whether the gigantic costs of regulatory approval are really a necessary evil. Libertarian-minded critics were especially inclined to question whether hugely expensive studies and paperwork should really be required in the case of grandfathered or “generally recognized as safe” drugs, many of which have been familiar to the medical profession for decades or even centuries, allowing for a collective sense to emerge of their safety and effectiveness. But the view that progressives tended to champion — which prevailed — was that older compounds and those used for rare diseases should be held to no less stringent a standard than any other, and should either be withdrawn from the market or have their safety and effectiveness proved at someone’s expense. A bunch of now generics were introduced when studies were just not very good. There are good reasons to want to see evidence of safety and efficacy.

deleted 11y ago

[deleted]

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.