I've seen this argument made regarding American health care costs in general. Everyone else pays much less because we're subsidizing them, the argument goes. Except that American medical R&D spending is about $500/year per capita, while the gap in health care costs is thousands. That's some combination of waste and people getting rich off of other people's suffering.
This product could pretty clearly be sold at a profit at the old price. But they can make more money if they charge more. People will die because they can't afford it anymore? Fuck 'em, apparently.
So in that sense there is not a properly functioning market.
Comments in this discussion seem to fall into two categories: 1) free market has failed, lower the price via administrative fiat 2) free market doesn't exist, adjust regulations to encourage competition
One suggestion I have is to simply allow non-FDA approved devices to be sold but to be clearly labeled as not having been evaluated by the FDA. This would allow the market mechanism to put pressure on the FDA approved vendor. Re-thinking the FDA approval process is also a possibility, or even providing different types of FDA labeling (e.g., experimental, provisional, approved) based on different stages of the FDA process.
100% of the surplus accruing to pharmaceutical does not go toward research. Of the X% that does go to research, that marginal increase is likely not as effective as the budgets before the increased margin.
Also, patents shift effort from areas with low patentability prospects to areas with higher patentability prospects, even if the rate of return in terms of public health would have been substantially higher if the former opportunities were maximized first.
For that and many other reasons, the net social gain from pharmaceutical patents is contentious. Many economists have argued that the only justification is improved incentive to cover the cost of our expensive regulatory environment. Patents for almost everything else? Almost certainly a net loss.
There's little evidence that patent monopolies are needed to induce investment, generally. Don't forget that there's almost $100 trillion in liquid, investable assets floating around out there. There's more than enough capital to fund anything with even a tiny predicted profit. But individual capitalists want to maximize their returns, and monopolies often provide better margins. That good patents attract more capital is not evidence of anything; capital will first go to anything that promises higher returns relative to anything else, even if the net effect is reduced overall wealth creation for investors.
Imagine two countries with equivalently sized economies at year 1. The first is run by a dictator who will use the power of the state to extract wealth from the citizens. Part of the process involves giving sweet-heart deals to foreign investors, partly as a way to off-shore the money. For those investors the returns are 20%.
The second country is a stable democracy with low corruption. Politicians only seek foreign investment when it makes fiscal sense, and the terms only provide returns of about 10%.
In the short-term, where do you think all the capital will go to first? Over 30 years, where do you think most of the net global wealth creation will come from?
Ergo, that investors prefer investments backed by patents is proof of nothing.
That the U.S. and developed countries are leaders in research and investment also proves very little. We're also leaders in areas like consumer and industrial design, organizational management, etc, with no or minimal regulatory protection. We could be (and arguably are) leaders in technology despite protections, not because of them.
If you develop an EpiPen and it costs you a bunch of money then in theory you can make it up by selling more volume. Except your competitor can just cut the price because they are already selling for an absurd amount of money, so how do you win now?
Maybe we should have a non-profit that does generic versions, and we can subsidize it by preferring them to companies like this (e.g. all medicare provided drugs now go through this company which sells generics). Unless the companies are willing to match prices.
It's not the insurance company, it's the drug company. The insurance companies are probably livid about the extra costs they're having to cover.
The answer to "how" is a variety of different techniques, including changing the formulation slightly (http://www.nytimes.com/2014/09/16/business/new-york-files-an...) and outright bribery of competitors (https://www.washingtonpost.com/opinions/pay-to-delay-pharmac...).
One of the alternatives was potentially better as they had additional features, but there were problems with the injector itself and it was recalled. That's what other companies have to contend with. It's bad if the injector fails to deliver the dosage and a person dies.
So, people making a 3D printed alternative can't really ensure that the injector works reliably without a lot of work.
That is incorrect -- devices can do that. Devices shown to be equivalent to an existing device can be put on the market with minimal regulatory overhead. The form to submit to the FDA for an equivalent device is a 510k Premarket Notification. Details are here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
This is what an acceptance letter from the FDA looks like for a substantially equivalent device:
http://www.texasbiogene.com/upload/content/file/TBGFDAapprov...