You write as if Srinivasan is being considered to run HHS/Obamacare. He's not. The FDA has nothing to do with health insurance.
When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living.
I get the impression you want to remove this option from people, thereby giving them exactly zero ways to make a living. Is that correct?
Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans.
You seem very confused. The FDA does not currently regulate prices. However, FDA regulations do drive prices up and create a lot of monopolies in the pharmaceutical space.
If you want to learn what Srinivasan might actually mean for the FDA, I strongly recommend reading this blog post (written by a Trump hater, FYI): http://slatestarcodex.com/2017/01/18/watch-new-health-picks/
The hypothesis Balaji and others here suggest is that the FDA requires drugmakers to pass useless onerous regulations and expensive studies before it'll approve a drug. In so doing, the drugs become more expensive to market.
Having worked a little in the drug discovery area, I'd advance a different hypothesis: the low hanging fruit are gone.
Balaji in his post explicitly mentions insulin coming to market in 2 years. That's a pretty easy thing to approve: you have a molecule that is identical to one produced by your own body, that has known or easily understood physiology and pharmacokinetics. All you have to show is that your preparation isn't toxic, so of course it's going to take nearly no time to get approved.
Contrast with a cancer drug. There you have a really complicated disease, not very good model systems before you get to test the molecule in a human subject, and when you get there most of your patients die anyway because diseases are hard/they're too sick/it doesn't work well enough.
I think the information/silicon technology side of silicon valley doesn't quite understand how hard biochemistry and biotech actually is. In traditional engineering you know a lot about the inputs to your system (code, silicon, plastic, etc.) and you know a lot about how they work. In Biology/Biochemistry/Physiology none of that is true. Your inputs, underlying system and outputs are hugely complex and in many ways completely non-understood.
That's why it takes so long to "innovate" or develop new drugs. Bureaucracy may not help, but it's not the main cause either.
An essential blog to read if interested in drug discovery:
http://blogs.sciencemag.org/pipeline/
topic relevant post:
http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-...
Full disclosure: I once met with Balaji for an informal job interview/get to know the company at Counsyl
However, that doesn't mean bad FDA rules are not also an issue. From the blog post I linked to:
Any pharma company that wants their medication approved in both the US and Europe has to spend a billion or so dollars getting it approved by the FDA, and then another billion or so dollars getting it approved by the Europeans. A lot of pharma companies don’t want to bother, with the end result that Europe has many good medications that America doesn’t, and vice versa. Just in my own field, amisulpride, one of the antipsychotics with the best safety/efficacy balance, has been used successfully in Europe for twenty years and is totally unavailable here despite a real need for better antipsychotic drugs.
For genuine public health emergencies (anyone remember AIDS?) there's fast-track approval, the first antiretrovirals were at market remarkably quickly.
Let me play devil's advocate here and suggest that entrenched market participants love high-barrier-to-entry regulatory regimes. The FDA is "people in the drug discovery business'" moat.
Still, I'd be willing to say EU approval should drop the cost in some way by reusing studies or other things.
Why the purportedly? Do you have reason to believe he has any ulterior motives?
I didn't know anything about this guy before this so I googled him.
http://online.stanford.edu/instructors/balaji-s-srinivasan
"the co-founder and CTO of Counsyl, a genomics startup"
Ok, so he clearly has some experience as a biotech innovator.
> He's described it as the big enemy for any biotech innovator to overcome.
Seems reasonable.
The current market in biotech and rate of innovation seems underwhelming. Would you agree?
The current level of legislation in biotech seems to favor too-big-to-fail type companies? They sure seem to get away with egregious crimes. Eg: bribery [1] , knowingly selling HIV contaminated blood products , even moving such sales to Asia and Africa after it became public in the US [2] , numerous other ethical issues [3]
[1] https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-...
[2] https://www.ncbi.nlm.nih.gov/pubmed/24785997
[3] http://ethics.harvard.edu/pharmaceutical-industry-institutio...
Seems to me the current system isn't working properly. Is there reason to believe a guy like Baraji shouldn't be allowed to try to reform it?
About the opt-in society, I think it can create rules to prevent the disadvantages you mention; for example by paying a percentage of your salary/profits instead of a fixed amount; or perhaps by taking -free of charge- one sick poor person for every 10 healthy ones that enter the system.
This is a very rough way to put it, but it's a fantastic idea. Policymakers call this universal healthcare.
These people need our votes, though.
Banning patents sounds good; it sounds like freeing technology from greedy capitalists. But in practice, it means freezing (or at least dramatically slowing) the development of new medical technology.
The Epipen does not "still have an enforceable patent" because there is not an Epipen; there is a series of them. The original design is not encumbered by a patent.
The specific problem with patents and drugs or medical devices is the FDA decisions on what products are interchangeable. The reason drug companies get away with these "minor tweak" patents is that the FDA doesn't see the changes as minor, and so will not permit a prescription written for a new patented version to be filled with a generic based on the old unpatented version.
You can make the argument in this case that the problem is not patents per se, but the interaction of patents with prescription drug regulations. These sorts of "tweak patents" are useless outside the world of prescription drugs.
Balaji Srinivasan is being considered to run the FDA. If chosen, he is expected to radically weaken its regulatory power, purportedly in the interests of promoting innovation in the pharma space. He's described it as the big enemy for any biotech innovator to overcome.
When we have an opt-in healthcare system, people who are in perfectly good health will opt into favorable plans only they qualify for. Those born with expensive conditions or who develop a chronic illness won't be able to opt in, and will find themselves in a high risk pool paying hardship-tier premiums.
When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living. Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans.
The problem with an opt-in society is that only some people get the privilege of opting in. It's an almost self-contradicting concept. Societies only hold together if their members don't favor exit. Members collectively recognize they're all on the same side, by way of the social contract they've entered into, and they know the rules need to be the same for everyone. A modicum of loyalty - in Hirschman's sense - is an absolute prerequisite for a group to be called a society.
When it comes to our health, let's show some loyalty to our fellow Americans and use our voices, instead of fleeing the inconveniently poor and sick. The veil of ignorance hasn't come off yet, after all: if you get cancer tomorrow, you might well become one of them.