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Better way: Have the federal government bare the cost of certification and human testing. Extend this to other products too like wireless devices in electronics

Better way: Have the federal government bare the cost of certification and human testing. Extend this to other products too like wireless devices in electronics to be consistent. Instead of outsourcing to external labs or running own experiments that cost tremendous amount of money, the common trial-and-error type drugs (i.e. not a wildly advanced/theoretical treatment, those can be done the old fashioned way) testing should be fully State funded. This makes it easy for generics/functionally similar drugs to enter the market. New pharma startups would only have to bare R and D manpower and material costs (which according to YC at least, is plunging), the most expensive human testing is fully done by third-party i.e. government. It democratises drug development. There is a serious problem with the pharmaceutical and healthcare industry on the supply side. Shortage of drugs, difficulty of building and approving new hospitals, shortage of residencies and medical school intake restrictions. These all can be dealt with in one sweep if the FDA changes its regulatory process and restructures the healthcare industry. Almost every bio grad I know is going into software and CS. We have people who have spent years studying life sciences only to give up all their knowledge and choosing to do web dev/data science because they see no future in their own industry. It's basically med school (or worse, nursing), pharmaceutical or academia. All with tremendous amount of regulatory capture or extreme shortages. A proteomics PhD's highest calling shouldn't be too fiddle with Webpack configs so that React can interop with Vue. Just as the Soviet apparatchiks are responsible for mass famine due to incompetent central economic planning among other things(despite their economists inventing Linear Programming), modern policy makers need answer as to why a premed student would choose to work in DevOps instead of a wet lab. People complain about cancer drugs not hitting the market or breakthrough research that never seem to be commercialised. It's not the poorly paid scientists you ought to hold responsible, it's the people who set the rules in the first place. Sure YC just released a post on how Biotech investment is going to magically be the next software industry. But biotech has been hyped for years and there has been no real progress on the regulatory side. Only under the current US Presidential administration did the Right to Try become legalised. Unlike aerospace(a similarly bureaucratic domain) where the worst outcome of a long time to market for a plane is a less comfortable/fuel efficient plane, the opportunity cost in medicine and pharmacy is paid in human lives.

eesmith 7y ago
"These all can be dealt with in one sweep if FDA changes its regulatory process." That is not true. For one, the FDA has little influence on the degree of difficulty in building and approving new hospitals. You'll note too that one of the problems is that existing medical facilities are disappearing from poorer and rural areas. For another, the "shortage of residencies and medical school intake restrictions" is due to the Balanced Budget Act of 1997, which "capped the number of residency slots the federal government would fund ... The shortfall-what is not covered by the Federal government-is paid for by the hospitals where residents train. While it is possible to increase the number of residents they train, to do so, hospitals must fund the entire cost of those training positions." - https://thehill.com/blogs/congress-blog/healthcare/266610-shortage-of-residency-slots-may-have-chilling-effect-on-next https://thehill.com/blogs/congress-blog/healthcare/266610-sh... . The FDA has nothing to do with that.
- sansnomme 7y ago
  You are correct. The exact detail of my comment is inaccurate, but the point still stands that it is up to the federal government. The buck has to stop somewhere. Continuously blaming the insurance industry for high costs is popular but there are a lot of other factors too which the media conveniently seem to neglect to mention. It helps no one if brilliant minds would rather go work on a "data analytics" healthcare startup (think fancy wearables) using "machine learning" that is purely dry lab (the bio academia preferred term for data science) without a single bit of wet lab physiology research that contributes to drug cures because commercialisation is too difficult, takes too long, too regulated.
  - eesmith 7y ago
    "which the media conveniently seem to neglect to mention" What? No. These are well-known structural problems that are mentioned often. I mentioned one related to funding residency programs. Another which has come up is the lack of public pricing information. Eg, "how much does it cost to give birth at your hospital if there are no complications?" - https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bills https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bi... . (I believe this information is now required to be public.) A third is how Medicare is prohibited from negotiating for better drug prices. The exact details of your comments are important because if you don't know the source of the problems - which in part are due to the same federal government that you pin your hopes on - then you are at a high risk of being manipulated by the same mistaken views that have perpetuated this broken system. Take your final statement, "takes too long, too regulated". That is a common talking point pushed by those who want to sell "drugs" that haven't been proven to actually work, and by those who are philosophically opposed to government regulations. Quite simply, the US isn't the only country developing new drugs. Other countries have their own, different regulations, and if it were a simple matter of the US being "over regulated" then we see companies elsewhere doing significantly better. Or, look at all the people who, desperate for treatment, go to another country with weaker regulations to seek an experimental treatment which not only doesn't work, but drains them of money, and sometimes makes things worse.

eesmith 7y ago

"These all can be dealt with in one sweep if FDA changes its regulatory process." That is not true. For one, the FDA has little influence on the degree of difficulty in building and approving new hospitals. You'll note too that one of the problems is that existing medical facilities are disappearing from poorer and rural areas. For another, the "shortage of residencies and medical school intake restrictions" is due to the Balanced Budget Act of 1997, which "capped the number of residency slots the federal government would fund ... The shortfall-what is not covered by the Federal government-is paid for by the hospitals where residents train. While it is possible to increase the number of residents they train, to do so, hospitals must fund the entire cost of those training positions." - https://thehill.com/blogs/congress-blog/healthcare/266610-shortage-of-residency-slots-may-have-chilling-effect-on-next https://thehill.com/blogs/congress-blog/healthcare/266610-sh... . The FDA has nothing to do with that.

sansnomme 7y ago
You are correct. The exact detail of my comment is inaccurate, but the point still stands that it is up to the federal government. The buck has to stop somewhere. Continuously blaming the insurance industry for high costs is popular but there are a lot of other factors too which the media conveniently seem to neglect to mention. It helps no one if brilliant minds would rather go work on a "data analytics" healthcare startup (think fancy wearables) using "machine learning" that is purely dry lab (the bio academia preferred term for data science) without a single bit of wet lab physiology research that contributes to drug cures because commercialisation is too difficult, takes too long, too regulated.
- eesmith 7y ago
  "which the media conveniently seem to neglect to mention" What? No. These are well-known structural problems that are mentioned often. I mentioned one related to funding residency programs. Another which has come up is the lack of public pricing information. Eg, "how much does it cost to give birth at your hospital if there are no complications?" - https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bills https://www.vox.com/2016/5/5/11591592/birth-cost-hospital-bi... . (I believe this information is now required to be public.) A third is how Medicare is prohibited from negotiating for better drug prices. The exact details of your comments are important because if you don't know the source of the problems - which in part are due to the same federal government that you pin your hopes on - then you are at a high risk of being manipulated by the same mistaken views that have perpetuated this broken system. Take your final statement, "takes too long, too regulated". That is a common talking point pushed by those who want to sell "drugs" that haven't been proven to actually work, and by those who are philosophically opposed to government regulations. Quite simply, the US isn't the only country developing new drugs. Other countries have their own, different regulations, and if it were a simple matter of the US being "over regulated" then we see companies elsewhere doing significantly better. Or, look at all the people who, desperate for treatment, go to another country with weaker regulations to seek an experimental treatment which not only doesn't work, but drains them of money, and sometimes makes things worse.