4 ms·
This is old hat. The USA's process for pricing drugs is totally in service of the drug company - even that much is obvious to mercenary financiers like Shkreli.
by Gatsky 9y ago
This is old hat. The USA's process for pricing drugs is totally in service of the drug company - even that much is obvious to mercenary financiers like Shkreli.
The deeper problem is that we aren't getting newer better drugs. Once a blockbuster like Humira happens, it seems to kill off the field. This is mostly because you need to spend a lot to do a massive trial to show your Humira 2.0 is better, with no guarantee it will actually be better. The economics are very hostile. Pharma tends to do smaller trials with their new drug in more select populations eg those not responding to Humira, and therefore end up having a much smaller market if the drug works.
Drug pricing should be re-engineered to encourage more development rather than the opposite. If better alternatives exist then pharma obviously won't be able to charge extortionate prices.
- remontoire 9y agoReduce costs of getting FDA approval and reduce patent lengths?
- mcny 9y agoI think I read here about the problem of 1. Patent a drug 2. Make inconsequential changes 3. Patent it again 4. Repeat I don't have any first hand experience in the industry so I don't know if this is a serious problem. I don't even know if it has a name!
- pmyteh 9y agoIt's called 'evergreening', FWIW.
- adrianN 9y agoWhat's stopping a third party from doing 2 and 3?
- celticninja 9y agoThe original patent.
- adrianN 9y agoDoes the original patent apply if the compound is sufficiently different to warrant a new patent? That seems strange to me, but I know nothing about patent law.
- rayiner 9y agoOnce the original patent is expired, you can do whatever you want with it. Evergreening can’t lfsvent you from creating a generic version of the original patented drug. But demand for the generic might be limited if the new version of the drug is better. (People don’t want to be stuck taking an inferior version of a drug.)
- kgwgk 9y agoExclusivity is extended with patents covering new formulations, manufacturing processes, alternative dosings, injection devices, risk evaluation and mitigation strategies... When the molecule itself becomes “free” to copy, there may be still several patents more or less enforceable that prevent competitors from entering the market. Often the validity of patents is decided in court (see Copaxone for a recent high-profile case study).
- deleted 9y ago[deleted]
- marvin 9y agoWhat's stopping doctors from using a replica of the original once the initial patents expire?
- kgwgk 9y ago> Once a blockbuster like Humira happens, it seems to kill off the field. Actually what kills the field is effective drugs losing exclusivity. While the best-in-class treatments have patent protection R&D investment in the same therapeutic category is less risky than when you have to come up with something much better than the unexpensive generic/biosimilar already available.
- JumpCrisscross 9y ago> we aren't getting newer better drugs Source? My casual understanding of American pharmaceutical R&D is the majors drive profits into acquiring successful biotech companies, which in turn drives investment in a thriving biotech industry (which tends to do the early-stage research). This model pushes economic gains to research risk takers and lets the majors focus on marketing and distribution, a decent division of labour.