4 ms·
Since my wife works in pre-fills and other things I can tell you for a fact that you still have to go through FDA approval. If you change something slightly, yo
by wheaties 9y ago
Since my wife works in pre-fills and other things I can tell you for a fact that you still have to go through FDA approval. If you change something slightly, you go through approval. There are often clinical trials if the change is not incremental, sometimes even if it is. Change the packaging? FDA review. Change the color of the label? FDA approval. Change suppliers? FDA review.
So yes, the syringe and container themselves don't cost that much on a per unit basis (no clue but it's not nothing.) The regulatory costs are astronomical and have to be paid for over time. The general inanity of this stuff is mind boggling. The amount of paperwork insane.
- maxerickson 9y agoMylan has a patent on some minor improvement to Epipens. So it isn't just the FDA, they pushed generics off the market. Mylan flat out admitted that costs aren't any more than $150 per pen when they launched a generic version of their own branded product. Everything above that is clearly them working to get as much price differentiation as possible.
- pc86 9y agoSo why not sell Epipens without those minor, patented improvements for $20? Surely if there's profit to be made another provider would come in and destroy the $700 marginally better Epipen market.
- maxerickson 9y agoI don't know why there weren't more competitors. Apparently part of it is that it is difficult to get right. Adrenaclick generics have been on the market much of that time for $150 or less. One thing though, they would be epinephrine auto injectors, not Epipens, that's one of the things the patent did, it made it so that a prescription for Epipen could only be filled with Mylan's product.
- deleted 9y ago[deleted]