Manufacturers of generics aren't actually barred from making insulins . . but rather most likely choose not to because there's no money it for them. Making generics is rather quite easy, as the "name brand" has already done all the research, studies, clinical trials to get the product approved and to market. This is money and time the "generics" don't have to spend. All they have to do is make the product and prove through a small scale study that their product reaches the same therapeutic level as the "name brand". They don't even have to prove it works, that it justs reaches the same level therapeutic level in the human body.
The regulations don't specifically ban any one from making insulin, but rather place the same regulations and processes involved that the big names have to follow to get an insulin to market. The patents on animal and regular insulins died out years ago and no ones making a generic. Certainly there are plenty of people worldwide using R to justify a generic company taking one to market.
Unfortunately the costs of bringing an insulin to market are prohibitive for the generics (and doesn't fit their business model), what with starting up the rDNA department to alter/construct the bacteria to make the insulin, all the clinical trials to prove efficacy and then applying for approval. With a generic having to go through all the steps the original went through to get to market along with the costs associated is just not financially lucrative enough.
It will be interesting to see what will happen when the patents run out on the current "analouges" as there is nothing in the pipeline to replace them. That with added pressure on the FDA to relax it's position on biologics may change the picture. I would think that relaxing the regulations on the manufacturing of insulins would make it cost effective for a generic to come to market, but would we trust it?
Thanks for a great explanation. I too have been forced to pay OTC and was aghast at the cost. One thing it did was motivate me to lower my carb intake to make that vial last as along as possible.
One thing that would impact prices for health care would be if consumers had a personal financial stake in costs. We'd see many fewer "nice to do" tests of dubious value. Demand would drop and so would costs. But with insurance and government paying the freight there is no motivation for consumers to make decisions based on costs. Further, many doctors get compensated on how much medicine they practice, not how well. Unfortunately we are getting farther and farther away form any models that will encourage cost containment and that applies to insulin as well.
Another consideration guiding pricing is that with insulin, nothing else will do. Not purchasing it is not an option and just like other similar goods and services price does not correlate to demand. The only alternative would be cost controls imposed by the government but every time that has been tried it inevitably leads to shortages - a sitiuation that insulin users literally cannot live with.
While I hear what you're saying, Tom, about consumers having a greater personal financial stake in cost of care, the idea of that happening is terrifying to me because I see a system where only the wealthy can properly care for their health.
I think medical costs place a huge financial burden already on those with chronic illness and not everyone is financially capable of taking on a greater financial stake in the cost of their care. So what I see happening if a system were in place that required greater financial stake by consumers is that more people with chronic illness would not get the care that they so desperately need...this is already happening.
Those in this world who are currently rationing their insulin because they're in the Medicare gap are a good example. If they can't afford insulin, they sure can't afford a greater financial stake in the cost of a heart cath or some other procedure.
If you live near the Canadian border and can go across to get insulin you can get it even cheaper. The standard pharmacy in any big grocery there has great prices. For example, Humulin Regular is $25 a vial.
Has anyone else experienced a new price hike? My wife is T1 and WITH insurance the price just went from $75 to $180 (for her usual order). Should this sort of price gouging be legal? It reminds me of what people do during natural disasters; charging people $50 for a bottle of water or something.
Yes, I just received a letter today stating that Humalog was no longer on the preferred list and that I would be charged a much higher copay unless I switch my sons insulin to Novolog. He is only 3 years old and I am concerned how he will react to the Novolog since the only insulin he has ever been on is Humalog. Hopefully, they are almost identical!