@BunsenBurner :
I think the discussion has gone beyond generics (which if I recall correctly, they have to show that their formulation is identical to the brand name drug, and obviously have to certify as to quality of the products and so forth, so it is likely a lot cheaper to bring a generic to market). Whether drug companies are multi national or not doesn’t make a difference, while I know that for example countries in the EU subsidize research, give companies tax breaks for R and D and so forth, the problem is that countries outside the US put price limits on the drug prices and the US ends up subsidizing, not necessarily the research, but rather the profits, that the levels established overseas would not return a big profit, if one at all, so the companies price shift it onto the US consumer to make their profits. The difference in price between the US and other countries varies (and I am leaving out the Indian drug companies peddling probably illegal generics that have who knows what in them, talking name brand drugs through real pharmacies outside the US). Either that, or the outside the US prices are actually fair, guaranteed to return a nice rate of return, and the US is pure greed (I doubt it, the economist a number of years ago looked into it, and they basically said a lot of the differential was cost shifting).
I have also heard the usual suspects blaming the cost of meeting US regulatory practices, but the irony is that the European standards are generally a lot tougher than ours, both for prescription meds and for things like OTC supplements and the like, that is one of those claims that people accept as fact that is myth.
“I have also heard the usual suspects blaming the cost of meeting US regulatory practices, but the irony is that the European standards are generally a lot tougher than ours.”
The usual suspects are somewhat correct, actually. For example, this article briefly touches upon medical device (where the pens fall into) approval differences in the EU and the US:
[quote]
From a timeline perspective, there is generally a one- to three-year delay in launching new medical devices into general clinical practice in the U.S. compared to in the E.U. This is partly because the regulatory process in Europe is less bureaucratic, more efficient, and more predictable than in the U.S. **Another reason is that the FDA requires evidence of both safety and efficacy of a device, whereas a European CE Mark only requires proof of safety and that the device performs in a manner consistent with the manufacturer’s intended use. ** Additionally, it’s becoming ever more difficult and arduous to conduct clinical trials in the U.S. due to the FDA’s clinical data requirements. Thus, the timeline for obtaining a CE Mark is typically much shorter than the timeline for gaining FDA regulatory approval./quote https://www.mdtmag.com/article/2012/02/which-way-go-ce-mark-or-fda-approval
^^just to be clear, the FDA is just enforcing federal law which requires that drugs and medical devices to be both safe and efficacious. (Which is probably not a bad thing if Medicare/Medicaid are gonna pay for them.)
That being said, of course, the FDA is also prone to bureaucratic delays and political pressure.
Yes, of course, the FDA does not make the law. Personally, I want my devices to be efficacious AND safe. The delays… I can write a treatise on how the human egos and need for control etc. affect the approval process. It is not uncommon that the company itself creates unneeded layers of complexity, not the FDA.
@bunsenburner:
That is interesting, does the same thing apply with approval of a new drug (rather than a delivery device)? While I know in some things FDA approval is ridiculously long (in cosmetics, for example, the FDA allows things the European regulators have banned, and there are safe replacements for those that the FDA has dragged its feet on), I have heard that with new drugs European countries are as tough if not tougher, hence my original post…
Patients experiencing anaphylaxis are advised to call 911 because the effects of epinephrine can be temporary, and other more longer lasting solutions are often needed (diphenhydramine, as already noted) .
But it will have a pricing scheme that is lower cost for individuals ($0 to $360 for two injectors) but much higher cost for insurance companies ($4,500, though that may be inflated as a starting point in negotiations). Presumably, Kaleo learned from the backlash against Mylan but still wants to inflate its take from the health care money pot.