Leftists are short on their understanding of cause and effect.
Drugs in the US cost so much because of regulation (some of which is good). It takes close to a billion dollars to get a big time successful drug through the FDA, and that money has to be recouped by the company somehow. Yet, the actual production cost of the drug might be very low. So, the company prices the drug in the USA to recover costs, and any sales abroad are done at marginal cost plus, which is much lower.
So, we have a situation where:
- Excessive regulation in the interest of safety and liability avoidance make the hurdle to drug introduction high
- Marginal costs of production are low
- and bleeding heart sentiment says US companies shouldn’t price their drugs out of availability for poor foreign markets because they still make a profit on marginal production.
Now, Bernie (and many others) want to treat the problem of high prices here by going outside to purchase at the low-price country cost.
That’s messed up. A more rational solution would be for drugs to cost less here because of an expedited FDA process, some tolerance of mistakes, and some leashing of the plaintiff bar.
“It takes close to a billion dollars to get a big time successful drug through the FDA”
A Polish insulin was developed for about $40 million about 15 years back.
A simple and easy fix is to pass a federal law stating:
Medicines that have been approved by the European Medicines Agency (EMA) at least six months in the past and are currently in good standing with the EMA shall treated by domestic law as if they have been FDA approved. Such medicines, if marketable in the European Union, shall be importable into and marketable in the United States under the conditions specifically imposed by the European Union.
“some leashing of the plaintiff bar”
Here’s your prescription today. Would you like to have tort coverage for it?
Will someoneelse be paying for that tort coverage?
No, it’s patient pay.
No, thanks!
I hear what you're saying...the industry is heavily regulated, but the FDA isn't holding up reviews excessively, in my opinion. The bottom line is that it takes time to research (and money) and develop medicines.
The phased approach to clinical development isn't because regulators want it--it makes sound clinical and ethical sense. We must first test for safety, then efficacy, and then to compare the drug for health outcomes. The industry doesn't want trials expedited at the expense of dead bodies.
Personally, I would love to see other countries shoulder more of the expense. Just as they rely on our Department of Defense for military actions, they seem to assume that we have an endless stream of innovative, efficacious and safe medicines that we can dispense like Pez.