Posted on 07/29/2019 6:56:40 AM PDT by rickmichaels
You know, if it wasn’t such a heavily regulated industry, it’d be relatively easy to start a drug company, sell something like insulin at a reasonable price, and thereby corner the market.
Just sayin....
Democrats are pros at bitching whining and moaning about things but they never fix anything.
However they sure make a lot of money doing so.
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 all comes down to what protection you’re offering patent holders. Canada won’t let them charge whatever they want. We will. Personally I have had a change of heart about pharmaceutical patents. I would reduce the time of exclusivity and fix it so it can’t be extended. Make the pharmacy companies compete.
The insulin they sold in the twenties is completely different from the insulin sold today. Today’s insulin is designer insulin.
Re “heavily regulated”: I agree.
It seems to me that once a pharm. company jumps through all of the hoops and their product is approved for sale by the masterminds at the FDA that the company should not be held responsible if something goes wrong, unless, UNLESS they withheld data or falsified data. I believe that would bring down the costs significantly.
Not to mention that sometimes it’s only one person who had a problem and 10,000,000 who benefit from the drug but the manufacturer is forced to remove the product (and lose its revenue) because of the liability.
“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.
“patent holders”
Recombinant insulin dates back to the 1980’s.
Some newer varieties may have some patent protections.
Where would you get "something like insulin," in order to sell it at a reasonable price? What's reasonable?
That would certainly stir the domestic research/legal establishment. Every manufacturer would develop their new medicines in the EU.
Not that the above projection is all bad. There would be thrashing, but eventually laws on medical development would get more or less harmonized.
“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.
I agree that the three step rationale in FDA approval makes sense, but is costly. But, there was mention of a Polish drug being developed in a short period for $40 or $50 million. Did they skip steps? Or was the drug so close to another existing one that it was easily approved, so the contrast is not as great as it would seem?
https://www.medindia.net/drug-price/insulin.htm
https://www.medindia.net/drug-price/insulin/lantus.htm
I think that translates to about $38 for a 10ml vial.
“Every manufacturer would develop their new medicines in the EU.”
US drug designers aren’t going to move readily. Learning French or German isn’t easy and it would interfere with drug design work. Housing in England is generally terribly expensive. Scotland gets real cold.
Drug approval testing is often multi-national.
I believe it was molecularly identical.
Patents must describe how the protected article is made in sufficient detail for one skilled in the art to make the patented item.
If a product came out in 1981, the patents would have expired around 2001, or before.
The structure of insulin was given in my organic chemistry book I bought in the mid-1960’s.
As a drug company you would manufacture it. Charge less for it than what others are charging.
If the price of insulin is as outrageous as the article claims, that’d be easy to do.
If not, then it is priced correctly.
“I have a condition which requires drugs and I pay to fill the prescriptions a lot. I also frequently travel to EU. Prescriptions drug prices (for the same drugs I take in Canada) in Germany for example, are much lower and often 1/4 of that what I have to pay in Canada. Same in Australia and NZ.”
Canadian reader comment from:
https://www.cbc.ca/news/health/drug-prices-1.5007636
Canada doesn’t have the lowest drugs prices of a Westernized country.
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