7 ms·

What I don't understand is why the FDA doesn't automatically rubber stamp approvals on medicine approved in Canada and the European Union. We all know their med

What I don't understand is why the FDA doesn't automatically rubber stamp approvals on medicine approved in Canada and the European Union. We all know their medicine is good - so why can't I get it?!

m3kw9 3y ago
So all drugs will always be trialed at the most lax country and get approved at a stricter one? Then why make rules because the laxest country will be the one used and in control of approvals
deleted 3y ago
[deleted]
LordShredda 3y ago
Because they might make mistakes? See: thalidomide
tekla 3y ago
> USA rubber stamps probably safe food items. Europe goes WTF how dare they think its safe. > USA refuses to accept rubber stamp European experimental medication. Europe pikachu face
Latty 3y ago
Somewhat famously the US not doing this stopped Thalidomide being such a large issue in the US, but of course one example of it failing doesn't mean it is inherently bad policy.
- casefields 3y ago
  It’s strange how people trot that out and never discuss the inverse.
maxbond 3y ago
Thalidomide was widely approved, and I'm glad the FDA didn't rubber stamp it.
- chroma 3y ago
  But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
  - maxbond 3y ago
    If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled? If you think that regulatory bodies make mistakes - then surely you want them checking each other's work? It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable. But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity. If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
    - dghughes 3y ago
      > thalidomide, a deadly and basically worthless medication, Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
      - maxbond 3y ago
        It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely. That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use. I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."
Glawen 3y ago
Because it then becomes a kind of race to the bottom, where all manufacturers will approve medecine in the easiest country, a bit like flag on convenience for ships
- baggy_trough 3y ago
  Sounds great, where do I sign up?
- YZF 3y ago
  They already do that. Having approval and data in another country makes it much easier to get FDA approval. But it's still a lengthy process, costs a lot of money, and often puts you in competition with other options that are approved. There are drugs that have been used for decades in Europe, are perfectly safe and proven to be more effective, and are not available in the USA (and likely the other way around, I'm just aware of specific examples there).
dkasper 3y ago
I guess we know that, but why doesn't the EU rubber stamp medicine that's approved in the US? In my opinion it's actually good for there to be independent bodies reviewing things.
- tb_technical 3y ago
  We all know why the EU doesn't rubber stamp US medicine...
YZF 3y ago
Money and politics. Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license? I've had this misdiagnosed medical condition for 25 years by multiple doctors. Nothing serious but extremely annoying. There are approved drugs in Europe for decades which are much better than the ones approved in North America. One day the company making the drug that's approved in North America decided to stop making it! You just could not get it. This was the event that finally led to the correct diagnosis for my condition because I was in so much pain I got to see the expert. Turns out my condition has a very simple non-prescription solution and for 25 years I've been taking the wrong meds that happen to alleviate this different condition as well! So I am good but this condition is not uncommon. What are all the other people that really need this drug in North America doing? I'm not sure what's the takeaway here. Maybe that efficient/smart organizations generally don't exist. This is just a reflection of human nature.
- dashmeet 3y ago
  If you're okay with it, could you expand/name the condition you thought you had, the actual one, and the medication(s)? Never know, might help someone else out
  - YZF 3y ago
    I'm a bit concerned about my privacy but the condition is herpes virus infection of the eye. The similar condition is Thygeson's disease. The drug in question (that I could not get) is called Viroptic which for some reason helps with both conditions (despite them not being related). Thygeson's is thought to be more of an immune system issue. So if you've been diagnosed with herpes, and anti-virals don't seem to help, maybe you don't have herpes. If you do have herpes of the eye there are good drugs approved in Europe but not in the North America (though there are likely some approved drugs in the US which will still help - it's complicated).
- webmobdev 3y ago
  Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license? A government issued id, like a driver's license, is often required for various services like opening bank account, a telephone connection, avail some government service etc. Thus a local driver's license can be used for deception by a foreigner who wants to pretend to be a local citizen.
anjel 3y ago
There are many divergent if not contradictory regulatory findings levels and limits between the US Canada and Europe. eg. Tolerable total cholesterol levels US:200 Euro: 240 (last I checked, these move around quite a bit. In the 70s the US banned Cyclamates as an artificial sweetener, but approved Sacharine while Canada approved Cyclamates and banned Sacharin. For Glaucoma treatment Europe is "Laser first, drugs second" while the US is Drugs first, laser surgery second. etc etc.

What I don't understand is why the FDA doesn't automatically rubber stamp approvals on medicine approved in Canada and the European Union. We all know their medicine is good - so why can't I get it?!

m3kw9 3y ago

So all drugs will always be trialed at the most lax country and get approved at a stricter one? Then why make rules because the laxest country will be the one used and in control of approvals

deleted 3y ago

[deleted]

LordShredda 3y ago

Because they might make mistakes? See: thalidomide

tekla 3y ago

> USA rubber stamps probably safe food items. Europe goes WTF how dare they think its safe. > USA refuses to accept rubber stamp European experimental medication. Europe pikachu face

Latty 3y ago

Somewhat famously the US not doing this stopped Thalidomide being such a large issue in the US, but of course one example of it failing doesn't mean it is inherently bad policy.

casefields 3y ago
It’s strange how people trot that out and never discuss the inverse.

maxbond 3y ago

Thalidomide was widely approved, and I'm glad the FDA didn't rubber stamp it.

chroma 3y ago
But that’s the problem. No regulatory body has perfect judgement, so they’ll all approve some harmful things and ban some helpful things. If you’re so strict that you don’t allow thalidomide, you’ll also ban stuff like beta blockers for an extra decade, causing 80,000 deaths. The argument in favor of loosening restrictions is that it would reduce overall death and suffering.
- maxbond 3y ago
  If you think the fact that thalidomide, a deadly and basically worthless medication, being successfully blocked by the FDA is an example of a problem, then I'm a bit baffled? If you think that regulatory bodies make mistakes - then surely you want them checking each other's work? It's very frustrating to feel you are dying just shy of a breakthrough that can save you. I get that. And the author's contention, that they have a right as a human being to join studies that can potentially save them, is entirely reasonable. But that's an entire universe apart from rubber stamping medications. We should not give the pharmaceutical industry that much credulity. If pharmaceuticals have improved the length and quality of our lives, it's because they've been kept on the straight and narrow. This isn't a self regulating industry, they have a desperate base of customers and their "sales people" (doctors) are trusted implicitly - they hold a tremendous amount of power and would abuse it at the drop of a hat.
  - dghughes 3y ago
    > thalidomide, a deadly and basically worthless medication, Thalidomide is what is used to treat erythema nodosum leprosum (ENL) better known as just leprosy.
    - maxbond 3y ago
      It used to be regarded as a miracle drug that could be used over the counter in many circumstances, and as they looked into it they discovered it just couldn't be used safely. That they've narrowed it down to some use case is more of a testament to the thoroughness of the investigation, I'm sure there are many chemicals that could treat leprosy this just happens to be the one we understand how to manufacture and when it is safe to use. I'm sure it's very meaningful for the people who do take it, but that is what I meant by "basically worthless."

Glawen 3y ago

Because it then becomes a kind of race to the bottom, where all manufacturers will approve medecine in the easiest country, a bit like flag on convenience for ships

baggy_trough 3y ago
Sounds great, where do I sign up?
YZF 3y ago
They already do that. Having approval and data in another country makes it much easier to get FDA approval. But it's still a lengthy process, costs a lot of money, and often puts you in competition with other options that are approved. There are drugs that have been used for decades in Europe, are perfectly safe and proven to be more effective, and are not available in the USA (and likely the other way around, I'm just aware of specific examples there).

dkasper 3y ago

I guess we know that, but why doesn't the EU rubber stamp medicine that's approved in the US? In my opinion it's actually good for there to be independent bodies reviewing things.

tb_technical 3y ago
We all know why the EU doesn't rubber stamp US medicine...

YZF 3y ago

Money and politics. Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license? I've had this misdiagnosed medical condition for 25 years by multiple doctors. Nothing serious but extremely annoying. There are approved drugs in Europe for decades which are much better than the ones approved in North America. One day the company making the drug that's approved in North America decided to stop making it! You just could not get it. This was the event that finally led to the correct diagnosis for my condition because I was in so much pain I got to see the expert. Turns out my condition has a very simple non-prescription solution and for 25 years I've been taking the wrong meds that happen to alleviate this different condition as well! So I am good but this condition is not uncommon. What are all the other people that really need this drug in North America doing? I'm not sure what's the takeaway here. Maybe that efficient/smart organizations generally don't exist. This is just a reflection of human nature.

dashmeet 3y ago
If you're okay with it, could you expand/name the condition you thought you had, the actual one, and the medication(s)? Never know, might help someone else out
- YZF 3y ago
  I'm a bit concerned about my privacy but the condition is herpes virus infection of the eye. The similar condition is Thygeson's disease. The drug in question (that I could not get) is called Viroptic which for some reason helps with both conditions (despite them not being related). Thygeson's is thought to be more of an immune system issue. So if you've been diagnosed with herpes, and anti-virals don't seem to help, maybe you don't have herpes. If you do have herpes of the eye there are good drugs approved in Europe but not in the North America (though there are likely some approved drugs in the US which will still help - it's complicated).
webmobdev 3y ago
Why can someone drive for 6 months in a country with a foreign driver's license but can't get a local license? A government issued id, like a driver's license, is often required for various services like opening bank account, a telephone connection, avail some government service etc. Thus a local driver's license can be used for deception by a foreigner who wants to pretend to be a local citizen.

anjel 3y ago

There are many divergent if not contradictory regulatory findings levels and limits between the US Canada and Europe. eg. Tolerable total cholesterol levels US:200 Euro: 240 (last I checked, these move around quite a bit. In the 70s the US banned Cyclamates as an artificial sweetener, but approved Sacharine while Canada approved Cyclamates and banned Sacharin. For Glaucoma treatment Europe is "Laser first, drugs second" while the US is Drugs first, laser surgery second. etc etc.