4 ms·

But who provides the quality standards oversight? The drug is apparently produced in India. What if pills were shipped to the US and it was found after the fact

by ssmoot 11y ago

But who provides the quality standards oversight? The drug is apparently produced in India. What if pills were shipped to the US and it was found after the fact that many batches contained unacceptable levels of iron? Who to blame? I'm sure Canada has decent oversight, but who wants to say that the solution is no direct US agency oversight, and that we want a "Pharmaceuticals-NAFTA"? It seems funding oversight with a "homeland" agency is one issue you could get bipartisan support on. While sure, I doubt many have a problem with medical tourism, I'm not sure bringing drugs across the border intended for distribution without FDA approval is the answer. On the other hand maybe countries working together at the agency level to ensure their oversight measures are in compliance with some agreed upon standard is a sane way to move forward. But then who maintains the list of approved drugs? Is that power given to some international body? Or does the FDA still have to approve drugs for distribution and only alternatives are brought in? And then what about drugs that are patented in the US (like this one), but freely available in other markets from other manufacturers? It seems a worthy enough goal in general, but I don't think a fully libertarian approach to the problem comes close to being the right answer either.

danmaz74 11y ago
> Pharmaceuticals-NAFTA I'm not a libertarian and I'm in favor regulations when needed, but in this case I think that recognizing drug testing and quality controls between countries that have similar standards would be a great help at curbing costs. "FDA approval" in this case should mean that the FDA could recognize that if agency X from Country Y says that a generic pharmaceutical is safe, you don't need to do the same tests again. Of course this should work both ways - I'm from the EU, and I'd like to be able to get drugs manufactured in the US when they're cheaper and just as safe.
leshow 11y ago
Did you miss the main caveat? Countries with good quality testing standards. If you have many countries with very similar quality assurance standards then surely it makes sense to rely on the work of others, or have a revised (shorter, cheaper) process for drugs to go through which have already been approved by certain countries. I don't think anybody is suggesting mass importation of low quality Indian or Thai versions of drugs.
robotresearcher 11y ago
We import all kinds of stuff from all over the world and enforce quality standards very well. The current situation is more like protectionism than consumer protection in many cases.
- Kalium 11y ago
  While broadly true, this is an area where counterfeiting is easier, detection is difficult, enforcement is harder, and legitimate manufacturing is often expensive. In other words, exactly the conditions to encourage all kinds of abuses.
  - robotresearcher 11y ago
    That is all true but we don't have to buy from shady producers. Canadian and European producers supply their own very safe and mature markets. Buy the stuff that the UK NHS buys and at the same prices - their scale gets them good deals (with notable exceptions). This can't be worse than the current deal.
    - Kalium 11y ago
      This might surprise you, but conditions that encourage abuse also encourage people to find ways to avoid having their abuse detected. Yeah, it can be worse than the current deal. Just look at the problems China has with counterfeit food.
      - robotresearcher 11y ago
        This whole thread is about a horrible abuse present in the current system. The potential for abuse in an alternate system does not disqualify it. There is no perfect system and bad actors are everywhere. However, I don't see terrible endemic problems in the UK, Canada or the Eurozone from importing drugs. I'm sure they exist sometimes. But in the entire rest of the G7 drug costs are less and their outcomes no worse than the US.

by ssmoot 11y ago

danmaz74 11y ago

> Pharmaceuticals-NAFTA I'm not a libertarian and I'm in favor regulations when needed, but in this case I think that recognizing drug testing and quality controls between countries that have similar standards would be a great help at curbing costs. "FDA approval" in this case should mean that the FDA could recognize that if agency X from Country Y says that a generic pharmaceutical is safe, you don't need to do the same tests again. Of course this should work both ways - I'm from the EU, and I'd like to be able to get drugs manufactured in the US when they're cheaper and just as safe.

leshow 11y ago

Did you miss the main caveat? Countries with good quality testing standards. If you have many countries with very similar quality assurance standards then surely it makes sense to rely on the work of others, or have a revised (shorter, cheaper) process for drugs to go through which have already been approved by certain countries. I don't think anybody is suggesting mass importation of low quality Indian or Thai versions of drugs.

robotresearcher 11y ago

We import all kinds of stuff from all over the world and enforce quality standards very well. The current situation is more like protectionism than consumer protection in many cases.

Kalium 11y ago
While broadly true, this is an area where counterfeiting is easier, detection is difficult, enforcement is harder, and legitimate manufacturing is often expensive. In other words, exactly the conditions to encourage all kinds of abuses.
- robotresearcher 11y ago
  That is all true but we don't have to buy from shady producers. Canadian and European producers supply their own very safe and mature markets. Buy the stuff that the UK NHS buys and at the same prices - their scale gets them good deals (with notable exceptions). This can't be worse than the current deal.
  - Kalium 11y ago
    This might surprise you, but conditions that encourage abuse also encourage people to find ways to avoid having their abuse detected. Yeah, it can be worse than the current deal. Just look at the problems China has with counterfeit food.
    - robotresearcher 11y ago
      This whole thread is about a horrible abuse present in the current system. The potential for abuse in an alternate system does not disqualify it. There is no perfect system and bad actors are everywhere. However, I don't see terrible endemic problems in the UK, Canada or the Eurozone from importing drugs. I'm sure they exist sometimes. But in the entire rest of the G7 drug costs are less and their outcomes no worse than the US.