3 ms·

What does "seek FDA review" involve? Is 10m an appropriate lead time, or do we expect to see a lot of extension requests? What's the likelihood that FDA in ea

by r00fus 7y ago

What does "seek FDA review" involve? Is 10m an appropriate lead time, or do we expect to see a lot of extension requests? What's the likelihood that FDA in early 2020 will not again kick the can down the road?

loeg 7y ago
I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. This obviously limits the number of products and vendors that can participate in the market, although it isn't at all clear that it will reduce uptake by non-smokers.
- Mirioron 7y ago
  So, the point of this is to reduce competition from smaller companies?
  - Clubber 7y ago
    Expensive regulation usually benefits the organizations that can afford it to the detriment of those that can't. Regulation is certainly a two edge sword in this regard. I'm left to wonder if this is an intended or unintended consequence. A British study recently came out finding eCigarettes 95% less harmful than cigarettes. https://www.theguardian.com/society/2018/dec/28/vaping-is-95-safer-than-smoking-claims-public-health-england https://www.theguardian.com/society/2018/dec/28/vaping-is-95...
    - lotsofpulp 7y ago
      Large scale health studies are going to cost a lot of money since they use up a tremendous amount of human time and resources in short supply. If we want the data, we have to pay for it. One option is to pay for it with tax dollars (which already happens).
  - atlasunshrugged 7y ago
    I think the point is to make sure that no one dies or is hurt - the FDA takes a very strong view on preventing injury and death, not always weighting the opposite side of the coin of people who are already dying or being hurt (ex. taking years to approve drugs that have a high likelihood of helping more people than they hurt, but not doing so until being as close to totally sure as possible to try to prevent new deaths/injury)
    - Mirioron 7y ago
      Basically, what you're saying is that the FDA likes keeping their jobs, because the only thing that can threaten them is them screwing up. It doesn't matter if approval is expensive or takes a long time, because they have no competition or incentive to do better.
- anthony_doan 7y ago
  > I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. While the FDA is not perfect, such as medical devices regulation was in limbo and theranos, it did prevent many harmful drugs from enter market. When I was interning at FDA NCTR, the director then was very proud that they've prevented thalidomide, that causes deformities in newly born babies, from entering market.
deleted 7y ago
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by r00fus 7y ago

loeg 7y ago

I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. This obviously limits the number of products and vendors that can participate in the market, although it isn't at all clear that it will reduce uptake by non-smokers.

Mirioron 7y ago
So, the point of this is to reduce competition from smaller companies?
- Clubber 7y ago
  Expensive regulation usually benefits the organizations that can afford it to the detriment of those that can't. Regulation is certainly a two edge sword in this regard. I'm left to wonder if this is an intended or unintended consequence. A British study recently came out finding eCigarettes 95% less harmful than cigarettes. https://www.theguardian.com/society/2018/dec/28/vaping-is-95-safer-than-smoking-claims-public-health-england https://www.theguardian.com/society/2018/dec/28/vaping-is-95...
  - lotsofpulp 7y ago
    Large scale health studies are going to cost a lot of money since they use up a tremendous amount of human time and resources in short supply. If we want the data, we have to pay for it. One option is to pay for it with tax dollars (which already happens).
- atlasunshrugged 7y ago
  I think the point is to make sure that no one dies or is hurt - the FDA takes a very strong view on preventing injury and death, not always weighting the opposite side of the coin of people who are already dying or being hurt (ex. taking years to approve drugs that have a high likelihood of helping more people than they hurt, but not doing so until being as close to totally sure as possible to try to prevent new deaths/injury)
  - Mirioron 7y ago
    Basically, what you're saying is that the FDA likes keeping their jobs, because the only thing that can threaten them is them screwing up. It doesn't matter if approval is expensive or takes a long time, because they have no competition or incentive to do better.
anthony_doan 7y ago
> I think the main hurdle is that you have to take a huge pile of money and light it on fire as a sacrifice to the FDA. While the FDA is not perfect, such as medical devices regulation was in limbo and theranos, it did prevent many harmful drugs from enter market. When I was interning at FDA NCTR, the director then was very proud that they've prevented thalidomide, that causes deformities in newly born babies, from entering market.

deleted 7y ago

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