3 ms·

> The FDA has long said it polices foreign plants by prioritizing inspections based on risk. every time i read something like this - and it is with increasing

> The FDA has long said it polices foreign plants by prioritizing inspections based on risk. every time i read something like this - and it is with increasing frequency - i can't help but recall The Formula as laid out in Fight Club. in this case, a few people dead is just 'doing business,' i guess, since it isn't crossing whatever 'n' their threshold is at. which is clearly MUCH greater than 0...

s1artibartfast 2y ago
welcome to the real world where zero risk is impossible for any product. These are the risk/benefit tradeoffs at consideration for the FDA. To be clear, the formula laid out in fight club is illegal, and not practice in US medical, but similar tradeoffs are still there. If it is too hard and expensive to reduce risk to an acceptable level, the product isnt made. In many cases, if the product isnt made, more people die than if the product has residual risk.
pas 2y ago
the US and EU could do a mutual acceptance of each others drug marketing authorizations. but it's messy, so there's no political will. USA first anyway. (and the pharma industry probably likes it this way.) and even then ... the industry is complex, costs are high, funding is always finite, keeping product quality consistently high is a lot of effort, which is definitely not cheap, etc. many generics "don't break even" as far as I understand there's a lot of potential for having some kind of centralized mass-manufacturing setup of these low-profit drugs. but the cautionary tale is the baby formula brouhaha. it shouldn't be a single point of failure. but then it's not that low cost, right? so it should be some kind of industry-wide system. (ie. every big manufacturer should have some capacity that is pooled for these. but it must not hinder the market, it must not be a barrier to entry, and it must not lead to manufacturers exiting the market. so many considerations and challenges.)
- polymatter 2y ago
  What’s the “baby formula brouhaha”?
  - pas 2y ago
    https://en.wikipedia.org/wiki/2022_United_States_infant_formula_shortage https://en.wikipedia.org/wiki/2022_United_States_infant_form... protectionism (high tariffs) market concentration (ie. suppliers dropping out of the market due to a government program favoring/subsidizing some manufacturers, thus distorting prices/preferences/demand) recurring unaddressed problems at Abbott's plant until kids died :/
    - polymatter 2y ago
      thanks

s1artibartfast 2y ago

welcome to the real world where zero risk is impossible for any product. These are the risk/benefit tradeoffs at consideration for the FDA. To be clear, the formula laid out in fight club is illegal, and not practice in US medical, but similar tradeoffs are still there. If it is too hard and expensive to reduce risk to an acceptable level, the product isnt made. In many cases, if the product isnt made, more people die than if the product has residual risk.

pas 2y ago

the US and EU could do a mutual acceptance of each others drug marketing authorizations. but it's messy, so there's no political will. USA first anyway. (and the pharma industry probably likes it this way.) and even then ... the industry is complex, costs are high, funding is always finite, keeping product quality consistently high is a lot of effort, which is definitely not cheap, etc. many generics "don't break even" as far as I understand there's a lot of potential for having some kind of centralized mass-manufacturing setup of these low-profit drugs. but the cautionary tale is the baby formula brouhaha. it shouldn't be a single point of failure. but then it's not that low cost, right? so it should be some kind of industry-wide system. (ie. every big manufacturer should have some capacity that is pooled for these. but it must not hinder the market, it must not be a barrier to entry, and it must not lead to manufacturers exiting the market. so many considerations and challenges.)

polymatter 2y ago
What’s the “baby formula brouhaha”?
- pas 2y ago
  https://en.wikipedia.org/wiki/2022_United_States_infant_formula_shortage https://en.wikipedia.org/wiki/2022_United_States_infant_form... protectionism (high tariffs) market concentration (ie. suppliers dropping out of the market due to a government program favoring/subsidizing some manufacturers, thus distorting prices/preferences/demand) recurring unaddressed problems at Abbott's plant until kids died :/
  - polymatter 2y ago
    thanks