3 ms·

Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" th

Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" their equivalent foreign agencies and whitelist those whose processes are sufficiently analogous and in some cases allow US entities to rely upon the work done in those whitelisted jurisdictions. I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. [1] https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act https://en.wikipedia.org/wiki/Sunscreen_Innovation_Act

fgonzag 8y ago
I agree, safety is very important but so is actually getting the drugs to people at prices they can afford. Perfect drugs are still useless if no one can buy them. An international certification, recognized by all the major countries, could work very well
refurb 8y ago
I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. The reason is thalidomide. The US was one of the few countries that chose not to approve it despite other countries doing so. Saved a lot of US children from birth defects.
- elliekelly 8y ago
  Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clinical research.[1] In the late 80's there was even a study conducted to determine the relationship between obesity and risk for breast and uterine cancer. Guess how many women were enrolled? Zero. Thanks to the FDA's misguided knee jerk policy response to thalidomide. It seems to me the FDA's process might "protect" a small number of people but that comes at the expense of many thousands of lives. [1]https://www.drugwatch.com/news/2018/07/25/excluding-women-from-drug-trials-kills-people/ https://www.drugwatch.com/news/2018/07/25/excluding-women-fr...
  - refurb 8y ago
    Hey, I don’t disagree that that FDA is very conservative. My comment was more around the politics of it. Look back at the Vioxx hearings. People crapped all over the FDA because they didn’t catch an increased risk of CV issues until post-approval. If you’re the FDA, it’s “damned if you do, damned if you don’t”.
    - elliekelly 8y ago
      That’s fair and the struggle for all regulators I would imagine (though the stakes are higher with human health). The crypto people drive me nuts the same way. One minute they’re extolling the virtue of markets “free” from regulatory interference but the second it turns out the market was a scam they want to know what the government plans to do to get their money back.
- boyband6666 8y ago
  The studies performed are the same ones, but companies submit it to the FDA first, who are more likely to approve, and approve faster than European regulators (the European Medicines Agency, EMA). The FDA are the most permissive regulator is what has been seen in the literature - there was a really good study looking at the same drugs (TKIs) submitted to various agencies (it's not the only one, but is the cleanest): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769667/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769667/ As for thalidomide, yep the FDA had an amazing employee who saved a lot of damage being done, and shows exactly why regulators exist, and assess the safety and efficacy before you can sell things!

fgonzag 8y ago

I agree, safety is very important but so is actually getting the drugs to people at prices they can afford. Perfect drugs are still useless if no one can buy them. An international certification, recognized by all the major countries, could work very well

refurb 8y ago

I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later. The reason is thalidomide. The US was one of the few countries that chose not to approve it despite other countries doing so. Saved a lot of US children from birth defects.

elliekelly 8y ago
Ah yea, thalidomide. That drug is often used to justify poor policy decisions at the FDA. It's the reason the FDA banned women of child bearing age from clinical research.[1] In the late 80's there was even a study conducted to determine the relationship between obesity and risk for breast and uterine cancer. Guess how many women were enrolled? Zero. Thanks to the FDA's misguided knee jerk policy response to thalidomide. It seems to me the FDA's process might "protect" a small number of people but that comes at the expense of many thousands of lives. [1]https://www.drugwatch.com/news/2018/07/25/excluding-women-from-drug-trials-kills-people/ https://www.drugwatch.com/news/2018/07/25/excluding-women-fr...
- refurb 8y ago
  Hey, I don’t disagree that that FDA is very conservative. My comment was more around the politics of it. Look back at the Vioxx hearings. People crapped all over the FDA because they didn’t catch an increased risk of CV issues until post-approval. If you’re the FDA, it’s “damned if you do, damned if you don’t”.
  - elliekelly 8y ago
    That’s fair and the struggle for all regulators I would imagine (though the stakes are higher with human health). The crypto people drive me nuts the same way. One minute they’re extolling the virtue of markets “free” from regulatory interference but the second it turns out the market was a scam they want to know what the government plans to do to get their money back.
boyband6666 8y ago
The studies performed are the same ones, but companies submit it to the FDA first, who are more likely to approve, and approve faster than European regulators (the European Medicines Agency, EMA). The FDA are the most permissive regulator is what has been seen in the literature - there was a really good study looking at the same drugs (TKIs) submitted to various agencies (it's not the only one, but is the cleanest): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769667/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3769667/ As for thalidomide, yep the FDA had an amazing employee who saved a lot of damage being done, and shows exactly why regulators exist, and assess the safety and efficacy before you can sell things!