4 ms·

The implied argument in your statement seems to be that we should lower the regulatory costs of developing new pharmaceuticals. Is that what you are implying?

The implied argument in your statement seems to be that we should lower the regulatory costs of developing new pharmaceuticals. Is that what you are implying? My outsider view is that large-scale phased testing of medication is the primary cost required by regulations, and the primary assurance of quality of a medication. Since you can't get rid of those test stages without sacrificing quality, removing regulation would have the primary effect of allowing companies to sacrifice quality.

nickff 6y ago
I did not intend for that post to imply that regulations should be loosened on pharmaceuticals. That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year. My point about pharmaceuticals was more about the problem of having the Patent and Trademark Office trying to compensate for costs imposed by the Food and Drug Administration. I think the FDA is imposing costs, and if these are causing problems, the FDA should be held responsible for finding a solution; this would also have the effect of incentivizing the agency to balance costs and benefits more carefully.
- bsder 6y ago
  > That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year. This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem. If your budget is a billion+ dollars, a 30,000 person Phase III trial is no big deal. If your budget is a million+ dollars, a 30,000 person Phase III trial is painfully expensive. The problem is that those 10K+ Phase III trials are where you first really see low probability problems.
  - nickff 6y ago
    >"This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem." Regulations are the cause of the costs; I am not saying that regulatory compliance is a waste of money, but it definitely is a cost which should be considered. Delays also cost money and reduce return on investment (ROI), so I am sure the pharmaceutical companies do spend a great deal of money to expedite the process. Could all drug approvals go through faster if the pharma companies were willing to run larger trials? Would the FDA allow for these larger trials, and expedite the process for approval? What about rarer diseases, are they worth curing or treating on a timely basis?
- pkaye 6y ago
  I wonder how much of the delay is due to FDA staffing levels. If they had more staff they can evaluate more trials in parallel?
  - nickff 6y ago
    According to the FDA, 2/3 of their spending on human drug regulation is covered by user fees. Given that some or most of the rest must be non-approval related (ongoing supervision and overhead), and the approval work doesn't go away if they delay it, I'd guess that they have the resources to evaluate as many trials as are ongoing. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glan...
    - pkaye 6y ago
      In that case the priority review voucher process doesn't make sense if they can evaluate them concurrently.
- MereInterest 6y ago
  Thank you for the clarification. Hacker News tends to lean toward free market solutions, even in cases like healthcare where the free market has many significant failure modes. Regarding the different time scales for most approvals as compared to the coronavirus approval, my understanding is that there is a vast difference in the amount of resources being put into the preliminary studies. When you have 5-10 thousand deaths every day, it is reasonable to study as many possible routes as possible in parallel, such that one may result in a working vaccine. For diseases with a smaller impact, there may be several candidates on the back burner, but only enough funding to investigate one at a time. If something fails in Stage 3 trials, then in may mean going back to Stage 1 trials on the next option. (Caveat: I am a data scientist, but not in the medical field, so there are almost certainly considerations that I am missing here.)

nickff 6y ago

I did not intend for that post to imply that regulations should be loosened on pharmaceuticals. That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year. My point about pharmaceuticals was more about the problem of having the Patent and Trademark Office trying to compensate for costs imposed by the Food and Drug Administration. I think the FDA is imposing costs, and if these are causing problems, the FDA should be held responsible for finding a solution; this would also have the effect of incentivizing the agency to balance costs and benefits more carefully.

bsder 6y ago
> That said, I am not sure whether regulatory approvals should take 5-15 years, when it seems like everyone's happy working through a coronavirus vaccine in less than 1 year. This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem. If your budget is a billion+ dollars, a 30,000 person Phase III trial is no big deal. If your budget is a million+ dollars, a 30,000 person Phase III trial is painfully expensive. The problem is that those 10K+ Phase III trials are where you first really see low probability problems.
- nickff 6y ago
  >"This has nothing to do with regulations and everything to do with how much money the companies are willing to throw at the problem." Regulations are the cause of the costs; I am not saying that regulatory compliance is a waste of money, but it definitely is a cost which should be considered. Delays also cost money and reduce return on investment (ROI), so I am sure the pharmaceutical companies do spend a great deal of money to expedite the process. Could all drug approvals go through faster if the pharma companies were willing to run larger trials? Would the FDA allow for these larger trials, and expedite the process for approval? What about rarer diseases, are they worth curing or treating on a timely basis?
pkaye 6y ago
I wonder how much of the delay is due to FDA staffing levels. If they had more staff they can evaluate more trials in parallel?
- nickff 6y ago
  According to the FDA, 2/3 of their spending on human drug regulation is covered by user fees. Given that some or most of the rest must be non-approval related (ongoing supervision and overhead), and the approval work doesn't go away if they delay it, I'd guess that they have the resources to evaluate as many trials as are ongoing. https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glan...
  - pkaye 6y ago
    In that case the priority review voucher process doesn't make sense if they can evaluate them concurrently.
MereInterest 6y ago
Thank you for the clarification. Hacker News tends to lean toward free market solutions, even in cases like healthcare where the free market has many significant failure modes. Regarding the different time scales for most approvals as compared to the coronavirus approval, my understanding is that there is a vast difference in the amount of resources being put into the preliminary studies. When you have 5-10 thousand deaths every day, it is reasonable to study as many possible routes as possible in parallel, such that one may result in a working vaccine. For diseases with a smaller impact, there may be several candidates on the back burner, but only enough funding to investigate one at a time. If something fails in Stage 3 trials, then in may mean going back to Stage 1 trials on the next option. (Caveat: I am a data scientist, but not in the medical field, so there are almost certainly considerations that I am missing here.)