4 ms·

The FDA is largely composed of Type B people. They are very risk averse and will often delay a new technology simply because there might be unknown risks. There

The FDA is largely composed of Type B people. They are very risk averse and will often delay a new technology simply because there might be unknown risks. There are technologies widely used in European ventilators such as automatic alarm control or adaptive alarm limits which the FDA views as unsafe based on their fear that the alarm system might fail somehow. It doesn’t surprise me that they tried to slow the approval process down. Anyone that believes the FDAs mandate is to foster progress is severely misinformed. Their actual mandate as I understand it is specifically to protect the public from injury by making progress really slow and making sure there are enough barriers to prevent someone selling a product which makes patients worse off than competitors. In this case they probably caused a lot more damage than they prevented.

jokowueu 6y ago
There were some great drugs that were blocked because it raised blood pressure slightly :/
- refurb 6y ago
  Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.
  - deleted 6y ago
    [deleted]
  - cyphar 6y ago
    Especially in a country where 2/3rds of the adult population are overweight or obese and likely already have elevated blood pressure.
  - jokowueu 6y ago
    It depends what ur treating . For some disease an increase in blood pressure is nothing ,taking BP meds fixes this issue
  - amanaplanacanal 6y ago
    You really need to look at all cause mortality. You can’t just say A is associated with B, therefore we should keep A low. We make that mistake all the time as far as I can tell.
    - refurb 6y ago
      My understanding is that connection has already been made through several robust trials. There may be drugs that raise blood pressure, but not mortality, but so far we haven’t actual data on one of them.
hanniabu 6y ago
> They are very risk averse and will often delay a new technology simply because there might be unknown risks. I think this is smart simply because of how difficult it is to undo something that's been approved. You have people coming forward with side effects and the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else.
- refurb 6y ago
  the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else That's not how it works. It doesn't matter if the company "shrugs their shoulders", if the FDA wants to pull the drug, it gets pulled. The FDA has a requirement that all adverse events reported to a company must be reported to the FDA (massive fines if you don't). The FDA will then take that data and do their own analysis. Yes, they will work with the company to discuss the data and it's implications, but have zero qualms with yanking a drug if the company thinks it's still safe. When we were negotiating our label with the FDA, we asked for a wording change because we thought the current wording was confusing. FDA came back with "we don't agree". So we added more explanation and they came back with "we're not changing it". We just accepted it as it was just delaying launch and it was clear we werne't going to get our way.
refurb 6y ago
I work with the FDA as a part of my job and I disagree they are overly risk adverse. When we previewed our development plan with the FDA, they actually asked us "can't you move faster?". When a safety signal showed up, they were more than willing to work with us to develop a protocol to reduce the risk while still providing patients with drugs. I don't disagree that the FDA is very concerned about safety, but in situations where there is a very strong need, the FDA is willing to move quickly and accept a level of risk.
- gwern 6y ago
  It's nice that they offered to slightly tweak the protocol for you. How very generous and magnanimous of them. On the other hand: coronavirus.
  - refurb 6y ago
    I honestly don't think it's fair to crap all over the FDA for Covid. One day we read that people become immune, the next day they lose it. One day hydroxychloroquine works, then next day it doesn't. It's hard enough managing drug approvals when you have all the data and plenty of time.
newyankee 6y ago
The big question is whether any other country has processes and a market that is leading to faster drug discovery, development and launch ? If yes, that may help and in the current circumstances there is only 1 country big and powerful enough that i can think of, China.
pinkfoot 6y ago
How would you classify Frances Kesley who prevented thalidomide from being sold in the USA. And how would you rank the German authorities who allowed it to be sold over the counter?

jokowueu 6y ago

There were some great drugs that were blocked because it raised blood pressure slightly :/

refurb 6y ago
Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.
- deleted 6y ago
  [deleted]
- cyphar 6y ago
  Especially in a country where 2/3rds of the adult population are overweight or obese and likely already have elevated blood pressure.
- jokowueu 6y ago
  It depends what ur treating . For some disease an increase in blood pressure is nothing ,taking BP meds fixes this issue
- amanaplanacanal 6y ago
  You really need to look at all cause mortality. You can’t just say A is associated with B, therefore we should keep A low. We make that mistake all the time as far as I can tell.
  - refurb 6y ago
    My understanding is that connection has already been made through several robust trials. There may be drugs that raise blood pressure, but not mortality, but so far we haven’t actual data on one of them.

hanniabu 6y ago

> They are very risk averse and will often delay a new technology simply because there might be unknown risks. I think this is smart simply because of how difficult it is to undo something that's been approved. You have people coming forward with side effects and the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else.

refurb 6y ago
the company simply shrugging their shoulders and saying there's no way you can prove that it's from this vs something else That's not how it works. It doesn't matter if the company "shrugs their shoulders", if the FDA wants to pull the drug, it gets pulled. The FDA has a requirement that all adverse events reported to a company must be reported to the FDA (massive fines if you don't). The FDA will then take that data and do their own analysis. Yes, they will work with the company to discuss the data and it's implications, but have zero qualms with yanking a drug if the company thinks it's still safe. When we were negotiating our label with the FDA, we asked for a wording change because we thought the current wording was confusing. FDA came back with "we don't agree". So we added more explanation and they came back with "we're not changing it". We just accepted it as it was just delaying launch and it was clear we werne't going to get our way.

refurb 6y ago

I work with the FDA as a part of my job and I disagree they are overly risk adverse. When we previewed our development plan with the FDA, they actually asked us "can't you move faster?". When a safety signal showed up, they were more than willing to work with us to develop a protocol to reduce the risk while still providing patients with drugs. I don't disagree that the FDA is very concerned about safety, but in situations where there is a very strong need, the FDA is willing to move quickly and accept a level of risk.

gwern 6y ago
It's nice that they offered to slightly tweak the protocol for you. How very generous and magnanimous of them. On the other hand: coronavirus.
- refurb 6y ago
  I honestly don't think it's fair to crap all over the FDA for Covid. One day we read that people become immune, the next day they lose it. One day hydroxychloroquine works, then next day it doesn't. It's hard enough managing drug approvals when you have all the data and plenty of time.

newyankee 6y ago

The big question is whether any other country has processes and a market that is leading to faster drug discovery, development and launch ? If yes, that may help and in the current circumstances there is only 1 country big and powerful enough that i can think of, China.

pinkfoot 6y ago

How would you classify Frances Kesley who prevented thalidomide from being sold in the USA. And how would you rank the German authorities who allowed it to be sold over the counter?