The FDA's perpetual process machine
paulromer.net
The FDA's perpetual process machine
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Re: The FDA's perpetual process machine
#2The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regardless of how many hundreds of lives it saved.
Re: The FDA's perpetual process machine
#3There are number of conflated regulatory problems in this piece:
1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path.
3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered
Re: The FDA's perpetual process machine
#4The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regar…
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.
Re: The FDA's perpetual process machine
#5The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regar…
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 approv…
> 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.
Re: The FDA's perpetual process machine
#6Unfortunately, we need to be skeptical about almost every decision and communication from the CDC, FDA, and a number of other federal agencies. The current administration has done a remarkably effective job of bending these agencies to their will and forcing out anyone who doesn't fall in line.
Re: The FDA's perpetual process machine
#7The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regar…
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 approv…
There were some great drugs that were blocked because it raised blood pressure slightly :/
Re: The FDA's perpetual process machine
#8Unfortunately, we need to be skeptical about almost every decision and communication from the CDC, FDA, and a number of other federal agencies. The current administration has done a remarkably effective job of bending these agencies to their will and forcing out anyone who doesn't fall in line.
I think this is one of the great side tragedies of the coronavirus. The US generally had a lot of trust in these federal agencies. They've always been susceptible to political interference, as demonstrated now. But it's never (?) gotten to the point it has now, where you simply can't trust the CDC to provide accurate information, or information that every other country has accepted months ago.
Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever?
Re: The FDA's perpetual process machine
#9The sorry state of the FDA and drug development and deployment as a whole is in my opinion due to a preponderance of two types of people: Type A will happily bankrupt their customers while giving them heart failure in order to reduce allergy symptoms by 10%, and Type B would rather let ten thousand people die in unmedicated screaming agony than have a drug show up in a news story saying it killed three of them, regar…
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 approv…
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.
Re: The FDA's perpetual process machine
#10Earlier quoted context omitted.
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 approv…
There were some great drugs that were blocked because it raised blood pressure slightly :/
Higher blood pressure is linked to increased mortality. It's not like they are blocking the drug for fun.