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The FDA's perpetual process machine

paulromer.net

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Re: The FDA's perpetual process machine

#11

Post by killjoywashere »

The main economic function of employees of agencies in DC is the transfer of risk away from the DC housing market, onto the American people. The career employees of the military, as a particularly extreme example, exist to transfer risk away from the DC housing market as far away as possible, which ultimately ends with special forces personnel deployed to hostile territory.

Similarly, the main economic function of employees of big tech companies is transferring risk away from the West Coast housing markets, onto their users.

In my experience, the only way to handle the government side of this is to "not waste the crisis" and execute under conditions where they will see stopping you as more risky than not stopping you.

The only way I know of to manage large corporations is to get the government to create incentives that make it riskier for them to transfer risk onto their customers. That's what financial penalities and anti-trust law are for. The trick is you have to go back to the point about the government: you have to make action less risky for the government actors than non-action.

Re: The FDA's perpetual process machine

#13

Post by BurningFrog »

causality0 wrote: post #2

The 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…

Those types of people exist in all countries. Yet the FDA is uniquely American.

A different agency working under different incentives could produce much different, and hopefully better outcomes.

Re: The FDA's perpetual process machine

#14

Post by bsder »

wonnage wrote: post #8
chmaynard wrote: post #6

Unfortunately, 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 administr…

> Will the next administration provide a V-shaped recovery in trust? Or is it just gone forever?

The big problem is that in order to fix trust, you will need to purge a lot of the senior bureaucrats who decided that keeping their job was more important than serving the public.

If you don't do this, then you have sent the signal that being a political operator is more important than doing your actual job.

Re: The FDA's perpetual process machine

#15

Post by Symmetry »

BurningFrog wrote: post #13
causality0 wrote: post #2

The 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…

Those types of people exist in all countries. Yet the FDA is uniquely American. A different agency working under different incentives could produce much different, and hopefully better outcomes.

I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.

Re: The FDA's perpetual process machine

#16

Post by tridentlead »

wonnage wrote: post #8
chmaynard wrote: post #6

Unfortunately, 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 administr…

It's not the administration. It's just the general ineptitude of many government processes. The current crisis has just laid inadequacies bare.

Re: The FDA's perpetual process machine

#17

Post by bsder »

causality0 wrote: post #2

The 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…

> 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.

Who gets to set those numbers and by what process? And, probably more importantly, who gets the indemnification liability for the ones who die?

If you don't have good, solid answers for those questions, you don't get to bitch about the FDA.

This isn't theoretical. It's playing itself out in the Type-1 Diabetes arena right now. Nobody wants to be holding the liability bag, so progress is glacially slow.

Re: The FDA's perpetual process machine

#18

Post by seehafer »

Symmetry wrote: post #15
BurningFrog wrote: post #13

Earlier quoted context omitted.

Those types of people exist in all countries. Yet the FDA is uniquely American. A different agency working under different incentives could produce much different, and hopefully better outcomes.

I think the Europeans Medicine Agency is a model for making sensible tradeoffs here, at least compared to the FDA. I sort of with the US could just outsource drug approval to them.

EMA and FDA make different tradeoffs. They’re not necessarily easier. But I agree with you in part, I wish we had more harmonization or at least regulatory overlap — approved in EU you can sell in US, and vice versa, for instance.

Re: The FDA's perpetual process machine

#19

Post by rayhendricks »

wonnage wrote: post #8
chmaynard wrote: post #6

Unfortunately, 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 administr…

Yeah it’s readily gotten bad. University of Washington/Seattle flu study actually had to start testing people for Covid first.

Re: The FDA's perpetual process machine

#20

Post by zaroth »

chmaynard wrote: post #6

Unfortunately, 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 you’re giving the current administration too much credit here.

There’s no reason to claim a grand conspiracy to knee-cap the initial testing response. The CDC and the FDA managed to fail out of pure incompetence and ineptitude all by themselves.

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