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Who regulates the regulators? We need to go beyond review-and-approval

rootsofprogress.org

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Re: Who regulates the regulators? We need to go beyond review-and-approval

#51

Post by firstlink »

pjscott wrote: post #5
majormajor wrote: post #2

So, summarizing the timeline here: Bad things happened. Review-and-approve regulation happened, things improved. Another bad thing happened, at a much lower scale. Regulators cracked down, professional admins replaced experts, things got buried in red tape. The author argues against review-and-approve but they don't present a better alternative than that first review-and-approve. They mention, but don't really endors…

> They mention, but don't really endorse, liability law models. But today's adversarial legal model in the US is also slow, expensive, and results in tons of cover-your-ass legalese at large places. They allude to no-fault workman's compensation laws, discussed at greater length in this excellent article: https://rootsofprogress.org/history-of-factory-safety The trick there was to take the liability out of the advers…

All three of these things are orthogonal:

1) Negligence vs strict liability

2) Tort model

3) adversarial truth-seeking

Re: Who regulates the regulators? We need to go beyond review-and-approval

#52

Post by Karrot_Kream »

majormajor wrote: post #2

So, summarizing the timeline here: Bad things happened. Review-and-approve regulation happened, things improved. Another bad thing happened, at a much lower scale. Regulators cracked down, professional admins replaced experts, things got buried in red tape. The author argues against review-and-approve but they don't present a better alternative than that first review-and-approve. They mention, but don't really endors…

> So is the problem just that politicians don't relate or understand something like a medical study as well as they do driving, and don't understand the tradeoffs and burden required to try to make sure nothing went wrong, ever? If anything, I'd expect that to result in industry lobbyists pushing deregulation to have a much easier go of it than they have. So I don't get it.

Yes, it's that politicians and importantly members of the public don't relate. Driving is so ubiquitous in the US that almost everyone does it. Almost everyone with the ability to decide things in America or who has the time to lobby for something has been a driver and can empathize with a driver who was doing their best but encountered something unexpected on the road and ended up in a crash (note my usage of passive language, specifically to build up this frame-of-mind, even though in reality it isn't like this.)

The average American doesn't see themselves as the creators of new drugs nor do they see themselves as airline pilots. Even if the harms American perpetuate via driving are actually worse than the harms of the other two, without the ability to empathize as the creator of a drug or a commercial airline pilot, they're much more likely to favor heavy censure for wrongdoing for something they see as being done by someone else. It's a case of "Look grandma was trying her best when she accidentally crashed into the kid" vs "Those elites at Johns Hopkins trying to pull the wool over our eyes." The less likely the average American is to work a job, the more likely the average American is at heavily regulating that job.

It's a big problem with American regulations because everyday harms are swept under the rug while rare harms perpetrated by a minority are dealt with harshly.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#53

Post by pjscott »

firstlink wrote: post #51
pjscott wrote: post #5

Earlier quoted context omitted.

> They mention, but don't really endorse, liability law models. But today's adversarial legal model in the US is also slow, expensive, and results in tons of cover-your-ass legalese at large places. They allude to no-fault workman's compensation laws, discussed at greater length in this excellent article: https://rootsofprogress.org/history-of-factory-safety The trick there was to take the liability out of the advers…

All three of these things are orthogonal: 1) Negligence vs strict liability 2) Tort model 3) adversarial truth-seeking

Indeed, and I didn't mean to imply otherwise.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#55

Post by pjscott »

mcguire wrote: post #24
pjscott wrote: post #4

Earlier quoted context omitted.

> The regulator can still set legal penalties high enough to stop any innovation, if they want to. A liability model has a couple of advantages despite this: 1. The regulator has some slack to not set penalties insanely high. As long as they're seen enforcing those penalties against someone periodically, and as long as the penalties sound like a big number to the general public, they can look like Stern Serious Regul…

1. If the penalties are not insanely high, it just becomes another cost of doing business issue. 2. If you look at IRBs, how much do you think Scott Alexander is going to be able to pay for liability insurance? The review model does have some advantages.

Making it part of the cost of doing business is precisely the point -- you allow business to go on when it passes a cost/benefit test, and the business tries to minimize that cost by taking safety measures. There's a middle ground between "basically nonexistent" and "insanely high".

Re: Who regulates the regulators? We need to go beyond review-and-approval

#56

Post by Karrot_Kream »

firstlink wrote: post #50
rt4mn wrote: post #47

Earlier quoted context omitted.

I feel like thats a deliberate misreading of the parent comment. Of course the FDA is not, itself, a democratic instution. But then neither is your local police department or NASA. The reason those institutions are accepted despite the lack of direct democratic accountability is because they are still situated within the larger democratic institution (the US government) and subject to oversight by those elected repre…

> Groups like the FDA are democratic institutions > deliberate misreading of the parent comment > Of course the FDA is not, itself, a democratic instution. Can't tell if doublethink or just motte-and-bailey.

What are we supposed to get out of your comment, or is this supposed to just be an unvarnished sneer?

Re: Who regulates the regulators? We need to go beyond review-and-approval

#57

Post by JumpCrisscross »

lacker wrote: post #3

I think the core problem is the incentives of the regulators. Groups like the FDA are democratic institutions, but if their only goal is to have the approval of national politicians, the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released. The FDA must have done something right - what have they done right? We don't even know. Their incentives are…

> the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released

Patient activists and drug companies lobby to make stonewalling approvals difficult.

Re: Who regulates the regulators? We need to go beyond review-and-approval

#58

Post by [deleted] »

konschubert wrote: post #19
js8 wrote: post #7

Earlier quoted context omitted.

The liability model has a big downside, though. Because sometimes people in charge are idiots, they ignore common sense and make risks. So they possibly get burned only when accident happens, which costs human health and lives. Regulation is intended to prevent human harm by setting and enforcing a safety standard.

That is where mandatory liability insurance comes into play. Because the insurer will check... and if the people in charge are idiots, the insurance will charge them high premiums. I am not sure how well this works in practice - but I think the idea has real merit.

[deleted]

Re: Who regulates the regulators? We need to go beyond review-and-approval

#59

Post by throwway120385 »

JumpCrisscross wrote: post #57
lacker wrote: post #3

I think the core problem is the incentives of the regulators. Groups like the FDA are democratic institutions, but if their only goal is to have the approval of national politicians, the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released. The FDA must have done something right - what have they done right? We don't even know. Their incentives are…

> the feedback they get is either negative if there's a bad product released, or neutral if there is no terrible product released Patient activists and drug companies lobby to make stonewalling approvals difficult.

Yeah, I'm pretty sure lobbying and hiring good lobbyists to the FDA is the only reason one of the projects I worked on saw the light of day. If our CEO hadn't already been through the process it would have died in De Novo.
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