Who regulates the regulators? We need to go beyond review-and-approval
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Who regulates the regulators? We need to go beyond review-and-approval
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Re: Who regulates the regulators? We need to go beyond review-and-approval
#2Bad 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 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.
The "ratcheting up" of the regulation enforcement seems like the much bigger problem here than an "review and approve" model itself. The need to look like you're doing anything to try to prevent bad things from ever happening.
We don't see that everywhere - we enforce speeding and reckless driving laws, but sometimes people still die from traffic incidents caused by those. The reaction hasn't been to put ten times as many cop cars on the road, or ubiquitous speed cameras. We did put in cameras for red lights, but those lost a lot of momentum and were pulled back in some places instead of rapidly turning into constant monitoring of everything about driving.
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.
Re: Who regulates the regulators? We need to go beyond review-and-approval
#3As long as the incentives stay the same, I don't see how a change to, say, liability model, would make any difference. The regulator can still set legal penalties high enough to stop any innovation, if they want to.
Ideally there would be some positive incentive on the regulator as well as negative incentives. Perhaps somehow they could be responsible for the overall success of an industry, rather than just avoiding the negatives.
It's especially hard though when you are regulating foreign businesses. It might be dumb to prevent the Microsoft-Activision merger, but what incentive do UK regulators have to get it right?
If the incentives are all just politics then maybe the only real answer is politics, like the YIMBY movement seems to be somewhat effective at fighting anti-housing regulation. It is not really changing the paradigm per se, it is just changing the rules to be more pro-housing.
Re: Who regulates the regulators? We need to go beyond review-and-approval
#4I 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…
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 Regulators who are doing their jobs properly. The difference between a $5M fine and a $10M fine can have huge financial implications, but to the political circus those numbers are both roughly the same size, i.e. big. This allows the regulators to be more reasonable if they want to be.
2. Using liability rather than specific procedural rules lets the people closer to the ground decide how to most efficiently mitigate risk. Suppose that you run a factory, and sometimes people get injured by careless operation of a rotary saw. A naive regulatory approach might be to require that an additional person be watching whenever the rotary saw is in use. And that would probably help with safety somewhat, though at great cost. But if the regulator instead just requires workman's compensation payments to be made when someone gets hurt, then you can try to figure out a better way using your own knowledge of how your factory operates. (Historically, the adoption of workman's comp laws led to factories hiring engineers to make the equipment harder to accidentally misuse. That rotary saw, for example, would have had a cheap guard retrofitted -- and that would improve safety much more, for a much lower cost, than the "have an observer at all times" rule.)
Re: Who regulates the regulators? We need to go beyond review-and-approval
#5So, 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 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 adversarial court system, by not requiring the injured party to prove that the employer was at fault -- only that they got injured somehow. And it worked much more reliably, with less ass-covering and less overhead, than the previous tort-based model.
Re: Who regulates the regulators? We need to go beyond review-and-approval
#6I 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…
Re: Who regulates the regulators? We need to go beyond review-and-approval
#7I 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 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…
Regulation is intended to prevent human harm by setting and enforcing a safety standard.
Re: Who regulates the regulators? We need to go beyond review-and-approval
#8I 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…
Yeah, this is tough, because the obvious counterbalance to "only negative incentives" is to add some positive incentives but the US Patent and Trademark Office is an example of what can go wrong with positive incentives: there are loads of garbage patents on the book and one can't help but wonder if that's because the USPTO is financially incentivized to put them there.
Re: Who regulates the regulators? We need to go beyond review-and-approval
#9 they hired a new staff of administrators to wield the real power. These administrators had never done research themselves, had no particular interest in research, and their entire career track had been created ex nihilo to make sure nobody got sued.
This is not limited to drug approvals, and is imo on it's way to destroying society. Everything we do it governed by safety obsessed technocrats with no understanding of human priorities, only of minimizing liability. There needs to be a return to some sensible balance.Re: Who regulates the regulators? We need to go beyond review-and-approval
#10I 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…
So there is some sort of equilibrium forming, not necessarily an optimal one, but the ratchet does loosen occasionally. For example, FDA has famously succumbed to public pressure and reformed its procedures for drugs for terminal diseases so that patients who have nothing to lose can accept much riskier treatment trials, to speed up development for such drugs.
I say it's not an optimal equilibrium because nobody incentivizes for the common good. Politicians should, but they seldom do. For example, the nuclear industry would lobby and pressure for rapid approval of their existing traditional methods, but they would, as a whole, be very aggressive against a startup with an innovative design. What better way to kill such a competition than to call your regulator, lay out your 'concerns' and bash the startup with thick rulebook, even if those rules are not at all relevant for the new thing, they still have to comply for a 'fair' playing field.