Live data from Hacker News

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

rootsofprogress.org

31–40 of 105 posts

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

#33

This is a curious extract - why didn't the author do the obvious research? > "I don’t know much about what happened in the ~60 years since Kefauver–Harris [1962]. But today, I think there is good evidence, both quantitative and anecdotal, that the FDA has become too strict and conservative in its approvals, adding needless delay that holds back treatments from patients." There have been endless scandals since then re…

The presence of a handful of scandals with huge settlements does not need that we need more FDA. We need less. Much less. At the very least we need to separate the concept of it being legal for doctors to prescribe a drug and mandatory for insurance to pay for a drug. Right this minute, hundreds or thousands people are actively suffering and dying from rare diseases because it's ludicrously expensive to bring new med…

There's an easy fix for these rare disease cases, but it's not one the pharmaceutical industry likes - open source drug development with clinical trials run by research agencies themselves.

This would mean such drugs would not be exclusively licensed by any private entity, but instead could be manufactured and distributed by anyone that met quality standards, greatly reducing prices for consumers. See Linux etc.

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

#34
post #29

I think the idea of MANDARORY liability insurance against regulatory fines is very interesting. The insurer is motivated to incentivise effective risk-reduction behaviour - the government only has to define the penalties.

Or the insurers are incentivized to lobby for regulation reduction or, worse, cover-ups

It’s true. But the current state is also untenable. People are dying that could be saved if we weren’t making medical trials and environmental review so costly.

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

#35
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…

I wonder if part of the issue is that FDA approval implies Medicare coverage, which is expensive. And so as a pragmatic matter the FDA slows approval for financial reasons. I don't know if it works at all like this, but the thought did come to mind.

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

#36
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…

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.

I agree, though I am much less bothered by a proliferation of pointless patents than by a dearth of life-saving treatments.

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

#37

Another aspect of this is that a lot of regulation doesn't really work, it gets corrupted or bloated in numerous ways because it might help but actually doesn't. The separation between people doing the thing and those overseeing it leads to ineffective regulation that ends up not actually saving lives and also potentially costing a lot of manual time to adhere too. I am not sure liability insurance is necessarily the…

I see this all the time but it seems every time we go through a round of regulation trimming based on that premise we see the industry in question suffering issues within a couple years, and the cycle seems to just keep getting tighter.

The 90s/early 00s cut back banking regulation and then we had the 08 crash. Trump rolled back some rail regulations and now we've got serious incidents happening there. Of course businesses hate the regulations they're generally preventing profitable but very risky behaviors with externalities beyond the business that's taking the risk.

Combine that with Supreme Court decisions that have limited courts abilities to punish companies when they do mess up by limiting things like punitive damages and the picture gets bleak for any option other than up front, very paperwork heavy regulation.

If we could trust businesses to actually follow rules and not take disastrous short cuts to make a buck maybe we could have a less heavy handed regulatory system but time and time again shows voluntary compliance or self regulation isn't a viable option.

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

#38
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 FDA must have done something right

They have just as many issues as any other regulating body. There's many ingredients that are deemed safe in the US that the rest of the world has banned.

Every regulating body has been compromised thanks to late stage capitalism.

Post reply on HN