[freedomben]

Personally, I think it's egregious to deny people possible treatments, particularly in cases like that. I think FDA should be very strict on approvals (i.e. giving it that stamp), but should not be gatekeeping people. If people want to take non-FDA approved stuff, I don't see why regulatory and/or law enforcement should care. There's an incredible amount of paternalism inherent in the current system that nobody ever seems to question, and that blows my mind.

Now that said, I have a huge problem with this skipping. FDA rules need to be applied consistently and follow the process. I'm sympathetic to the desired outcome, but the problem is the system is set up as a gatekeeper. Fix the system, don't try to hack around it like this. That just further undermines trust and faith in the system.

[dabraham1248]

> If people want to take non-FDA approved stuff, I don't see why regulatory and/or law enforcement should care.

Well, among other things, if anyone makes money selling colored water, it encourages others to sell colored water. It also encourages companies that are trying to sell actual drugs to skip that expensive "testing" phase. Bad money usually chases out the good (https://en.wikipedia.org/wiki/Gresham's_law) so it's likely that we will devolve into a system where very few drugs are adequately tested.

I'm not saying it never happens, but if a law, policy, or agency reduces big corporation profits, then it's almost always because lots of people were dying.

[freedomben]

If so many people were buying non-FDA approved drugs that drug-makers stopped pursuing FDA approval, I think that would be quite indicative that there are some serious issues with the FDA process. At a minimum, that would demonstrate severe system mistrust. Some pressure to improve might be good for them. If the FDA process were bad enough, there would also be a possibility of new standards bodies emerging to provide some third party system. FDA could learn from these and adapt to be better.

I just can't imagine that people would widespread start using drugs that aren't approved though. That's definitely something to watch out for though.

[makmanalp]

> If so many people were buying non-FDA approved drugs that drug-makers stopped pursuing FDA approval, I think that would be quite indicative that there are some serious issues with the FDA process. At a minimum, that would demonstrate severe system mistrust

Or, it might indicate a financial incentive to get consumers to mistrust a barrier to profit. People in the aggregate are not the most rational actors, in no small part due to information asymmetry. Self interest does not necessarily yield optimal or even good results.

For example, take the new trend of waiving inspections when purchasing homes to outcompete other buyers. This is legally allowed in some places and is getting more common in places where it's a seller's market and there's lots of potential buyers.

Now I'm not so pompous enough to think that even after reading a few articles or books that I can reliably tell structural damage from easily repairable shoddy work. At least not enough that on a million dollar home purchase, I could risk being out of a home for a while or a couple of hundred thousand dollars.

But there are some buyers for whom this is not an impediment: ones who have enough capital that a bad house or two wouldn't make a big dent in their bottom line, and ones who don't truly understand the kind of risk they're taking and think they have a decent deal on their hands.

The result is that waiving inspections to buy homes is the new standard to be able to compete as a buyer at all, meaning there is now incentive to not fix serious issues in homes or even patch over them to make them less visible. Financial incentive for selling a better product reduces because the bad ones will sell. Quality of homes on the market goes down. Meanwhile those who can compete to buy the better deals are now a smaller population, but they still need homes. Price efficiency goes down because on average people are buying worse homes for more money.

[michaelmrose]

The argument against it is soaking the health care system for unlimited funds until it collapses or simply becomes unaffordable.

For the horrible things at the edge of treatability and beyond there are always many promising ideas most of them worthless or bad and the price people are willing to pay is either all their money or all everyone's money depending on whether insurance covers it.

If you don't allow insurance to cover it then only a handful of rich folks get soaked but this is politically difficult to maintain.

[freedomben]

Insurance already has plenty of leeway to deny coverage for medications, even ones that are FDA approved. If the political unpopularity mattered that much, I'd expect it to already be the case.

[michaelmrose]

Despite the thorny nature of insurance they do already cover lots of things that don't do much good or aren't very efficient. Also medicaid/medicare are more susceptible to political considerations.

[tchalla]

What’s the best argument you’ve heard against your position about it people taking non-FDA approved stuff?

[freedomben]

well, "best" is subjective, but IMHO the best argument against it is that some companies would skip FDA altogether and try to go direct to market, and would use marketing tactics to undermine faith in the FDA and convince people that the lack of FDA approval doesn't matter.

Personally, I do think this would happen, but I think there are better ways to combat this than to use force of law to gatekeep which molecules people are legally allowed to put into their own bodies. We could (and should) still require them to provide evidence for any claims they make, and failure to provide evidence opens them up for liability. There are situations in which paternalism seems justified, but I think in this we've gone way overboard.

[camel_Snake]

AFIAK FDA doesn't regulate what you, yourself, are legally allowed to consume but rather what companies are allowed to market as drugs and legally distribute as such.

For example you can bring your own non-FDA approved drugs with you to the US for personal consumption. I found the following document, section 9-2 covers this topic: https://www.fda.gov/media/71776/download?attachment

[freedomben]

That's a fair point, although the FDA (IIUC) has power to say whether some drug must be gated behind a prescription or can be over the counter. For over-the-counter stuff I think you have a good point, but for prescription drugs (which I'm sure is all or nearly all of the interesting drugs) they are gatekeepers.

[thayne]

That gatekeeping protects desperate people from being scammed into spending tons of money on ineffective, and possibly dangerous treatments.

Is it perfect? No. Could it be improved? Yes. But the rules exist for a reason.

[freedomben]

You would still have FDA and the approval process, and it could continue to be strict (or even stricter). If vendors are lying about their product being FDA approved, that would be illegal (just like it is now). I don't see how this would change anything in that regard.

[redserk]

I'm surprised how many people are either forget or intentionally misrepresent the actual real-world scenario of letting people handle medical advice by themselves.

We already did this experiment 1-Javascript-Framework-lifecycle-equivalent ago.

https://en.wikipedia.org/wiki/Ivermectin_during_the_COVID-19...