However, I do agree that it's a difficult topic, in general. Off-label drug uses is one example.

Well, if all you have to do is compare the patient's health outcome of, say, 3 days with water vs. 3 days without, I am sure you could find a very positive correlation between the two treatment paths.

I have no problem with the FDA as a certification agency, whether they're certifying safety or efficacy or both. I do have a problem with their approval being mandatory in order for the product to be sold. If their stamp of approval means anything—if lack of FDA approval implies that a product is unsafe and/or ineffective—then doctors, insurers, and patients will all look for that approval and avoid products without it. The problem is that "safe and effective" is neither necessary nor sufficient to obtain FDA approval.

The existence of uncertified, or just differently certified, options should also put some downward pressure on the prices of the certified options compared to the current monopoly environment. When everyone has to obtain FDA approval there is no incentive to minimize the cost and plenty of reason for established incumbents to make approval as expensive as possible to lock out any potential competition. You can always push for "more safety" above and beyond the level of risk reasonable people would be willing to accept.

Downward pressure is nice from unapproved/unknown stuff, but any kind of price stratification inevitably leads to harm for those who are at risk the most.

People already order generics on "ebay" and a lot of those shipments are seized at customs, etc.

We know why prices are high in the US. And that's not because the need to go through FDA approved trials, but because of patents and because every other developed market got their shit together and negotiates in bulk with suppliers. (Thus the US market is what pays for most of R&D.)

> FDA approval there is no incentive to minimize the cost

Do you mean the cost of going through the approvals? I think it should be largely subsidized (and ratio should be computed from a reputation score of the requester - of course using the lower bound of the Wilson score interval, or something similarly fast converging).

> established incumbents to make approval as expensive as possible

True. But there are quite a lot of newcomers. VC money is pouring into medical tech. (Though usually small promising research projects [and sometimes the labs themselves too] are bought up wholesale by bigger companies that then do the preclinical and clinical trials and the FDA approval.) This of course incentivizes incumbents to consolidate.

Keeping the approval sane is largely the job of watchdog organizations (NGOs, other civil advocacy groups, expert groups). Of course filtering the lobbyist bullshit should be the job of everyone's beloved dear leaders. The incentives are not stacked in the common man's favor, as we already know it for some time.

Pushing for safety is of course the usual think of the children argument, but I'm not pushing for more. I'm pushing for the same amount that is currently there.

Furthermore, the FDA costs are almost negligible compared to the development cost of new drugs. (Seriously, it's less than one percent.) And running clinical trials themselves cost a lot of money. Which is something that cannot be simply avoided. Because human biology is very complex, and even with these trials getting the signal from the noise is not easy. Just look at the mess in psychiatry ( https://slatestarcodex.com/2019/05/07/5-httlpr-a-pointed-rev... how basically targeting one gene is [almost?] completely uselss)

How do you handle situations where the provider doesn’t know/care which is best either and just chooses the intervention that was the most heavily marketed to them?

Why do we see new patent drugs replace the “old and boring” generics without any proven efficacy benefit?

It's not perfect, there are still abuses, but it's nowhere the circus we see in the US.

In the same vein, I often get to read about an emerging approach called precision medicine.

Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology or prognosis of those diseases they may develop, or in their response to a specific treatment [1]

[1] https://en.wikipedia.org/wiki/Precision_medicine

SSRIs being top of the list of drugs that "sometimes work sometimes don't" I think are a good example of why the FDA rubber stamping efficacy are still good. I'm not convinced I'd had those sheets of paper if drug makers had the run of the market.

I've never actually seen evidence that a "free market" (i.e. drug market with no FDA) results in a better world for consumers, unilaterally.

This may work if the decentralized decisions were made based on results. But they are often made based on profits and there is a lot of money to be made in doing useless therapies.

Nothing is stopping decentralized decision making, you just need to market whatever non-effective but safe remedy you're selling as a food supplement, a tea or whatever. You just can't advertise that it's a drug.

Unfortunately, this is false. The FDA will still intervene in situations where it doesn't like what you're doing even if you don't advertise your work as a drug, medical procedure, or as having any particular efficacy.

https://www.technologyreview.com/s/603530/a-biohackers-plan-...

On another note, see the sensor pads story here: http://www.fdareview.org/devices.shtml

"We rarely get to try products that the FDA fails to approve, and we never get to try products that are never brought into existence because FDA rules and regulations have made research and development uneconomic. As a result, the public remains ignorant of the true costs of FDA power."

But yes, the FDA aren't complete morons. If you're selling genetically modified dogs you're obviously selling the results of an unapproved medical procedure to the public, even if all you say about it is that you're selling fluffy friends to the public.

The second story you've linked to is one where someone was clearly trying to sell a replacement for breast examinations to the public.

I've never heard about the "sensor pad" before, and there's probably a good case to me made for such a device being more beneficial than not, and that the FDA made a mistake etc.

But I think their process is more sound than not in demanding clinical trials of these sorts of products. This is because in practice people will use them as a replacement for going to their physician, so having some DYI breast cancer scanning kit doesn't just need to be harmless in isolation. You also need to consider the increased death rate from people not going to their doctor for an examination as a result.

This is completely false. Proof: homeopathy and chiropractic are very popular and still on the market.