[nybble41]

That would be plain false advertising. The FDA doesn't need to get involved in such trivia.

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.

[pas]

The lack of safety would affect those who can't afford the "approved" options. :/

[nybble41]

Which is more likely to cause an issue, a treatment with no FDA safety approval (but also no history of problems, and possibly safety approval from some other trusted organization) or going without treatment altogether because you can't afford the one with FDA approval and everything else is prohibited?

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.

[pas]

Mixing up cross-approval (from let's say the EU's EMA) with no history is very dangerous. Exactly because snake fucking oil salesfolk rely on the latter.

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)