The whole reason the FDA is set up this way was due to the rampant fraud that was occurring before there were standards for what could be sold to consumers as medicine.
This is probably true for most patients, but not doctors. Normally, a patient consults a doctor on what drugs to use for their illness and the risk of taking it.
I take your point that companies can falsely advertise their products. I think there is a place for a government body to make sure claims about healthcare products are factual. In this particular case we are talking about a drug that appears to not cause any harm. So I don’t see any reason to prevent an adult to make a decision with the help of a physician to administer said drug.
The problem is that deciding whether something is factual is a lot easier for simple things. For something like this, there are vaguer connections between facts like plaque removal and more nebulous things like meaningful outcomes for patients.
> In this particular case we are talking about a drug that appears to not cause any harm.
Other than brain swelling or bleeding, headache, falling, diarrhea, and confusion, delirium or disorientation, you mean?
Informed decisions are not risk-free decisions. If you're saying that literally no one can provide informed consent to take a drug until years and years of trials have been performed, and their inability to provide informed consent invariably subjects them to functional degradation or death, then this is a perverse system, to say the least.
Note that many people made the same arguments against fast-tracking COVID vaccines for public distribution, which undoubtedly saved thousands if not millions of lives.
I personally agree that the FDA isn't always perfect (they should never have approved SSRI's, for instance) but claiming that there's no tradeoff here is just incorrect.
The fact the people who make a policy have a specific thing they want to achieve with that policy does not automatically make it a good policy. That remains true even if the thing they want to prevent is bad and could kill people.
Stopping stuff like that seems like a reasonable thing for the FDA to do, even at the cost of it taking longer to approve drugs.
"Taking longer to approve drugs" can be restated as "forbidding the use of potential treatments for longer". To the extent that those treatments work better than the next-best option, delaying approval is effectively forcing the worse treatment on everyone who would have switched for the duration of the delay. If there is no alternative treatment, delaying approval is effectively equivalent to forcing the people affected by a disease to just live with that disease for the duration of the delay.
Picking pretty much at random from stuff recently approved by the FDA, we find that Ocrelizumab, a drug to treat multiple sclerosis (MS), was approved in 2017. Patients treated with Ocrelizumab have just over half the chance of developing symptoms bad enough to require a walking aid (4.2% vs 7.3%) as compared to the next-best treatment (interferon beta-1a) over 96 weeks.
Phase III clinical trials of Ocrelizumab started in March of 2011, and completed in July of 2015. In October 2015, Genentech presented the results of the phase III trials to the FDA. The FDA recognized how important this treatment was, and gave it breakthrough therapy designation, fast track designation, and priority review. It was approved for use in March of 2017.
That is uncommonly fast for the FDA, but even so it took them a year and a half to "move fast" on this treatment. Let's be generous and say that determining that the phase III results were not literally fraudulent takes fully 6 months -- that means that in the case of this particular drug, the FDA only delayed approval for a single year. About 150,000 people take Ocrelizumab worldwide, most of which are probably in the US.
As such, the FDA's (much shorter than usual) delay for this particular drug "only" cost about 2,500 people the ability to walk unaided.
How many delays like this does it take before we decide that the cure (delaying effective treatments for nasty diseases) is worse than the disease (occasionally letting through a medication with extremely nasty side effects)?
This isn't a rhetorical question by the way. My personal answer is probably somewhere in the ballpark of "aim for a 1:1 ratio of QALYs lost to drugs that were approved and shouldn't have been : QALYs lost to drugs that should have been approved and weren't". Maybe 1:5, if we think harm from inaction isn't quite as bad as harm from action. But my best ballpark guess for the actual ratio the FDA is achieving is probably more like 1:100 or 1:1000, and I don't find that even remotely reasonable.
(Note that this entirely ignores the question of whether the current FDA does even have the benefit of delaying / not approving stuff that doesn't work, which is the subject of another rather active discussion on HN today: https://news.ycombinator.com/item?id=27472107).