I think this risks creating a perverse incentive where actually creating a cure is hard but looking like you maybe, sometimes, if you squint just right, cure the illness is easy. So companies start to ignore those hard cures in favour of sugar pills with warning labels on.
You can already do that though. There's a massive essentially unregulated market full of "supplements" and "alternative medicine" and "faith healing" you can play in if you're dedicated to the business of scamming people who don't look at claims skeptically, including but not limited to people who have terminal diseases. This regulatory process does absolutely nothing to prevent that. However, due to the broad authority of agencies like the FDA and DEA to outlaw drugs that demonstrably do something, we are left with a situation where most of what gets shut down is actual useful medicine
These aren't black markets, and they're frankly not regulation failures either. Regulatory bodies serve an important role in creating a standard people can rely on for claims that things work as medicine. They should not serve the role of making it so that people can't get their hands on things at all if the regulatory body doesn't deem them effective. If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fails to get their treatment approved, it's often more illegal to sell it than if they just claimed it worked without trying to go through the proper channels
This situation is made even worse by the Controlled Substances Act and the Analogue Act, which not only artificially restrict both supply and access to a ton of effective medications, but also create this onerous donuthole where a substance can be shown to be effective enough to warrant criminalization, but not pass the rigorous standards to be approved as medicine. It would be a lot better for everyone but enormous pharmaceutical monopolies and police states if we kept regulatory bodies' role to quality control, an official standard by which medical claims could be judged as a guide for laypeople, and fraud prevention.
> If a person can see that a treatment is not FDA-approved and decides to try it anyway, the FDA's hands are clean. The failure is that if someone tries and fails to get their treatment approved, it's often more illegal to sell it than if they just claimed it worked without trying to go through the proper channels.
This is a regulation failure because a good regulatory framework shouldn’t allow this at all. It’s not about whether “the FDA’s hands are clean,” it’s about what system should be in place that gets us to the outcome we want. In my mind, this would be a place where ineffective treatments aren’t allowed (because why should they be?), but safety/efficacy is then traded off against what the patient needs.
Coming from outside the USA, it sounds to me like the regulatory system isn’t achieving any of that? I think I agree with the broad thrust of what you’re putting forward, my issue only comes with the “guide” part. Medical experts need to be the ones leading the treatment because… well… they’re the experts.
Don’t get me wrong, I can see how Americans distrust government after having a president suggest drinking bleach during Covid might work live on TV.
No because bleach is a cleaning product and it works. But I don’t want a pharmacy advertising sugar pills as being able to cure anything outside of your sweet tooth. Obviously this is an extreme example (I’m sure even the USA doesn’t allow sugar pills to be sold as actual medicine) but I’m taking from this thread that there are ineffective medicines being sold but potentially useful medicines being blocked. Maybe I’m wrong, I don’t live in the US.
Right, regulatory agencies should absolutely resolve false advertising disputes, and the FDA is well-positioned to assess claims about medicinal efficacy. I don't think it should be able to prevent people from voluntarily accessing experimental treatments they can't verify, knowing the risks of doing that, which they currently do