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Comment by lettergram | Hacker News Reader

Every time I see the FDA doing anything it drives me nuts.

They are a labeling agency. Ie they confirm and enforce something is what the manufacturer says it is.

That’s the level of consumer protections I want. If it says it’s heroine that’s good, don’t want fentanyl laced heroine.

Why did the FOOD AND DRUG ADMINISTRATION ever keep HEARING aids off the open market?

Im so happy SCOTUS started using the major questions doctrine. Hopefully this can fix some of this stuff

https://eelp.law.harvard.edu/2022/07/supreme-court-embraces-...

Remove the executive authority to regulate hearing devices, eye glasses, prosthetics, etc. I’m fine with a stamp of approval, but not banning sales.

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The FDA has been authorized (and mandated) by Congress to regulate medical devices (including hearing aids, among other things) since the Medical Device Regulation Act was passed in 1976-- this isn't a regulatory agency reaching outside its authorized purview, nor is it the same sort of legal ambiguity that was in question with West Virgina v. EPA.

If you want less regulation in this space, that's a change in the law that needs to go through Congress. Which is exactly what happened here for hearing aids.

Why though? Why stop at drugs and food? Why shouldn't all medical interventions be regulated?

Companies can already sell what is effectively a hearing aid[1] without FDA approval. They just can't market it as such.

There's already too much quackery in the world today, we shouldn't be inviting more of it.

[1] https://www.amazon.co.uk/Bose-Hearphones-Conversation-Enhanc...

You are suggesting that regulation is both an effective way to combat quackery and perhaps even the most effective way?

What about costs and benefits, too?

> You are suggesting that regulation is both an effective way to combat quackery and perhaps even the most effective way?

Yes. To the extent that there are regulatory gaps today, they're almost exclusively filled with quack medicines.

I'm sure the market might work it out in the long-run, but in the meantime people will suffer from inadequate (or even detrimental) medical care.

You seem to accept this logic for drugs, but quack mechanical devices can cause harm as well. For instance, an inappropriate hearing aid could hasten hearing loss.

> What about costs and benefits, too?

We should definitely work to improve the regulatory process, but just giving up on the whole concept of regulation seems counterproductive.

> We should definitely work to improve the regulatory process, but just giving up on the whole concept of regulation seems counterproductive.

Who suggested that?

The original comments suggestion was to improve the regulatory process to the following ideal:

> They are a labeling agency. Ie they confirm and enforce something is what the manufacturer says it is.

> That’s the level of consumer protections I want. If it says it’s heroine that’s good, don’t want fentanyl laced heroine.

That's essentially what the FDA is doing with regards to most medical devices. The 'stamp' is allowing you to make certain claims about a device's ability to have some medicinal effect.

As already demonstrated, Bose was able to sell what was effectively a hearing aid in this new category, but without making any claims about assisting with hearing loss.

I guess what you're suggesting is that manufacturers should be able to make any claims they please with the FDA being relegated to a position of endorsing those claims.

Nothing that has happened in the past few years has given me any confidence that such a system would work (see: Ivermectin, Hydroxychloroquine, Bleach, intravenous UV light, Chelation, et al.).

See https://astralcodexten.substack.com/p/adumbrations-of-aducan... and https://www.econlib.org/archives/2017/01/why_are_drug_pr.htm...

> If we simply went back to pre-1962 law, the FDA could still require proof of safety, but would not be able to require evidence on efficacy. This one change would allow drugs to be developed faster–often as much as 10 years faster. Market success would establish efficacy. Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time. This is nothing new; doctors and patients regularly evaluate drugs for efficacy. Clinical trials often show that perhaps only 20 percent, 40 percent, or 60 percent of patients benefit. Even when the FDA finally approves the drug as “safe and efficacious,” doctors must still evaluate the drug to find out how efficacious it is for each particular patient. In practice, an FDA certification of efficacy is just a starting point.

Btw Ivermectin is FDA approved. I am not sure why you bring that up?

> Market success would establish efficacy.

In the meantime, patients will be switching from drugs with known efficacy to wonder drugs with potentially no clinical evidence of having a medicinal effect.

> Could there be ineffective drugs? Sure. But as doctors and patients learn, such drugs would disappear over time.

Trying to do that piece meal won't work. You need controlled statistical studies to establish such things.

> doctors must still evaluate the drug to find out how efficacious it is for each particular patient.

Generally informed by subsequent clinical trials. They don't just go with their gut.

> Btw Ivermectin is FDA approved. I am not sure why you bring that up?

You know very well why. In fact it kind of makes my point. Patients are attempting to switch from a treatment regime with known efficacy (vaccines) to one with highly questionable efficacy (Ivermectin). If you follow through with your plans to deregulate the pharmaceuticals industry, you'll see a lot more of that.

Because it's the same. A label is a label. Both involve health.

Instead of some fent analogue cooked up in a chinese lab, this knockoff would be cooked up in a chinese lowest cost, cheating encouraged (if you don't get caught), grab parts from wherever, alibaba store room.

We do need to evaluate trade offs between danger, effectiveness, quality control, and price.

IMHO so long as the hearing device won't cause further damage this is a great move and should be treated like OTC glasses.

As to SCOTUS rulings, see below about this specific mandate by law.

However both parties have ceded massive authority to the executive over the last two decades (accelerating with Cheney).

Feels like that is a big part of the problem here.

Regardless, I don't think SCOTUS is making the right rulings on a ton of things, including EPA specifically per your example. Everything under the sun shouldn't have to be enumerated. we have to look holistically and allow the executive to adapt as dangers and circumstances change.

Executive should be allowed to use the powers Congress has given and often been purposefully ambiguous about (see 9/11 security state).

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