The FDA's creation was directly triggered by multiple mass poisoning incidents in the early 1900s.In 1937 over 100 people died from diethylene glycol-contaminated medicine, leading to the 1938 Food, Drug, and Cosmetic Act that significantly expanded FDA authority.

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3D30497420 12 hours ago | parent | next [-]

As the adage goes, "regulations are written in blood". The problem is the blood was spent before many people can remember (or bother to remember). They just know the "limitations" imposed by those regulations and therefore want to get them removed.

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roenxi 8 hours ago | parent | next [-]

They also would like it if occasionally everyone reviewed legislation in light of whether it actually had a positive cost-benefit. The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. 3,000,000 people die in the US each year right now. Optimising the medical system for nimbleness and low costs is a much better path to take rather than optimising for something that is presented as a statistical rounding error.

If people don't think a drug manufacturer is safe they don't have to buy drugs from them.

	▲	atmavatar an hour ago \| parent \| next [-]
		> The claim has to be something significantly more valuable than a few 100 people dying from poisons each year for the thousands to millions of deaths caused by inefficiencies in the biomedical industry. It's extremely misleading to argue with confidence that even a significant fraction of those thousands to millions of deaths would be prevented if only we had the good sense to eliminate medical regulations entirely and that doing so would only result in a few hundred deaths. It's not just about poisoning deaths from toxic medicine -- it's also about additional deaths from people taking snake oil treatments over proven effective treatments. If the US response to COVID shows us anything, it's that this latter group can be quite significant. A big problem that's led us to where we are is that many in the right wing fringes that brought us the current administration make their fortunes off selling snake oils in the form of supplements. And while I'm sure some will immediately point out that left wing fringes have their own bullshit cures (e.g., essential oils, healing crystals, etc.), the difference is that this group is still treated as the kooks they are.
	▲	JKCalhoun 7 hours ago \| parent \| prev \| next [-]
		I remember the Tylenol hysteria (in the 1980's?) when there were a few poisonings. It may well be that the legitimate drug manufacturers benefit from tight regulation by the FDA. They can give them legitimacy when the public may otherwise overreact. I'm not sure an anything-goes environment is going to be something they're going to enjoy. Oh well.
	▲	morgannewman 3 hours ago \| parent \| prev [-]
		[dead]

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IAmBroom 8 hours ago | parent | prev | next [-]

Maybe it's like Jefferson's admonition that each generation must purchase their liberty in blood.

Not happy about that possibility, but it is a possibility. "What's so bad about measles, anyway?"

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ourmandave 8 hours ago | parent | prev [-]

Like before his confirmation, when RFK wanted to Make Polio Great Again.

And Mitch McConnell, who suffered from polio when he was 2 years old back in 1944, had strong words, but confirmed the anti-vaccine halfwit anyway.

Good job Mitch!

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terminalshort 7 hours ago | parent | prev | next [-]

And if they had stuck with making sure medicine sold is exactly what it says on the bottle instead of expanding to telling me which medications I am allowed to have, I would be their biggest supporter.

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os2warpman 5 hours ago | parent [-]

I was going to say "The FDA, in general, does not tell you which medications you can or cannot take." but often when people make a comment like yours and you press them on it, it turns out they're angry because they can't find a doctor who will inject something insane into an unusual part of their body so instead I am going to ask:

What medicine, SPECIFICALLY PLEASE, does the FDA not allow you to have?

edit: because I'm pretty sure you can find doctors who will prescribe 3 liters per minute of elephant farts to treat high blood pressure, or compound up some turbofentanyl mixed with vitamin q to grow hair on your gooch if you look hard enough and there's nothing the FDA can do about it so most of the time peoples' problems are with insurance companies or pesky medical ethics and various state boards of medicine.

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terminalshort 3 hours ago | parent [-]

Good question. I have narcolepsy. There is a medication called TAK-861 which is the first drug to actually treat the root cause of the disease. It has passed phase 1 and 2 trials proving it is safe and effective. My doctor is involved in the research has said he wishes he could prescribe it to me now, but it is still in phase 3 trials and will not be approved by the FDA for another 2 years, so he can't give it to me.

I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice. If someone else doesn't then that's fine too. I'm not the one telling other people what to do, these worthless busybody bureaucrats are.

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os2warpman 2 hours ago | parent | next [-]

>will not be approved by the FDA for another 2 years, so he can't give it to me.

edit: I wrote a bunch of bullshit and then deleted it but the points are:

1. Narcolepsy sucks

2. The FDA can't stop your doctor from giving you TAK-861, the likely culprit is Takeda. It is 100% legal for Takeda to sell Oveporexton so long as they don't claim that it treats narcolepsy until it has been approved, and it is 100% legal for your doctor to give it to you.

3. Have you looked at >>>RIGHT TO TRY<<<? Again, with this the ball's in Takeda's court.

https://www.fda.gov/patients/learn-about-expanded-access-and...

I know nobody believes me.

Here's an ambulance chaser's blog:

>Unapproved drugs exist in a gray area in U.S. law. Although it is not illegal to prescribe non-FDA approved drugs, it is also not viewed as best practice. If a doctor prescribes an unapproved drug, he or she could face civil liability for the patient’s injuries, illnesses, side effects or death upon taking the drug if the physician reasonably should have known of the potential health risks due to the lack of FDA approval.

https://www.liljegrenlaw.com/can-my-doctor-prescribe-non-fda...

	▲	terminalshort 2 hours ago \| parent [-]
		It may not be the FDA that is directly responsible here, but if the FDA approved it tomorrow, all my problems will go away. That's because, as you mentioned, our system relies on bureaucratic stamps of approval to adjudicate responsibility rather than anything real. Doctors who prescribed oxycontin and harmed their patients get off scot free because they can just say "but I was told it wasn't addictive" because it has this stamp of approval. I will certainly take a look at those links as they may help me, but this doesn't change my opinion on the state of things. It infuriates me that I have to jump through all these bureaucratic hoops to get what I need. There is a company with a product they want to sell, and a customer who wants to buy it. The fact that they won't just sell it to me is an indication that our system is fundamentally broken. I put little weight on the fact that the FDA in particular isn't outright banning me access. They are just one arm of the bureaucratic squid that is strangling me. The FDA says "take this at your own risk" which is on the face of it a fair statement. But they know that the civil liability system, which is just the other arm of the squid, will deny me the ability to actually take my own risk. And they know that the arm of the squid that mandates Takeda can't sell me the medicine without the approval of a doctor means that I won't be able to get through that bureaucratic gatekeeper. So the whole system works together against me while ensuring that no part of it can be blamed because it isn't the decision of any one part that prevents me from getting it, but rather the interaction between these parts. This is why "burn it all down" is such a popular position.

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curt15 3 hours ago | parent | prev [-]

>I despise nothing more than these bureaucrats. If I want to take the risk on a new medication then that's my choice.

Are there laws that would indemnify the healthcare provider for unexpected adverse outcomes for voluntary recipients of experimental drugs?

	▲	terminalshort 3 hours ago \| parent [-]
		I don't know. I doubt it. This points to a fundamental problem in our liability system that there is no simple "This is my choice and there is nobody to blame but me. I take all the risk and can't sue anybody" contract. Our laws are written by lawyers for lawyers.

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JKCalhoun 7 hours ago | parent | prev | next [-]

So it's Chesterton's Fence then.

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api 8 hours ago | parent | prev [-]

My concern is that today this could happen and people wouldn’t care. Peoples cultlike ideologies, political tribalism, and belief systems are more important to them. There was a father whose child died of measles in Texas who continues to be anti vax.

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JKCalhoun 7 hours ago | parent [-]

> cultlike ideologies, political tribalism

It didn't use to be like this. I've considered a number of things in our society that I could point a finger at as the cause but often when I dig just a little below the surface the one thing that I always seem to uncover in all cases is fear.

How did we (U.S.) become such a fearful country? The pace of change? A media narrative? Starting with cable television and 24-hour news?

	▲	api 7 hours ago \| parent \| next [-]
		The US became a fearful (and hateful) country because of the media, both traditional and tech/social. Fear, hate, and other base emotions maximize engagement. A negative story that inspires fear or hate will get often thousands of times more clicks than a neutral or positive one. Media tends to be ad supported and run on attention maximizing KPIs, therefore the media pushes fear and hate. Social media added a layer of personalized algorithm-driven amplification that dialed this way up, which is why politics has become hyper-polarized and dominated by insane narratives. It drives engagement. Edit: the reason for this is probably an evolutionary bias toward negativity and paranoia. As the saying goes: If your ancestor mistook a bush for a lion, they lived. If your ancestor mistook a lion for a bush, they are not your ancestor. We are all the descendants of paranoids. Negative media pushes that button.
	▲	UltraSane 3 hours ago \| parent \| prev [-]
		Fox News has been brainwashing people for a very long time now.