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The Collapse of the FDA

nytimes.com

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Re: The Collapse of the FDA

#41

Post by jcranmer »

monero-xmr wrote: post #34
sorcerer-mar wrote: post #31

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

The more-or-less unregulated drug industry that you envision is something that already exists: it's called "health supplements." And it's a disasters; there's been quite a few studies that show that many of the companies selling health supplements can't even be bothered to put in their claimed active ingredients.

This isn't some hypothetical "well, we haven't tried to see what it would look like without regulation;" this is something that is already in existence and whose effects can be measured today!

Re: The Collapse of the FDA

#42

Post by Skates1616 »

cosmicgadget wrote: post #17
dmm wrote: post #9

Reading "Bottle of Lies" by Katherine Eban, I'd argue that the collapse of the FDA was well underway before the current administration. The FDA was completely unable to regulate overseas drug manufacturers, resulting in many, many problems. Sincere attempts to inspect overseas drug makers with random inspections universally results in shutdowns, which cause politically unpopular drug shortages, making enforcement pol…

That seems more like an "underfunded and underjurisdictioned" problem for a portion of what they do, rather than collapse of the agency.

I’m very familiar with this space, specifically parenteral manufacturing.

The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.

As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.

And truly it gets worse every year…

Re: The Collapse of the FDA

#43

Post by op00to »

monero-xmr wrote: post #29
sorcerer-mar wrote: post #27

Earlier quoted context omitted.

[flagged]

Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is

Weird. I worked for and dealt with the government for extensive periods of time, namely cancer and basic biomedical research. We did fucking awesome things. Go hide in a lot cabin in the wilderness or something and leave the rest of us to our civilization. Don’t take us all down with you.

Re: The Collapse of the FDA

#44

Post by AdieuToLogic »

monero-xmr wrote: post #34
sorcerer-mar wrote: post #31

Earlier quoted context omitted.

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

> Should allow pharma to sell drugs to the market.

This was the case pre-FDA. IIRC, that is how heroin was sold in drug stores. See also OxyContin[0].

> Allow people to sue if they are harmed.

So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations?

> Do not care about a government agency preventing access to new drugs.

See previous reference to heroin once being an over-the-counter product.

0 - https://apnews.com/article/purdue-pharma-sackler-settlement-...

Re: The Collapse of the FDA

#45

Post by terminalshort »

sorcerer-mar wrote: post #31
monero-xmr wrote: post #29

Earlier quoted context omitted.

Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is

Anyone who has worked in drug development knows how vital FDA is. The FDA costs taxpayers less than $4 billion per year. If FDA is a net negative, next time you need a medication you're aware you can go participate in a Phase I study, and get paid to take a cutting edge drug for it? Why bother looking at the stuff on the medicine shelf that costs you money? Can you give us all an idea of your experience working with…

The actual budget of the FDA is $4 billion. The overly restrictive regulations it puts on drug development and manufacture of generic medication costs 10-100x that.

Re: The Collapse of the FDA

#46

Post by terminalshort »

AdieuToLogic wrote: post #44
monero-xmr wrote: post #34

Earlier quoted context omitted.

Should allow pharma to sell drugs to the market. Allow people to sue if they are harmed. Do not care about a government agency preventing access to new drugs. They can gatekeep government funds at best, limiting Medicaid / Medicare to those that want to pass their hoops My experience is in selling tech to government. Disgusting and corrupt.

> Should allow pharma to sell drugs to the market. This was the case pre-FDA. IIRC, that is how heroin was sold in drug stores. See also OxyContin[0]. > Allow people to sue if they are harmed. So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations? > Do not care about a government agency preventing access to new drugs. See previous reference to heroin once…

> So you advocate a costly post-harm remediation instead of a preemptive solution provided by governmental regulations

Absolutely. Such solutions tend to be much cheaper and more effective. It's how we deal with the vast majority of problems for a good reason.

If we sold oxycontin over the counter we would have much less of an overdose problem than we do. Would also take a lot of stress off our emergency medical care system which spends an inordinate amount of time just dealing with addicts looking for drugs.

It's a funny example to use to justify the current regulatory framework because oxycontin got approved by the very same.

Re: The Collapse of the FDA

#47

Post by GregDavidson »

stevenAthompson wrote: post #32
clumsysmurf wrote: post #8

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma." Anyone know what chelating compounds he is talking about…

"We do our peers, countrymen, students, and children a grave disservice by admonishing them to think for themselves without also giving them the critical thinking tools to do so, for in so doing we foster a culture where "independent thought" is equated with "contrarian thought". This gives rise to an anti-intellectual, anti-science paradigm that supports an idea not because it meets a basic standard of evidence, but…

Important quote! Citation?

Re: The Collapse of the FDA

#48

Post by nine_zeros »

monero-xmr wrote: post #38
nine_zeros wrote: post #35

Earlier quoted context omitted.

> Government agencies that spend massive amounts of tax dollars while accomplishing nothing and being net-negative for society. Anyone who has worked for or dealt with the government for extended periods of time will clearly know how fucked it is This is only true of republican governments. Republican-led governments are truly appalling in their spending, and wasteful tax cuts. Democrat governments are far far more e…

[flagged]

> The funds then are redirected to a sclerotic and uncaring state, and then the productive people are shamed when they ask for less of it to be taken.

In republican governments, yes this is real.

In democrat governments, the vast majority of taxes goes into productive issues such as education, transportation, and healthcare. Even the type of bills passed by democrats are friendly towards building a society.

Now, YOU may not want to pay for other's education, transportation, and healthcare. But a lot of people appreciate that access to high quality is not merely limited to the wealthy. This is why you'll see amazing companies in blue states vs red, you'll see amazing companies starting during blue federal governments vs red.

The data is very clear on what produces great outcomes for society. You might not want others to get a decent life but you need to admit your selfishness.

Re: The Collapse of the FDA

#49

Post by alejohausner »

kevin_thibedeau wrote: post #33

I wish someone would convince RFK that prescription drug ads are bad for his brand of quack medicine. We could at least get rid of that societal cancer while the rest is torn down.

I’ve heard RFK say that it’s hard to ban TV ads for drugs. They are “speech” according to the 1st amendment, or something like that.

Too bad. News broadcasts are full of those ads, and hence TV journalists are loath to investigate the people that pay their salaries.

Re: The Collapse of the FDA

#50

Post by frosted-flakes »

stevenAthompson wrote: post #32
clumsysmurf wrote: post #8

“FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma." Anyone know what chelating compounds he is talking about…

"We do our peers, countrymen, students, and children a grave disservice by admonishing them to think for themselves without also giving them the critical thinking tools to do so, for in so doing we foster a culture where "independent thought" is equated with "contrarian thought". This gives rise to an anti-intellectual, anti-science paradigm that supports an idea not because it meets a basic standard of evidence, but…

Excellent statement, but who is the "great man" who once said this?
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