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The FDA approval process ensures both that drugs perform an intended function, and that drugs don't harm people. Part of the expense of this process is making sure that both of these aspects are performed to sufficient standards.

It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.

I'm curious how you would see this playing out in a positive light, particularly given the money involved and the incentives to game the system.

Pharmaceutical companies have every incentive to make their drugs safe, because if their drugs hurt people, the drugs will not sell.

Many drugs have passed FDA approval but later killed people. If the FDA were a private company, it might have gone out of business. But as a government monopoly, it's very hard to stop paying for. Between pharma companies, the government, and individual patients, the FDA has the least stake in the health of a particular patient.

UL is an example of a non-government organization that offers product safety certification. You see the UL seal on most consumer electric appliances. Imagine an FDA seal.

Drugs are not magical or special. They are a product like any other, and it is the consumer's right to choose a doctor, and for that doctor to choose proper medication. We regularly choose the best mechanics, plumbers, and other specialists we can find, and their reputation is partly a function of the type and quality of the parts and tools they use.

If you want to see where this kind of free-wheeling approach to cGMP certification and product quality gets you - just take a look at the developing world, where big-name generics manufacturers knowingly dump subpar-quality (or even outright dangerous or ineffective) drugs on the market with impunity. This leads to all sorts of unsavory outcomes, and puts healthcare providers in the position of resorting to incredibly unscientific approaches to dosage management (it's not uncommon for physicians in such cases to recommend dosages many times in excess of what's recommended due to extremely poor active ingredient potency, based mainly on strictly qualitative feedback from patients). It effectively reduces the pharmaceutical market to a guessing game. The quality issues seen in the developing world are also directly linked to antibiotics usage practices that directly contribute to development of resistant strains of bacteria.

It is my understanding that malnutrition, clean water, and access to education/information are foremost among the problems of the developing world, and it's not at all clear to me that regulating medication in those countries would improve anyone's situation measurably.

For my part, here in the "developed" world, I have a family member with a rare autoimmune condition, and access to comparatively few medications. Those that are available are very expensive and not covered by any insurance. There is little competition between their manufacturers.

Because it costs at least 1.4B to bring a drug to market, and because of the rarity of her illness, it's unlikely any company will pursue new research. Thanks to the FDA's inordinately expensive approval process, no company is incentivized to bring a drug to market with an upside of <= 1.4B, regardless of how many people it could help.

UL is not a government organization, but it's not completely disconnected from government regulation.

Most states or localities in the US have building codes which are required to be met to be allowed to build anything in their jurisdiction. These building codes typically require devices to be tested by a recognized lab, of which UL is one.

So there is a choice between UL or some other very similar organization, but you don't have the choice to forgo testing completely or to rely only on some completely different type of testing.

Now of course the public would be better served if the UL could focus on their business without being subjected to the whims of politicians. But the fact that private companies other than the UL can at least compete for the job ensures that costs are reasonable. If the UL charges too much consumers can choose one of their competitors. Even if they have no competition right now another company will arise to compete, if it isn't illegal for another private company to start providing this service.

I see no reason why an individual should not be allowed to build their house with whatever inspection regimen they desire (even none at all). A poorly built house, a house without the endorsement of a respected engineering body, will surely have this reflected in the sale price. I don't see a problem here that needs to be solved.

> It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.

The other side of this is:

1) Since the FDA is a monopoly, it's entirely possible (and probably demonstrable) that they've set the wrong bars, which could have fatal consequences.

2) It's arguable that the costs imposed by the FDA may have fatal consequences themselves, in the form we're seeing today, where life-saving drugs (antibiotics, in this case) can't be developed because of them.

I'm interested in hearing your response to the above two points. I'd also be interested to hear what you'd think of a "de-fanged" FDA wherein they are able to approve or disapprove medications, but are not able to enforce those decisions. People would be allowed to do with their own bodies as they please, but they'd be able to reference the FDA to make those decisions.

Your concept of a de-fanged FDA reminds me of the NTSB and is interesting to think about.

Drugs are not somehow different from any other type of product. All products have some level of risk to the consumer, and may or may not do what they're advertised to do.

    The Car & Truck Administration (CTA) approval process
    ensures both that cars and trucks perform an intended
    function, and that cars and trucks don't harm people.
    Part of the expense of this process is making sure that
    both of these aspects are performed to sufficient
    standards.

And yet, we don't seem to need an FDA of cars and trucks costing auto manufacturers $1.4B to develop a new car, and our cars don't explode and kill us. The reason? A car maker who makes unsafe cars goes out of business. Consider Ralph Nader's "Unsafe At Any Speed" did to the Corvair corporation.

Unsafe at Any Speed as an argument _against_ safety regulations? A creative approach, at least.

Uh, what? In the US, the NHTSA and DOT enforce rather rigorous safety standards, and this requires automakers to front relatively expensive R&D and certification costs. It's a huge (and given the history of motor vehicle safety, necessary) barrier to market entry.

Like the FDA, and as monopolies, NHTSA and DOT have much less stake in the safety of a consumer than do either car producers and drivers.

Personally, I trust myself not to buy a car that I've heard explodes. You may not, and I respect that. But I see no reason to pay for a service that assures you when I myself require no such assurance.

If NHTSA and DOT operated like UL, products that were less safe probably wouldn't have NHTSA or DOT seals, and those products would be much cheaper. People willing to trade safety for cost would be able to own a car. People willing to pay for safety would pay more. Because of the lower barrier to production, there would be probably much greater choice in car buying, and cars would be universally cheaper. In either case, the choice would rest with individual consumers, who know best their situation and risk tolerance.

You're completely ignoring the fact that consumer choices about automobile safety have externalities beyond the buyer. Sure, maybe you and I care enough about auto safety standards to buy a vehicle that isn't dangerous, but I don't trust other consumers to necessarily do the same thing. I don't want to be sharing the road with some corner-cutting jalopy that's likely to throw a tire through my windshield while we're passing each other on the highway, and I definitely don't want a market that permits such low-quality products to be operated in public spaces.

I can think of a few systems in place that mitigate cases like the one you mention.

First, I can think of very few things that could happen to someone's car that would disadvantage you without disadvantaging them. In the case you mention, the missing tire would render the jalopy inoperable, and so the buyer suffers for their poor choice of vehicle. Any buyer thus factors reliability and safety into their decision, whether or not they are particularly concerned about the safety of others. Plus, now they have to walk, and you probably won't be giving them a ride. A counter-argument to this would be effect on climate, an externality that's maybe best left out for now :-)

Second, individuals may sue other individuals for personal or property damage. So, at least one factor preventing everyone from terrorizing you with their jalopies is that they are liable for damage their jalopy causes to others. The decision to purchase a jalopy includes this risk, disincentivizing the purchase of dangerous (to others) vehicles.

Third, it's already a requirement in most jurisdictions that drivers are insured because of the above liability, and insurance companies could easily deny coverage to unsafe vehicles, as determined by any (private) mutually agreed 3rd NHTSA/DOT-like party.

Finally, because there is no competition in the area of safety certification, it seems highly unlikely that the government's assessments of risk correspond to the risk assessed by the average consumer. The fact that most people choose to drive used vehicles that don't meet the government's latest safety standards feels like implicit proof of this.

None of your defenses work outside of a thought experiment where every actor is rational. Real human beings are anything but, and there's a long history of precedents for why all of your positions here are bad ideas (and why regulatory bodies like NHTSA, DOT, and other regulators became necessary).

And your arguments rest on the assumption that politicians and voters are rational, surely?

My bet is on individuals to act in their own best interest. Likewise, politicians have every incentive to act in ways that benefit themselves and their friends at the expense of everyone else. In both cases I acknowledge the capabilities of these humans to use their own brains to think, but only politicians have an incentive become corrupt.

The FDA provides an essential role in verifying the safety of medications and their standards are high because people lives matter.

The reality is that drug development is hard and failure percentage is high. Don't blame the FDA for that. Getting the government out of the picture will either increase the danger to the public with relaxing regulations or have negligible impact on drug development because most drugs fail anyways.

I think it's totally fair to blame the FDA, as it's a monopoly. No entrepreneur is allowed to compete with them and they have no obligation to the consumer -- their only obligations are to politicians. So naturally the costs are sky high and their services don't align with what the consumer wants.

"Peoples lives matter" is meaningless nonsense, and even taken at face value does not imply standards should be high. Remember that high costs and overly restrictive rules introduce delays and prevent drugs from reaching the consumer, and people are harmed and die because of this.

How do we know when the FDA procedures are too restrictive? Well, we can't! Only the consumer can make those tradeoffs for him/herself and communicate their needs and desires via their preferences when selecting products where there are alternatives. With the FDA being a government monopoly there is no such feedback loop, so we just don't know how well their procedures actually align with what the people need.

It's depressing to see how many Americans believe that if something "matters" the only option is to have the government micromanage it. If you're not American then I understand, of course.

How could there not be a monopoly on public safety? The state and the government should have the final word on all things public safety related. Trusting private corporations or companies with public safety is insane.

It's sad and hilarious that Americans truly believe that the government, who is accountable to the electorate, should be somehow disabused of those role simply because it doesn't work as well as they'd like.

You know, instead of reforming it or fixing the problems we have.

The Libertarian "let the free market work" is just complete garbage and history has shown time and time again this doesn't work and will never work.

> How could there not be a monopoly on public safety?

Easily. Simply allow the private sector to provide the services currently under the exclusive domain of the FDA, for example.

> Trusting private corporations or companies with public safety is insane.

I agree 100%. However, companies are not in a position to provide public safety anyway. It's consumers who make up the public, through their choices, who provide for the public safety. They are perfectly capable of being safe without needing the government to interfere in their affairs.

> You know, instead of reforming it or fixing the problems we have.

What's really sad here is the belief that if only we had smarter experts in Washington D.C. they could make the perfect set of rules to regulate everyone's lives, and we would not have any problems. This is utterly naive, and is quite impossible in practice. No matter how smart an expert is, they simply can't know enough to make the optimal balance for you or me. They don't know anything about my life, so how could they evaluate all the trade-offs to make optimal choices for me? There are just too many variables and life is too dynamic.

This is exactly why free markets are great, they provide the distributed feedback that democracy can't. Individuals are free to choose the services and goods that provide the most value, and collectively these preference signals propagate through the market to guide producers, who are in turn free to innovate and create new services they think I will prefer. This "invisible hand" guides the interactions of millions of people across the globe, but it requires freedom.

Wherever there is a free market we see innovation and prosperity. The evidence is all around you.

You start going in the right direction by talking about the cost of the FDA process, but then veer off into the weeds with a solution from extreme Libertarianism. History has shown over and over and over again that this type of hands-off approach and “let the consumer decide” mumbo jumbo absolutely does not work. It’s just as debunked as the trickle down economics theories. They have been tried so many times and failed every time.

If I’m in the ER am I supposed to stop and check every single drug they give me before having emergency surgery? Is the hospital? Would we give the right for every citizen in the country to inspect the premises of every drug manufacturer? So now anyone must be allowed to walk into any factory whenever they want to see what’s going on? How should any layperson be expected to have the knowledge and expertise to even perform an evaluation?

I can imagine some kind of review site where people post 1-star reviews like “took drugs, died anyway”. How many bad reviews/people dead would you say should be enough for a company to be removed?

If you have any choice in how you are treated, you will make your best judgement based on information available to you, such as by the recommendation of a friend, or a Yelp review. This is the same process you use to make any important purchase.

Before you have work done on your car, do you fly to China to inspect the part factory? You don't, because the relatively low risk you perceive that these parts will fail doesn't justify the expense of travel.

Do you perceive low risk because a government agency put a stamp of approval on the part? Probably not. Most likely, your risk assessment is based on information you've gathered about the final product, the auto shop -- that it is well-reviewed, and that your mechanic seems knowledgeable.

Furthermore, only you really know your exact needs. An expensive high-performance car part might provide you some marginal benefit, but not so much benefit that you're willing to buy that part at the expense of something else that's important to you, like your electric bill. A race car or Uber driver might make a different decision and choose a different part to suit their needs.

Medicine is like car parts. Bad ones can kill. But through the free market, a system of feedback is established that tends toward a wider variety, and higher quality, of parts overall.

When politicians prioritize some drugs over others, they interfere with this system, and money is spent on drugs and research that people don't necessarily want or need. You can imagine race car drivers getting together and lobbying politicians to subsidize high performance parts. Because these subsidies are funded by taxes, money is effectively taken from individuals who might prefer a different part. Now, those individuals who are not race car drivers have less purchasing power, and fewer choices overall.

You're correct that this is more or less the libertarian perspective, but I find it in no way extreme. I find it principled, direct, and humane. In our society, where nearly everyone has a smart phone and may conduct research at any time, I can't imagine a more effective system. I'm sure it was much easier to criticize the free market in a time when people couldn't read, or didn't have a global information database accessible on their person at every waking moment.

Man, if only there were some way we could run an experiment where we could see how the industry would react if drugs were not required to be vouched for by a regulatory agency.

Wait, there is: the health supplement industry. You know, the people who can't be bothered to even put in their claimed active ingredients because it's all placebo anyways?

The FDA was set up literally because of these snake oil situations, and modern evidence suggests that snake oil still thrives wherever the FDA is banned from setting foot.

What upsets you about other people using their own money to buy placebos, other than the fact that you can't understand why? At this very moment, millions of people across the globe are buying things for themselves you would never buy for yourself.

Has it occurred to you that the health supplement buyer is in a much better position to decide how to allocate their money than you are? You have limited, aggregate information; they have a total view of their own finances and life situation, and are willing to devote their own time to research their personal decision to buy. For example, they might discover through research that a supplement generally regarded as a placebo has a benefit under circumstances known only to the them.

When you limit the choices of others, based only on general information or your personal perspective, you limit the set of choices others may take. If you do this long enough, you might find yourself some day prohibited from buying something you desperately need, because your situation is an exception to some general rule that nobody ever considered.

The FDA might have made sense at a time when most people were illiterate and information was hard to come by. Now that most (at least in the US) are literate, and own smartphones, taking away choices for the benefit of some hypothetical illiterate serves only to worsen the life of the average person.

> The FDA might have made sense at a time when most people were illiterate and information was hard to come by.

The FDA was established at a time when virtually the entire population of the US was literate [1]. While I don't have the heart to look up statistics, I suspect that the US at the time had the highest (or at least among the highest) newspaper penetration of any country, and that newspaper penetration would have been quite higher than today. Public libraries and schools would have been in full flourish too, by that time. My grandparents grew up on farms on the edges of the High Plains--where you would expect to find the most bumpkin of country bumpkins--and illiterate and ignorant they were not.

For someone whose argument is that the federal agency is necessary only because of public ignorance, you sure seem to be modelling that ignorance you think no longer exists. The problem with your argument is that you neglect to reason that both information and misinformation are incredibly easy to come by, and most people are unwilling or unable to differentiate between them.

[1] It is worth pointing out that, if you measure literacy by the ability to read in your native language, Western Europe has been majority literate for over a millennium.

You're right, that last paragraph is a flawed argument. I retract it, and your findings compel me to assert that I think there was probably never a good reason for the FDA.

But it's the second, and weaker, of the two arguments I made. The argument I develop in my first three paragraphs stands.

Nobody is arguing that the population of the US was illiterate when the FDA was established. The argument is that it might have made sense at a time when the US population was illiterate, but now that everyone has access to a world of knowledge in the palm of their hand 24x7x365 the FDA does not make sense.

The argument was that the FDA never made sense, not even when it was first established in America, and for precisely that reason -- Americans were not illiterate.

>Medicine is like car parts

Creating medicines is nothing like creating car parts. At all. There's not a single aspect of drug discovery, manufacturing, or distribution logistics that in any way resembles something as crude as producing unregulated widgets for automobiles.

You're simply highlighting how poorly you understand the pharmaceutical industry with this line of argumentation.

I mean only to say that they are both products, and that they may both result in injury or death if they are produced irresponsibly.

Would you not agree with those two points of comparison?

I think it's an inane and inept comparison. The manner in which defects arise in each type of product, and the manner in which failure modes manifest are so different as to be incomparable.

I don't see how you can contest that they're both products and that they can both kill people if they're defective. To me these two similarities are plainly true, and it is only these two similarities that are material to my argument.

I might misunderstand, but the direction your argument seems to be heading is that the free market is somehow incompatible with products that have complex failure modes or that can be defective in subtle ways, and that the FDA is thus necessary. Is that right?