4 ms·

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 s

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.

michaniskin 6y ago
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.
- sithadmin 6y ago
  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.
  - wooby 6y ago
    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.
    - sithadmin 6y ago
      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.
      - wooby 6y ago
        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.
        sithadmin 6y ago
        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).
- Agathos 6y ago
  Unsafe at Any Speed as an argument _against_ safety regulations? A creative approach, at least.
wooby 6y ago
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.
- sithadmin 6y ago
  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.
  - wooby 6y ago
    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.
tetrometal 6y ago
> 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.
- wooby 6y ago
  Your concept of a de-fanged FDA reminds me of the NTSB and is interesting to think about.

michaniskin 6y ago

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.

sithadmin 6y ago
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.
- wooby 6y ago
  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.
  - sithadmin 6y ago
    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.
    - wooby 6y ago
      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.
      - sithadmin 6y ago
        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).
Agathos 6y ago
Unsafe at Any Speed as an argument _against_ safety regulations? A creative approach, at least.

wooby 6y ago

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.

sithadmin 6y ago
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.
- wooby 6y ago
  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.

tetrometal 6y ago

> 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.

wooby 6y ago
Your concept of a de-fanged FDA reminds me of the NTSB and is interesting to think about.