4 ms·

> accurately labeled product with a risk-benefit trade off, the customer knows what the product is and is exercising informed consent, and the government says t

by rchaud 3y ago

> accurately labeled product with a risk-benefit trade off, the customer knows what the product is and is exercising informed consent, and the government says they can't have it anyway. The FDA's regulatory purview is to limit the collateral damage (negative externalities) of even accurately labeled products. Informed consent from the customer is one side of the equation. Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage".

AnthonyMouse 3y ago
> Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage". By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. The government should generally be concerned with preventing deception and coercion and pricing externalities, because otherwise people have the incentive to do them and they would be prolific. Things nature punishes directly don't need the state to deter them. They happen by accident rather than by motive and we choose purposely to spread the cost of this across the population as a form of insurance and a cost of living in a free society, sometimes even when the misfortune is a result of their own stupidity. Other times we send them a bill for costs.
- growse 3y ago
  > By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. It's almost like there's a balance of harms to be evaluated. I'd bet the cheap availability of paracetamol etc. saves more hospital visits than it causes, but I don't have the data to hand.
  - AnthonyMouse 3y ago
    > It's almost like there's a balance of harms to be evaluated. Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all?
    - TimTheTinker 3y ago
      In my opinion, this the best type of argument for a liberal, free society that is possible within a utilitarian moral framework. Generally speaking, each person is best aware of their own context and can choose best for themselves how to take care of themselves and those in their family. I'm not arguing against regulatory oversight of the free market - the FDA should exist. But there's a lot of talk about "harm reduction" and even "nudging" or "shaping" of society that I think needs to go away. I'm fine with billboards being banned (along with corporate lobbyism); but don't tell me I can't buy something because some other people could hurt themselves with it if they use it in the wrong way.
    - error_logic 3y ago
      Even that depends on the scale of the risks involved.
    - growse 3y ago
      > Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all? It depends on the context. In many, many contexts, people are explicitly not the people with the most knowledge about their circumstances. When I'm crossing a pedestrian foot-bridge, I have much less knowledge about whether this particular bridge is safe or not than the people who built it and the regulators who regulated it. The same is true when I drive my car, take medication, eat food, etc. etc. etc. I make risk decisions every day, but those decisions occur within a societal context, and part of that context is a general regulatory framework. We are not all experts in everything. Which is why we (The People) gather together and delegate that responsibility in general to bodies of experts who try to make context-aware determinations about what in general should be allowed, what shouldn't be, and what should be left up to the end-user. It's a vast spectrum, and people often disagree about what goes where - this is fine! But if you want to get rid of the spectrum and have everything decided by people who should have "the most knowledge of their own circumstances", then it sounds like you're in favour of people dying and then blaming them for it.
      - junofan 3y ago
  - akira2501 3y ago
    > It's almost like there's a balance of harms to be evaluated. Yes, and I don't trust that the government can generate a one size fits all model that universally reduces harm. They're just not capable of it, and yet they comfortably assert their authority as if they are, and so they act without actually taking any measure of the impact of their own actions. It's the problem with any agency. Sometimes the best answer is actually "do nothing" or most likely "regulate elsewhere through different authority." So, I don't think the FDA paying an oversized amount of attention to one retail segment is going to do anything meaningful in the long term and we shouldn't have to pay for their amateur expeditionary efforts here, both in terms of funding the agency, and in allowing them to control markets on their own without any request or complaint process driving their actions.
- paulmd 3y ago
  Paracetamol is one of the most dangerous OTC drugs on the market, with one of the narrowest theraputic ranges and almost certainly would not be approved today. However, as the article mentions the FDA tends to lean strongly towards grandfathering existing things regardless of risk, unless they're "the fun drugs" or pose a manufacturing/diversion risk somehow.
fluidcruft 3y ago
I'm not really sure what you're referring to, but the closest I can interpolate is that you are probably confusing the FDA with the DEA.

by rchaud 3y ago

AnthonyMouse 3y ago

> Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage". By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. The government should generally be concerned with preventing deception and coercion and pricing externalities, because otherwise people have the incentive to do them and they would be prolific. Things nature punishes directly don't need the state to deter them. They happen by accident rather than by motive and we choose purposely to spread the cost of this across the population as a form of insurance and a cost of living in a free society, sometimes even when the misfortune is a result of their own stupidity. Other times we send them a bill for costs.

growse 3y ago
> By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. It's almost like there's a balance of harms to be evaluated. I'd bet the cheap availability of paracetamol etc. saves more hospital visits than it causes, but I don't have the data to hand.
- AnthonyMouse 3y ago
  > It's almost like there's a balance of harms to be evaluated. Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all?
  - TimTheTinker 3y ago
    In my opinion, this the best type of argument for a liberal, free society that is possible within a utilitarian moral framework. Generally speaking, each person is best aware of their own context and can choose best for themselves how to take care of themselves and those in their family. I'm not arguing against regulatory oversight of the free market - the FDA should exist. But there's a lot of talk about "harm reduction" and even "nudging" or "shaping" of society that I think needs to go away. I'm fine with billboards being banned (along with corporate lobbyism); but don't tell me I can't buy something because some other people could hurt themselves with it if they use it in the wrong way.
  - error_logic 3y ago
    Even that depends on the scale of the risks involved.
  - growse 3y ago
    > Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all? It depends on the context. In many, many contexts, people are explicitly not the people with the most knowledge about their circumstances. When I'm crossing a pedestrian foot-bridge, I have much less knowledge about whether this particular bridge is safe or not than the people who built it and the regulators who regulated it. The same is true when I drive my car, take medication, eat food, etc. etc. etc. I make risk decisions every day, but those decisions occur within a societal context, and part of that context is a general regulatory framework. We are not all experts in everything. Which is why we (The People) gather together and delegate that responsibility in general to bodies of experts who try to make context-aware determinations about what in general should be allowed, what shouldn't be, and what should be left up to the end-user. It's a vast spectrum, and people often disagree about what goes where - this is fine! But if you want to get rid of the spectrum and have everything decided by people who should have "the most knowledge of their own circumstances", then it sounds like you're in favour of people dying and then blaming them for it.
    - junofan 3y ago
- akira2501 3y ago
  > It's almost like there's a balance of harms to be evaluated. Yes, and I don't trust that the government can generate a one size fits all model that universally reduces harm. They're just not capable of it, and yet they comfortably assert their authority as if they are, and so they act without actually taking any measure of the impact of their own actions. It's the problem with any agency. Sometimes the best answer is actually "do nothing" or most likely "regulate elsewhere through different authority." So, I don't think the FDA paying an oversized amount of attention to one retail segment is going to do anything meaningful in the long term and we shouldn't have to pay for their amateur expeditionary efforts here, both in terms of funding the agency, and in allowing them to control markets on their own without any request or complaint process driving their actions.
paulmd 3y ago
Paracetamol is one of the most dangerous OTC drugs on the market, with one of the narrowest theraputic ranges and almost certainly would not be approved today. However, as the article mentions the FDA tends to lean strongly towards grandfathering existing things regardless of risk, unless they're "the fun drugs" or pose a manufacturing/diversion risk somehow.

fluidcruft 3y ago

I'm not really sure what you're referring to, but the closest I can interpolate is that you are probably confusing the FDA with the DEA.