Conceptually, however the issue is the way risk aversion is arbitrarily scattered around. It makes perfect sense to me for regulators to value a human life or QALY higher now than in 1900 or 19040 pr even 1970. What does NOT make sense is to value a life lost to nuclear power plant melt down to be valued more than a life lost to coal fire electricity plant emission or the life lost to the side effect of a vaccine more than the life lost from the delay in approving a vaccine while the first life loss was assessed.
Another important distinction between regulations are those that are performance based versus those that are process based.
The Clean Air Act and Clean Water Act are performance based. There is an evidence based process at EPA to set acceptable pollution levels based on best available science. This involves direct open debates about health impacts and cost benefits. Then from those standards permitting systems are developed to reduce pollution below the limits.
Process based regulations like NEPA are completely different. They have no objective, agency defined standards. They are supposed to be public disclosure documents but decades of lawsuits make them ever larger and larger.
For the FDA how much of the growth in expenses for approval is tighter standards and how much is more elaborate processes? I see the IRB craziness as a process step gone awry.
Do you think as a country becomes more "developed", the bureaucratic bloat around regulations deepen which inherently ushers in risk aversion which slows down productivity and progress? Is it a developed vs. developing world phenomenon and the stage in their economic cycle that they are in?
I basically agree with your thrust.
Conceptually, however the issue is the way risk aversion is arbitrarily scattered around. It makes perfect sense to me for regulators to value a human life or QALY higher now than in 1900 or 19040 pr even 1970. What does NOT make sense is to value a life lost to nuclear power plant melt down to be valued more than a life lost to coal fire electricity plant emission or the life lost to the side effect of a vaccine more than the life lost from the delay in approving a vaccine while the first life loss was assessed.
Another important distinction between regulations are those that are performance based versus those that are process based.
The Clean Air Act and Clean Water Act are performance based. There is an evidence based process at EPA to set acceptable pollution levels based on best available science. This involves direct open debates about health impacts and cost benefits. Then from those standards permitting systems are developed to reduce pollution below the limits.
Process based regulations like NEPA are completely different. They have no objective, agency defined standards. They are supposed to be public disclosure documents but decades of lawsuits make them ever larger and larger.
For the FDA how much of the growth in expenses for approval is tighter standards and how much is more elaborate processes? I see the IRB craziness as a process step gone awry.
Do you think as a country becomes more "developed", the bureaucratic bloat around regulations deepen which inherently ushers in risk aversion which slows down productivity and progress? Is it a developed vs. developing world phenomenon and the stage in their economic cycle that they are in?
So what exactly do you have against pillows?😁