There are a few rationales for this difference in approach of
the two agencies-
- Many factors of failure vs one factor- A particular type of
drug is extremely standardized and has same components (mostly one)
and works the same way. Any product such as a coffee maker is
assembled from hundreds of different parts. A single part out of a
thousand product being defective doesnt mean the product overall is
defective. Simmilarly, as the products under CPSC's ambit are so
varied, they may be failing because of other things or user failure
(like a coffee maker failing due to faulty surge or someone
plugging it in the wrong line). This risk is very less in case of
medicines or food items. The product under CPSC's ambit can be
deemed defective only when there are consistent reports of it
failing in the same manner. A drug or food item on the other hand,
is a chemical and will affect everyone in the same way and hence if
one is defective, all can be considered defctive and can ba banned
even before reaching the public.
- Harm- Most general products, even if systemically defective,
will cause some harm but not on the same level as a defective drug.
Its a calculation between possible harm and monetary cost/effort
from the agency. FDA cant be lax and has higher resources and
researches each product because they will cause griveous bodily
harm to millions already sick people. The CPSC on the other hand
relies on post facto recalls as they judge the risk of harm not
that high.
- Variety- FDA studies same types of products and there is a set
way to test them. It is mostly standard, even if the drugs are
different. The CPSC's ambit has products of extreme variety.
Testing each of them before their release is extremely costly, time
consuming and requires huge amount of resources and expertise. That
is not practical.
For the above reasons, these two agencies work very
differently.
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