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Comment by WalterBright | Hacker News Reader

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WalterBright·

I don't need government approval to start manufacturing cars. Why for generic drugs?

Note that you're paying plenty for having the FDA as gatekeeper.

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You actually do need approval for selling cars -- EPA and CARB. Similar organizations worldwide.

For emissions, but not for safety. My understanding is the NTHSA does not actually approve a car for sale in the US, it just requires that the manufacturer certify it meets the regulations.

There are numerous federal regulations concerning the manufacturing of cars.

Conforming to regulations are not the same thing as getting approvals/certification.

Your car needs to be certified to not spew shit everywhere in the same way your drug needs to be certified to not harm people who take it. For obvious reasons, one is far more expensive to test and certify.

Is the food in your local supermarket certified to not harm people to eat it? It's regulated, and the FDA can inspect to verify compliance with regulations, but suppliers do not have to get approval from the FDA to ship.

The problem here is the scale of harm and manufacturing of inert or ineffective products, not even too mention harmful ones. This is why every formulation has to be approved.

GMP etc. Requirements have been added after some scandals with tainted stuffs making people sick instead of better.

This would be not compared to mom and pop food stand but a big supermarket chain or food manufacturer.

Actually quite a lot of food is inspected by the USDA.

That's right. But the point is you do not have to send food products to the USDA for approval prior to selling them.

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