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vrganjtoday at 3:26 PM3 repliesview on HN

> A peer-approval system would work both ways. Europe would also take into account FDA decisions

This doesn't seem like a given at all. Just because the FDA accepts EMA approvals wouldn't mean the EMA would accept FDA ones and as a European, I wouldn't want it to.

I have a lot more trust in the EMA than the FDA.


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bogeholmtoday at 5:26 PM

3 years ago I was in pharma in Europe. Back then (a political lifetime ago), the FDA had an excellent reputation and was considered a kind of gold standard.

Get your new drug approved by the FDA, and ~50+ countries would follow more or less on autopilot.

This wasn’t necessarily a bad thing, because as far as I know, they really _were_ that good.

bobthepandatoday at 4:22 PM

The FDA’s big claim to fame is not approving thalidomide when European regulators did, preventing a bunch of birth defects https://en.wikipedia.org/wiki/Thalidomide

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delusionaltoday at 3:39 PM

Peer approval schemes are usually implemented as trade efficiency measures. A one sided peer approval would make it easier to import, while not making it easier to export, causing a delta trade deficit.

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