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Comment by vrganj | Hacker News Reader

> 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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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.

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

This was also an entire lifetime ago.

The modern FDA's big claim to fame is having the previous head of it forced out, then nearly immediately approving controversial fruit-flavored vape products at the behest of a POTUS who both owns stock in Altria/Philip Morris and receives millions in Super PAC money from the tobacco industry.

Past performance is perhaps not indicative of future results.

Theoretically speaking, if the standards are broadly aligned, there is something to be said about reducing duplicative efforts to regulate. The EMA has partnerships with other regulatory agencies already. https://www.ema.europa.eu/en/partners-networks/international...

Like, you don't need two agencies to test that the side effect of a medicine is nausea.

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.

That how you end up with chlorinated chicken you'd never knowingly eat.

Obviously any authority that takes its job seriously makes decisions based on facts and not blind trust.

Why is a trade deficit something to worry about? After all, my local grocery store buys nothing from me, but we both benefit from the exchange of goods and currency.

Furthermore, even if the trade deficit was something to worry about, why should the food and drug safety bureaucracies be the ones to determine that kind of economic policy?

That's a problem for the country with insufficient approval schemes to deal with, especially if they're also doing more work out of spite.

For a country which has a sufficient approval scheme, they lose little by choosing not to trusting an insufficient approval scheme.

This isn't about trade efficiency though, it's about bypassing an inefficient bureaucracy by allowing for approval by a more efficient one as an option.

We have no intention of dropping our standards to US ones, but they are welcome to follow our lead. (Or don't! It's up to you, just don't make it our problem!)

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