[e-_pusher]

There is the famous example of Thaladomide, which was approved by the regulators in the Germany and caused a disaster in birth defects:

https://en.wikipedia.org/wiki/Thalidomide_scandal

US FDA however was skeptical of the safety of the drug and never approved it for sale in US.

[smsm42]

It doesn't look like FDA - or, specifically, Frances Oldham Kelsey - had any data or any evidence to suspect something was wrong with thalidomide. Partly it was because the manufacturers hid whatever suspicious data they had, but Kelsey had no way of knowing it - she basically just run out the clock until it so happened that the news about birth defects caused by it started coming in. That seems to have validated the idea that the strategy should be "delay approval as long as possible and request more and more tests for as long as possible". Which, of course, technically makes it safer for the drugs that manage to pass - but the cost is hugely inflated costs and absence of access to many drugs.

[dekhn]

Wrong: FDA was approved in the US and is used as an effective cancer drug. We just don't give it to people who would be at risk.