[gburt]

Regulators are, in general, too sheltered and disconnected from the impact of their actions.

Incentives matter. When you get to make decisions that impact others, but not feel any of the costs associated with that, you do not have the correct incentives. I hope the staff of FDA read this and can’t sleep tonight. We can hope they feel some emotional pain, even if it is only some small subset of the pain they have and continue to cause to others.

FDA delenda est.

[janeway]

I would disagree with this. Regulators that I have worked with in US and EU knew what it meant. Maybe not the most amazing technical people I’ve ever worked with, but they were as competent as any random sample of pharma/tech types. Their jobs is to verify that you have completed all the valid documentation to demonstrate that your drug does what you claim it does. Their opinion on personal emotions are irrelevant. They are supposed to be guideline checkers.

[gburt]

I understand some people are checking boxes, with no space to consider their impact. Please generously reinterpret my point to extend to their management stack and the political establishment that is responsible for the system.

Those who establish, support and tolerate that system should be as directly exposed to its consequences as practicable. It is good for them to see these stories and feel the consequences of their decisions.

[Arainach]

The consequences to their actions are that when a doctor prescribes me a medication or when I purchase one off the shelf, I have incredibly high confidence that if I follow the dosage instructions it is safe - safe now, safe in 15 years, not worth further thought on my part. That hasn't been true in most places for most of human history.

The consequences to their actions are that millions of people are saved from the consequences of consuming seemingly promising drugs such as Thalidomide: https://en.wikipedia.org/wiki/Thalidomide

I could sleep just fine knowing that some people looking only at a tiny local example while ignoring the big picture considered me the villain

[gburt]

To the extent that is true, I agree, they should see the positive impact of what they do as well. Your blind faith in the regulatory regime, however, is deeply undeserved. Many approved drugs prove to be dangerous and we can reasonably expect that many effective drugs never make it to market because of bureaucracy.