I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
I was following the case in real time, and it certainly looked like a failing of the FDA and being way way too cozy with Merck about it; compared to how it looked then, the wikipedia article looks incredibly white washed.
I'm not sure we read the same Wikipedia article - the one I read said that Merck withheld information from the FDA, and makes no mention of any resulting sanctions or penalties (which is exactly how I remember it). Does this sound like a working regulatory agency to you?
> And OxyContin's issues (I think) fall on the DEA and not the FDA. Oxy does what it is supposed to do really well, and the side affects are known.
Not at all. Perdue made false claims about how long acting OxyContin is, and as a result of the recommended prescription, many people both suffered and got hooked, see e.g. [0], which was the first result for "oxycontin perdue abuse", but by no means the only one.
> I just used Thalidomide as an example of where the FDA got it right. The fact that we havn't see other drugs like that pop up, tells me that the system is working.
... to me, the fact that Thalidomide is basically the only example that everyone brings up, it means that the European system is essentially equally effective, despite your implied claim ("Europe had a massive problem, while the US didn't.") that the US one is superior.
[0] https://www.nytimes.com/2018/05/29/health/purdue-opioids-oxy...
Yeah - it's all for our safety...nothing to do with regulatory capture.
This is what people don't realize when they try and say the FDA is a bureaucratic nightmare. Every process in place is designed to make sure that the drugs that hit the US market work. Look at what happened with Thalidomide. The FDA didn't allow it to hit the US market due to strict requirements about what tests and processes the drug companies were required to follow. Europe had a massive problem, while the US didn't.
What most people don't realize or know, is that the FDA will readily expedite promising drugs and/or products if results are promising and the data is valid. Companies, if they have strong data from Phase I or II trials, can be bumped to the top of the review queue or be granted interim permission to sell their drugs before Phase III trials are complete.
I personally think the FDA is a great example of a well designed bureaucracy. The value it adds to the public is insurmountable, while not being unreasonable.