Arguing will now commence on whether pre-emption is a good idea or not. I've thought for some time that all approved medications should be labeled as "investigational new drugs", and that everyone taking them agrees that they are participating in a post-approval clinical study of their safety and efficacy. (I suppose that's my own form of pre-emption). But there's room to argue if the FDA is ready to take on the full responsibility of drug approval, without the option of later redress in the courts if something goes wrong. (Counterargument: that's what they're supposed to be doing now. . .) And all of these schemes have to make room for new information turning up, or for outright fraud (which is most definitely in the eye of the beholder). Personally, I'm glad not to be a judge.I wonder why the FDA doesn't do the clinical trials itself. Our drive for liability stems from our fear that the pharma companies know something they aren't telling us--so why not give the responsibility for testing this stuff over to a presumably neutral arbiter?
This article available online at:
http://www.theatlantic.com/business/archive/2008/04/pharmaceutical-liability/3198/
