Biotech Values

[zipjet]

>>There’s a fallacy* in this argument: In most cases, the FDA would gladly agree to adding a warning to a product label that was proposed by the sponsoring company.

I do not agree. Assuming your statement is correct. Would we really want companies asking for additional warnings in the label JUST to fend off liability for something that is not a learning from the studies? That is what you should expect if that is the only way for a company to defend themselves from creative lawyering. Once FDA issues the label, it should stand for something. Enough on that.

DD, where do you think that the nature/extent of a drug company's liability should be determined? By policy-directed laws which Congress drafts to address the issue or by courts all over the country acting to fashion the remedy they judge appropriate?

As an attorney I have experienced just how differently two judges in the same court house can see things. It is enough to make a sane man long for laws that clarify situations*.



ij

* Don't worry about the lawyers - they will make enough money to raise revenue for Obama even with clear laws and preemption.