Biotech Values

[DewDiligence]

>So my failings are not just "selective memory" if they do not follow. Nor do I see the "point" I am failing to address. If you want to state a question do so.<

Q: In your opinion, would a drug company run into resistance from the FDA if it wanted to add a warning to its drug label?

My contention is that, in most cases, a drug company would not run into resistance from the FDA. Based on the article in #msg-33326305, Justice Souter agrees:

>>
Justice David Souter said that “Wyeth could have gone back to the FDA at any time and said, either based on experience or just our rethinking of the data that we have, we think the label ought to be changed to say, 'Don't use IV push.'”
<<

But you said in #msg-33208603: “I do not agree.”

This goes to the heart of the Wyeth v. Levine case. If Wyeth could in fact have strengthened the warning against IV push by merely requesting such a change, the preemption defense is but a smokescreen.