4 ms·
> The courts don't all agree. The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has a
by lvs 13y ago
> The courts don't all agree.
The one case you cite is very fresh precedent in a single Circuit, and it's highly controversial. No other Federal Circuit has applied First Amendment standards to FDA misbranding regulations before. Even within the Second Circuit (three states), is it still illegal under law to misbrand a drug in marketing materials. The decision in Cariona hinges on the question of whether "misbranding" and "promotion of off-label use" are different narrowly defined legal scenarios. The Second Circuit was concerned that, in the latter scenario, doctors may be legally deterred from promoting off-label use, which is a common practice in medicine and research. You should not take away from this case that drug marketing is now a First Amendment free-for-all. Yes, I am awfully certain.