Law

So this one is over.

Now, however, everybody in the industry, and in the Agency, knows the drill with respect to truthful off-label promotion.  If an FDA-regulated entity is convinced that:  (1) the off-label use is safe, (2) the product is effective for the use; and (3) it has valid science (not necessarily meeting FDA’s “substantial evidence” standard) supporting items 1 and 2; then it can submit a truthful off-label promotion proposal to FDA.  If FDA rejects the proposal, then the threat of FDA prosecution of the entity creates sufficient First Amendment “chilling effect” to give the entity standing to take the FDA to court and prove the truth of items 1-3 to a presumably unbiased federal judge.  As the plaintiff, the entity can choose the forum in which to sue, and given the Caronia v. United States, 703 F.3d 149 (2d Cir. 2012), precedent, that forum will be in the Second Circuit, probably in New York City.

This First Amendment process doesn't change the off-label warning impossibility argument that we've discussed, because not only is prior FDA review still required, but also a prior (perhaps lengthy) litigation process before any change to labeling (or promotion) can legally occur.

We’ll be watching for the next case.