We learned about it yesterday from a reporter, but were sworn to secrecy until today. Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls “favorable resolution.” Pursuant to the settlement agreement, the FDA is formally rescinding its unfortunate warning letter that attempted a retroactive reduction in the scope of the indications of Exparel’s (the drug at issue) approval. That kind of retraction by the Agency is very rare, if not unprecedented. FDA is also giving the OK to labeling for the drug that reflects the original broad surgical indication. In return, Pacira will drop the litigation before any ruling on its First Amendment-related request for an injunction against the FDA.
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.