The FDA may be in for a lot of this. In the wake of Amarin’s preliminary injunction win, another pharmaceutical company has brought a First Amendment challenge to the FDA’s restriction of off-label promotion. Last year, the FDA issued a warning letter claiming that Pacira Pharmaceuticals, Inc. had engaged in false and misleading promotion and misbranded its non-opioid pain drug, EXPAREL, by promoting it for pain relief in surgeries other than those (hemorrhoids and bunions) for which Pacira had conducted the two clinical trials that won EXPAREL its FDA approval. The FDA issued that warning letter in 2014, before the recent Amarinwin. Understandably emboldened, Pacira has now sued the FDA in the same court that decided the Amarin preliminary junction motion—the Southern District of New York—which is part of the same federal circuit that decided Caronia—the Second Circuit. This will almost certainly not be the last time that we see a pharmaceutical company take this play from the playbook.
Now, the Pacira litigation is a little different. The Indications and Usage section of EXPAREL’s label does not limit its use to bunion and hemorrhoid surgery. It references surgery more generally. But the FDA now claims that the indication is so limited, citing other language contained in the Dosage and Administration and the Clinical Studies sections of the label. Yet Pacira had been promoting the drug more broadly for three years without a word from the FDA. Thus, this case involves issues not involved in theAmarin litigation: whether the FDA is reading its own approved label correctly and whether its arguably new treatment of that label raises clarity and vagueness issues under the First Amendment.
There are also a couple of new twists on the Amarin litigation. The FDA’s 2014 warning letter stated that Pacira could not claim that EXPAREL provides pain relief for 72 hours. Pacira, on the other hand, claims that its clinical trials support the claim of 72 hours of pain relief. Pacira even relies on the conclusion of one of the FDA’s own medical reviewers. That should be interesting. Pacira also argues that the FDA’s categorical ban on any efficacy and comparative claims not supported by two clinical trials violates the First Amendment. Relying on the Amarin decision, Pacira argues that a pharmaceutical company can make such claims about an already approved drug based on lesser evidence so long as there is sufficient supporting science and the claim is accompanied by appropriate disclosures and qualifications.
Pacira and the doctors make other, more general, claims similar to those in Amarin. They claim, for instance, that the Pacira’s promotion of EXPAREL as safe and effective for other types of surgeries is truthful and non-misleading and that the FDA’s restriction of such promotion violates the First Amendment. They also claim, more generally, that the FDA’s regulation of off-label promotion is so vague as to violate the First Amendment.