FDA won't appeal free-speech ruling on off-label marketing

Since a federal appellate court called one pharma rep's off-label marketing a form of protected speech, legal experts have been sifting for clues. How might the U.S. v. Caronia case change the rules of drug marketing?

Well, the FDA did some noodling of its own. Its conclusion? Not much. The agency says it will let the ruling stand. It won't appeal to the Supreme Court, and it won't ask the Second Circuit to rehear the case en banc. In fact, as The Wall Street Journal reports, the agency says it "does not believe that the Caronia decision will significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act."

The Second Circuit's ruling was very clear on that point, however. "The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug," U.S. Circuit Judge Denny Chin wrote. So what makes the FDA think that the ruling will have no significant effect?

Well, one court ruling in one circuit does not a sea change make. At the time of the decision, lawyers pointed out that the ruling would only apply in the Second Circuit. Drug marketing isn't a regional business, certainly not limited to a few U.S. states. So, the FDA's hands weren't exactly tied by that ruling.

But the FDA may be looking at this another way. The agency may figure that appealing to the Supreme Court risks extending the Second Circuit's opinion nationwide. Its marketing police may prefer to work around the Second Circuit, at least for awhile.

A case up for review in the Ninth Circuit addresses another aspect of free-speech protection for off-label marketing. That court decision could set up a Supreme Court hearing. And at least one other off-label-promotion-is-free-speech claim is making its way through the courts. So, even without an FDA appeal, the Second Circuit won't have the last word.

- read the WSJ piece (sub. req.)