Law

Here is another guest post, one expressly not emanating from the Dechert side of the blog.  Rather it is written by Reed Smith's Elizabeth Graham Minerd.  As always with our guest posts, she is entitled to all the credit from her shared wisdom, as well as any blame.  So, without further ado:

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I recently had a partner ask me:  Will the court consider our client's actions (not in any FDA safe harbor) to be off-label promotion—i.e., were their actions "promotional" in nature even though they were not advertising the product for off-label uses.  After extensive research, I returned to him more or less empty-handed.  I explained the arguments for and against our client's actions being considered "promotion" of off-label uses, but I could not provide a definitive answer because there was simply no case law on point.

Over the last several years, there have been numerous cases discussing the legal ramifications of promoting drugs or medical devices for off-label uses from seemingly every angle.  Indeed, this blog has a handy tag "Off-Label Use" that discusses many of these cases.  But this basic question—what counts as off-label promotion?—has largely gone unanswered.  Recently, however, the Court in United States ex rel. King v. Solvay S.A., 2016 U.S. Dist. LEXIS 14804 (Feb. 8, 2016 S.D. Tex.), laid out a few examples of what is not off-label promotion. 

In United States ex rel. King, the Relators filed suit under the False Claims Act alleging that the defendant unlawfully influenced certain third-party payers to place its drugs onto their formularies.  Id. at *6.  The Relators claimed it was "off-label promotion" for the defendant to: (1) send dossiers of information to TPP formulary committees which included off-label information, and (2) distribute a supplement of the American Journal of Managed Care reporting proceedings at a symposium (allegedly chaired by a consultant for the defendant) where off-label information was discussed.  Id. at *17-*18.  The defendant filed a motion for summary judgment arguing, as a matter of law, that neither of these actions constituted unlawful off-label promotion and the Court agreed.  Id. at *19-*21. 

First, as to providing dossiers which included off-label information, these were sent by the defendant in response to requests from the relevant formulary committees for "'all available clinical data' for the drug."  Id. at *20.  These dossiers consisted of "information that was compiled by doing literature searches and providing references" and the defendant did not consider this to be promotional in nature.  Id.  The Court agreed finding that:

[W]hile Relators have shown that [defendant's] dossiers likely contained off-label information, they have not provided any evidence showing that such information in a document requested by the [formulary] committees was prohibited or that sending the dossiers constituted unlawful promotion.

Id. at *21.

Second, as to distributing the supplement of the American Journal of Managed Care, the defendant argued that there was no evidence that it (as opposed to the journal's publisher) distributed the supplement.  Id. at *20.  The defendant's sales force was also warned not to use the supplement in any promotional manner.  Id. at *18 n.7.  The Court found that the Relators lacked evidence that the defendant violated any promotional regulations concerning this supplement reasoning that:

[T]he evidence shows that the supplement was sent out, by some entity, along with the journal.  [Defendant's] sales representatives, however, were warned that the supplement could not be used to promote [the drug at issue].

Id. at *21.

That's the interesting part of King from our point of view.  The defense won the rest of the case, too, about allegations of improper "wining and dining" – both because the allegations were unfounded and because there was no proof of causation.  Id. at *24-*47. 

Overall, a solid win for the defense that will help to define what constitutes off-label promotion.