United States: First Amendment Right To Off-Label Promotion – Has Pandora's Box Been Opened For FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products. Following on the heels of the Amarin case, another drug maker recently filed a lawsuit that may be the first of many seeking authority to promote off-label use.

Pacira Pharmaceuticals, Inc., filed a complaint against the Food and Drug Administration (FDA) on September 8 in the U.S. District Court for the Southern District of New York seeking to establish that FDA cannot prevent it from promoting off-label uses, so long as those promotional efforts use statements that are truthful and non-misleading.

Pacira manufactures Exparel, an anesthetic administered into the surgical site that controls postsurgical pain. FDA's 2011 approval of Exparel was based on studies involving bunionectomies and hemorrhoidectomies. Since the drug's launch in 2012, Pacira promoted Exparel for use in surgical sites generally, and not only in connection with the two procedures addressed in the studies submitted with its new drug application. FDA, however, issued a warning letter in 2014 demanding that Pacira stop promoting use of Exparel outside of bunionectomies and hemorrhoidectomies.

In its complaint, Pacira argues both that Exparel is approved for more than just the two procedures and that even if Pacira were trying to promote off-label uses of Exparel, it has the right to do so under the First Amendment.

Pacira's lawsuit comes on the heels of a decision issued in drug maker Amarin Pharma, Inc.'s lawsuit against FDA holding that Amarin has a First Amendment right to make certain "truthful and non-misleading" statements about unapproved uses of its drug Vascepa. The August 2015 decision in Amarin followed a 2012 decision by the U.S. Circuit Court of Appeals for the Second Circuit overturning the conviction of a pharmaceutical sales representative for off-label promotion involving truthful speech.

Pacira's complaint may be an isolated case of a drug maker relying on a relatively new legal theory. However, if Pacira prevails in its arguments that the First Amendment protects its free speech right to engage in off-label promotion so long as it is truthful and non-misleading speech, it may pave the way for other pharmaceutical manufacturers to assert the same right. In addition, it may provide more ammunition for other manufacturers to assert similar arguments and to push for other regulatory standards. For example, should the FDA regulatory standard utilize the truthful and non-misleading standard applied by the FTC or even those utilized in USDA National Appeals Division hearings? One thing is certain – the case will undoubtedly be closely watched by regulators and drug manufacturers alike.

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