Sept. 10, 2015 – On the heels of last month’s ruling in Amarin v. FDA, which held that the FDA cannot prohibit companies from communicating truthful and non-misleading speech about the off-label uses of their products, a second lawsuit calling the FDA’s marketing enforcement practices into question has been filed in the U.S. District Court for the Southern District of New York. Pacira Pharmaceuticals Inc. filed a complaint Sept. 8 seeking injunctive relief from future FDA enforcement and declaratory relief that the FDA’s current position is unconstitutional (15-7055 Pacira v FDA Complaint (Filed)).

“It didn’t take long for the next shoe to drop after this summer’s dramatic Amarin decision,” said Coalition for Healthcare Communication Executive Director John Kamp. “Indeed, the Pacira complaint may be even more compelling because it challenges under the First Amendment many traditional theories that the FDA’s Office of Prescription Drug Promotion [OPDP] has used to regulate marketing.”

For example, Kamp explained, the Pacira complaint “challenges the use of Warning Letters to limit both on-label and off-label marketing of drugs when that marketing is neither false nor misleading, as well as challenging the often-used broad definitions of labeling and advertising. Moreover, the complaint argues that FDA inappropriately used a Warning Letter to impose after-the-fact limitations on the use of its drug. This case is another significant challenge to the way OPDP does its business.”

APCO Worldwide’s Wayne Pines remarked that “It is clear that some companies are going to be more aggressive in challenging FDA’s rules for the regulation of promotion.” He told the Coalition that “based on recent court decisions, the companies will win some of these cases. Either the FDA or the Congress is going to have to address these issues. I think change is inevitable.”

Pacira’s move follows a September 2014 Warning Letter sent to the company by the FDA, which advised Pacira to cease promotion of its non-opioid pain medication Exparel for any indication beyond the two procedures studied in clinical trials, a practice which the FDA considered criminal misbranding.

Pacira’s lawsuit asserts that FDA granted Pacira a broad approval for Exparel in October 2011 and that Pacira communicated with physicians about Exparel in truthful and non-misleading ways, “explaining to them that the drug had been approved by FDA ‘for administration into the surgical site to produce postsurgical analgesia,’ and sharing with physicians the actual experiences that other physicians had administering EXPAREL in different surgical sites.” During this time, Pacira submitted promotional materials for its “on-label” uses to FDA, as required.

The 2014 Warning Letter from the FDA asserted that “some of Pacira’s speech was criminal because it established ‘new intended uses’ for Exparel, and that other speech was criminal because it lacked the support of two clinical trials.” Pacira charges that “FDA’s attempt to silence Pacira’s truthful and non-misleading speech is inconsistent with the [Food, Drug and Cosmetic Act (FDCA)] and the First Amendment.”

The company charges that the product’s label reflects that it is approved for use in surgical sites generally, and that the FDA is, through its Warning Letter, “is attempting retroactively to revise Exparel’s label to limit the product’s approved indication to use in connection with bunionectomy or hemorrhoidectomy,” the procedures studied in pivotal trials, which Pacira states is not permitted under the FDCA except in limited circumstances.

The complaint, which cites the Amarin ruling, further seeks to call attention to the FDA’s extremely broad definition of “labeling,” and states that the agency has even interpreted oral statements as advertising or labeling. “This redefinition of ‘labeling’ results in a broad criminalization of speech in part due to its effect on a different section of the FDCA,” according to the complaint.

In spite of the quick succession of several cases challenging FDA’s regulation of drug promotion, Pines noted that “It is premature for companies to change any of their policies or review procedures now. FDA will continue to enforce the rules and companies that are out of compliance will face enforcement. Change will come, but gradually.”