Penalized for “On-Label” Marketing? In Wake of Amarin, Pacira Files First Amendment Complaint Against FDA
Last week, Pacira Pharmaceuticals, Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to establish its right to provide truthful and non-misleading information to doctors about its anesthetic product, Exparel. This case follows last month’s decision in Amarin v. FDA, in which the Southern District of New York held that, under the First Amendment, FDA could not restrict Amarin Pharma’s ability to promote truthful non-misleading off-label information about Vascepa. Pacira’s case brings a number of interesting facts to the table that have the potential to further shape how FDA regulates promotion of pharmaceutical and device products.
Background on Exparel
Pacira demonstrated Exparel’s safety and effectiveness in providing postsurgical pain control through two clinical trials. “Pacira conducted these pivotal studies in two very different surgical procedures: bunionectomies, which involve an orthopedic and hard tissue site, and hemorrhoidectomies, a highly vascular soft tissue site,” the company writes in its complaint. “These two successful trials in markedly different surgical sites provide a valid basis—consistent with FDA’s own practice—from which to determine that EXPAREL can be used safely and effectively in any surgical site.”
2014 Warning Letter
However, Pacira’s lawsuit alleges that in 2014, “nearly three years after FDA approved EXPAREL for use in surgical sites generally and after receiving, without objection, three years worth of promotional materials from Pacira promoting EXPAREL for that broad indication, FDA issued Pacira a formal Warning Letter demanding that ‘Pacira immediately cease’ sharing with surgeons, anesthesiologists, and other sophisticated audiences certain information about using EXPAREL outside of a bunionectomy or hemorrhoidectomy.” In the months after the Warning, Pacira states that FDA refused to meet with the company to explain its position.
Lawsuit
Pacira’s complaint states that the agency’s speech restrictions have “harmed and continue to harm Pacira, the plaintiff doctors, other health care providers, and their patients.” Thus, they brought suit to obtain declaratory and injunctive relief in order to speak in truthful and non-misleading ways about its product without fear of having enforcement actions taken against it.
Pacira alleges that all of its marketing is on-label, and that the FDA is illegally trying to narrow the indication of the drug it has already approved after the fact. For this reason, Pacira’s case is “even stronger” than recent industry First Amendment victories Caronia and Amarin, the company states, because while the speech at issue in those cases concerned “off-label” drug uses, the speech Pacira wants to engage in concerns on-label information about use of Exparel for its FDA-approved indication. Further, even if FDA could retroactively limit the drug’s approval to use in bunionectomy and hemorrhoidectomy, Pacira argues, their truthful and non-misleading speech to physicians about administration of Exparel in connection with other surgeries would be constitutionally protected under Caronia and Amarin. “Doctors, scientists, and FDA, routinely extrapolate from clinical studies in limited models to more general use of an analgesic to control pain, notes Aamrin, and extrapolation is “particularly appropriate” in a “well-understood pain medication” like Exparel. “Accordingly, it is truthful and non-misleading for Pacira to discuss with healthcare professionals how EXPAREL’s trials, and approval, demonstrate its safety and efficacy in other surgical sites,” the company concludes (emphasis added).
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Coalition for Healthcare Communication Executive Director John Kamp aptly noted: “It didn’t take long for the next shoe to drop after this summer’s dramatic Amarin decision.” Indeed, Pacira shares a number of similarities to Amarin in that both are relatively small companies with one signature product.
Kamp added that Pacira’s complaint “may be even more compelling” than Amarin “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, Pacira “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.” (View the Coalition’s full announcement here).
Links To:
Pacirin Complaint for Declaratory and Injunctive Relief
Pacirin Memo in Support of Motion for Preliminary Injunction