Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a lawsuit it filed in September, which reaffirms the broad indications for Pacira’s non-opioid pain medication EXPAREL, results in the FDA’s rescission of a 2014 Office of Prescription Drug Promotion (OPDP) Warning Letter about the promotion of those indications, and clearly is a victory for an industry that in the past has been somewhat reluctant to fight the FDA’s enforcement actions.
“This case marks a turning point in dealing with the FDA on Warning Letters on marketing issues,” said Coalition for Healthcare Communication Executive Director John Kamp. “In the past, when faced with such a letter that a company thought was wrong, the company bitched to its lawyers and caved to the FDA. Now, following Pacira’s example, companies faced with this type of letter can ask for a meeting and probably get it. If not, they can go to court and force the OPDP staff to rethink their decision,” he noted.
The Dec. 14 settlement of Pacira’s case filed in the U.S. District Court for the Southern District of New York follows a September 2014 Warning Letter sent to the company by OPDP, which advised Pacira to cease promotion of Exparel for any indication beyond the two procedures studied in clinical trials, a practice which the FDA considered criminal misbranding.
Pacira’s lawsuit asserted that the 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.
Further, after the Warning Letter was issued, Pacira “repeatedly sought a dialogue with the FDA to address points of misunderstanding and disagreement with their Warning Letter assertions,” said Pacira Chief Administrative Officer and General Counsel Kristen Williams, in a Dec. 15 call with investors. “In July, while continuing to deny the company’s request for a meeting and declining to offer further insight into its interpretation of the Exparel label, the agency issued a close-out letter, indicating that it regarded the matter of the Warning Letter closed,” Williams continued.
Following the close-out letter, Pacira filed suit against the FDA, asserting Constitutional and Administrative Procedures Act violations. It its complaint the company charged that the product’s label reflects that it is approved for use in surgical sites generally, which was affirmed by the FDA in the settlement.
Additionally, the FDA has approved a Pacira labeling supplement which amends the Exparel package insert to state that use of the product is not limited to any specific surgery type or site, among other revisions; formally withdraws its September 2014 Warning Letter to Pacira; acknowledges that the rescission of the Warning Letter and approval of the labeling supplement reflect the scope of the indication approved on Oct. 28, 2011; and agrees to deal with Pacira in an “open, forthright and fair matter,” according to a Pacira press release.
“With the legal action, we created an opportunity to have discussions with folks at the FDA, and once they understood that an error had been made, they moved very quickly in a collaborative way to get us resolution,” Pacira CEO and Chairman Dave Stack said in the investor call about the FDA settlement.
According to Kamp, “that’s a major shift in industry/agency relations, and it’s all about the First Amendment challenges to drug communication regulation, especially the IMS v. Sorrell decision by the Supreme Court in 2012, the Caronia federal appeals decision in 2014, and last summer’s FDA loss in the Amarin case.”