The FDA has backed down in its fight with Pacira Pharmaceuticals ($PCRX). The agency agreed to abandon limits to the company's Exparel marketing, in a deal that resolves the lawsuit Pacira filed against it earlier this year.
The closely watched legal battle centered on a warning letter the FDA issued in September 2014, which cautioned Pacira to restrict its promotions to two specific Exparel uses studied in clinical trials: pain following removal of bunions or hemorrhoids. Pacira had been promoting Exparel for other types of surgical pain as well, the FDA said.
In its lawsuit, Pacira demanded that the FDA expand Exparel's indication beyond those two surgeries. And now, the FDA has agreed to update Exparel's label to say it's approved for treatment of pain at any surgical site.
It's a victory for Pacira. But is it a vindication for drug marketing in general? After a series of related legal rulings, drugmakers had been watching the Pacira suit for clues to the FDA's evolving views on off-label marketing and free speech.
No such luck, the agency said in a statement about the settlement: "It's important to note that this resolution is specific to the parties involved in this matter."
Indeed, the settlement thwarts Pacira's First Amendment argument in favor of broader Exparel marketing--an argument that other drugmakers have used in similar disputes. Companies contend that off-label marketing restrictions interfere with their rights to free speech. In August, a federal judge bought that argument, ruling in favor of Amarin ($AMRN) to allow off-label marketing of its cardiovascular drug Vascepa.
By making a deal with Pacira, the FDA avoids another court ruling on the free-speech issue, gaining time to tweak its marketing rules in its own fashion. The agency has tried to avoid broader application of the Amarin ruling as well, by saying that its Vascepa promotions wouldn't have broken FDA rules in any case. It helps that the Amarin ruling didn't bless all off-label drug marketing; rather, it made way for a sort of pathway other drugmakers could use to win agency permission for their own off-label marketing plans.
For its part, Pacira is satisfied with the FDA's decision, which is retroactive to Exparel's original approval date back in 2011. The agency also withdrew last year's warning letter, which had already been pulled down from its website.
"We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand--reducing postsurgical opioid exposure by providing a non-opioid option like Exparel to as many patients as appropriate," Pacira CEO Dave Stack said in a statement.
Pacira and the individual physician plaintiffs were represented by Ropes & Gray; Pacira is also represented by Latham & Watkins and Lowenstein Sandler.
Pacira received a subpoena from the U.S. Justice Department earlier this year, seeking information and documents about its Exparel marketing. At the time, Pacira said it was cooperating with the investigation.
- read the FDA's latest letter to Pacira (PDF)
- get the statement from Pacira
- see more from Reuters
Editor's note: This story was updated to clarify Pacira's claims against the FDA.