The FDA settles with Pacira, rescinds warning letter

The FDA formally withdrew a 2014 warning letter regarding Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.

Also as a result of the settlement, the FDA will allow Pacira to market Exparel as a pain treatment beyond the two surgeries cited in the company's pivotal clinical data and has approved a labeling supplement that reinforces the indication.

The warning letter, issued in September 2014, had alleged that the drugmaker had been illegally marketing the painkiller for off-label uses, while the company maintained that the drug had been approved in 2011 to treat a broader group of postsurgical patients.

Pacira filed suit in September 2015. A month later the FDA removed the warning letter from its website.

In a Dec. 14 letter to Pacira CEO David Stack, the FDA's Dr. Janet Woodcock wrote that the agency had “determined that different statements in various parts of the approved labeling created ambiguity with respect to the scope of the approved indication.”

The FDA's Office of Prescription Drug Promotion had identified medical journal ads and administration guides developed by the company that provided information about using Exparel in two types of surgeries, cholecystectomy and colectomy. But the FDA then said that the drug was only approved to be used after surgeries for bunions and hemorrhoids.

“Both parties have agreed to revise the drug's approved labeling to clarify the scope of the approved indication in the original labeling,” an FDA spokeswoman said.

The settlement is the latest successful off-label marketing case that drugmakers have brought against the FDA. In August a federal judge ruled in favor of Amarin, which had gone to the courts to make the case to market certain off-label uses of Vascepa, its prescription fish-oil pill.

Still, Pacira's case, which argued that the FDA illegally narrowed the indication for Exparel, isn't unique. Similar cases are not likely to be brought by other drugmakers, said James Smith, a lawyer at law firm Reed Smith.

“That's almost unprecedented,” he said.

Because of the ties to the Amarin case—Pacira filed its complaint in the same court that Amarin did, the US District Court for the Southern District of New York, and it also alleged First Amendment violations—Pacira's case represents another successful example of a pharma lawsuit brought against the FDA.

“This adds to the perceived benefits of doing it because of the results that Pacira was able to achieve,” Beck said.

PhRMA, the industry's lobbying group, and the Medical Information Working Group, another group representing drugmakers, had filed amicus briefs in support of Pacira.