Pacira, FDA reach agreement on pain drug marketing restrictions

[December 15, 2015]  By Brendan Pierson

(Reuters) - The U.S. Food and Drug Administration has agreed to drop restrictions on the marketing of Pacira Pharmaceuticals Inc's post-surgery pain drug Exparel, resolving a lawsuit the company filed against the agency earlier this year.

Under the agreement, announced Tuesday, Exparel's label will be updated to say the drug is indicated for the treatment of pain at any surgical site.

The FDA had told the company in a September 2014 warning letter that the drug was indicated only for treatment of pain following bunionectomies and hemorrhoidectomies, the surgeries that were studied in clinical trials.

Pacira sued the FDA in September 2015 in federal court in Manhattan, seeking an order that Exparel was indicated for other surgeries as well. Pacira and the FDA said they have agreed to drop the lawsuit in light of the agreement.

"The revised labeling is based on scientific evidence that was previously submitted" as part of Pacira's application for Exparel's approval, the FDA said in a statement.

"It’s important to note that this resolution is specific to the parties involved in this matter," the agency added.

Exparel, launched in 2012, was approved for administration into the site of surgery for post-surgery pain relief. Its approval was based on studies of its use in bunionectomies and hemorrhoidectomies, and the drug's label gives specific doses only for those operations.

Pacira, however, has promoted it for use in all kinds of surgeries. The drug generated 95 percent of Pacira's nearly $197.6 million in revenue last year.

Pacira argued in its lawsuit that, even if the FDA were right about Exparel's indicated use, the company would have a First Amendment right to promote Exparel for unapproved, or off-label, uses. Tuesday's agreement means the court will not have a chance to address that argument.

The issue of off-label drug marketing drew attention in August, when drugmaker Amarin Corp Plc won an order from a federal judge in Manhattan allowing off-label marketing of its fish oil drug Vascepa.

The case is Pacira Pharmaceuticals inc et al v. U.S. Food & Drug Administration et al, U.S. District Court, Southern District of New York, No. 1:15-cv-07055.

(Reporting by Brendan Pierson in New York; Editing by Leslie Adler)

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