FDA Removes Warning Letter Issued to Pacira

The FDA has quietly removed a September 2014 warning letter issued to Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel. The removal comes after the drugmaker sued the agency late last month claiming a First Amendment right to promote the drug for unproven uses.

The Sept. 22, 2014, warning letter cited problems with promotional materials for Exparel (bupivacaine liposome injectable suspension), which is approved as a postsurgical analgesic for bunion and hemorrhoid removal surgeries. According to the FDA, the promotional materials suggested Exparel could be used in aparoscopic cholescystectomy, a procedure to remove gallstones, and in open colectomy to remove part of a patient’s colon.

In Pacira Pharmaceuticals Inc., et. al v. Food and Drug Administration et. al, the company maintains that the promotional material is truthful and should be allowed under the same ruling as Amarin Pharma Inc., et. al v. Food and Drug Administration et. al.

That ruling rejected the agency’s arguments to prevent off-label promotion, and Pacira said the agency’s arguments are even less persuasive because its promotions met the standards of the drug’s indications and usage section.

FDA spokesman Christopher Kelly said the agency cannot comment on the reasoning behind the letter’s removal because it is a matter related to pending litigation. — Kellen Owings