Pacira Sues FDA for Right to Promote Drug for Unproven Uses

Citing a recent federal court ruling that truthful off-label claims are protected free speech, Pacira Pharmaceuticals has sued the FDA, claiming a First Amendment right to promote its Exparel postsurgical non-opioid analgesic for unproven uses.

In 2011, the FDA approved Exparel following clinical trials on patients recovering from hemorrhoid and bunion surgeries. The indications and usage section of the approved labeling states that it is indicated “for administration into the surgical site to produce postsurgical analgesia.”

The Parsippany, N.J., company produced and distributed materials to physicians, including reports of experiences administering the drug in different surgical sites, and submitted the materials to the FDA for review.

In 2014, the FDA issued a warning letter demanding that Pacira immediately cease sharing information about using Exparel following surgeries other than bunion or hemorrhoid. At the agency’s direction, the company issued a statement correcting the earlier claims and agreed to stop distributing those promotional materials.

In Pacira Pharmaceuticals Inc., et. al v. Food and Drug Administration et. al, filed last week in the U.S. District Court for the Southern District of New York, the company maintains that its promotional information is truthful and should be allowed under the recent Amarin ruling.

The FDA’s rejected arguments for prohibiting free speech in Amarin Pharma Inc., et. al v. Food and Drug Administration et. al are even less persuasive here because the promotions were not off-label according to the indications and usage section, the drugmaker says.

Pacira says it had discussions with the FDA regarding the agency’s knowledge of other uses for Exparel, such as tonsillectomies in children, and proposed studies to support that use, since children don’t suffer from bunions or hemorrhoids. The FDA responded that studies should be performed on adults first, thereby bolstering Pacira’s claim that the drug is safe for a broader range of surgical sites, court documents say.

Pacira’s lawsuit citing Amarin will likely be followed by others, weakening the FDA’s enforcement arm against drugmakers that promote products for off-label uses. Amarin recently asked New York federal Judge Paul Englemayer to halt further litigation in its case against the FDA until Oct. 30 while the parties discuss possible settlement options.

The FDA does not comment on pending lawsuits. — John Bechtel