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Pacira Sues FDA Over Marketing of Exparel

The company and the FDA disagree on whether the marketing is consistent with the label

Pacira Pharmaceuticals has filed a lawsuit against the FDA in its quest to communicate what it describes as truthful and nonmisleading information about its flagship product, Exparel (bupivacaine liposome injectable suspension).

Exparel is approved for administration at the site of surgery to produce post-surgical 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. In September 2014, according to the lawsuit, the FDA sent Pacira a warning letter telling it to stop promoting Exparel for use in any surgeries other than bunionectomies or hemorrhiodectomies.

Pacira’s complaint outlines the company’s belief that the FDA has violated the Administrative Procedure Act (APA), the Fifth Amendment, and its own guidance materials by threatening enforcement action for promoting Exparel consistent with its approved indication.

Pacira also claims that the FDA violated the First Amendment rights of the company and its coplaintiffs by restricting the exchange of truthful and nonmisleading speech. The lawsuit cites a recent federal district court decision allowing Irish drugmaker Amarin to market its fish oil drug Vascepa for off-label uses, although Pacira contends that its own marketing is not for off-label use. The judge ruled that Amarin’s truthful speech to doctors is protected by the First Amendment, even if it is intended to promote off-label use. The Amarin case was closely watched by the pharmaceutical industry because it was one of the first to raise a First Amendment argument in defense of off-label drug promotion.

Over the last year, Pacira says, it repeatedly sought a dialogue with the FDA to address points of misunderstanding and disagreement and repeatedly was denied. Six weeks ago, while declining to offer further insight into its interpretation of the Exparel label, the FDA issued a close-out letter, indicating that it regarded the matter of the warning letter to be closed.

Pacira brings up three counts in its complaint:

  • The FDA’s unilateral attempt to narrow the approved broad indication for Exparel without observing the procedure required by law for modifying a drug’s label violates the Administrative Procedure Act.
  • The FDA regulations as applied to Pacira are vague, deprive the company of fair notice of what is prohibited, and operate as a retroactive, ex post facto penalty, all in violation of the due process clause of the Fifth Amendment.
  • The FDA’s attempt to forbid Pacira from sharing truthful and nonmisleading information regarding the efficacy and administration of Exparel violate the company’s First Amendment right to engage in truthful and nonmisleading speech.

Sources: Pacira; September 8, 2015; and Reuters; September 9, 2015.

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