Drugmaker Settles Free Speech Dispute as FDA Agrees on Label

  • Pacira reaches deal with FDA over post-surgical drug Exparel
  • Label to say treatment isn't limited to any specific surgery

U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing. The company’s shares climbed as much as 20 percent.

After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel, rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries.

The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use.

Pacira rose 15 percent to $71.50 at 11:46 a.m. in New York. The drugmaker had fallen 31 percent in the past 12 months through Monday.

The FDA agreed in a letter Monday, saying that after further review, the agency had concluded that the drug’s approval wasn’t limited to the two types of surgeries. The language of the label had "created ambiguity," Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in the letter.

The FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses. Pacira had also filed a lawsuit, since dropped, against the FDA in the Southern District of New York, the same court where Amarin won the ruling.

Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request.

Broad Approval

Pacira Chief Executive Officer David Stack distanced Pacira’s deal with the FDA from the Amarin ruling since Amarin’s lawsuit was over its ability to promote its pill for moderately elevated triglycerides when it is approved only to treat severely elevated levels of the fats in the blood.

“We were looking for affirmation that we have a broad label,” Stack said in an interview.

Pacira filed its lawsuit against the FDA in September after the agency warned a year earlier that some of the drugmaker’s promotional material violated the law. The FDA has since withdrawn the warning letter to Pacira and approved a supplement to the drug’s label that reinforces use of Exparel isn’t limited to a specific surgery.

Pacira and Amarin both cited the First Amendment in their lawsuits against the FDA, saying their right to free speech was being infringed by the agency.

"It’s important to note that this resolution is specific to the parties involved in this matter," the FDA said in a statement on the Pacira agreement. "The FDA supports an open
dialogue with companies regarding questions about the intended use and promotion of approved medical products."

Exparel’s sales are expected to more than quadruple to $886 million in 2020 compared with 2014, according to analysts’ estimates compiled by Bloomberg. The painkiller is used on the site of the surgery and is marketed as an alternative to opioid pain pills.

“For sure, we expect to have more meaningful interactions with our customers” following the agreement, Stack said. “It’s clear that this product is going to continue to grow.”

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