Cry 'Hemorrhoids!', and let slip the dogs of war

  • by: |
  • 09/10/2015

First there was Orphan Medical (Caronia), then Amarin. Now Pacira Pharmaceuticals has filed a lawsuit against FDA seeking declaratory judgment that the agency may not prohibit them from providing "truthful and non-misleading" information about the use of Exparel bupivacaine. 

Pacira is seeking preliminary and permanent injunctions to prevent FDA from taking action against them on the basis of proposed "truthful and non-misleading" speech. The suit was filed in the U.S. District Court for the Southern District of New York. 

FDA approved Exparel in 2011 for postoperative pain management. 
In September 2014, FDA sent Pacira a warning letter asking the company to stop promoting it for use in surgical procedures other than bunionectomies or hemorrhoidectomies. The agency letter also disputed Pacira's claim that Exparel provides pain control "that lasts for up to 72 hours" as an overstatement of efficacy that was "false and misleading."

Pacira argues that, even if the indications it promoted were considered off-label, they still have the right to promote "truthful and non-misleading" information about the drug under the First Amendment and cited the recent district court opinion allowing Amarin to engage in "truthful and non-misleading speech" to promote off-label use of Vascepa.

What do the Caronia, Vascepa, and Pacria cases have in common? Well, for one thing all the plaintiffs are small companies, largely dependent on the sales of a single product for their revenues. Suing the FDA used to be considered a high-stakes gamble, but recent rulings – and the lack of action on the part of the agency to put forward new draft guidance – seem to have changed the risk/benefit analysis. At least for small companies.

(And the odds-makers of Wall Street think so too. 
Pacira gained $2.71 to $60.18 on Wednesday.)

Can lawsuits by Big Pharma be far behind?

As far as anything from White Oak … Car 54 where are you?


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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