- Pacira Secures Expanded Marketing for Painkiller Medication as FDA Agrees to Settle Lawsuit, Revoke Warning Letter
- January 8, 2016 | Author: Scott S. Liebman
- Law Firm: Loeb & Loeb LLP - Washington Office
- The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses, as the Food and Drug Administration agreed to allow Pacira expanded marketing for its painkiller drug. The FDA settled a suit in which Pacira alleged the agency had overstepped its bounds by preventing some off-label marketing.
The FDA and Pacira came to terms in a battle over the regulatory agency's authority to stymie Pacira's right to market the painkiller Exparel - the latest in a round of industry complaints that the agency oversteps its limits when preventing drugs from being promoted for unapproved uses. The suit, which was filed in the U.S. District Court for the Southern District of New York, follows a successful suit brought against the agency by Amarin for the right to promote its Vascepa product for some off-label uses.
As part of the settlement, the agency decided to revoke its September 2014 warning letter alleging that Pacira promoted the drug for unapproved uses and overstated its effectiveness. The agency previously removed the letter from its website after it began discussing possible resolutions with Pacira.
The regulatory authority also agreed to allow Pacira to promote Exparel for use after an expanded number of surgeries, instead of exclusively after the removal of bunions and hemorrhoids. The drugmaker is also allowed to tell clinicians that the drug can relieve pain for up to 72 hours, extending the 24-hour limit the FDA imposed on the drug when it was approved in 2011.
While Pacira chalked up the decision to the FDA's realization that "an unfortunate mistake had been made," the FDA said the revised label was based on scientific research previously submitted as part of the original marketing application. This was a marked difference from the language the agency used in the warning letter, in which it said the violations were "extremely concerning from a public health perspective."
Pacira had also accused the FDA of infringing its free speech rights - a hotly debated issue since 2012, when a federal appeals court overturned a criminal conviction of a sales rep for promoting off-label sales on the basis that his speech was protected since the information conveyed was truthful and nonmisleading. Pacira reportedly didn't need to push the free speech issue since the FDA agreed to revise the label, permitting more widespread marketing. Several pharmaceutical industry groups, including the Medical Information Working Group and PhRMA, supported Pacira.
At this time, it's not clear whether the Department of Justice is still probing Exparel marketing. The agency subpoenaed Pacira in April requesting documents, but declined to comment following the FDA settlement.