Pacira Pharmaceuticals Inc. filed a lawsuit on Tuesday, Sept 8, to battle for its continued promotion of Exparel to alleviate pain after a wide range of surgeries. The company is locked in a battle with the federal government because the U.S. Food and Drug Administration (FDA) strongly opposes Pacira's marketing actions.
In 2012, Exparel was launched after the FDA approved it for the treatment of postoperative pain by administering it on the surgical site. The studies that showcased the efficacy of Exparel involved hemorrhoidectomies and bunionectomies, and the dosages indicated on the labels only pertained to what are applicable to those procedures. The company, however, has advertised Exparel for the treatment of pain following all types of surgeries.
FDA then sent Pacira a warning letter on September 2014, asking the company to halt advertising Exparel as a drug that may be used after surgeries aside from hemorrhoidectomy and bunionectomy.
Pacira, which is based in New Jersey, iterated that all their marketing efforts are based on information that are stated on the label. The FDA is unlawfully attempting to limit the indications of Exparel, which it has already approved in the past. The company also said that even if they promote off-label indications, the act is still justifiable as it is truthful. In 2014, 95 percent of Pacira's entire revenue, which is $197.6 million came from Exparel.
The lawsuit filed by Pacira also mentioned that Irish drug-manufacturing company Amarin Plc was allowed by a New York judge to promote Vascepa, a fish oil medication, for off-label indications. However, Pacira disputes that its own advertising strategy is not for unapproved use.
A representative or spokesperson from the FDA is not immediately available to comment on the issue.
Exparel is an efficient substitute for opioids to manage postoperative pain, which is a vital aspect of patient care as the U.S. is currently embattled by opioid addiction, says Dave Stack, the president, chairman and chief executive officer of Pacira. By submitting a lawsuit, the company hopes to maintain its legal right to promote accurate data about Exparel that is compatible to the 2011 FDA-approved indication of the drug as postoperative analgesia. As the federal agency has not responded to Pacira's constant pleas for dialog, the company was left with no option but to file a case.
Photo: Brian Turner | Flickr
