A consumer group sued Pharmacia Corp. over its promotion of the pain drug Bextra, alleging that the pharmaceutical company is circumventing federal marketing regulations.
The Congress of California Seniors filed the suit in California Superior Court in Los Angeles on Monday, alleging that Pharmacia is illegally promoting the off-label use of Bextra.
Doctors may prescribe drugs in any way they see fit, but drug companies can only market their products for indications approved by the U.S. Food and Drug Administration. Drug companies can share research and journal articles with doctors that discuss unapproved uses, but can’t actively suggest the physicians incorporate those uses in their practices.
The lawsuit says that Pharmacia hired Scirex, a clinical testing firm owned in part by Omnicom, a large advertising conglomerate, to study Bextra for use in cases of acute pain caused by impacted molars. Bextra is not approved for acute pain but is approved for chronic pain associated with arthritis, osteoporosis and menstrual cramps, according to the suit.
The results of the study were published in the Journal of the American Dental Association, and the lawsuit alleges it increased the drug’s sales.
The lawsuit alleges that Pharmacia went against the spirit of the law by orchestrating the study when the FDA specifically refused the company’s request for an indication for acute pain.
Pharmacia spokesman Paul Fitzhenry said the company hadn’t seen the lawsuit and had no comment.
The Congress of California Seniors is part of the Prescription Access Litigation project, a Boston-based coalition of nonprofit organizations that has been organizing lawsuits against drug companies to end practices that it contends raise prices.
Off-label promotion has become an issue lately. The U.S. Attorney’s office in Boston, 47 states and the District of Columbia are investigating whether Warner-Lambert illegally promoted off-label uses for Neurontin, an epilepsy medication. Warner-Lambert is now owned by Pfizer Inc.