Pharmacia Corp. and Pfizer Inc. have been sued by a consumer group that says the drug makers are promoting Pharmacia’s arthritis painkiller Bextra for a use not approved by the US Food and Drug Administration.
Pharmacia makes Bextra, which it markets with Pfizer. The Congress of California Seniors filed the lawsuit Monday in Los Angeles Superior Court, accusing Pharmacia of using research to promote Bextra for acute pain. The plaintiffs asked that Pharmacia be ordered not to market the drug for unapproved uses and to forfeit any profit from such actions.
Doctors may prescribe drugs in any way they see fit, but drug companies can only market their products for indications approved by the FDA. 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 FDA regulations exist for a reason,” said Ahaviah Glaser, director of Prescription Access Litigation, which is sponsoring the litigation. Pharmacia ”tried to find another way around it, and that puts consumers at risk.”
Glaser’s group is part of Community Catalyst, a Boston-based consumer health group.
The FDA may send warning letters or take other action when companies promote drugs improperly. A call to the FDA’s offices yesterday afternoon wasn’t immediately returned.
Pharmacia expects to be bought by Pfizer for about $57 billion in the first quarter of 2003. The companies jointly sell Bextra and its predecessor, Celebrex.