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Bextra Lawsuits
Group Sues Pharmacia Over Bextra Promotion
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.
Bextra Lawsuits
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