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Seniors Sue Pharmacia Over Off-Label Marketing

Dec 25, 2002 | Star-Ledger

A seniors group has sued Pharmacia Corp., alleging the drug maker used improper marketing tactics to promote its Bextra painkiller.

The Congress of California Seniors claims Pharmacia exploited a loophole in government regulations that prohibit the promotion of medicines for off-label use, uses not approved by the Food and Drug Administration.

In doing so, the lawsuit charges, Pharmacia was able to market Bextra as a treatment for acute pain a lucrative segment of the multibillion-dollar prescription painkiller market. Bextra was approved late last year, but only for treating only chronic pain.

"The FDA regulations exist to protect consumers, and Pharmacia's efforts to circumvent those regulations without regard for anything but its own bottom line must stop," said Ahaviah Glaser of Prescription Access Litigation, a consumer advocacy group that assisted the nonprofit seniors organization with the lawsuit.

Pharmacia spokesman Mark Krajnak said the company had not seen the lawsuit, which was filed earlier this week in California state court, and could not comment.

The litigation is the latest effort by consumer groups to challenge the pharmaceutical industry's pricing and promotions. Prescription Access Litigation is involved in several such lawsuits against drug makers.

Off-label usage, however, is a contentious issue that pits the FDA's mandate to protect public health against free-speech rights in this case, the rights of drug makers to communicate with customers.

Doctors can prescribe medicines for off-label uses, but the FDA worries patients may be harmed if drug makers promote their products for those uses without data to support the product works as a treatment for them. The FDA has lost several recent court decisions, though, and is reviewing its rules on the issue.

The Pharmacia lawsuit claims the drug maker hired Scirex, a clinical testing firm that is partly owned by Omnicom, a large advertising agency, to generate scientific literature that could be used as "propaganda."

According to the lawsuit, Scirex recruited patients with impacted molars and gave them Bextra. The results, which were published last May in the widely read Journal of the American Dental Association, claimed Bextra was useful in treating acute pain.

Consequently, a "significant portion" of recent Bextra sales were generated by off-label uses, but independent doctors who reviewed the study doubted the conclusions, according to the lawsuit. Scirex officials could not be reached for comment.

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