Pfizer settles with 34 states over Celebrex, Bextra marketing

Chris Rizo Oct. 22, 2008, 11:27am

Lisa Madigan (D)

NEW YORK (Legal Newsline)- Pfizer Inc. has settled with 34 state attorneys general over complaints that the pharmaceutical company illegally marketed its Bextra and Celebrex medications.

Under an agreement hammered out by Oregon Attorney General Hardy Myers, Pfizer has agreed to pay a $60 million settlement to resolve the enforcement action against it and its subsidiary, Pharmacia, Inc.

"Today's settlement is valuable not only in terms of the financial judgment entered, but perhaps even more importantly in the clear restrictions it places on Pfizer's ability to deceptively promote prescription drugs and other biological products," Myers said.

Celebrex and Bextra are Cox-2 inhibitors, were illegally marketed to treat acute surgical pain, while the medications were only approved by the U.S. Food and Drug Administration to treat common pain and inflammation.

Merck & Co. settled similar allegations in May over its Cox-2 inhibitor, Vioxx. The drug was taken off the market after studies showed the medication increased the risk of heart attacks and strokes.

"Pfizer's misleading claims and deceptive actions put consumers' health at risk," said Illinois Attorney General Lisa Madigan, one of the leaders of the multi-state investigation.

"This settlement should send a strong message to the pharmaceutical industry that we won't tolerate deceptive and dangerous marketing promotions and tactics," the Illinois Democrat added.

The attorneys general alleged that Pfizer and Pharmacia had a marketing campaign that encouraged physicians, hospitals and health insurers to use Bextra in higher doses for uses that were not FDA approved.

Pfizer and Pharmacia's marketing effort began after federal regulators rejected the company's application for FDA approval for use of Bextra at higher doses. Pfizer claimed that Celebrex was safer and more effective than traditional non-steroidal anti-inflammatory drugs, such as ibuprofen.

Investigators also found that the companies gave high volume off-label use prescribers paid consultancies and resort weekends as rewards.

While Bextra was taken off the market in 2004 amid evidence the drug increased risk of heart attack and stroke, Celebrex is still used, but now contains a black box warning about its side effects.

The settlement requires Pfizer to submit all of its "direct-to-consumer" television advertisements to the FDA for approval and comply with any FDA comment before running the spots.

The agreement also requires Pfizer to register all clinical trials, post clinical trial results, and ensure that subjects in clinical trials sponsored by Pfizer give adequate informed consent.

"It is my hope that the broad injunctive terms against payments and gifts to physicians and other deceptive marketing practices will serve as a model for what we should expect of the entire industry," Myers said.

States taking part in the settlement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.

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