Acting Attorney General Peter J. Nickles today filed a stipulated judgment with Pfizer Inc. resolving a five-year investigation by 33 states concerning the company’s promotion of the Cox-2 drugs Celebrex® and Bextra®. The District received a $1,573,854 share in the $60 million payment settlement. The judgment filed in District of Columbia Superior Court will largely restrict Pfizer’s ability to deceptively promote any of its products.
“This judgment, along with our other recent drug cases, should send a strong message to the pharmaceutical industry that we will not tolerate deceptive and misleading drug promotion. The comprehensive injunctive relief obtained in this case addresses all concerns identified over five years of investigation,” General Nickles said.
The multistate investigation was initiated in 2003 to determine whether Pfizer and Pharmacia, a drug company subsequently purchased by Pfizer, misrepresented that their jointly sold Cox-2 drug Celebrex was safer and more effective than traditional non-steroidal anti-inflammatory drugs such as Ibuprofen.
After additional concerns were raised regarding Pfizer’s second generation Cox-2 drug Bextra, the investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra “off label” for uses that had been expressly rejected by the Food and Drug Administration (FDA). “Off-label” uses are uses that are not approved by the FDA. While a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for these uses.
Today’s judgment contains injunctive terms addressing all concerns raised during the investigation regarding both Celebrex and Bextra. Terms of the judgment will help to prevent deceptive use of scientific data when marketing to doctors; “Ghost writing” of articles and studies; the distribution of samples with the intent to encourage off-label prescribing; the use of incentives to sales staff to increase off-label prescribing; the use of patient testimonials to misrepresent a drugs efficacy; and many other marketing practices.
States joining the District in the settlement include: Alaska, Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Idaho, Illinois, Iowa, Kansas, Kentucky, 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.