(DES MOINES) Pfizer Inc. will pay $60 million and is required to change its marketing practices as the result of an agreement settling a 33-state investigation of its marketing of the drug Bextra, Attorney General Tom Miller said today.
Pfizer promoted the drug to reduce pain and inflammation without the significant gastro-intestinal side effects potentially resulting from the use of non-steroidal anti-inflammatory drugs. “The states alleged that the company deceptively and aggressively marketed Bextra, for “off-label” uses that were expressly rejected by the FDA,” Miller said.
The states alleged that Pfizer promoted the use of Bextra for acute and surgical pain after those claims had been specifically rejected by the Food and Drug Administration (FDA). “We alleged that Pfizer paid influential doctors consultant fees and provided them with lavish weekends at high end resorts and distributed hundreds of copies of positive study results without disclosing the negative study results that caused the FDA to reject those claims,” Miller said. “We also alleged that Pfizer also gave prizes to sales representatives who touted off-label uses of the drug, and distributed hundreds of thousands of samples of high dose Bextra to specialties whose only possible use for high dose Bextra was off-label.” Bextra was withdrawn from the market in 2005.
Miller said that the settlement sends a strong message to other drug manufacturers to stick to marketing for uses approved by the FDA and avoid using marketing tactics that may increase sales but result in unsafe use of prescription medications. “Government must not only ensure that prescription drugs are safe, but that drug companies tout only safe and effective uses of the medications, ” Miller said. “This settlement effectively prevents Pfizer from promoting any medications for uses that are not FDA approved.”
Attorneys General of 33 states plus the District of Columbia reached the settlement with Pfizer. Under the Consent Judgment entered Wednesday by the Polk County District Court, the company must pay $60 million to the Attorneys General to be used for consumer education and litigation purposes and is ordered to avoid deceptive marketing practices for any of its products. The Consent Judgment is based on allegations included in a lawsuit filed by the Attorney General earlier on Wednesday.
The Consent Judgment specifically bars Pfizer from a variety of marketing practices. The company is specifically barred from the deceptive use of scientific data when marketing to doctors. The company is also prohibited from distributing samples with the intent to encourage off-label prescribing and from distributing information about an off-label use rejected by the FDA unless it clearly discloses the FDA rejection. In addition, the judgment requires Pfizer to submit all television drug advertisements to the FDA for approval and to comply with any FDA comment before running the advertisement.
The settlement is one of a series of recent consumer protection settlements reached by the Attorneys General with drug companies. In 2007 the Attorneys General reached a settlement with Bayer Corporation regarding “Baycol”, a cholesterol-lowering drug. In February 2008 a settlement was reached with Caremark, one of the nation’s largest pharmacy benefit managers. In May 2008, a settlement with Merck and Co. dealt with its promotion of the drug “Vioxx”. Earlier this month a settlement was announced with Eli Lilly concerning its marketing of the drug “Zyprexa.”
The Attorney General of Oregon led the Pfizer investigation. The participating states in the settlement are: Alaska, Arizona, Arkansas, California, Connecticut, Florida, 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, plus the District of Columbia.