STATE SETTLES CLAIMS AGAINST PFIZER INC. RESOLVING FIVE-YEAR INVESTIGATION INTO THE COMPANYS MARKETING OF BEXTRA AND CELEBREX
Arkansas and 32 other states share in $60 million settlement
LITTLE ROCK- Today, Attorney General Dustin McDaniel 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®. In addition to a $60 million payment to the participating states, the Consent Judgment filed in the Pulaski County Circuit Court will largely restrict Pfizer's ability to use deceptive practices in the promotion of any Pfizer product.
Celebrex and Bextra are non-steroidal anti-inflammatory drugs (NSAIDS) that were designed to reduce pain and inflammation without the negative gastrointestinal side effects of traditional NSAIDS. In its Complaint, the State alleges that despite the fact that significant safety concerns led the FDA to reject a request to market high dose Bextra for acute and surgical pain, Pfizer conducted a systematic, multi-pronged "off-label" promotional campaign for these indications. The off-label promotional campaign consisted of trying to convince doctors to prescribe the drug for uses not approved by the FDA. While a physician is allowed to prescribe drugs for off-label uses, pharmaceutical manufacturers are prohibited from marketing their products for off-label uses.
Today's Judgment includes injunctive terms addressing the concerns raised during the investigation regarding both Celebrex and Bextra. Included in the Judgment are terms that will help prevent Pfizer from:
• Failing to adequately disclose conflicts of interest for Pfizer promotional speakers when these consultants also speak at independent Continuing Medical Education;
• Distributing samples with the intent to encourage off-label prescribing;
• Distributing off-label studies and articles in a promotional manner;
• Providing incentives to sales staff to increase off-label prescribing;
• Deceptive use of scientific data when marketing to doctors;
• Using grants to encourage use of Pfizer products;
• Using patient testimonials to misrepresent a drug's efficacy.
In addition, the judgment requires Pfizer to submit all "direct-to-consumer" (DTC) television drug advertisements to the Food and Drug Administration (FDA) for approval and comply with any FDA comment before running the advertisement. Finally, the Judgment prohibits Pfizer from deceptive and misleading advertising and promotion of any Pfizer drug, requires Pfizer to register all clinical trials, post clinical trial results, and ensures that subjects in Pfizer sponsored clinical trials give adequate informed consent.
"This judgment, along with our other recent pharmaceutical settlements, 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 is outstanding and addresses all concerns identified over five years of investigation," McDaniel said.
Arkansas will receive $1.7 million that will go to the Consumer Education and Enforcement fund in the Attorney General's office.
Joining Arkansas on today's settlement are: Alaska, Arizona, 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.