Attorney General Jack Conway announced his office has reached an agreement 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 judgment filed in Franklin Circuit Court will restrict Pfizer’s ability to deceptively promote all Pfizer products and requires Pfizer to pay a total of $60 million to investigating states, including more than $850,000 to the Commonwealth of Kentucky.
“This judgment, along with our other recent investigations, should send a strong message to the pharmaceutical industry that we will not tolerate deceptive and misleading drug promotion. The judgment provides substantial protection for consumers from potentially deceptive off-label marketing practices,” Attorney General Conway said.
The multistate investigation was initiated in 2003 to determine whether Pfizer and another drug company Pharmacia, subsequently purchased by Pfizer, misrepresented that their jointly sold drug, Celebrex, was safer and more effective than traditional non-steroidal anti-inflammatory drugs (NSAIDS), such as Ibuprofen (Advil®) and naproxen (Aleve®). As the investigation proceeded, additional concerns were raised regarding Pfizer’s second generation drug Bextra. Ultimately, the investigation concluded that Pfizer engaged in an aggressive, deceptive and unlawful campaign to promote Bextra for “off label” 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, law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
In its complaint, the Commonwealth 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 very same uses. Pfizer’s objectionable conduct included distributing results of positive studies relating to the use of high dose Bextra without disclosing a negative study; providing influential doctors with paid consultancies and lavish trips; providing prizes and other incentives to sales reps to promote off-label use; using imagery and language in advertisements that implicitly promoted off-label use; and mispresenting Bextra’s safety. The state alleges these efforts continued even after Pfizer completed a study that confirmed the FDA’s reason for rejecting the acute and surgical pain indications for Bextra.
The judgment contains injunctive terms addressing all concerns raised during the investigation regarding both Celebrex and Bextra. Included in the judgment are terms that will help prevent the deceptive use of scientific data and providing improper incentives to doctors and sales reps, as well as other misleading conduct. In addition, the judgment requires Pfizer to submit all “direct-to-consumer” television drug advertisements to the FDA for approval and comply with any FDA comment before running the advertisement.
Joining Kentucky on today’s 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.
Consumers wanting more information about this settlement may call the Attorney General’s Office of Consumer Protection at 502-696-5389 or go to www.ag.ky.gov .
# # # #