Attorney General Gansler and 32 other Attorneys General agree to a Consent Judgment
BALTIMORE (Oct. 22, 2008)—Attorney General Douglas F. Gansler announced Wednesday that his Consumer Protection Division, along with consumer protection agencies from 31 other states and the District of Columbia, reached a settlement with Pfizer, Inc. concerning the companys promotion of the Cox-2 drugs Celebrex and Bextra. Attorney General Gansler and Pfizer agreed to a Consent Judgment that was filed today in the Circuit Court for Baltimore City that concerned Pfizers off-label marketing of Bextra and Celebrex for uses previously rejected by the United States Food and Drug Administration (FDA).
Pharmaceutical companies cannot market drugs to consumers for uses that have not been approved by the FDA, Attorney General Gansler stated. This settlement protects consumers from drugs being promoted for purposes rejected by the FDA.
The Attorney General alleged that Pfizer engaged in a campaign to promote Bextra for uses that had been expressly rejected by the FDA, including use for acute and surgical pain relief, due to safety concerns. While a physician is allowed to prescribe drugs for unapproved uses, pharmaceutical manufacturers such as Pfizer are prohibited from marketing their products for uses that have not been approved by the FDA (off-label). COX-2 drugs such as Bextra and Celebrex are drugs that were developed to block the COX-2 enzyme without blocking other enzymes that have a beneficial effect on the gastrointestinal system. The Attorney General also alleged that Pfizer deceptively used research data concerning its Celebrex product to explain the safety and efficacy of Bextra. Bextra, Celebrex and other Cox-2" drugs have been associated with an increased risk of serious cardiovascular adverse events such as heart attacks and strokes. Bextra also has been found to carry a risk of a serious and sometimes fatal skin condition.
In a complaint filed today by the Attorney General with the Consent Judgment that was agreed to by Pfizer, the Attorney General alleged that despite significant safety concerns that led FDA to reject a request to market high dose Bextra for acute and surgical pain, Pfizer conducted a systematic, multipronged off-label promotional campaign for these very indications by:
-- distributing hundreds of thousands of copies of a positive study from the denied application, as well as other positive studies relating to use of high dose Bextra, without distributing or disclosing the negative study that was the basis for FDAs rejection, or disclosing that FDA had expressly rejected approving Bextra for acute and surgical pain;
-- distributing hundreds of thousands of samples of high dose Bextra to specialists whose only possible use for high dose Bextra was off-label;
-- providing prizes and otherwise encouraging sales representatives to promote Bextra off label;
-- using supposedly non-promotional Continuing Medical Education to promote Bextra offlabel;
-- using imagery and language in advertisements that implicitly promoted Bextra off-label; and
-- misrepresenting Bextras safety. Todays settlement contains injunctive terms addressing these concerns regarding both Celebrex and Bextra. Included in the Judgment are terms that:
-- bar deceptive use of scientific data when marketing to doctors and prohibit off label promotion of pharmaceuticals;
-- prevent ghost writing of articles and studies by drug company representatives;
-- require disclosure of conflicts of interest for Pfizer promotional speakers when these consultants speak at supposedly independent Continuing Medical Education events;
-- prohibit the distribution of samples with the intent to encourage off-label prescribing;
-- limit the distribution of information about off-label uses of a drug when FDA has rejected such off-label uses;
-- bar the payment of incentives to sales staff for promoting off-label uses;
-- regulate Pfizers relationships with physicians who use Pfizer products and the incentives that Pfizer can pay to such physicians; and
-- regulate Pfizers direct-to-consumer (DTC) television drug advertisements by requiring it to seek FDA approval and to comply with any FDA comment before running the advertisement.
Source: Attorney General Douglas F. Gansler