Date: 10/22/2008 NEW YORK (AP) _ Pfizer Inc. said Wednesday it finalized part of a larger, $894 million deal to settle lawsuits over its promotion of the painkillers Celebrex and discontinued Bextra. The company made official a deal that would pay $60 million to settle investigations by 33 states and Washington, D.C., over Bextra, while also agreeing to adopt compliance measures. Various states alleged Pfizer promoted the painkiller for “off-label” uses, or uses it was not approved for. While a physician is allowed to prescribe drugs for off-label uses, a company cannot market them for unapproved uses. States also alleged the company misrepresented the safety of the drug. As part of the settlement, Pfizer denied that its promotional practices violated any laws. Among other strictures, the settlement requires Pfizer to submit all consumer television advertisements to the FDA for approval, the New Jersey attorney general’s office said. Pfizer said such practice was already company policy. Last week, the company said it would pay $745 million to settle personal injury cases, $60 million to cover settlements with attorneys general in the 33 states and Washington, D.C., and $89 million to cover consumer fraud class action cases over reimbursement for money spent on the two drugs. In all, the company said the settlements would cover more than 90 percent of the pending legal actions. “As we announced last week, these settlements avoid the disruption and expense of litigation and put these matters behind us,” Amy W. Schulman, senior vice president and general counsel of Pfizer, said in a statement. Celebrex and Bextra came under scrutiny following lawsuits over a similar drug made by Merck & Co., called Vioxx. Merck has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming the drug caused heart attacks, ischemic strokes or death. Bextra, like Vioxx, was a Cox-2 inhibitor. “This medicine (Bextra) was rigorously studied and tested by the company and independent medical experts, and information about its benefits and risks was fully disclosed to the FDA,” Schulman said. Celebrex is currently the only Cox-2 inhibitor on the market. Pfizer has also agreed to other compliance measures regarding its promotional programs. The New Jersey Attorney General’s office, in a statement, said the settlement places strictures on such practices as companies “ghost writing” drug-related articles and studies, deceptively using scientific data when marketing to doctors, and awarding incentives to sales staff to increase off-label prescribing by doctors. “This case should send a strong message to the industry at large that New Jersey does not tolerate deception and misleading claims in the promotion of prescription drugs,” Attorney General Anne Milgram said in a statement.
Copyright 2008 The Associated Press.
