Pfizer Finalizes $60M Settlement With States Over Off-Label Marketing Of COX-2 Inhibitors

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Litigation / Medical Malpractice
Article Date: 24 Oct 2008 - 7:00 PDT

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Pfizer on Wednesday said it will pay $60 million to 33 states and Washington, D.C., to settle lawsuits that claimed the company promoted the COX-2 inhibitors Bextra and Celebrex for unapproved uses, the Miami Herald reports. The agreement is part of an $894 million settlement that the company announced last week to cover more than 90% of pending lawsuits involving the drugs. The settlement also includes $745 million to settle personal injury claims and $89 million for consumer fraud claims brought by insurers and consumers seeking to recoup money spent on the drugs.

COX-2 inhibitors drew increased scrutiny when Merck in 2004 withdrew its COX-2 inhibitor Vioxx from the market because of a link to cardiovascular risks. Celebrex is the only remaining COX-2 inhibitor on the market.

Pfizer, as part of the settlement, will not admit to unlawful marketing practices. However, the company will be required to submit all future television advertisement to FDA for approval, according to the New Jersey attorney general's office. Pfizer said the practice already is company policy. Amy Schulman, senior vice president and general counsel of Pfizer, in a statement said, "As we announced last week, these settlements avoid the disruption and expense of litigation and put these matters behind us," adding, "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."

Pfizer also has agreed to other compliance measures related to its marketing practices. New Jersey Attorney General Anne Milgram (D) in a statement said the settlement restricts companies' practices, including "ghost writing" articles and studies related to their pharmaceutical products, misrepresenting scientific data when they market the medications to physicians, and using incentives to encourage physicians to prescribe the drugs for off-label uses. She added, "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" (Miami Herald, 10/22).

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