Pfizer to pay $490.9 million to settle charges of illegal marketing of Rapamune

The US Department of Justice announced Tuesday that Pfizer agreed to pay $490.9 million to resolve criminal and civil liability regarding illegal marketing of the kidney transplant drug Rapamune (sirolimus), which the company acquired from its takeover of Wyeth. The department claimed that Wyeth had trained its national Rapamune sales force to promote the drug for unapproved uses.

Sanford Coats, US Attorney for the Western District of Oklahoma, described the actions by Wyeth, which he said included promoting the drug for ex-renal uses, and also paying bonuses to encourage those sales, as "a systemic, corporate effort to seek profit over safety." The government alleged that Wyeth marketed the drug from 1998 through 2009 for some uses that "were not medically accepted indications and, therefore, were not covered by Medicare, Medicaid and other federal healthcare programmes." These included non-renal transplants, conversion use and using Rapamune in combination with other immunosuppressive agents not listed on the label, which resulted in the submission of false claims to government healthcare programmes," the government said.

According to the Department of Justice, Wyeth has pled guilty to a misbranding violation under the Federal Food, Drug and Cosmetic Act, with the resolution including a criminal fine and forfeiture totaling $233.5 million. The resolution also includes civil settlements with the federal government and the states totaling $257.4 million. The civil settlement resolves two lawsuits pending in federal court in the Western District of Oklahoma, the department added.

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