Cell Thera will pay US govt $10.5M to resolve Trisenox case

Cell Therapeutics of Seattle, USA, has agreed to pay the US government $10.5 million to resolve allegations of the company's illegal marketing of the anti-cancer prescription drug Trisenox (areseic trioxide), the Justice Department has announced. According to the government's complaint, CT promoted the drug for various uses that were unapproved by the Food and Drug Administration.

The alleged "off-label" uses caused doctors to prescribe Trisenox to treat various forms of cancer, for which the drug was neither approved by the FDA nor proven to be either safe or effective. The government's suit alleged that, because of CT's actions, physicians who prescribed Trisenox off-label unwittingly submitted false claims for reimbursement to the Medicare program from 2001 until 2005. In 2005, CT sold Trisenox to another company, Cephalon, which halted CT's misleading off-label promotion campaign.

"Cell Therapeutics essentially subverted a regulatory system designed to assure that patients receive only those drugs that have been proven to be effective for their illness," said Peter Keisler, Assistant Attorney General for the Justice Department's Civil Division.