(COLUMBUS, Ohio) -- Ohio Attorney General Mike DeWine today announced that Ohio has joined with other states and the federal government to settle allegations involving misleading representations regarding the drug Tarceva. The agreement will result in a combined state and federal settlement amount of $306,178 for Ohio.
Genentech, Inc. and OSI Pharmaceuticals, LLC allegedly made misleading representations to physicians and other health care providers about the effectiveness of the drug to treat non-small cell lung cancer (NSCLC). These misleading representations caused false or fraudulent claims for Tarceva to be submitted to Medicaid programs for use that was not approved by the FDA.
Specifically, this settlement resolves allegations that OSI and Genentech promoted Tarceva (FDA-approved for second-line NSCLC) off-label by making false and misleading representations to physicians and other health care providers that Tarceva was effective to treat first-line NSCLC in certain patients who were current or former smokers. There is little evidence to support Tarceva’s effectiveness in this patient population, unless the patient also presents with a certain gene mutation. The agreement also resolves allegations that the companies paid kickbacks to health care professionals as inducement to prescribe Tarceva.
The overall settlement amount to resolve the off-label marketing allegations for all states and the federal government is $67 million.
The investigation resulted from a whistleblower action originally filed in the United States District Court for the Northern District of California under the federal False Claims Act and various state false claims statutes.
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