Genentech, Inc. and OSI Pharmaceuticals Pay $67 Million Dollars To Resolve Off-Label Marketing Allegations
Atlanta, GA- Today, Attorney General Olens announced that Georgia has joined with other states and the federal government to settle allegations that Genentech, Inc. (“Genentech”) and OSI Pharmaceuticals, LLC (“OSI”) made misleading representations to physicians and other health care providers about the effectiveness of the drug, Tarceva, to treat non-small cell lung cancer (“NSCLC”). These misleading representations caused false or fraudulent claims for Tarceva to be submitted to the State’s Medicaid Program for use that was not approved by the FDA.
More 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 encouragement to prescribe Tarceva.
Attorney General Olens said, “Pharmaceutical companies are not permitted to make misleading representations about their drugs or to submit claims for reimbursement to the Georgia Medicaid program for uses that are not approved by the FDA. Such conduct can put patients at risk. My office is committed to holding pharmaceutical companies accountable for how they market their products.”
The investigation resulted from a qui tam 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. As part of the settlement the State of Georgia will receive $197,423.05 in restitution and other recovery.
A National Association of Medicaid Fraud Control Units (NAMFCU) Team participated in the investigation and conducted the settlement negotiations with Genentech and OSI on behalf of the states and the District of Columbia. The NAMFCU Team included representatives from the Offices of the Attorneys General for the states of Texas, California, Massachusetts, and New York.