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# Genentech, OSI Paying $67 mil. for Tarceva False Claims
- URL: https://www.fdaweb.com/genentech-osi-paying-67-mil-for-tarceva-false-claims/
- Published: 2016-06-08T12:00:00.000Z
- Updated: 2026-09-14T21:08:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135871

The Justice Department says that Genentech and OSI Pharmaceuticals, who are co-promoting the cancer drug Tarceva, have agreed to pay $67 million to resolve a whistleblower’s False Claims Act allegations that they made misleading statements about the drug’s effectiveness. A department [statement](https://www.justice.gov/opa/pr/pharmaceutical-companies-pay-67-million-resolve-false-claims-act-allegations-relating-tarceva?ref=fdaweb.com) says the allegations claimed that between 1/2006 and 12/2011 the two companies made misleading representations to doctors and other healthcare providers about Tarceva’s effectiveness to treat certain patients with non-small cell lung cancer when there was little evidence to show that the drug was effective to treat those patients unless they also had never smoked or had a mutation in their epidermal growth factor receptor.

Under terms of the agreement, the federal government will receive $62.6 million and state Medicaid programs will receive $4.4 million. The allegations were in a lawsuit filed in California federal court by a Genentech whistleblower, **Brian Shields**, who will receive about $10 million, the department says.