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June 6, 2016

Genentech and OSI to pay $67m to resolve False Claims Act allegations for Tarceva

US-based pharmaceutical companies Genentech and OSI Pharmaceuticals will pay $67m in order to resolve False Claims Act allegations regarding misleading statements made about the effectiveness of Tarceva for treating non-small cell lung cancer.

By Lopamudra Roy

US-based pharmaceutical companies Genentech and OSI Pharmaceuticals will pay $67m in order to resolve False Claims Act allegations regarding misleading statements made about the effectiveness of Tarceva for treating non-small cell lung cancer.

Genentech and OSI Pharmaceuticals co-promote Tarceva, which received approval for the treatment of certain patients affected with non-small cell lung cancer or pancreatic cancer.

According to the allegations, the two pharmaceutical companies made misleading representations to physicians, as well as other health care providers about the effectiveness of Tarceva between January 2006 and December 2011.

However, there was very little evidence to prove Tarceva effective enough for treating certain patients suffering from non-small cell lung cancer, unless the patients had never smoked or had a mutation in their epidermal growth factor receptor, which is a protein responsible for the growth and spread of cancer cells.

"The FDA will continue to work to protect the public’s health by ensuring companies do not mislead healthcare providers about their products."

US Department of Justice civil division head and principal deputy assistant attorney general Benjamin C. Mizer said: "Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs.

"The Department of Justice will hold those companies accountable that mislead the public about the efficacy of their products."

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Of the $67m settlement, the federal government will receive $62.6m, while $4.4m will be received by the state Medicaid programme, which is jointly funded by the state and federal governments.

FDA global regulatory operations and policy deputy commissioner Howard R. Sklamberg said: "Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients at risk.

"The FDA will continue to work to protect the public’s health by ensuring companies do not mislead healthcare providers about their products."

This settlement is a result of the emphasis of the government to fight against health care frauds and thereby marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative.

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