Mark Iandolo Jun. 9, 2016, 12:39pm


LOS ANGELES (Legal Newsline) — The Department of Justice has announced Genentech Inc. and OSI Pharmaceuticals LLC have agreed to pay $67 million to resolve allegations of violating the False Claims Act through misleading statements about the effectiveness of the drug Tarceva.

“Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs,” said principal deputy assistant attorney general Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will hold those companies accountable that mislead the public about the efficacy of their products.”

Between January 2006 and December 2011, the companies purportedly provided misleading information to physicians and health care providers about Tarceva’s ability to fight non-small cell lung cancer. According to the Justice Department, little evidence existed to show that Tarceva was effective.

“Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients at risk,” said Howard R. Sklamberg, deputy commissioner for FDA’s global regulatory operations and policy. “The FDA will continue to work to protect the public's health by ensuring that companies do not mislead healthcare providers about their products.”

Of the $67 million settlement, $62.6 million will go to the federal government while $4.4 million will go toward state Medicaid programs.

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