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