In the first False Claims Act settlement that turns on cancer-drug survival data, Roche’s Genentech unit and OSI Pharmaceuticals agreed to pay $67 million to settle claims that they misled doctors about Tarceva’s effectiveness in lung cancer.
From the drug's launch in 2004 to 2010, the two companies overstated Tarceva’s ability to fight the disease, the Justice Department said in a statement. The companies’ marketing materials and interactions with doctors led them to prescribe Tarceva for newly diagnosed patients, even though it was FDA-approved as a second-line treatment, the feds say.
Genentech and OSI knew that little evidence supported Tarceva to treat the majority of lung cancer patients, the statement said. Rather, data showed that Tarceva was most effective in non-small cell lung cancer patients who’d never smoked, or who had the EGFR genetic mutation.
“Not only does this case involve a cancer drug, but it is [the] first False Claims Act recovery involving allegations of a drug manufacturer making misleading representations about its drug’s survival data,” said Jeb White, an attorney at Nolan Auerbach & White, which represented the whistleblower in this case, noting that survival data is important to doctors’ prescribing decisions.
OSI was Genentech’s marketing partner on Tarceva until 2011, when Japanese drugmaker Astellas bought the company. The marketing allegations range from 2006 to 2011.
In the realm of marketing settlements, $67 million is a minor amount, and in contrast to other deals, Genentech was not required to sign a corporate integrity agreement with the government.
In a statement, the Roche unit said it believes its Tarceva promotions "were and are entirely proper and in compliance with the law."
"Genentech is committed to ethical and legal sales and marketing practices, and we are confident in our high standards for the promotion of our products," spokesman Andrew Villani said via email. "We have robust policies for good promotional practices and these policies and practices are enforced through training, management oversight and strict promotional review processes."
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Editor's note: This story was updated with additional comments from Genentech.