First False Claims Act Settlement Turns on Cancer-Drug Survival Data

Activedia / Pixabay

Activedia / Pixabay

In the first False Claims Act settlement that turns on cancer-drug survival data, Roche Holding AG’s (Basel CHE) Genentech unit and OSI Pharmaceuticals LLC (Farmingdale NY) 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.

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.”

Spokesman Andrew Villani said,

“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. We have robust policies for good promotional practices and these policies and practices are enforced through training, management oversight and strict promotional review processes.”

OSI was Genentech’s marketing partner on Tarceva until 2011, when Japanese drugmaker Astellas Pharma Inc. (Tokyo) bought the company. The marketing allegations range from 2006 to 2011.

Monday, June 13, 2016 / Vol. 24 / No. 23

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