June 8, 2016

Tarceva Whistleblower Settlement Shows Government Willingness to Scrutinize Efficacy Data Even for On-Label Uses

By the C|C Whistleblower Lawyer Team

On June 6, 2016, the Department of Justice announced that Genentech Inc. and OSI Pharmaceuticals would pay $67 million to resolve whistleblower allegations that the companies misled physicians and patients about the effectiveness of Tarceva to treat certain types of lung cancer.  The whistleblower’s complaint alleged that the companies deployed sales forces and physician speakers to promote the message that Tarceva was effective for the entire range of non-small cell lung cancer (NSCLC) patients.  In fact, according to the allegations, the companies knew that there was scant evidence the drug had any beneficial effect unless the patients had never smoked or had an EFGR mutation.

What makes this settlement remarkable is that, in contrast to the government’s prior focus on unlawful off-label promotion of pharmaceuticals, a significant component of the alleged wrongdoing here appears to have involved on-label use.  The FDA had approved the drug for NSCLC patients.  The defendants, however, allegedly knew through review of survival data and studies that the drug essentially did not work for a majority of lung cancer patients.  In contravention of the known data, the companies are accused of both discouraging prescreening testing for the EGFR mutation and affirmatively promoting the drug, using inflated survival data, for use in a “broad range” of patients.  The misleading data allegedly resulted in lung cancer patients choosing Tarceva over other cancer drugs with better efficacy.

To be sure, the whistleblower’s underlying qui tam False Claims Act case also made certain off-label promotion accusations.  In describing the allegations resolved, however, the DOJ did not focus on whether the promoted use was “on label” or “off label,” but stated generally that “[p]harmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs.”  And FDA Deputy Commissioner Howard R. Sklamberg said about this matter:  “Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients at risk.”  Thus, while prior cases have focused on the marketing of unapproved uses of drugs, here the FDA and DOJ demonstrated their willingness to scrutinize the accuracy of data and representations used to promote on-label as well as off-label usage.

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