Genentech joins the whistleblower-settlement crowd, albeit with a payment dwarfed by most of the pharma industry's False Claims Act deals. As the San Francisco Business Times reports, the Roche unit agreed to pay $20 million to wrap up the suit, which claimed that the company marketed Rituxan for off-label uses.
Approved in 1997 for patients with non-Hodgkin's lymphoma, Rituxan was used for a variety of other diseases--so much so that approved uses only accounted for about 30% of the drug's sales by 2002, the Business Times reports. Doctors are free to prescribe drugs for unapproved uses; however, companies aren't allowed to tout their meds for those uses--and the whistleblower suit alleged that Genentech trained physicians to do just that.
The suit also claimed that Genentech pressured its sales reps to increase off-label uses of Rituxan and sponsored workshops to school reps in off-label uses of the drug. Among the unapproved uses Genentech encouraged, the suit alleged, were for treatment of chronic lymphocytic leukemia, autoimmune hemolytic anemia and rheumatoid arthritis. The drug is now approved for both CLL and RA.
Genentech didn't admit any wrongdoing as part of the settlement. The company did agree to cover attorney's fees and expenses incurred by the whistleblower, John Underwood, who'll also net $5.7 million as his share of the FCA settlement.
- read the Business Times piece