Two drug makers — Roche’s Genentech and OSI Pharmaceuticals — announced a deal on Monday to pay $67 million to resolve charges they made misleading statements about the effectiveness of the Tarceva drug to treat non-small cell lung cancer.
Specifically, the feds contend that between 2006 and 2011, the companies gave promotional materials to oncologists that included misleading and overstated survival data to influence prescribing. The drug was originally approved by the US Food and Drug Administration as a second-line or back-up treatment, but the inflated data prompted some doctors to use Tarceva as a first choice, which boosted usage.
In fact, there was little evidence to show Tarceva was effective in treating patients unless they had never been smokers or had a mutation in a protein involved in the growth and spread of cancer cells, according to a US Department of Justice statement. As a result, the feds contend the companies violated the False Claims Act, because federal health care programs, such as Medicare and Medicaid, overpaid for the medicine.