- Genentech and OSI Pharmaceuticals reached a $67 million agreement earlier this week in a whistleblower case involving the non-small lung cancer drug (NSCLC) Tarceva (erlotinib).
- According to the Department of Justice, the two companies misled physicians who treated patients with NSCLC with Tarceva between 2006 and 2011.
- The case was brought to the attention of the DOJ in 2011 by whistleblower Brian Shields, formerly a Tarceva senior product manager, at Genentech. His suit alleged use of unethical marketing practices to increase Tarceva prescribing, including kickbacks.
In November 2004, the FDA approved Tarceva for first-line treatment of NSCLC in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.. Almost 10 years later, in May 2013, the FDA approved Tarceva for first-line treatment of metastatic NSCLC.
However, according to the allegations that led to the fine, Genentech (part of Roche) and OSI were engaged in marketing practices that supported use of Tarceva in first-line settings between January 2006 and December 2011 — well before the first-line indication was approved.
The DOJ released a statement in which Deputy Commissioner Howard R. Sklamberg for FDA’s global regulatory operations and policy, said: "Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients at risk. The FDA will continue to work to protect the public's health by ensuring that companies do not mislead healthcare providers about their products."
Genentech maintains its promotional communications around Tarceva were appropriate and not in violation of the False Claims Act. However, the decision to settle will allow the company to avoid a long, drawn-out civil case. The settlement will be split, with the federal government receiving $62.6 million and state Medicaid programs receiving $4.4 million.