Yet another drugmaker finds itself under the U.S. Justice Department microscope. As Pharmalot reports, Cephalon ($CEPH) has received some requests from the feds for documents relating to potential off-label promotion of its leukemia drug Treanda.
The drugmaker received a notice from DoJ about documents related to off-label Treanda use, including as a first-line treatment for non-Hodgkin's lymphoma, sources tell the pharma blog. The feds are also asking for info on particular clinical studies that might have been used to support off-label use before the trials were wrapped or submitted to the FDA. And then there are questions about educational and speaker programs that might have referenced uses not approved by the agency.
Cephalon has indeed been studying Treanda as a lymphoma treatment. For example, a study named Bright was designed to test the drug as a first-line treatment for advanced non-Hodgkin's and mantle cell lymphoma, as Pharmalot notes.
Cephalon is operating under a corporate integrity agreement forged along with a 2007 settlement of a probe into off-label promotion of its wakefulness drug Provigil, Pharmalot reports. That settlement involved a $375 million fine. And as the record-setting, $2.3 billion Pfizer settlement shows, the feds do tend to lean harder on companies that are repeat off-label offenders. Whether the DoJ's fishing expedition will turn up wrongdoing in this case remains to be seen.