Off-Label Marketing Schemes
Back on November 8, 2007, Ed Silverman's Pharmalot reported that Cephalon had struck a deal with the US Attorney in Philadelphia to pay $425 million to settle off-label marketing charges. He noted that the settlement was no surprise because the firm had been under a microscope for off-label marketing for some time and had received an FDA warning letter in February 2007, ordering an end to promotional materials claiming Provigil could be used to treat fatigue.
The underlying lawsuits were filed in 2003, by three former employees, Bruce Boise, Michael Makalusky, and Lucia Paccione, and another whistleblower, Joseph Piacentile, in federal court in the Eastern District of Pennsylvania, under the False Claims Act, arising from false claims submitted to Medicaid, Medicare and other federal insurance programs that do not provide coverage for such off-label uses.
About six months after the settlement became known, on April 30, 2008, Cephalon announced the hiring of Gerald Pappert, former Attorney General of Pennsylvania, as Executive Vice President and General Counsel. Pappert was First Deputy Attorney General from 1997 to 2003 and Attorney General from 2003 to 2005.