The government's investigation began in January 2003, when Bruce Boise, a sales representative in Ohio, contacted the FDA about Cephalon's sales practices. Boise agreed to wear a wire to a company sales conference to help the government gather evidence, according to his attorney, Peter Chatfield, in a September 29, 2008 press release by his firm, Phillips & Cohen. In November 2003, another sales rep, Lucia Paccione of Philadelphia, filed the first lawsuit. The complaints remained sealed until the settlement was announced.
"What makes this case unique is that it's the first time, in the absence of substantial kickbacks, that the federal government has used the False Claims Act to go after a pharmaceutical company for marketing drugs for off-label indications for which there were no credible published scientific research supporting these drugs' safety or effectiveness," Chatfield said. "Not only were these uses marketed by Cephalon not approved by the FDA, there was absolutely no literature published in any medical compendia that supported them."
While federally funded healthcare programs "often will pay for off-label use of drugs supported by credible medical research and prescribed based on the medical judgment of physicians, Cephalon's marketing efforts pushed well beyond those constraints," according to the press release.
From 2001 through 2006, "Cephalon improperly promoted Provigil to treat sleepiness, tiredness, decreased activity, lack of energy and fatigue," the DOJ sentencing memorandum reports.