The Purdue Frederick Co. and three of its officers entered a plea agreement with the FDA in which the company agreed to pay more than $600 million to resolve criminal charges and civil liabilities over illegal promotion of OxyContin between its 1995 approval and 2001.
According to an FDA news release, an investigation by the Office of Criminal Investigations uncovered “an extensive, long-term conspiracy” by the company “to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes.”
Despite the approved NDA's statements that OxyContin's opioid effects and adverse event profile would be similar to oxycodone, the conspirators began promoting it as less addictive and less likely to cause tolerance, according to a plea agreement.
These efforts included training sales reps to make false claims, disseminating false blood-level graphics showing superiority over immediate-release or short-acting opioids, and publishing false superiority statements in a journal distributed by sales reps.
CEO Michael Friedman, general counsel Howard Udell and medical director Paul Goldenheim, pled guilty to a violation of misbranding OxyContin.