Monday, March 25, 2013
Whistleblower says Cephalon ignored DoJ pact to push off-label uses
Drugmakers being accused, sued and abused for pushing drugs for off-label uses is a regular thing in the industry. But the allegations in a recently released lawsuit against Cephalon suggest that company was particularly obscene about pushing off-label uses, because at the time it was operating under a Corporate Integrity Agreement forged after getting caught for similar problems a few years earlier.
The whistleblower lawsuit is from a former employee identified only as John Doe in the litigation, in which the Department of Justice (DoJ) declined to participate. The suit says the essence of Cephalon's scheme was to illegally promote its leukemia treatment Treanda in combination with rituximab for front-line use against indolent non-Hodgkin's lymphoma, a use for which the FDA had not approved it. It alleges Cephalon is also accused of pushing Fentora to pain specialists for non-cancer pain although the drug was approved for only breakthrough cancer pain. The suit was filed in 2010 but just unsealed a few days ago, Pharmalot reports.