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.
Cephalon, which is now part of Teva Pharmaceutical Industries ($TEVA), initiated a compliance program to keep a lid on its promotional practices after a 2007 off-label marketing settlement with the DoJ. The company agreed to pay $425 million to settle a probe into its promotions of wakefulness drug Provigil.
Suggestions that the company was back at its old tricks surfaced in 2011, even as it was in the midst of its buyout deal with Teva. It disclosed then that the DoJ was interested in its Treanda operations but also was checking on what it was up to with Provigil and Nuvigil.
The suit accuses Cephalon of having used "bogus" market surveys and even speakers to promote the drugs. The speaker aspect is interesting given that the earlier settlement forced the company to start disclosing on its website the names of doctors it paid to promote its products.