What's the cost of off-label marketing? For Cephalon, it's $425 million and a criminal misdemeanor plea, plus a promise to disclose payments to doctors. With this penalty package, the drugmaker wrapped up its settlement of several long-running state and federal investigations.
As you know, Cephalon had been under scrutiny for promoting its painkiller Actiq, a strong and highly addictive opioid, for migraine relief and other unapproved uses. The narcolepsy pill Provigil had been touted for fatigue, and epilepsy med Gabitril for anxiety, insomnia and pain, prosecutors said. "This company ... put patients at risk for nothing more than the bottom line," Acting U.S. Attorney Laurie Magid said at a news conference announcing the settlement terms.
One of the most interesting provisions of the settlement is the doctor-disclosure requirement. It falls under a five-year integrity agreement, which stipulates that the company must post on its website a database of doctors who speak on behalf of the company or serve as paid consultants. Their payments have to be reported in $10,000 increments. It's set to start by 2010.
- check out Cephalon's release
- read the Justice Department's release
- view the whistle blower's release