Cephalon agreed yesterday to a $444 million settlement with the Department of Justice that will control its marketing of Actiq, Provigil and Gabitril. (Scroll to the bottom of this page if you want to read the prosecutors' documents describing the scale of wrongdoing at the company.)
The company admitted that it promoted Actiq for various types of pain, under the mantra "Pain is pain," even though it was only approved for cancer pain. As for Provigil, the company promoted that drug to combat any kind of sleepiness, and not just diagnosed narcolepsy for which it is approved.
A doctor associated with similar activity was caught by the FDA doing something like this last year.
Which kind of explains why Actiq and Provigil just seemed to be everywhere in the last few years, even though they're supposed to be used only rarely.
It brings to mind a similar agreement signed by Eli Lilly in 2006 over its off-label marketing of Evista. That agreement essentially handled complete oversight of Evista's marketing to prosecutors. It's still in effect.
The Cephalon deal, brought in also for off-label marketing, contains even more strict provisions than the one Lilly signed. The provisions include:
- The deal includes a "corporate integrity agreement" (CIA) which for the next five years covers virtually anyone associated with the marketing of these products.
- Cephalon staff must work under a chief compliance officer who shall use the CIA to create company-wide rules.
- The compliance officer must not be subordinate to the general counsel or the CFO.
- All Cephalon's marketing vendor agencies will be covered by the CIA.
- The company must track and report incoming inquiries about off-label use of products.
- "Any third party activity" must be covered by the CIA.
- This includes payments to doctors.
Cephalon's spin on the matter is here.