Cephalon has finalised an agreement with the US Department of Justice and other federal agencies which will see the firm pay $425 million plus interest to settle criminal and civil charges regarding the off-label promotion of three of its drugs.

The settlement, which was agreed upon in principle last November, covers off-label promotion of its sleep drug Provigil (modafinil), the opioid painkiller Actiq (fentanyl) and the epilepsy treatment Gabitril (tiagabine). From 2001 through at least 2006, Cephalon was allegedly promoting Actiq for non-cancer patients to use for migraines, sickle-cell pain crises, injuries, and in anticipation of changing wound dressings or radiation therapy. The firm also pushed Actiq for use in patients who were not yet opioid-tolerant, and for whom it could have life-threatening.

Over roughly the same period, Cephalon promoted Gabitril as a remedy for anxiety, insomnia, and pain, while Provigil was being sold as a non-stimulant drug for the treatment of sleepiness, tiredness, decreased activity, lack of energy, and fatigue.

The US Department of Justice said that Cephalon “trained its sales force to disregard the restrictions of the US Food and Drug Administration-approved label” and structured its sales quota and bonuses in such a way that reps “could reach their sales goals only if they promoted and sold the drugs for off-label uses”. Acting US Attorney Laurie Magid noted that “these are potentially harmful drugs that were being peddled as if they were, in the case of Actiq, actual lollipops instead of a potent pain medication intended for a specific class of patients”.

Ms Magid claimed that “this company subverted the very process put in place to protect the public from harm, and put patients’ health at risk for nothing more than boosting its bottom line”. She concluded by saying that “people have an absolute right to their doctors’ best medical judgement. They need to know the recommendations a doctor makes are not influenced by sales tactics designed to convince the doctor that the drug being prescribed is safe for uses beyond what the FDA has approved.”

Cephalon has pleaded guilty to a single misdemeanour violation of the US Food, Drug, and Cosmetic Act and will pay $50 million in a plea agreement. Most of that money will be split by “former Cephalon sales representatives “who were disturbed by the company’s off-label marketing practices” and filed whistleblower cases.

A $375 million civil settlement will be split by various state Medicaid programs, the US Medicaid and Medicare Trust Funds and other federal entities. Cephalon will also pay out an extra $12 million in interest and has also settled its two outstanding state government investigations with Connecticut ($6.15 million) and Massachusetts ($700,000).

Cephalon will also enter into a five-year corporate integrity agreement with the Department of Health and Human Services, which requires the drugmaker to disclose payments to physicians on its website starting in 2010. This will be the first time a pharmaceutical firm has been obliged to publicly report payments to doctors as part of such an agreement.