Processing Magazine

Cephalon settles improper drug marketing case for $425M

September 29, 2008

Bizjournals reports that Cephalon will pay $425 million to settle charges that it promoted three of its drugs for uses that were not approved by the Food and Drug Administration. U.S. Attorney General Michael Mukasey simultaneously announced the filing of a criminal information against Cephalon and the settlement. His office said Cephalon had also entered into a Corporate Integrity Agreement. Under it, Cephalon must inform doctors of the resolution of the case and report payments to doctors, among other things. Frazer, Pa.-based Cephalon was accused of improperly promoting Actiq, Gabitril and Provigil, and charged with a misdemeanor called “distribution of misbranded drugs, inadequate directions for use.” Actiq is a cancer pain drug in the form of a lollipop. Gabitril is an anti-epilepsy drug, and Provigil is a treatment for excessive sleepiness caused by sleep apnea or shift work sleep disorder. Among the off-label uses the company allegedly promoted Cephalon advanced Actiq for migraines in non-cancer patients, Gabitril for anxiety and Provigil for lack or energy and fatigue. The company will pay the United States $50 million in a plea agreement. Most of that money, $46.5 million, will be split by former Cephalon sales representatives who filed whistleblower cases. A $375 million civil settlement will be split by various state Medicaid programs, the U.S. Medicaid and Medicare Trust Funds and other federal entities. Doctors are permitted to prescribe off-label uses. Drug companies are not permitted to promote them.