$425 Million Cephalon Civil Settlement and Criminal Fine; In America...( Additionally Cephalon entered a corp...)

Additionally, Cephalon entered a corporate criminal plea and paid a $50 million fine. The criminal case was based upon information provided by relators in the civil case, Kenney noted.

The first drugs on which Cephalon started its business are the three prescription medicines listed in Kenney's client's Complaint, the whistleblower attorney noted. Today, Cephalon's Web site presents nine medications, including those original three: Actiq(R), Gabatril(R), and Provigil(R).

Under FDA rules, prescription drug manufacturers and marketers may only promote their products for approved uses. Physicians are free to prescribe drugs for conditions beyond those for which approval has been received but marketing to induce off-label, unapproved use is not permitted.

Under Medicaid, the state-and-federally underwritten program for low-income and disabled Americans, reimbursement is allowed only for the FDA-approved use of a drug, not for off-label use, Kenney, a former federal prosecutor, explained.

Among many schemes to support off-label marketing alleged in the relators' and Government Complaints are:

-- Intensively marketing Actiq to physical medicine and rehabilitation, and pain management specialists;

-- Encouraging sales reps to make false statements about the efficacy of Gabatril, and providing dosing recommendations when none have been determined for depression;

-- Leaving "huge doses of Gabatril" with psychiatrists when no approved use or dosage existed for psychiatrists;

-- Encouraging sales representatives to recruit psychiatrists by paying the physicians honoraria in return for recommending Gabatril to other psychiatrists; and

-- Assisting physicians in securing Medicaid reimbursement for Actiq when off-label use was ineligible for Medicaid payment.

Federal and state False Claims Acts allow private citizens with knowledge of fraud to help the government recover ill-gotten gains and additional
'/>"/>