Contradictory actions on off-label use of prescription drugs? The FDA and CMS versus the U.S. Justice Department.

On January 15, 2009, the U.S. Justice Department posted a notice on its website that Eli Lilly and Company had agreed to pay a criminal fine of $515 million, the largest such fine ever paid in a health care case, to resolve allegations that the company had promoted olanzapine (Zyprexa) for uses not approved by the U.S. Food and Drug Administration (FDA).1 The indications approved by the FDA for olanzapine include (a) schizophrenia, (b) bipolar disorder, and (c) agitation associated with schizophrenia and bipolar I mania.2 In the plea agreement, Eli Lilly admitted that it promoted olanzapine for “off-label” uses such as treatment of dementia. In addition to the $515 million criminal fine, Eli Lilly agreed to forfeit assets of $100 million and to pay up to $800 million to compensate states and the federal government for “false claims” paid by Medicaid, TRICARE, and the Federal Employee Health Benefits Program; drug coverage in these programs is restricted to use for FDA-approved indications. The federal government will receive 55% of the $800 million civil fine, and up to $361 million will be paid to the states that participate in the agreement negotiated by the U.S. Justice Department. The $800 million civil fine resolves 4 qui tam (false claim) motions, all filed by former Lilly sales representatives. Less than 2 weeks later, on January 26, 2009, Pfizer agreed to a settlement for the off-label promotion of valdecoxib (Bextra) that eclipsed the size of previous settlements.3,4 The proposed settlement for $2.3 billion made the $430 million settlement paid by Pfizer in 2004 (on behalf of Warner-Lambert) for the off-label promotion of gabapentin (Neurontin) look small.5 And, there appear to be more settlements in process between pharmaceutical manufacturers and the U.S. Justice Department. In early February 2009, GlaxoSmithKline warned that its earnings in 2008 would be affected by a $400 million legal charge related to the 5-yearold federal investigation into “marketing and promotional practices for several products for the period 1997 to 2004.”6 The notice from the U.S. Department of Justice of the $1.415 billion that Eli Lilly will pay for the off-label promotion of olanzapine included a quote from the Special Agent-in-Charge of the Defense Criminal Investigative Service: “The illegal scheme used by Eli Lilly significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system. This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its partners in law enforcement to investigate and prosecute those that abuse the government’s healthcare proContradictory Actions on Off-Label Use of Prescription Drugs? The FDA and CMS Versus the U.S. Justice Department