The United States Department of Justice has announced the largest health care fraud settlement in U.S. history. Global health care giant GlaxoSmithKline LLC has agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.
The prescription drug manufacturer GlaxoSmithKline plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). The settlement also resolves civil claims relating to Paxil, Wellbutrin, Zofran, and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.
The government alleged that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleged that the drug company:
- participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.
- did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.
- sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents; and
- paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended.
GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.
The United States alleged that, from January 1999 to December 2003, GSK promoted Wellbutrin (approved at that time only for Major Depressive Disorder) for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. The United States contended that the drug manufacturer:
- paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted; and
- used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wellbutrin for these unapproved uses.
GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses.
The United States alleged that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine for its unlawful conduct concerning Avandia.
Civil Settlement Agreement
GSK alos agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Court documents related to the settlement can be viewed online at: www.justice.gov/opa/gsk-docs.html.